Pharmacy Information for Providers

The Advanced Health Formulary is a list of medications that are covered for Advanced Health members. Some medications listed on the formulary require a prior authorization to ensure the least costly alternatives for treatment are utilized, and the condition being treated is funded for coverage by Oregon Health Plan.

Any medication may be requested for coverage, regardless of formulary status, through the prior authorization process.

Submission of a prior authorization request is not a guarantee of coverage, as certain requirements and criteria must be met in order for a prior authorization request to be approved.

Any prescription over $500 requires a prior authorization, even if the medication is on the Advanced Health Formulary.

Advanced Health is a mandatory generic plan, therefore, generic medications must be used when commercially available.

Mental Health medications are covered directly by the State Medical Assistance Program (MAP, previously known as the Division of Medical Assistance Programs or DMAP) as part of the mental health (or 7/11) carve-out.

Please contact Advanced Health Customer Service at (541) 269-7400 if you have any questions or need assistance.

For general formulary questions or any other questions, you can also email Advanced Health Pharmacy Department at ahpharmacy@advancedhealth.com. Please do NOT include member PHI.

Mail-Order Medications:

Please contact Postal Prescription Services (PPS) at 800-552-6694 to establish a new member profile. Advanced Health members are enrolled under “Doctors of the Oregon Coast” plan. New member profile and prescription transfer requests may be made by phone. PPS Customer New Prescription Request PPS Mail-Order Quick Reference Guide

DRUG USE CRITERIA AND GUIDELINES

Fee For Service (FFS) Drug Use Criteria will be used for coverage determinations for which Advanced Health drug use criteria is not available.
Click the link below for more information.

https://www.orpdl.org/drugs/

Acute Pain

Click HERE for a printable PDF

Ketorolac
Created: 6/8/17
Reviewed: 5/13/19
Includes:
Toradol© Ketorolac
*This policy applies only to oral ketorolac tablets prescribed for outpatient use. Injectable ketorolac administered at the provider office is not included as part of this drug use criteria for coverage.
GUIDELINE FOR USE:
1. Is the medication being used to treat a funded condition for coverage by Oregon Health Plan?
a. If yes, continue to 2
b. If no, deny as below the line.
2. Is the medication being used to treat kidney stones?
a. If yes, go to 3.
b. If no, deny as nonformulary and recommend use of a formulary NSAID such as ibuprofen, naproxen, diclofenac or meloxicam.
3. Is the dose prescribed less than 40mg/day and duration does not exceed 5 days and no contraindications to therapy exist (see below section on Contraindications)?
a. If yes, approve for 5 days of therapy.
b. If no, deny as not meeting criteria. Off label use of medications is not a covered benefit on OHP.
Rationale:
Due to the high risk of adverse events associated with ketorolac and the availability of safer alternative therapies, ketorolac will only be covered when the above drug use criteria are met. Ketoralac should not be used in pediatric patients less than 17 years of age.
FDA Approved Indication:
Ketorolac is indicated for the short-term (≤ 5 days) management of moderate to severe acute pain requiring analgesia at the opioid level. Oral Ketorolac is only indicated as continuation treatment following IV or mg dosing of Ketorolac, if necessary. The total combined duration of use of Ketorolac tablets and injection should not exceed 5 days. Ketorolac is not indicated for use in pediatric patients
and is not indicated for minor or chronic painful conditions. Increasing the dose of ketorolac beyond labeled recommendations will not provide better efficacy but will increase the risk of developing serious adverse events.
Mechanism of Action:
Ketorolac reversibly inhibits the COX-1 and COX-2 enzymes which results in decreased formation of prostaglandin precursors.
Dosing:
20mg followed by 10mg every 4 to 6 hours as needed; maximum 40mg/day.
Contraindications:
• Hypersensitivity to ketorolac, aspirin, other NSAIDs,
• Active or history of peptic ulcer disease
• Recent or history of GI bleeding or perforation
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
• Advanced renal disease or risk of renal failure (due to volume depletion)
• Prophylactic analgesic before any major surgery
• Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis,
incomplete hemostasis, or high risk of bleeding
• Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
• Epidural or intrathecal administration (injection only)
• Use in the setting of coronary artery bypass graft (CABG)surgery
• Labor and delivery
References:
1. Ketorolac (systemic); Drug Information. UptoDate. Accessed April 18, 2019.
____________________________________________________________________________________________
Approved by WOAH P&T on August 28, 2017; Approved by Advanced Health Pharmacy and Therapeutics
Committee May 13, 2019

Alzheimer’s

Click HERE for a printable PDF

Donepezil Drug Use Criteria
Created: September 2011
Reviewed: 4/22/2019
Includes:
Aricept© Donepezil
GUIDELINE FOR USE:
1. Is the patient being treated for dementia of the Alzheimer’s type?
a. If yes, go to 2
b. If no, deny as not meeting criteria. Donepezil is an FDA approved for treatment of mild,
moderate and severe dementia of the Alzheimer’s type.
2. Is the requested dosing consistent with the FDA approved prescribing information for the patient’s
disease severity?
a. If yes, go to 3
b. If no, deny as not meeting criteria. Off label use of medication is not a covered benefit on OHP.
3. Does the patient have any contraindications to donepezil therapy?
a. If yes, deny as not meeting criteria. Medication should be prescribed consistent with the FDA
package insert.
b. If no, approve for 12 fills.
Rationale:
To promote the use of donepezil for FDA approved indications and dose consistent with the FDA approved
prescribing information.
FDA Approved Indications:
Donepezil is indicated for the treatment of mild, moderate and severe dementia of the Alzheimer’s type.
Mechanism of Action:
Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type.
Dosing:
Mild to moderate Alzheimer’s disease: 5 to 10 mg once daily
Moderate to severe Alzheimer’s disease: 10 to 23 mg once daily
Contraindications:
Known hypersensitivity to donepezil or to piperidine derivatives
References:
1. Aricept© (Donepezil) prescribing information. Revised 12/2018

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/2019

Anaphylaxis

Click HERE for a printable PDF

Injectable Epinephrine Drug Use Criteria

Created: October 2016

Reviewed: April 2019, 12/9/21

Includes:

Adrena-Click Auto-Injector©             Injectable Epinephrine

EpiPen©

Epi Pen Jr©

Auvi-Q©

Symjepi©

Adrenalin©

*Any other injectable epinephrine products

(Highlighted agents are on formulary)

Guideline for Use:

  1. Advanced Health members may fill up to two prescriptions per year of formulary Injectable Epinephrine products. Injectable Epinephrine is commercially packaged to include two injections per box, therefore a total of four injections per year will be allowed without a prior authorization. It is required that least costly alternative formulations be utilized.
  2. If more than two fills of Epinephrine are required for an Advanced Health member within a 12-month period, it will be required that a prior authorization is submitted with a current chart note supporting the patient’s condition has been evaluated by their provider or specialist.
  3. Additional doses will not be approved to allow for Epinephrine to be stored at multiple sites or locations (eg. school, daycare, etc.). The school districts have employees trained to administer Epinephrine on site and stock their own supply of Epinephrine. Items of convenience are not a covered benefit on Oregon Health Plan.
  4. It is encouraged that members are educated either by their provider or pharmacist on proper storage and handling of Epinephrine products and to ensure the expiration date is 12 months or greater prior to accepting the prescription from the pharmacy.
  5. If Epinephrine prescriptions are over $500 AND less than two fills have been dispensed within a 12-month period, the pharmacy will fax the Advanced Health Pharmacy team at (541) 269-7147 and request an over-dollar override. The Pharmacy Specialist will enter the override in MedAccess to allow the claim to process and contact the pharmacy to re-bill the prescription. It will NOT be required that a prior authorization be submitted by the provider to Advanced Health for review in this situation. If a provider receives a fax or call from the pharmacy to have a prior authorization submitted, they may call or fax the Advanced Health pharmacy team at (541) 269-7400 (phone) or (541) 269-7147 (fax) to check if a prior authorization needs to be submitted or check for fill history.

Rationale:

Due to the escalating cost of Injectable Epinephrine preparations and the importance of clinical evaluation and follow-up for anaphylaxis, this drug use criteria will be applied when more than two fills of Epinephrine are required within a 12-month period.

Definitions:

Over-dollar: Any prescription that is over $500 per fill including formulary agents

MedAccess: Advanced Health Pharmacy system utilized to populate overrides and prior authorizations to allow claims to pay

Approved by Advanced Health Pharmacy and Therapeutics Committee on 10/28/16, 4/22/19, 1/7/21

Asthma

Click HERE for printable PDF

Long-Acting Muscarinic Antagonist (LAMA) Drug Use Criteria

Created: 4/5/2021

Reviewed: 4/14/21

Includes:

Spiriva Handihaler©: inhalation capsule 18mcg                                                              tiotropium

Spiriva Respimat©: inhalation aerosol solution 1.25mcg and 2.5mcg/actuation           tiotropium

GUIDELINE FOR USE:

  1. Is the request for a funded condition?
  2. Yes, go to #2.
  3. No, deny as BTL.
  1. Is use an FDA-approved indication?
  2. Yes, go to #3 if diagnosis is COPD.
  3. Yes, go to #5 if diagnosis is asthma.
  4. No, deny as criteria not met.  Off-label use of a medication is not a covered benefit.
  1. Is request for treatment of COPD and has diagnosis been confirmed by history of respiratory symptoms and spirometry?
  2. Yes, go to #4.
  3. No, deny as criteria not met. Please submit spirometry confirming COPD diagnosis.
  1. Has the member had an adequate trial and failure of Incruse Ellipta? (Adequate trial is defined as adherent to therapy for at least 90 consecutive days and documentation of persistent symptoms).
  2. Yes, approve for 12 months.
  3. No, deny as criteria not met. Recommend trial with formulary alternative, Incruse Ellipta.
  1. Is request for treatment of asthma and has diagnosis been confirmed by history of respiratory symptoms and spirometry/Nitric Oxide testing?
  2. Yes, go to #6.
  3. No, deny as criteria not met. Please submit documentation, including respiratory symptoms and spirometry/Nitric Oxide testing, confirming asthma diagnosis OR forward to MD for review.
  1. Is Spiriva Respimat (tiotropium) prescribed as add-on therapy to ICS/LABA?  (Per GINA guidelines, add-on Spiriva Respimat (tiotropium) is supported for members aged 6 years and older whose asthma is not well-controlled with ICS-LABA.  Add-on Spiriva Respimat (5mcg once daily) modestly improves lung function (Evidence A) and modestly increases the time to severe exacerbation requiring oral corticosteroids (Evidence B).  Pulmonology consult is recommended for members aged 6-11 years).
  2. Yes, approve for up to 6 months.
  3. No, deny as criteria not met. Recommend formulary ICS/LABA, but will require PA request.

Renewal Request:

  1. Have symptoms improved and does documentation support continued therapy?
    1. Yes, approve for 12 months for COPD
    2. Yes, approve for up to 6 months for asthma
    3. No, deny as criteria not. Please consider stepping down treatment or alternative treatment options or forward to MD for review.

Rationale:  To ensure medical appropriateness and optimization of less costly formulary alternatives.

FDA Approved Indication:

Asthma (Spiriva Respimat only): Maintenance treatment of asthma in patients ≥6 years.

Chronic obstructive pulmonary disease: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; reduction of COPD exacerbations.

Mechanism of Action:

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Dosing:

Asthma: Oral inhalation: Spiriva Respimat (1.25 mcg/actuation): Soft-mist inhaler: Two inhalations (2.5 mcg) once daily (maximum: 2 inhalations per 24 hours). Note: Maximum benefits may take up to 4 to 8 weeks of dosing. 5 mcg once daily has been recommended for patients with insufficient response to inhaled corticosteroid plus long-acting beta agonist (GINA 2020) with efficacy found in adults with severe asthma (ERS/ATS [Holguin 2019]).

COPD: Oral inhalation:

Spiriva HandiHaler: Dry powder inhaler: Contents of 1 capsule (18 mcg) inhaled once daily

Spiriva Respimat (2.5 mcg/actuation): Soft-mist inhaler: Two inhalations (5 mcg) once daily (maximum: 2 inhalations per 24 hours).

Contraindications:

Hypersensitivity to ipratropium, tiotropium, or any component of the formulation.

References:

Canadian Thoracic Society Clinical Practice Guideline on pharmacotherapy in patients with COPD – 2019 update of evidence.  https://doi.org/10.1080/24745332.2019.1668652

Global Initiative for Asthma (GINA).  https://ginasthma.org/wp-content/uploads/2020/06/GINA-2020-report_20_06_04-1-wms.pdf.

Global Initiative for Chronic Obstructive Lung Disease (GOLD).  https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf

National Institute for Health and Care Excellence (NICE). https://www.nice.org.uk/guidance/ng80/chapter/Recommendations#principles-of-pharmacological-treatment

UpToDate: Tiotropium: Drug information

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/14/21

Click HERE for printable PDF

Non-Preferred Inhaler Drug Use Criteria

Created: May 19, 2021

Reviewed:

Includes:

Non-preferred medication          Generic name                                                   FDA-approved indication

                Advair Diskus© 500/50                  fluticasone/salmeterol                                  asthma and COPD

Advair HFA©                                     fluticasone/salmeterol                                   asthma

Asmanex HFA©                               mometasone                                                     asthma

Asmanex Twisthaler©                  mometasone                                                     asthma

Atectura Breezhaler©                   mometasone/indacaterol                             asthma

Breo Ellipta©                                    fluticasone furoate/vilanterol                     asthma and COPD

Dulera ©                                             mometasone/formoterol                              asthma

Flovent Diskus© 250mcg              fluticasone                                                          asthma

Flovent HFA©                                   fluticasone                                                          asthma

Pulmicort Flexhaler©                    budesonide                                                        asthma

Spiriva©                                              tiotropium                                                          asthma and COPD

Symbicort ©                                      budesonide/formoterol                                 asthma and COPD

Wixela Inhub©                                fluticasone propionate/salmeterol            asthma and COPD

***Preferred inhaled corticosteroids (ICS):

Alvesco© (ciclesonide) FDA approved for asthma in patients aged 12 and up.

Flovent Diskus© (fluticasone) 50mcg and 100mcg. Both are FDA approved for asthma in patients aged 4 and up.

-Qvar FDA approved for asthma in patients aged 4 and up.

***Preferred inhaled corticosteroid/long acting beta agonist (ICS/LABA):

Fluticasone/salmeterol (AirDuo RespiClick©) FDA approved for asthma in patients 12 and up.

Fluticasone/salmeterol (Advair Diskus©) 100mcg/50mcg and 250mcg/50mcg. Both strengths are FDA approved for asthma and COPD in patients aged 4 and up.

***Preferred long acting antimuscarinic (LAMA)

-Incruse Ellipta© FDA approved for COPD in adults 18 years and older.

GUIDELINE FOR USE

Initial request:

  1. Is the medication prescribed for a funded condition?
    1. Yes, go to #2.
    2. No, deny as BTL.
  1. Is the medication prescribed for an FDA-approved indication?
    1. Yes, go to #3.
    2. No, deny as criteria not met. Off-label use of an inhaler is not a covered benefit.
  1. Is request for a non-preferred inhaler for treatment of asthma and has spirometry confirmed diagnosis/assessed severity? (Spirometry must include reversibility test).
    1. Yes, go to #4.
    2. No, deny as criteria not met. Please resubmit PA request with spirometry.
    3. No, go to #5 if diagnosis is COPD.
  1. Has the member had an adequate trial and failure of a preferred inhaler (generic AirDuo Respiclick©, generic Advair Diskus©, Flovent Diskus©, or Alvesco©)? (Adequate trial is defined as adherent to therapy for at least 90 consecutive days and documentation of persistent symptoms).
    1. Yes, and the request is for a low or medium dose ICS or ICS/LABA, approve for up to 6 months.
    2. Yes, and the request is for a high dose ICS alone. If no recent history of exacerbation, recommend change to medium dose ICS/LABA combination. If agreeable to change, approve for up to 6 months. If current or recent history of exacerbation (documentation of hospitalization or oral steroids), approve up to 3 months.
    3. No, deny as criteria not met. Recommend trial of formulary alternative.
  1. Is request for a non-preferred inhaler for treatment of COPD and has spirometry confirmed diagnosis/assessed severity? (Spirometry must include reversibility test).
    1. Yes, go to #6.
    2. No, deny as criteria not met. Please resubmit PA request with spirometry.
  1. Is request for non-preferred ICS/LABA inhaler for treatment of COPD and has documentation included appropriate clinical rationale for use? (Per GOLD guideline, factors to consider when initiating ICS treatment in combination with one or two long-acting bronchodilators: history of hospitalization(s) for exacerbations of COPD OR 2 or more moderate exacerbations of COPD per year despite appropriate long-acting bronchodilator maintenance therapy, blood eosinophils over 300cells/microL, history of, or concomitant asthma. ICS/LABA inhaler could also be considered in members with history of 1 moderate exacerbation of COPD per year despite appropriate long-acting bronchodilator maintenance therapy or blood eosinophils 100-300cells/microL.  GOLD guidelines recommend against use of ICS/LABA inhaler if member has had repeated pneumonia events, blood eosinophils less than 100cells/microL or history of mycobacterial infection.)
    1. Yes, approve for 12 months.
    2. No, deny as criteria not met. Recommend formulary alternative, Incruse or request change to Anoro Ellipta© or submit to MD for review.

Renewal Request:

  1. Has pulmonary condition improved and is there support for continued therapy?
    1. Yes, approve for up to 6 months for treatment of asthma.
    2. Yes, approve for 12 months for treatment of COPD.
    3. No, deny as criteria not. Recommend formulary alternative or forward to MD for review.

Rationale:  To ensure medical appropriateness for use of inhalers and optimization of less costly formulary alternatives.

Please see individual FDA-approved package inserts for prescribing information.

References:

  1. Global Initiative for Asthma (GINA). https://ginasthma.org/wp-content/uploads/2020/06/GINA-2020-report_20_06_04-1-wms.pdf
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf
  3. Alvesco Prescribing Information. Revised 11/2017. https://www.alvesco.us/_resources/100296-Alvesco-PI-Nov%202017.pdf
  4. Flovent Diskus Prescribing Information. Revised 2/2020. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Flovent_Diskus/pdf/FLOVENT-DISKUS-PI-PIL-IFU.PDF
  5. Fluticasone/Salmeterol (AirDuo RespiClick) Prescribing Information. Revised 3/2018. https://www.myairduo.com/globalassets/myairduo/pdf/genericpi.pdf
  6. Fluticasone/Salmeterol (Advair Diskus) Prescribing Information. Revised 8/2020. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Advair_Diskus/pdf/ADVAIR-DISKUS-PI-PIL-IFU.PDF
  7. UpToDate: Drug information: Advair HFA, Wixela Inhub. https://www.uptodate.com/contents/fluticasone-and-salmeterol-drug-information?search=advair&source=panel_search_result&selectedTitle=1~26&usage_type=panel&kp_tab=drug_general&display_rank=1.
  8. Drug information: Atectura Breezhaler. https://www.uptodate.com/contents/search?search=atectura&sp=0&searchType=PLAIN_TEXT&source=USER_INPUT&searchOffset=1&autoComplete=false&language=en&max=10&index=&autoCompleteTerm=
  9. Drug information: Breo Ellipta.

https://www.uptodate.com/contents/search?search=breo%20ellipta&sp=0&searchType=PLAIN_TEXT&source=USER_INPUT&searchOffset=1&autoComplete=true&language=en&max=10&index=0~6&autoCompleteTerm=breo%20

  1. Drug information: Dulera.

https://www.uptodate.com/contents/mometasone-and-formoterol-drug-information?search=dulera&source=panel_search_result&selectedTitle=1~11&usage_type=panel&kp_tab=drug_general&display_rank=1.

  1. Drug information: Symbicort. https://www.uptodate.com/contents/search?search=symbicort&sp=0&searchType=PLAIN_TEXT&source=USER_INPUT&searchOffset=1&autoComplete=false&language=en&max=10&index=&autoCompleteTerm=

Approved by Advanced Health Pharmacy and Therapeutics Committee 10/13/2021

Attention Deficit/Hyperactivity Disorders (ADHD)

Click HERE for printable PDF

Long-Acting Stimulant Criteria for patients 6-22 years old

Created: 7/2013

Reviewed: 5/2019, 12/2021, 1/2022

Includes:

Adderall XR©                                                 amphetamine/dextroamphetamine

Focalin XR ©                                                   dexymethylphenidate

Dexedrine ER©                                               dextroamphetamine

Vyvanse©                                                       lisdexamfetamine

Ritalin LA©                                                     methylphenidate LA

Methylin ER©/Ritalin SR©/Metadate ER© methylphenidate

Metadate CD©                                               methylphenidate

*Includes any other non-formulary extended-release stimulants not listed

GUIDELINE FOR USE:

Initial Request:

  1. Is the patient being treated for attention deficit disorders with or without hyperactivity?
    1. If yes, go to 2
    2. If no, deny as below the line.
  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, go to 2
    2. If no, deny as not meeting criteria. Off label use of medication is not a covered benefit on OHP.
  1. Has the patient failed therapy with the formulary agent, methylphenidate extended-release tablets (generic Methylin ER, Ritalin SR, Metadate ER)? Trial defined as at least 2 weeks of therapy at optimal dosing.
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, go to 4.

 

  1. Is the patient unable to swallow tablets?
    1. If yes, approve for requested duration of therapy up to 12 months for a product that is able to be sprinkled.
    2. If no, go to 5
  1. Has the patient experienced adverse side effects to methylphenidate therapy (e.g. appetite suppression and/or weight loss, mood changes, tics, insomnia).
    1. If yes, Approve for requested duration of therapy up to 12 months.
    2. If no, go to 6
  1. Is the patient in a residential treatment program, or a patient of the CDRC, and is stable on a non-formulary agent?
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, go to 7
  1. Has the patient been stable on therapy greater than 2 years?
    1. If yes, approve as an exception for 12 months.
    2. If no, go to 8
  1. Has the provider documented that the Prescription Drug Monitoring Program (PDMP) has been queried?
    1. If yes, go to 9
    2. If no, request attestation that PDMP has been checked. If no attestation is available, deny as not meeting criteria. Attestation of PDMP check is required for coverage of C2 medications.
  1. Is the patient new on Advanced Health and therapy is already established with a non-formulary agent?
    1. If yes, approve as an exception for 3 months with coordination of care with new PCP to trial methylphenidate ER tablets.
    2. If no, deny as non-formulary and request trial of formulary alternative.
Brand Name

(Generic Name)

FDA Approved Indication Maximum Daily Dose

Adult/Pediatric

Duration of Action
Adderall XR Capsule

(amphetamine/dextroamphetamine)

ADHD ADHD (≥6yo) 30mg/day 10 hours
Focalin XR Tablet

(dexmethylphenidate)

ADHD Adult 40mg/day

Pediatric 30mg/day

8 to 12 hours
Dexedrine ER Spansule

(dextroamphetamine)

ADHD, narcolepsy 40mg/day 6 to 8 hours
Vyvanse Capsule

(lisdexamfetamine)

ADHD 70mg/day 10 to 12 hours (up to 14 hrs in adults)
Ritalin LA Capsule

(methylphenidate LA)

ADHD, narcolepsy 60mg/day 6 to 9 hours
Methylin ER/ Ritalin SR/

 Metadate ER TABLET

(methylphenidate)

ADHD, narcolepsy 60mg/day 2 to 8 hours (dose QD or BID)
Metadate CD Capsule

(methylphenidate)

ADHD, narcolepsy 60mg/day 6 to 9 hours

Rationale:

To promote use of the least costly extended-release stimulant, methylphenidate extended release tablets, for management of ADHD in children and adolescents aged 6 to 22 years of age. To ensure dosing consistent with the FDA approved prescribing information.

References:

  1. Adderall XR Prescribing Information. Revised October 2021. Accessed December 20, 2021.
  2. Focalin XR Prescribing Information. Revised June 2021. Accessed December 20, 2021.
  3. Dexedrine Prescribing Information. Revised October 2020. Accessed December 20, 2021.
  4. Vyvanse Prescribing Information. Revised July 2021. Accessed December 20, 2021.
  5. Ritalin LA Prescribing Information. Revised June 2021. Accessed December 20, 2021.
  6. Metadate CD Prescribing Information. Reference ID 3303893. Accessed December 20, 2021.
  7. Ritalin SR Prescribing Information. Revised January 2019. Accessed December 20, 2021.
  8. OAR 410-141-3855(15)
  9. 42 USC 1396w-3a

Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 1/7/21

Approved by Advanced Health Pharmacy and Therapeutics Committee on 5/13/19, 2/9/22

Click HERE for printable PDF

Short Acting Stimulant Drug Use Criteria for Adult Advanced Health Members ≥ 23 Years of Age

 

Created: 10/2015

Revised: 8/2018, 6/2019, 12/2021

 

Includes:

Adderall©                   amphetamine/dextroamphetamine

            Focalin ©                     dexmethylphenidate

Dexedrine©                dextroamphetamine

Ritalin©                      methylphenidate

GUIDELINE FOR USE:

Initial Request:

  1. Is the patient being treated for a funded condition by Oregon Health Plan?
    1. If yes, go to 2
    2. If no, deny as Below the Line. The condition being treated is below the funded line for Oregon Health Plan and is therefore not a covered benefit.
  1. Is the patient being treated for attention deficit disorder with or without hyperactivity or narcolepsy?
    1. If ADHD, go to 3
    2. If narcolepsy, go to 5
    3. If no, deny as Criteria Not Met. Stimulant therapy will be provided as a covered benefit for FDA approved indications supported by the medication package insert. Off label use of medication is not a covered benefit on Oregon Health Plan.

 

  1. Has the patient been evaluated and diagnosed with ADHD with or without hyperactivity and have co-morbid conditions that may contribute to ADHD symptoms been addressed (eg depression, anxiety, etc). Please provide documentation of assessment such as Adult ADHD Self-Report Scale (ASRS v1.1), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), clinical and historical interview. Demonstrated impairments should be present across multiple environmental domains (school, work, home, etc) and they should have been present since childhood/adolescence.
    1. If yes, go to 4
    2. If no, deny as Criteria Not Met. An evaluation and diagnosis of ADHD is required for coverage of stimulant therapy, including co-morbid conditions that may contribute to ADHD symptoms be addressed. Please submit documentation such as ASRS, PHQ-9, GAD-7, clinical and historical interview.
  1. Does the patient have a continued need for focus including school, work, or volunteer activities?
    1. If yes, go to 5
    2. If no, deny as Criteria Not Met. Patients should have a documented need for focus for coverage of stimulant therapy.

 

  1. Does the patient have a history of substance abuse?
    1. If yes, deny as Criteria Not Met. Schedule II stimulant medications have a high potential for abuse, misuse, and diversion. Use of stimulants are contraindicated in patients with a history of drug abuse. Consider therapy with a tricyclic antidepressant (desipramine or nortriptyline) or atomoxetine (Strattera). Buproprion is also an alternative if patients do not tolerate TCA therapy.
    2. If no, go to 6
  1. Is the patient using any other medications that have a potential for causing sedation or lack of focus? (e.g. opioid pain medications, marijuana, alcohol, benzodiazepines, etc). Urine drug screen should be provided that is negative for illicit substances.
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not indicated for treatment of sedation, fatigue, or lack of focus due to side effects of concomitant therapies.
    2. If no, go to 7

 

  1. Does the patient have blood pressure that is currently well controlled? (Chart notes documenting blood pressure will be required, and readings greater than 140/90 will not be approved for stimulant therapy)
    1. If yes, go to 8
    2. If no, deny as Criteria Not Met. Elevated blood pressure and heart rate are common side effects of stimulant therapy. Moderate to severe hypertension are contraindications to stimulant therapy. Consider therapy with clonidine for patients with ADHD and hypertension.

 

  1. Does the patient have preexisting structural cardiac abnormalities or other serious cardiac problems?
    1. If yes, deny as Criteria Not Met. Use of stimulant therapy has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems. Stimulants should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that can increase the risk of sudden death.
    2. If no, go to 9
  1. Does the patient have obstructive sleep apnea (OSA)?
    1. If no, go to 10
    2. If yes, is OSA managed with continuous positive airway pressure therapy (CPAP) or alternative therapies such as oral appliances?
      1. If yes, go to 10
      2. If no, deny as Criteria not Met. Untreated OSA is associated with poor concentration, excessive daytime sleepiness, and fatigue, which may impair daily function or induce/exacerbate cognitive deficits. OSA should be adequately controlled prior to initiating treatment with stimulants.

 

  1. Does the patient have bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, narrow angle or angle closure glaucoma, or hyperthyroidism?
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not recommended in patients with bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, glaucoma, or hyperthyroidism.

Note to reviewer: TCAs have been shown to be efficacious in adult ADHD.  TCAs have also been shown in clinical trials to reduce anxiety in patients with ADHD and comorbid anxiety.  Stimulants may exacerbate symptoms of behavior and thought disorder.  Stimulants may induce mixed/manic episodes in patients with bipolar disorder.  New onset psychosis or mania may also occur with stimulant use

  1. If no, go to 11
  1. Is the patient taking a MAO inhibitor, or quit taking a MAO inhibitor within 14 days of starting stimulant therapy? (e.g. isocarboxazid, phenelzine, tranylcypromine, or selegeline)
    1. If yes, deny as Criteria Not Met. Concomitant use of stimulants and MAO inhibitor therapy, or discontinuation within 14 days, is contraindicated due to increased risk of hypertensive crisis.
    2. If no, go to 12
  1. Has the provider documented that the Prescription Drug Monitoring Program (PDMP) has been queried?
    1. If yes, go to 13
    2. If no, request attestation that PDMP has been checked. If no attestation is available, deny as not meeting criteria. Attestation of PDMP check is required for coverage of C2 medications.

 

  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, approve for the requested duration of therapy up to 12 months
    2. If no, deny as Criteria Not Met. Doses above those supported by the FDA approved package insert are not a covered benefit on Oregon Health Plan.

 

 

Renewal Request:

  1. Does the above criteria continue to be met and do chart notes support positive response to therapy?
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, deny as not meeting criteria.

Rationale:

Stimulants used for the treatment of narcolepsy and attention deficit disorder with or without hyperactivity have a high propensity for abuse and diversion. Drug shortages of several stimulant medications have resulted in price increases for this class of drugs. Therefore, drug use criteria for stimulant therapy in adults is necessary to ensure appropriate patient selection, safety, and cost-effective management of ADHD and narcolepsy. Stimulant medications will not be approved for conditions not funded for coverage by Oregon Health Plan. Long acting stimulants will not be approved for members 23 years of age or older as they do not meet the least costly alternative rule for Oregon Health Plan. Short acting stimulants will be a plan benefit if the above drug use criteria are met.

FDA Approved Indication and Dosing:

Drug FDA Approved Indication Maximum Daily Dose

Adult/Pediatric

Duration of Action
amphetamine/dextroamphetamine

(mixed amphetamine salts)

ADHD, narcolepsy ADHD (≥6yo) 40mg/day

Narcolepsy 60mg/day

5 to 8 hours (duration increases with increased dose)
Dexmethylphenidate ADHD 20mg/day 4 to 5 hours
Dextroamphetamine ADHD, narcolepsy 40mg/day 4 to 6 hours
Methylphenidate ADHD, narcolepsy 60mg/day

Peds: NTE 2mg/kg/day

3 to 5 hours

Accepted Symptom Checklists and Questionnaire Links:

  • Adult ADHD Self-Report Scale (ASRS v1.1): http://www.mentalhealthprofessionalsinc.com/Forms/Adult_ADHD_Self-Report_Scale_(ASRS-v1.1).pdf
  • Patient Health Questionnaire (PHQ-9): http://www.agencymeddirectors.wa.gov/Files/AssessmentTools/13-PHQ-9%20form.pdf
  • Generalized Anxiety Disorder 7-item (GAD-7):

https://med.dartmouth-hitchcock.org/documents/GAD-7-anxiety-screen.pdf

References:

  1. Brent MD, David, Bukstein MD, Oscar, Solanto PhD, Mary. Treatment of attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  2. Bukstein MD, Oscar. Attention deficit hyperactivity disorder in adults: Epidemiology, pathogenesis, clinical features, course, assessment, and diagnosis. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  3. Bukstein MD, Oscar. Pharmacotherapies for attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  4. Clinical Resource, Comparison of ADHD Medications. Pharmacist’s Letter/Prescriber’s Letter. September 2021. Accessed December 20, 2021.
  5. Ritalin Prescribing Information. Novartis Pharmaceuticals Corporation. Revised 6/2021.
  6. Micromedix Healthcare Series Database 2.0. DrugDex Evaluation: Methylphenidate.
  7. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine.
  8. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dexmethylphenidate.
  9. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine/Amphetamine.
  10. Adderall Prescribing Information. Shire Pharmaceuticals. Reference ID: 4036383. Revised date January 2017. Accessed December 20, 2021.
  11. Dexedrine Prescribing Information. GlaxoSmithKline. Revised date February 2018. Accessed December 20, 2021.
  12. Kline MD, Lewi. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Literature review current Nov 2021. Accessed December 20, 2021.
  13. Kryger MD FRCPS, Meir H, Malhotra MD, Atul. Management of obstructive sleep apnea in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  14. OAR 410-141-3855(15)
  15. 42 USC 1396w-3a

Approved by Managed Care Committee 4/27/12

Approved by WOAH Pharmacy and Therapeutics Committee 10/26/15

Approved by Advanced Health Pharmacy and Therapeutics Committee 8/27/18, 6/17/19, 1/7/21, 2/9/22

Click HERE for printable PDF

Stimulant Drug Use Criteria for Adult Advanced Health Members ≥ 23 Years of Age

Created: 10/2015

Revised: 8/2018, 6/2019, 12/2021, 2/2022, 5/2022

Includes (long-acting and short-acting versions):

Adderall©                   amphetamine/dextroamphetamine

            Focalin ©                     dexmethylphenidate

Dexedrine©                dextroamphetamine

Ritalin©                      methylphenidate

GUIDELINE FOR USE:

Initial Request:

  1. Is the patient being treated for a funded condition by Oregon Health Plan?
    1. If yes, go to 2
    2. If no, deny as Below the Line. The condition being treated is below the funded line for Oregon Health Plan and is therefore not a covered benefit.
  1. Is the patient being treated for attention deficit disorder with or without hyperactivity or narcolepsy?
    1. If ADHD, go to 3
    2. If narcolepsy, go to 4
    3. If no, deny as Criteria Not Met. Stimulant therapy will be provided as a covered benefit for FDA approved indications supported by the medication package insert. Off label use of medication is not a covered benefit on Oregon Health Plan.

 

  1. Has the patient been evaluated and diagnosed with ADHD with or without hyperactivity and have co-morbid conditions that may contribute to ADHD symptoms been addressed (eg depression, anxiety, etc). Please provide documentation of assessment such as Adult ADHD Self-Report Scale (ASRS v1.1), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), clinical and historical interview. Demonstrated impairments should be present across multiple environmental domains (school, work, home, etc).
    1. If yes, go to 4
    2. If no, deny as Criteria Not Met. An evaluation and diagnosis of ADHD is required for coverage of stimulant therapy, including co-morbid conditions that may contribute to ADHD symptoms be addressed. Please submit documentation such as ASRS, PHQ-9, GAD-7, clinical and historical interview.

 

4    Does the patient have a history of substance abuse?

  1. If yes, deny as Criteria Not Met. Schedule II stimulant medications have a high potential for abuse, misuse, and diversion. Use of stimulants are contraindicated in patients with a history of drug abuse. Consider therapy with a tricyclic antidepressant (desipramine or nortriptyline) or atomoxetine (Strattera). Bupropion is also an alternative if patients do not tolerate TCA therapy. Or provide clinical rationale to prescribing stimulant therapy to patient with history of substance abuse.
  2. If no, go to 5
  1. Is the patient using any other medications that have a potential for causing sedation (e.g. opioid pain medications, heavy alcohol use (SBRT), benzodiazepines, etc). Attestation of PDMP check is required.
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not indicated for treatment of sedation or fatigue due to side effects of concomitant therapies.
    2. If no, continue to 6

 

  1. Has provider considered marijuana use as a contributing factor for sedation? Clinical rationale- please address reason for marijuana use and effect on ADLs.
    1. If yes, continue to 7
    2. If no, please submit clinical rationale of using a stimulant with a substance that causes sedation.

 

  1. Does the patient have blood pressure that is currently well controlled? (Chart notes documenting blood pressure will be required)
    1. If yes, go to 8
    2. If no, deny as Criteria Not Met. Elevated blood pressure and heart rate are common side effects of stimulant therapy. Moderate to severe hypertension are contraindications to stimulant therapy. Consider therapy with clonidine for patients with ADHD and hypertension.

 

  1. Does the patient have preexisting structural cardiac abnormalities or other serious cardiac problems?
    1. If yes, deny as Criteria Not Met. Use of stimulant therapy has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems. Stimulants should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that can increase the risk of sudden death.
    2. If no, go to 9
  1. Does the patient have obstructive sleep apnea (OSA)?
    1. If no, go to 10
    2. If yes, is OSA managed with continuous positive airway pressure therapy (CPAP) or alternative therapies such as oral appliances?
      1. If yes, go to 10
      2. If no, deny as Criteria not Met. Untreated OSA is associated with poor concentration, excessive daytime sleepiness, and fatigue, which may impair daily function or induce/exacerbate cognitive deficits. OSA should be adequately controlled prior to initiating treatment with stimulants.

 

  1. Does the patient have bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, narrow angle or angle closure glaucoma, or hyperthyroidism? Or is there clinical rationale to prescribing a stimulant without treating comorbid conditions.
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not recommended in patients with bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, glaucoma, or hyperthyroidism.

Note to reviewer: TCAs have been shown to be efficacious in adult ADHD.  TCAs have also been shown in clinical trials to reduce anxiety in patients with ADHD and comorbid anxiety.  Stimulants may exacerbate symptoms of behavior and thought disorder.  Stimulants may induce mixed/manic episodes in patients with bipolar disorder.  New onset psychosis or mania may also occur with stimulant use

SSRI/SNRI first, then add stimulant for anxiety (look at manufacturer labeling)

  1. If no, go to 11
  1. Is the patient taking a MAO inhibitor, or quit taking a MAO inhibitor within 14 days of starting stimulant therapy? (e.g. isocarboxazid, phenelzine, tranylcypromine, or selegeline)
    1. If yes, deny as Criteria Not Met. Concomitant use of stimulants and MAO inhibitor therapy, or discontinuation within 14 days, is contraindicated due to increased risk of hypertensive crisis.
    2. If no, go to 12

 

  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, approve for the requested duration of therapy up to 12 months
    2. If no, deny as Criteria Not Met. Doses above those supported by the FDA approved package insert are not a covered benefit on Oregon Health Plan.

 

 

Renewal Request:

  1. Does the above criteria continue to be met and do chart notes support positive response to therapy?
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, deny as not meeting criteria.

Rationale:

Stimulants used for the treatment of narcolepsy and attention deficit disorder with or without hyperactivity have a high propensity for abuse and diversion. Drug shortages of several stimulant medications have resulted in price increases for this class of drugs. Therefore, drug use criteria for stimulant therapy in adults is necessary to ensure appropriate patient selection, safety, and cost-effective management of ADHD and narcolepsy. Stimulant medications will not be approved for conditions not funded for coverage by Oregon Health Plan.

FDA Approved Indication and Dosing:

Drug FDA Approved Indication Maximum Daily Dose

Adult/Pediatric

Duration of Action
amphetamine/dextroamphetamine

(mixed amphetamine salts)

ADHD, narcolepsy ADHD (≥6yo) 40mg/day

Narcolepsy 60mg/day

5 to 8 hours (duration increases with increased dose)
Dexmethylphenidate ADHD 20mg/day 4 to 5 hours
Dextroamphetamine ADHD, narcolepsy 40mg/day 4 to 6 hours
Methylphenidate ADHD, narcolepsy 60mg/day

Peds: NTE 2mg/kg/day

3 to 5 hours

Accepted Symptom Checklists and Questionnaire Links:

  • Adult ADHD Self-Report Scale (ASRS v1.1): http://www.mentalhealthprofessionalsinc.com/Forms/Adult_ADHD_Self-Report_Scale_(ASRS-v1.1).pdf
  • Patient Health Questionnaire (PHQ-9): http://www.agencymeddirectors.wa.gov/Files/AssessmentTools/13-PHQ-9%20form.pdf
  • Generalized Anxiety Disorder 7-item (GAD-7):

https://med.dartmouth-hitchcock.org/documents/GAD-7-anxiety-screen.pdf

References:

  1. Brent MD, David, Bukstein MD, Oscar, Solanto PhD, Mary. Treatment of attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  2. Bukstein MD, Oscar. Attention deficit hyperactivity disorder in adults: Epidemiology, pathogenesis, clinical features, course, assessment, and diagnosis. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  3. Bukstein MD, Oscar. Pharmacotherapies for attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  4. Clinical Resource, Comparison of ADHD Medications. Pharmacist’s Letter/Prescriber’s Letter. September 2021. Accessed December 20, 2021.
  5. Ritalin Prescribing Information. Novartis Pharmaceuticals Corporation. Revised 6/2021.
  6. Micromedix Healthcare Series Database 2.0. DrugDex Evaluation: Methylphenidate.
  7. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine.
  8. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dexmethylphenidate.
  9. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine/Amphetamine.
  10. Adderall Prescribing Information. Shire Pharmaceuticals. Reference ID: 4036383. Revised date January 2017. Accessed December 20, 2021.
  11. Dexedrine Prescribing Information. GlaxoSmithKline. Revised date February 2018. Accessed December 20, 2021.
  12. Kline MD, Lewi. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Literature review current Nov 2021. Accessed December 20, 2021.
  13. Kryger MD FRCPS, Meir H, Malhotra MD, Atul. Management of obstructive sleep apnea in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  14. OAR 410-141-3855(15)
  15. 42 USC 1396w-3a

Approved by Managed Care Committee 4/27/12

Approved by WOAH Pharmacy and Therapeutics Committee 10/26/15

Approved by Advanced Health Pharmacy and Therapeutics Committee 8/27/18, 6/17/19, 1/7/21, 2/9/22, 6/8/22

GUIDELINE NOTE 20, ATTENTION DEFICIT/HYPERACTIVITY DISORDERS IN CHILDREN

Line 121

Use of ICD-10-CM F90.9, Attention deficit/hyperactivity disorder, unspecified type, in children age 5 and under, is appropriate only when the following apply:

  • Child does not meet the full criteria for the full diagnosis because of their age.
  • For children age 3 and under, when the child exhibits functional impairment due to hyperactivity that is clearly in excess of the normal activity range for age (confirmed by the evaluating clinician’s observation, not only the parent/caregiver report), and when the child is very limited in his/her ability to have the sustained periods of calm, focused activity which would be expected for the child’s age.

For children age 5 and under diagnosed with disruptive behavior disorders, including those at risk for ADHD, first line therapy is evidence-based, structured “parent-behavior training. Second line therapy is pharmacotherapy.

For children age 6 and over who are diagnosed with ADHD, pharmacotherapy alone or pharmacotherapy with psychosocial/behavioral treatment are included on this line for first line therapy.

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx

Atrial Fibrillation

Click HERE for a printable PDF

Direct Oral Anticoagulants Drug Use Criteria

Created: October 2016

Reviewed: 4/22/19, 12/9/21

Includes:

Xarelto©        Rivaroxaban

Pradaxa©       Dabigatran

Eliquis©          Apixaban

Savaysa©       Edoxaban

This drug use criteria will be used to determine ongoing coverage of the direct oral anticoagulants following the initial three months of therapy allowed through the Advanced Health formulary.

Guideline for Use:

  1. Does the member have an OHP funded condition?
    1. If yes, continue to question 2.
    2. If no, deny as BTL.
  1. Does the member have a diagnosis for any of the recommended FDA approved indications (DVT or PE treatment, secondary prevention of recurrent DVT or PE, prophylaxis of DVT in knee or hip replacement surgery, or prevention of stroke or systemic embolism in nonvalvular atrial fibrillation), AND is the appropriate dose of medication being prescribed consistent with the FDA approved prescribing information?
    1. If yes, continue to question 3
    2. If no, deny as not meeting criteria. Use of medications for off label indications is considered experimental and not a covered benefit on OHP.

**Note to reviewer: Please coordinate with prescriber prior to denying authorization request for inappropriate dosing to change to FDA approved dosing regimen.

Indications and Dosing

Xarelto© Pradaxa© Eliquis© Savaysa©
Deep vein thrombosis (DVT) or pulmonary embolism (PE) treatment 15 mg twice daily for 21 days followed by 20 mg once daily 150 mg twice daily following 5-10 days of parenteral anticoagulation 10 mg twice daily for 7 days followed by 5 mg twice daily 60 mg once daily following 5-10 days of parenteral anticoagulation
Reduction in risk of recurrent DVT/PE 10 mg once daily after initial 6 months of therapy 150 mg twice daily 2.5 mg twice daily after initial 6 months of therapy Not indicated
Nonvalvular atrial fibrillation 20 mg once daily 150 mg twice daily 5 mg twice daily 60 mg once daily
Postoperative DVT prophylaxis (hip and knee replacement surgery) 10 mg once daily

· Knee: 12 days

· Hip: 35 days

110 mg on day 1 then 220 mg once daily (hip replacement only)

· Minimum:10 days

· Maximum: 35 days

Not indicated for knee replacement

2.5 mg twice daily

· Knee: 12 days

· Hip: 35 days

Not indicated
Prophylaxis of VTE in acutely ill patients (not at high risk of bleeding) 10mg once daily

• Total recommended duration of 31 to 39 days

 
Peripheral artery disease, stable or Coronary artery disease, stable 2.5 mg twice daily in combination with 75-100 mg aspirin daily  

Duration of therapy

Provoked DVT/PE

· Surgery

· Nonsurgical transient risk factors: estrogen therapy, pregnancy, leg injury, flight >8h

· 3 months
Unprovoked DVT/PE · Low to moderate bleeding risk: extended               anticoagulation therapy (no stop date)

· High bleeding risk: 3 months

VTE associated with cancer: LMWH is the preferred agent over VKA, Pradaxa, Xarelto, Eliquis, or Savaysa · Extended anticoagulation therapy (no stop date)
  1. Does the member have any conditions in which the DOACs are not recommended or contraindicated? See chart below.
    1. If yes, deny as not meeting criteria. Warfarin or LMWH are alternatives
    2. If no, approve for appropriate duration of therapy for FDA approved indication medication is prescribed to treat.
Xarelto© Pradaxa© Eliquis© Savaysa©
Contraindication -Active bleeding -Active bleeding

-Mechanical prosthetic heart valve

-Active bleeding -Active bleeding
Use not recommended -Age <18-year-old -Prosthetic heart valves -Severe renal impairment (CrCl <15 ml/min) -Hepatic impairment (Child-Pugh B and C) -Hepatic disease associated with coagulopathy -Pregnancy -Nursing mothers -Prosthetic heart valves -Triple positive antiphospholipid syndrome -Bioprosthetic heart valve

-Severe renal impairment (CrCl <15 ml/min) -Pregnancy -Nursing mothers

-Age <18 years old -Prosthetic heart valve -Nursing mothers -Pregnancy -Severe hepatic impairment (Child-Pugh C) -Severe renal impairment (CrCl <15 ml/min) -Age <18 years old -Mechanical heart valve -Moderate to severe mitral stenosis -CrCl >95 ml/min (nonvalvular atrial fibrillation)

-Nursing mothers

-Moderate to severe hepatic impairment (Child-Pugh B and C)

Drug-Drug Interactions -Anticoagulants

-Combined P-gp and strong CYP3A4 inhibitors and inducers

-Anticoagulants

-Rifampin

-P-gp inducers

-Anticoagulants

-Combined strong CYP3A4 and P-gp inhibitors and inducers

-Anticoagulants

-Rifampin

*Example of potential drug-drug interactions:

-Strong CYP3A4 and P-gp Inducers: carbamazepine, phenytoin, rifampin, St. John’s wort

-Strong CYP3A4 and P-gp Inhibitors: cobicistat, conivaptan, danoprevir/ritonavir, elvitegravir/ritonavir, ketoconazole, clarithromycin, diltiazem, quinidine, tacrolimus, grapefruit juice

*Note: The International society on Thrombosis and Haemostatis (ISTH) 2016 guideline suggests avoiding the use of DOACs in patients with BMI >40 kg/m2 or weight >120 kg due to lack of clinical data in this population. If used in patients with BMI >40 kg/m2 or weight >120 kg, ISTH suggests measuring peak and trough levels using an anti-factor Xa assay or mass spectrometry. If drug level is below expected range, ISTH recommends changing to Vitamin K antagonist. Advanced Health will not restrict access to DOAC medication based on BMI or weight, however, a note will be sent to the requesting provider alerting them to the lack of clinical data in this population.

Dosing Adjustments

Xarelto© Pradaxa© Eliquis© Savaysa©
DVT or PE treatment 30 mg once daily (CrCl 15 to 50 ml/min or body weight ≤60 kg)
Reduction in risk of recurrent DVT/PE 15 mg once daily (CrCl 15 to 50 ml/min)
Nonvalvular atrial fibrillation 15 mg once daily (CrCl 15 to 50 ml/min) 75 mg twice daily (CrCL 15-30 ml/min) 2.5 mg twice daily (2 or more of the following: age ≥80, weight ≤60 kg, or serum creatinine ≥1.5 mg/dl) 30 mg once daily (CrCl 15 to 50 ml/min)

Rationale:

Due to high cost of therapy and potential for serious adverse events, drug use criteria help to promote safe, evidence-based prescribing of the direct oral anticoagulants.

FDA Approved Indications:

Xarelto© (rivaroxaban) is FDA indicated for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), reduction in the risk of recurrence of DVT and PE, reduction of risk of stroke and systemic embolism in patient with nonvalvular atrial fibrillation, and prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients, and to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease  (CAD) or peripheral artery disease (PAD).

Savaysa© (edoxaban) if FDA indicated for reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and the treatment of DVT and PE following 5-10 days of initial therapy with a parenteral anticoagulant.

Pradaxa© (dabigatran) is FDA indicated in adults for the reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of DVT and PE following 5-10 days of initial therapy with a parenteral anticoagulant, reduction in the risk of recurrence of DVT and PE, and DVT and PE prophylaxis in patients that have undergone hip replacement surgery. Pradaxa© is FDA indicated in pediatric patients 8 to less than 18 years of age for the treatment of venous thromboembolic events who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE.

Eliquis© (apixaban) is FDA indicated for reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery, treatment of DVT and PE, and reduction in the risk of recurrent DVT and PE.

References:

  1. Xarelto© Prescribing Information. Last updated 8/2021
  2. Savaysa© Prescribing Information. Last updated 9/2016
  3. Pradaxa© Prescribing Information. Last updated 6/2021
  4. Eliquis© Prescribing Information. Last updates 7/2016
  5. Kearin C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. CHEST 2016; 149(2):315-352
  6. International Society on Thrombosis Haemostasis (ISTH) 2016 Guideline

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/19, 1/7/21

Autoimmune Diseases

Click HERE for a printable PDF

Biologics for Autoimmune Diseases Drug Use Criteria

Created: February 2019, Reviewed: October 2020, August 2021

Includes:

Orencia©                                            Abatacept

Humira©                                            Adalimumab

Kineret©                                            Anakinra

Otezla©                                              Apremilast

Olumiant©                                         Baricitinib

Siliq©                                                  Brodalumab

Ilaris©                                                 Canakinumab

Cimzia©                                              Certolizumab

Enbrel© and biosimilars                    Etanercept

Simponi© and Simponi Aria©          Golimumab

Tremfya©                                           Guselkumab

Remicade© and biosimilars              Infliximab       

Taltz©                                                 Ixekizumab

Skyrizi ©                                             Risankizumab-rzaa

Rituxan© and biosimilars                  Rituximab

Kevzara©                                            Sarilumab

Cosentyx©                                         Secukinumab

Ilumya©                                             Tildrakizumab-asmn

Actemra©                                          Tocilizumab

Xeljanz ©                                             Tofacitinib

Rinvoq©                                             Upadacitinib

Stelara©                                             Ustekinumab

Entyvio©                                            Vedolizumab

GUIDELINE FOR USE:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria at:

https://www.orpdl.org/durm/PA_Docs/biologicsforautoimmunediseases.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medication based on the best available evidence.

References:

1)  Oregon Medicaid FFS Drug Use Criteria. Biologics for Autoimmune Diseases. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health P&T Committee 2/18/19, 10/21/2020, 10/13/2021

GUIDELINE NOTE 198, HIDRADENITIS SUPPURATIVA

Lines 418,​514

Hidradenitis suppurativa is included on Line 418 only for moderate to severe disease (e.g. Hurley Stage II or Hurley Stage III); otherwise this condition is included on Line 514.

Initial treatment with adalimumab is limited to adults whose disease has not responded to at least a 90-day trial of conventional therapy (e.g., oral antibiotics), unless such a trial is not tolerated or contraindicated. Treatment with adalimumab after 12 weeks is only included on Line 418 for patients with a clear evidence of response, defined as:

  1. a reduction of 25% or more in the total abscess and inflammatory nodule count, AND
  2. no increase in abscesses and draining fistulas.

GUIDELINE NOTE 21, SEVERE INFLAMMATORY SKIN DISEASE

Lines 426,​482,​504,​533,​542,​656

Inflammatory skin conditions included in this guideline are:

  1. Psoriasis
  2. Atopic dermatitis
  3. Lichen planus
  4. Darier disease
  5. Pityriasis rubra pilaris
  6. Discoid lupus
  7. Vitiligo

The conditions above are included on Line 426 if severe, defined as having functional impairment as indicated by Dermatology Life Quality Index (DLQI) ≥ 11 or Children’s Dermatology Life Quality Index (CDLQI) ≥ 13 (or severe score on other validated tool) AND one or more of the following:

  1. At least 10% of body surface area involved
  2. Hand, foot, face, or mucous membrane involvement.

Otherwise, these conditions above are included on Lines 482, 504, 533, 542 and 656.

For severe psoriasis, first line agents include topical agents, phototherapy and methotrexate. Second line agents include other systemic agents and oral retinoids and should be limited to those who fail, or have contraindications to, or do not have access to first line agents. Biologics are included on this line only for the indication of severe plaque psoriasis; after documented failure of first line agents and failure of (or contraindications to) a second line agent.

For severe atopic dermatitis/eczema, first-line agents include topical moderate- to high- potency corticosteroids and narrowband UVB.  Second line agents include topical calcineurin inhibitors (e.g. pimecrolimus, tacrolimus), topical phosphodiesterase (PDE)-4 inhibitors (e.g. crisaborole), and oral immunomodulatory therapy (e.g. cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, or oral corticosteroids).  Use of the topical second line agents (e.g. calcineurin inhibitors and phosphodiesterase (PDE)-4 inhibitors) should be limited to those who fail or have contraindications to first line agents. Biologic agents are included on this line for atopic dermatitis only after failure of or contraindications to at least one agent from each of the following three classes: 1) moderate to high potency topical corticosteroids, 2) topical calcineurin inhibitors or topical phosphodiesterase (PDE)-4 inhibitors, and 3) oral immunomodulator therapy.

ICD-10-CM Q82.8 (Other specified congenital malformations of skin) is included on Line 426 only for Darier disease.

Binge Eating Disorder

Click HERE for a printable PDF

Vyvanse for Binge Eating Disorder Drug Use Criteria

Created: June 6, 2019

Reviewed: August 2019, December 2020, January 2022

 

Includes:

Vyvanse©                   lisdexamfetamine

Schedule II CNS stimulant

GUIDELINE FOR USE:

 

  1. Is the member being treated for a funded condition by Oregon Health Plan?
    1. If yes and diagnosis is Binge Eating Disorder, go to 2 . If ADHD, see Stimulant/ADHD criteria.
    2. If no, deny as Below the Line, with message:

“Your request was received and denied based on the following: The condition being treated is below the funded line for Oregon Health Plan and is therefore not a covered benefit.”

 

  1. Has the member been diagnosed with moderate to severe binge eating disorder (BED)?
    1. If yes, go to 3.
    2. If no, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following: Vyvanse will only be provided as a covered benefit for FDA approved indications supported by the medication package insert. Off label use of medication is not a covered benefit on Oregon Health Plan.”

 

  1. Has the member received psychotherapy (eg, cognitive-behavioral therapy, interpersonal psychotherapy or dialectical behavior therapy) for BED?
    1. If yes, go to 4.
    2. If no, deny as Criteria Not Met, with message:

“Your request was reviewed and denied based on the following: Psychotherapy (eg, cognitive-behavioral therapy) is first-line treatment for binge eating disorder.  Psychotherapies that have demonstrated efficacy for treating binge eating disorder include cognitive-behavioral therapy (CBT), interpersonal psychotherapy, and dialectical behavior therapy.

 

  1. Has the member trialed a selective serotonin reuptake inhibitor (SSRIs)?
    1. If yes, continue to 5.
    2. If no, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following:  The use of selective serotonin reuptake inhibitors (SSRIs) are recommended for BED based on efficacy and tolerability. Note to Reviewer:  Doses are comparable or greater than those usually used for unipolar major depression and titration intervals are comparable as well.

 

  1. Does the member have a history of substance abuse?
    1. If yes, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following: Vyvanse is a schedule II CNS stimulant that has a high potential for abuse and dependence.  Use of Vyvanse for BED is not a covered benefit for members with a history of substance abuse.”

  1. If no, go to 6.

 

  1. Does the member have blood pressure that is currently well controlled? (Chart notes documenting blood pressure will be required, and readings greater than 140/90 will not be approved for Vyvanse).
    1. If yes, go to 7.
    2. If no, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following: Elevated blood pressure and heart rate are common side effects stimulant therapy. Moderate to severe hypertension is a contraindication to Vyvanse therapy.”

 

  1. Does the patient have preexisting structural cardiac abnormalities or other serious cardiac problems?
    1. If yes, deny as Criteria Not Met, with message:

Your request was received and denied based on the following:  Use of CNS stimulants has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems.  Vyvanse should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that can increase the risk of sudden death.”

  1. If no, go to 8.

 

  1. Does the patient have bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, narrow angle or angle closure glaucoma, or hyperthyroidism?
    1. If yes, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following: Vyvanse is not recommended in patients with bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, glaucoma, or hyperthyroidism.” 

  1. If no, go to 9.
  1. Is the patient taking a MAO inhibitor, or quit taking a MAO inhibitor within 14 days of starting Vyvanse? (e.g. isocarboxazid, phenelzine, tranylcypromine, or selegeline)
    1. If yes, deny as Criteria Not Met, with message:

“Your request was received and denied based on the following: Concomitant use of Vyvanse and MAO inhibitor therapy, or discontinuation within 14 days, is contraindicated due to increased risk of hypertensive crisis.”

  1. If no, go to 10.
  1. Has the provider documented that the Prescription Drug Monitoring Program (PDMP) has been queried?
    1. If yes, go to 11.
    2. If no, request attestation that PDMP has been checked. If no attestation is available, deny as not meeting criteria. Attestation of PDMP check is required for coverage of C2 medications.

 

  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, approve for 12 weeks. A limitation of the available data on medications for binge eating disorder is that most trials lasted 12 weeks or less, and thus little is known regarding longer term effects on binge eating.
    2. If no, deny as Criteria Not Met, with message:

Your request was reviewed and denied based on the following: Doses above those supported by the FDA approved package insert are not a covered benefit on Oregon Health Plan.”

Renewal Request:

Use of Vyvanse for BED beyond 12 weeks has not been studied in clinical trials and therefore lacks clinical evidence of safety and effectiveness supporting long-term use.  Chart notes supporting ongoing benefit outweighs risks of therapy will be required for consideration of coverage beyond 12 weeks.

Rationale:

To ensure the safe and effective use of Vyvanse for BED.  The potential for adverse effects may limit the utility of Vyvanse as use may cause anorexia, gastrointestinal distress, headaches, insomnia, and sympathetic nervous system arousal (eg, anxiety and dry mouth). CNS stimulants such as Vyvanse have a high potential for abuse or dependence.

FDA Approved Indication:

Binge Eating Disorder

ADHD

Mechanism of Action:

The exact mechanism of lisdexamfetamine in ADHD and binge eating disorder is not known. Lisdexamfetamine dimesylate is a prodrug that is converted to the active component dextroamphetamine (a noncatecholamine, sympathomimetic amine). Amphetamines are noncatecholamine, sympathomimetic amines that cause release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition.

Dosing:

Binge eating disorder, moderate to severe: Adolescents ≥18 years: Capsule, chewable tablets: Oral: Initial: 30 mg once daily in the morning; may titrate in increments of 20 mg/day at weekly intervals to target dose of 50 to 70 mg once daily; maximum daily dose: 70 mg/day; discontinue use if binge eating does not improve.

Contraindications:

  • Hypersensitivity to amphetamine products or any component of the formulation; concurrent use of MAO inhibitor, or within 14 days of the last MAO inhibitor dose.

References:

  1. Binge eating disorder in adults: Overview of treatment. Literature review current through: November 2021. Topic last updated: June 7, 2021.  Accessed December 20, 2021.
  2. Vyvanse Prescribing Information. Last updated 7/2021.

Approved by Advanced Health Pharmacy and Therapeutics Committee 8/21/19, 1/7/21, 4/13/22

Birth Control

Click HERE for a printable PDF

Drospirenone Containing Oral Contraceptives Drug Use Criteria

Created: October 2014

Reviewed: September 2015, April 2019

Includes:

Yaz©                           Ethinyl Estradiol and Drospirenone

            Yasmin©                     Ethinyl Estradiol and Drospirenone

Zarah©                       Ethinyl Estradiol and Drospirenone

Vestura©                    Ethinyl Estradiol and Drospirenone

Syeda©                       Ethinyl Estradiol and Drospirenone

Ocella©                      Ethinyl Estradiol and Drospirenone

Nikki©                         Ethinyl Estradiol and Drospirenone

Loryna©                     Ethinyl Estradiol and Drospirenone

Gianvi©                      Ethinyl Estradiol and Drospirenone

            Zumandimine©         Ethinyl Estradiol and Drospirenone

            Jasmiel©                     Ethinyl Estradiol and Drospirenone

**or any other brand or generic formulation of oral contraceptive containing drospirenone.

Guideline for Use:

  1. Is the patient being treated for a funded condition by Oregon Health Plan?
    1. If yes, go to 2
    2. If no, deny as Below the Funded Line for Oregon Health Plan.
  1. Does the patient have Polycystic Ovary Syndrome (PCOS) supported in the chart notes submitted for review?
    1. If yes, approve for 12 fills.
    2. If no, go to 3
  1. Does the patient have Premenstrual Dysphoric Disorder (PMDD) supported in the chart notes submitted for review?
    1. If yes, approve for 12 fills.
    2. If no, deny as not meeting criteria. Please use formulary alternative.

Rationale:

Drospirenone containing oral contraceptives have been associated with an increased risk of thromboembolic events; therefore, in order to ensure the safest and most cost-effective oral contraceptive preparations are utilized for Advanced Health members, the above drug use criteria was developed. Acne must meet Guideline Note 132: Acne Conglobata and Acne Fulminans or Guideline Note 65: Severe Cystic Acne of the Prioritized List of Health Services to be considered a covered comorbid condition.

FDA Approved Indications: Indicated for the prevention of pregnancy, treatment of premenstrual dysphoric disorder (PMDD), and treatment of acne.

References:

Lexicomp. Ethinyl Estradiol and Drospirenone: Drug Information. Last updated 12/7/21.

Health Evidence Review Commission Prioritized List of Health Services. Guideline Note 132: Acne Conglobata and Acne Fulminans and Guideline Note 65: Severe Cystic Acne. October 1, 2021 Prioritized List.

Approved by DOCS/WOAH Pharmacy and Therapeutics Committee on 10/27/2014

Approved by Advanced Health Pharmacy and Therapeutics Committee on 4/22/19, 1/22/20, 1/7/21

Cardiology

Click HERE for a printable PDF

Multaq (dronedarone) Drug Use Criteria

Created: March 2022

Reviewed: April 13, 2022

Includes:

Multaq                         dronedarone

GUIDELINE FOR USE:

Initial Request:

  1. Is this a request for and FDA approved indication?
    1. If yes, go to #2
    2. If no, deny as not meeting criteria. Off-label use of a medication is not a covered benefit under the Oregon Health Plan.
  2. Is Multaq being requested by or supervised by a cardiologist?
    1. If yes, go to #3
    2. If no, deny as not meeting criteria. Multaq needs to be prescribed and/or monitored by a cardiologist.
  3. Does the member meet and of the following exclusionary criteria: A) Symptomatic heart failure with recent decompensation requiring hospitalization; B) NYHA Class IV heart failure; or Permanent atrial fibrillation that will not or cannot be cardioverted into normal sinus rhythm?
    1. If yes, deny as not meeting criteria. Multaq increases the risk of death, stroke, and/or heart failure in this population.
    2. If no, go to #4
  4. Has the member tried and failed or have a contraindication to amiodarone?
    1. If yes, approve for up to 12 months.
    2. If no, deny as not least costly alternative. Request change to amiodarone.

References:

  1. Dronedarone: Drug Information. UpToDate. Accessed March 30, 2022

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/13/22

Chronic Pain

Click HERE for a printable PDF

Fentanyl Transdermal Patch Drug Use Criteria

Created: March 2016

Reviewed: April 2019, 12/2021

Includes:

Duragesic©    Fentanyl Transdermal Patch

Guideline for Use:

1.      Is the patient diagnosed and being treated for a funded condition?

a.      If yes, go to 2

b.      If no, deny as below the line

  1. Is the member unable to take medications by mouth or G-tube if one is present?
    1. If yes, go to 3
    2. If no, deny as not meeting criteria. Recommend trial of formulary alternative.
  2. Does the patient have any contraindications to therapy?
    1. If yes, deny as meeting criteria. Off-label use of medication is not covered by OHP.
    2. If no, go to 4
  3. Is Dosing consistency with FDA approved prescribing information?
    1. If yes, go to 5
    2. If no, deny as not meeting criteria. Off-label use of medication is not covered by OHP.
  4. Are all aspects of the Advanced Health Opioid Coverage Policy met?
    1. If yes, approve for requested duration of therapy up to 3 months
    2. If no, deny as not meeting criteria. Forward Advanced Health Opioid Coverage Policy and drug use criteria to requesting provider.

Rationale:

Due to the high potential for misuse, diversion and adverse health outcomes associated with opioid use, this criteria was developed to promote safer, evidence based prescribing of fentanyl products, to ensure use of least costly formulary alternatives when medically appropriate and to ensure prescribing consistent with the FDA approved prescribing information.

FDA Approved Indication:

Fentanyl patches are indicated for the management of pain in opioid tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Patients considered opioid tolerant are those taking, for one week or longer, at least 60mg of oral morphine per day, 25mcg of transdermal fentanyl per hour, 30mg of oral oxycodone per day, 8mg of oral hydromorphone per day, 25mg of oral oxymorphone per day, 60mg of hydrocodone per day, or an equianalgesic dose of another opioid.

Mechanism of Action:

Fentanyl is an opioid agonist. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Contraindications:

  • Opioid non-tolerant patients.
  • Acute or intermittent pain, postoperative pain, mild pain.
  • Significant respiratory depression.
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Known hypersensitivity to fentanyl or any of the components of the transdermal system.

Dosing and Administration:

  • To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
  • Initial dose selection: consult conversion instructions in the prescribing information.
  • Each transdermal system is intended to be worn for 72 hours.
  • Adhere to instructions concerning administration and disposal of fentanyl.
  • Mild to moderate hepatic and renal impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression.
  • Do not abruptly discontinue fentanyl in a physically-dependent patient.

References:

  1. Duragesic© package insert. Updated 3/2021
  2. DOCS criteria dated February 7, 2000
  3. Advanced Health Opioid Policy

Click HERE for printable PDF

Opioid Drug Use Policy for Chronic Non-Malignant Pain and Acute Opioid Prescriptions Exceeding SUPPORT ACT Safety Edits

Created: March 2016

Reviewed: May 2019, October 2019, December 2021

GUIDELINE FOR USE:

  1. Chronic use of opioid pain medications will be provided as a plan benefit for patients with a condition funded for coverage by Oregon Health Plan. Chart notes and a physical exam supporting the funded diagnosis will be required for determination.
  1. Use of opioids will not be a covered benefit for painful conditions the CDC, or other regulatory entity, has determined to be ineffective or with insufficient evidence to support improved pain or function with long-term use of opioids. For example:
    1. Low Back Pain
    2. Headache (including migraine headache)
    3. Fibromyalgia (Non-funded condition per the October 1, 2021 Prioritized List of Health Services)
  1. Chronic opioids will not be covered for patients currently using alcohol or other illegal substances due to increased risk of harms to patients.
  1. Two short acting opioids will not be covered concurrently due to safety concerns with this combination. The combination of long-acting opioid and short-acting opioid will not be a covered benefit due to lack of safety evidence supporting this combination and the potential for dose escalation with this practice.
  1. Concurrent use of benzodiazepines and opioids, or antipsychotics and opioids, will not be a covered benefit due to increased risk of adverse events. Coverage of a taper period may be allowed for patients with a documented taper plan submitted with the prior authorization request. Point of sale pharmacy safety edit for opioids-benzodiazepines is bi-directional and will result in a denied claim of either opioid or benzodiazepine if an overlapping prescription fill history exists. Point of sale pharmacy edit for opioid and antipsychotic prescriptions is one-directional and will result only in a denied opioid claim.
  1. A maximum Morphine Equivalent Dose (MED) of 50mg per day will be a covered benefit when all above criteria are met for new starts on chronic opioid therapy. For patients currently on opioid doses greater than 50 MED, coverage of a taper period to reach a maximum daily MED of 50mg will be allowed if a documented taper plan is submitted with the prior authorization request.
  1. Coverage of post-op pain medication will be allowed for up to 14 days following surgery date. There will be a 7-day supply limit for new starts of short acting opioids. A refill threshold of 85% will be applied consistent with general refill threshold for other controlled and non-controlled substances. A 90 MED limit for new starts of short acting opioids will be applied at POS by hard threshold. Exceptions may be requested through the prior authorization process if the below risk screening has been performed and the Oregon Prescription Drug Monitoring Program has been reviewed. The CDC guideline recommends use of opioids post-operatively for less than 7 days. Justification for ongoing use beyond 14 days will be required. A 50 MED soft threshold limit will be in place for new starts of short acting opioids and is overridable by pharmacy submitting appropriate DUR code.
  1. All prescriptions for extended release opioids will require a prior authorization.

Elements of Guideline Note 60: Opioids for Conditions of the Back and Spine of the Prioritized List of Health Services should also be met for opioid prior authorization requests for pain related to the back or spine.

Rationale:

Due to the high risk of adverse drug events, diversion and misuse of opioid pain medications, as well as recommendations from the Centers of Disease Control, the Health Evidence Review Commission, the Oregon Health Authority and guidance from the Center for Medicare and Medicaid Services regarding implementation of the SUPPORT ACT,  Advanced Health will encourage safe prescribing of opioid pain medications using the best available evidence, state and federal requirements for coverage of acute and chronic opioid prescriptions

Definitions:

Chronic use is defined as #60 tablets of any combination of opioid or opioid type medication dispensed by the pharmacy within a 180-day period.

Maximum Daily Morphine Equivalent Doses include the total of all opioids prescribed to the patient (eg. short acting opioid and long-acting opioid). See http://www.globalrph.com/narcotic.cgi for opioid dose calculators.

SUPPORT ACT is the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The SUPPORT ACT was designed to reduce opioid related fraud, misuse, and abuse. Section 1004 of the SUPPORT ACT requires states to implement minimum opioid standards.

Exclusions:

This policy does not apply to individuals receiving hospice, palliative care, or cancer treatment; residents of long-term care facilities described in 42 USC 1396a(oo)(3)(A)(ii); and individuals with sickle cell disease are exempt from these requirements. Advanced Health will ensure individuals in these categories continue to have appropriate access to opioid treatment.

Exceptions:

Doses greater than 50 MED per day may be considered for coverage if appropriate patient risk screening is performed (Annual SBIRT questionnaire, AUDIT, DAST), urine drug screen submitted, provider has reviewed the Oregon Prescription Drug Monitoring tool for inconsistencies or aberrancies, and functional treatment goals are established and submitted with the prior authorization request.

Tapers:

A 90-day taper period will be allowed for patients on >50 MED or prescribed concurrent benzodiazepines and/or antipsychotic. If greater than 90 days is required to safely taper the patient to 50 MED or less, a tapering plan must be submitted with the prior authorization request and a documented reduction in daily MED prescribed must be supported in the chart notes and by the dispensing history. See attached Tapering Flow Chart from Oregon Pain Guidance (also available at https://www.oregonpainguidance.org/guideline/tapering/. There will be no maximum timeframe enforced for opioid tapers.

References:

  1. CDC Guideline for Prescribing Opioids for Chronic Pain – United States. 2016.
  2. Pain Treatment Guidelines. Oregon Pain Guidance. https://www.oregonpainguidance.org/pain-treatment-guidelines/. Accessed on April 2019.
  3. Oregon Acute Opioid Prescribing Guidelines. Oregon Health Authority. October 2018
  4. Oregon Chronic Opioid Prescribing Guidelines: Recommendations for the safe use of opioid medications for patients with chronic pain. 2017-2018
  5. Oregon Health Authority Statewide Opioid Reduction Performance Improvement Project. 2016 https://www.oregon.gov/oha/HPA/DSI/pages/Performance-Improvement-Project.aspx
  6. Minimum Standards for SUPPORT Act Compliance, Effective October 1, 2019. Oregon Health Authority Communication. August 27, 2019.
  7. MedImpact Connect. 2019 Medicaid SUPPORT Act Requirements and Solutions. July 9, 2019.
  8. Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. Public Law 115-271.
  9. Guideline Note #60, Opioids for Conditions of the Back and Spine. Prioritized List of Health Services. Extracted from the October 1, 2021 Prioritized List.

Approved by the Western Oregon Advanced Health Pharmacy and Therapeutics Committee 3/29/16

Approved by Advanced Health Pharmacy and Therapeutics Committee on 5/13/19, 10/23/19, 1/7/21

GUIDELINE NOTE 56, NON-INTERVENTIONAL TREATMENTS FOR CONDITIONS OF THE BACK AND SPINE

Lines 361,​402

Patients seeking care for back pain should be assessed for potentially serious conditions (“red flag” symptoms requiring immediate diagnostic testing), as defined in Diagnostic Guideline D4. Patients lacking red flag symptoms should be assessed using a validated assessment tool (e.g. STarT Back Assessment Tool) in order to determine their risk level for poor functional prognosis based on psychosocial indicators.

For patients who are determined to be low risk on the assessment tool, the following services are included on these lines:

  • Office evaluation and education,
  • Up to four total visits, consisting of the following treatments: OMT/CMT, acupuncture, and PT/OT. Massage, if available, may be provided as part of these four total visits.
  • First line medications: NSAIDs, acetaminophen, and/or muscle relaxers. Opioids may be considered as a second line treatment, subject to the limitations on coverage of opioids in Guideline Note 60 OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE.

For patients who are determined to be medium- or high risk on the validated assessment tool, as well as patients undergoing opioid tapers as in Guideline Note 60 OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE, the following treatments are included on these lines:

  • Office evaluation, consultation and education
  • Cognitive behavioral therapy. The necessity for cognitive behavioral therapy should be re-evaluated every 90 days and coverage will only be continued if there is documented evidence of decreasing depression or anxiety symptomatology, improved ability to work/function, increased self-efficacy, or other clinically significant, objective improvement.
  • Prescription and over-the-counter medications; opioid medications subject to the limitations on coverage of opioids in Guideline Note 60 OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE.
  • The following evidence-based therapies, when available, may be provided: yoga, massage when not billed under 97124 and limited to one session per week, Pilates, supervised exercise therapy, intensive interdisciplinary rehabilitation. HCPCS S9451 is only included on Line 402 for the provision of yoga or supervised exercise therapy.
  • A total of 30 visits per year of any combination of the following evidence-based therapies when available and medically appropriate. These therapies are only included on these lines if provided by a provider licensed to provide the therapy and when there is documentation of measurable clinically significant progress toward the therapy plan of care goals and objectives using evidence based objective tools (e.g. Oswestry, Neck Disability Index, SF-MPQ, and MSPQ).
  • Rehabilitative therapy (physical and/or occupational therapy), if provided according to Guideline Note 6 REHABILITATIVE AND HABILITATIVE THERAPIES. Rehabilitation services provided under this guideline also count towards visit totals in Guideline Note 6. Massage billed under CPT 97124 is included in this category and is subject to the restrictions on massage in Guideline Note 6.
  • Chiropractic or osteopathic manipulation
  • Acupuncture

Mechanical traction (CPT 97012) is not included on these lines, due to evidence of lack of effectiveness for treatment of back and neck conditions.

The development of this guideline note was informed by HERC coverage guidances on Low Back Pain Non-Pharmacologic, Non-Invasive Intervention, Low Back Pain, Pharmacological and Herbal Therapies. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx

GUIDELINE NOTE 60, OPIOIDS FOR CONDITIONS OF THE BACK AND SPINE

Lines 346,​361,​402,​530

Opioid medications are only included on these lines under the following criteria. Time periods described below are relative to the patient’s initial injury or condition for which opioids were originally prescribed, regardless of whether the individual or any plan paid for the medication. Providers are encouraged to consider the recommendations of the Oregon Opioid Prescribing Guidelines Task Force when prescribing opioid medications: Oregon Acute Opioid Prescribing Guideline (October 2018) and the Oregon Chronic Opioid Prescribing Guidelines (2017-2018).

For acute conditions and flares

During the first 6 weeks after an acute injury, acute flare of chronic pain, or surgery opioid treatment is included on these lines ONLY:

  1. When each prescription is limited to 7 days of treatment, AND
  2. For short acting opioids only, AND
  3. When one or more alternative first line pharmacologic therapies such as NSAIDs, acetaminophen, and muscle relaxers have been tried and found not effective or are contraindicated, AND
  4. When prescribed with a plan to keep active (home or prescribed exercise regime) and with consideration of additional therapies such as spinal manipulation, physical therapy, yoga, or acupuncture, AND
  5. There is documented evaluation of the patient’s risk factors for opioid misuse or abuse (e.g., history of opioid misuse, verification of prescription history in the PDMP).

During subacute period

Treatment with opioids after 6 weeks of continuous therapy and up to 90 days after the initial injury/flare/surgery is included on these lines ONLY:

  1. With documented evidence of improvement of function of at least thirty percent as compared to baseline based on a validated tools (e.g. Oswestry, Neck Disability Index, SF-MPQ, and MSPQ).
  2. When prescribed with a plan to keep active (home or prescribed exercise regime) and additional therapies such as spinal manipulation, physical therapy, yoga, or acupuncture, when available.
  3. With verification that the patient is not high risk for opioid misuse or abuse. Such verification may involve
    • Documented verification from the state’s prescription monitoring program database that the controlled substance history is consistent with the prescribing record
    • Use of a validated screening instrument to verify the absence of a current substance use disorder (excluding nicotine) or a history of prior opioid misuse or abuse
    • Administration of a baseline urine drug test to verify the absence of illicit drugs and non-prescribed opioids.
  4. Each prescription must be limited to 7 days of treatment and for short acting opioids only

Long-term opioid therapy

Long-term opioid treatment (>90 days) after the initial injury/flare/surgery is included on these lines as described below.

For patients receiving long-term opioid therapy (>90 days) for conditions of the back and spine, continued coverage of opioid medications requires a comprehensive individual treatment plan for chronic pain, taking into account the biological, behavioral, psychological and social factors which may influence each individual’s experience of chronic pain as well as any current and past treatments. Treatment plans should be prescribed (unless contraindicated) with a plan to keep active (home or prescribed exercise regimen) and should include additional therapies such as spinal manipulation, physical therapy, yoga or acupuncture unless contraindicated and if available in a patient’s community and reasonably accessible to the patient. The treatment plan should conform with the Oregon Chronic Opioid Prescribing Guidelines (2017-2018). A taper plan may be indicated if and when clinically appropriate.

Opioid tapers

Opioid taper plans are not required in order for continued inclusion of long-term opioid therapy on these lines. Providers initiating taper plans are encouraged to follow Oregon Opioid Tapering Guidelines (January 2020). Taper plans should include nonpharmacological treatment strategies for managing the patient’s pain. During the taper, behavioral health conditions need to be regularly assessed and appropriately managed.

COPD

Click HERE for a printable PDF

Long-Acting Muscarinic Antagonist (LAMA) Drug Use Criteria

Created: 4/5/2021

Reviewed: 4/14/21

Includes:

Spiriva Handihaler©: inhalation capsule 18mcg                                                              tiotropium

Spiriva Respimat©: inhalation aerosol solution 1.25mcg and 2.5mcg/actuation           tiotropium

GUIDELINE FOR USE:

  1. Is the request for a funded condition?
  2. Yes, go to #2.
  3. No, deny as BTL.
  1. Is use an FDA-approved indication?
  2. Yes, go to #3 if diagnosis is COPD.
  3. Yes, go to #5 if diagnosis is asthma.
  4. No, deny as criteria not met.  Off-label use of a medication is not a covered benefit.
  1. Is request for treatment of COPD and has diagnosis been confirmed by history of respiratory symptoms and spirometry?
  2. Yes, go to #4.
  3. No, deny as criteria not met. Please submit spirometry confirming COPD diagnosis.
  1. Has the member had an adequate trial and failure of Incruse Ellipta? (Adequate trial is defined as adherent to therapy for at least 90 consecutive days and documentation of persistent symptoms).
  2. Yes, approve for 12 months.
  3. No, deny as criteria not met. Recommend trial with formulary alternative, Incruse Ellipta.
  1. Is request for treatment of asthma and has diagnosis been confirmed by history of respiratory symptoms and spirometry/Nitric Oxide testing?
  2. Yes, go to #6.
  3. No, deny as criteria not met. Please submit documentation, including respiratory symptoms and spirometry/Nitric Oxide testing, confirming asthma diagnosis OR forward to MD for review.
  1. Is Spiriva Respimat (tiotropium) prescribed as add-on therapy to ICS/LABA?  (Per GINA guidelines, add-on Spiriva Respimat (tiotropium) is supported for members aged 6 years and older whose asthma is not well-controlled with ICS-LABA.  Add-on Spiriva Respimat (5mcg once daily) modestly improves lung function (Evidence A) and modestly increases the time to severe exacerbation requiring oral corticosteroids (Evidence B).  Pulmonology consult is recommended for members aged 6-11 years).
  2. Yes, approve for up to 6 months.
  3. No, deny as criteria not met. Recommend formulary ICS/LABA, but will require PA request.

Renewal Request:

  1. Have symptoms improved and does documentation support continued therapy?
    1. Yes, approve for 12 months for COPD
    2. Yes, approve for up to 6 months for asthma
    3. No, deny as criteria not. Please consider stepping down treatment or alternative treatment options or forward to MD for review.

Rationale:  To ensure medical appropriateness and optimization of less costly formulary alternatives.

FDA Approved Indication:

Asthma (Spiriva Respimat only): Maintenance treatment of asthma in patients ≥6 years.

Chronic obstructive pulmonary disease: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; reduction of COPD exacerbations.

Mechanism of Action:

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Dosing:

Asthma: Oral inhalation: Spiriva Respimat (1.25 mcg/actuation): Soft-mist inhaler: Two inhalations (2.5 mcg) once daily (maximum: 2 inhalations per 24 hours). Note: Maximum benefits may take up to 4 to 8 weeks of dosing. 5 mcg once daily has been recommended for patients with insufficient response to inhaled corticosteroid plus long-acting beta agonist (GINA 2020) with efficacy found in adults with severe asthma (ERS/ATS [Holguin 2019]).

COPD: Oral inhalation:

Spiriva HandiHaler: Dry powder inhaler: Contents of 1 capsule (18 mcg) inhaled once daily

Spiriva Respimat (2.5 mcg/actuation): Soft-mist inhaler: Two inhalations (5 mcg) once daily (maximum: 2 inhalations per 24 hours).

Contraindications:

Hypersensitivity to ipratropium, tiotropium, or any component of the formulation.

References:

Canadian Thoracic Society Clinical Practice Guideline on pharmacotherapy in patients with COPD – 2019 update of evidence.  https://doi.org/10.1080/24745332.2019.1668652

Global Initiative for Asthma (GINA).  https://ginasthma.org/wp-content/uploads/2020/06/GINA-2020-report_20_06_04-1-wms.pdf.

Global Initiative for Chronic Obstructive Lung Disease (GOLD).  https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf

National Institute for Health and Care Excellence (NICE). https://www.nice.org.uk/guidance/ng80/chapter/Recommendations#principles-of-pharmacological-treatment

UpToDate: Tiotropium: Drug information

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/14/21

Diabetes

Click HERE for a printable PDF

Glucagon – like Peptide – 1 (GLP-1) Receptor Agonists Drug Use Criteria

Created: December 2017

Reviewed: April 2019, October 2020, September 2021

Includes:

Byetta©(preferred GLP-1 agonist)               Exenatide

            Trulicity©                                                       Dulaglutide

            Bydureon© Pen/Vial                                     Exenatide Microspheres

            Victoza©                                                        Liraglutide

Adlyxin©                                                        Lixisenatide

Ozempic©                                                      Semaglutide

Rybelsus©                                                      Semaglutide

*Saxenda and Wegovy are not a covered benefit on OHP as medications are approved for chronic weight management only. 

GUIDELINE FOR USE:

Initial Request:

  1. Is the medication being used for treatment of Type 2 Diabetes Mellitus? Use for chronic weight management alone is not a covered benefit on OHP.
    1. Yes: go to #2
    2. If no, deny as not meeting criteria. Off label or experimental use of medication is not a covered benefit on Oregon Health Plan.
  1. Has member tried and failed metformin and at least two other oral glucose lowering agents, SGLT2 inhibitor, and basal insulin or have contraindications to these treatments? * Does fill history support dose optimization and adherence?
    1. Yes: Go to #3
    2. If no, deny as not meeting criteria. Please optimize dose of metformin and/or oral glucose lowering agent (s).
    3. If no and on basal insulin: Trial of SGLT2 inhibitor is recommended as least costly alternative prior to use of GLP-1 agonist but will require a prior authorization request.
  1. Is HgA1c level >7.5%
  2. a) If yes and on prandial insulin, recommend approval for 3 months for Rebelsus, Trulicity or Ozempic.
  3. b) If yes and request is for Byetta, Bydureon, Victoza or Adlyxin then recommend change to Adlyxin as least costly alternative and approve for 3 months.

c).  If no, deny as criteria not met. Endocrinology consult is a covered benefit.

Renewal Request:

  1. Is there clinical documentation supporting response to therapy including reduction in HgA1c?
    1. If yes, approve for 6 fills.
    2. If no, deny as not meeting criteria. Recommend changing treatment plan to optimize HgA1c reduction.

Rationale:

To promote cost-effective and safe step-therapy management for type 2 diabetes mellitus. To ensure optimization of least costly formulary alternatives including metformin and sulfonylureas prior to initiating therapy with more costly GLP-1 agonists. Adherence and dose optimization will be reviewed using prescription refill history for consideration of coverage for GLP-1 agonists. GLP-1 agonists will not be covered for weight loss as use of medications for weight loss is not a covered benefit on OHP. To ensure engagement with lifestyle modifications to optimize glycemic control from Type 2 diabetic patients.

FDA Approved Indication:

These agents are add-on to lifestyle modifications such as diabetes education or dietary counseling to improve glycemic control in adults with Type 2 diabetes. Liraglutide is also indicated to reduce the risk of major adverse cardiovascular events in type diabetic adults with established cardiovascular disease. Dulaglitide has another indication of risk reduction of major cardiovascular events in adults with type 2 diabetes mellitus with cardiovascular disease or multiple cardiovascular risk factors. Semaglutide has an additional indication of risk reduction of major cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

References:

  1. American Diabetes Association (ADA). Standards of Medical Care in Diabetes – 2021. Diabetes Care 2021 Jan; 44(Supplement 1): S111-S124.
  2. Byetta Prescribing Information. Revised 6/2021.
  3. Trulicity Prescribing Information. Revised 9/2020.
  4. Bydureon Prescribing Information. Revised 12/2020.
  5. Victoza Prescribing Information. Revised 11/2020.
  6. Adlyxin Prescribing Information. Revised 7/2021.
  7. Ozempic Prescribing Information. Revised 4/2021.
  8. Wegovy Prescribing Information. Revised 6/2021.
  9. Saxenda Prescribing Information. Revised 12/2020.
  10. Guideline Note 5, Obesity and Overweight (Medications for weight loss are not a covered benefit of OHP)

Glucose-lowering medication in type 2 diabetes: 2021 ADA Professional Practice Committee (PPC) adaptation of Davies et al. (35) and Buse et al. (36).

Approved by Advanced Health Pharmacy and Therapeutics Committee 2/26/2018, 4/22/2019, 10/21/20, 10/13/2021

Click HERE for a printable PDF

Sodium-Glucose CoTransporter-2 Inhibitors (SGLT-2 Inhibitors) Drug Use Criteria

Created: August 2020

Reviewed: September 30, 2020, October 2020, September 2021, January 2022

Includes:

Invokana©                              Canagliflozin

Invokamet XR©                      Canagliflozin/Metformin HCI

Invokamet©                             Canagliflozin/Metformin HCI

Farxiga©                                 Dapagliflozin Propanediol

XigduoXR©                              Dapagliflozin/Metformin HCI

Qtern©                                    Dapagliflozin/Saxagliptin HCI

Jardiance©                              Empagliflozin

Glyxambi©                               Empagliflozin/Linagliptin

Synjardy XR©                           Empagliflozin/Metformin HCI

Synjardy©                                Empagliflozin/Metformin HCI

Steglatro©                              Ertugliflozin Pidolate (Preferred for glycemic control)

Segluromet©                           Ertugliflozin/Metformin

Steglujan©                               Ertugliflozin/Sitagliptin

Trijardy XR©                           Empaglifozin/Linagliptin/Metformin

(Bolded items are preferred agents)

GUIDELINE FOR USE:

Initial Request:

  1. Is this a request for renewal of a previously approved prior authorization?
  2. a) Yes: Go the Renewal Criteria
  3. b) No: Go to #2
Drug Name Risk Reduction for major CV events in T2DM and established CV disease Risk Reduction of end-stage kidney disease in patients with T2DM and diabetic nephropathy with albuminuria >300mg/day Risk Reduction of eGFR decline and end-stage kidney disease CV death and hospitalization for HF in patients with CKD at risk of progression HF risk reduction in patients with T2DM and established CV disease or multiple CV risk factors HF risk reduction in patients with HFrEF (NYHA Class II-IV)
Invokana (canagliflozin) X X      
Farxiga (dapagliflozin)     X X X
Jardiance (empagliflozin) X       X
Steglatro (ertugliflozin)          

*Abbreviations: CKD- chronic kidney disease; CV- Cardiovascular; eGFR- estimated glomerular filtration rate; HF- heart failure; HFrEF- heart failure with reduced ejection fraction; NYHA- New York Heart Association; T2DM- Type 2 Diabetes Mellitus

  1. Does the member qualify for the requested therapy based on the diagnoses and requirements in Table 1?
  2. a) Yes: Go to #5
  3. b) No: Go to #3
  1. Does the member have T2DM and an A1c >9%?
  2. a) Yes: Deny as not meeting criteria. SGLT-2 Inhibitors aren’t recommended due to inferior glycemic efficacy and the potential for increasing symptoms from polyuria. Recommend basal insulin and prandial insulin.
  3. b) No: Go to #4.

 

  1. Does the patient have T2DM and has tried and failed metformin and another oral glucose lowering agent, have contraindications to these treatments or is the request for use of a SGLT-2 inhibitor with metformin and an oral glucose lowering agent? (Please document dose optimization, medication adherence, and/or clinical contraindications, if any e.g., heart failure). For dose optimization of oral glucose lowering agents, has member trialed maximum dose supported by manufacturer labeling or highest tolerated dose? For dose optimization of basal insulin, has member trialed at least 80 units per day of basal insulin?
  2. a) Yes: go to question #5
  3. b) No and not on basal insulin: Deny and recommend trial of metformin, other oral glucose lowering agents (sulfonylurea, pioglitazone, or alogliptin), or basal insulin (Semglee).

c). No and on basal insulin:  Go to #5

  1. Is the request for the following treatments (including combination products) with an associated estimated glomerular filtration rate (eGFR):
  • Canagliflozin and eGFR <30 mL/min/ 1.73 m2, or
  • Empagliflozin and eGFR <30 mL/min/1.73 m2, or
  • Dapagliflozin and eGFR <25 mL/min/1.73 m2, or
  • Ertugliflozin and eGFR <60 mL/min/1.73 m2?

*Additional manufacturer labeling information will be used on an individual basis.

  1. a) Yes: Deny as criteria not met. Use is not recommended per manufacturing labeling.
  2. b) No: Approve for 3 months. Please submit follow-up chart note evaluating response to treatment, including HgA1c level after treatment was initiated.

Renewal Request:

  1. Does member still meet initial criteria?

a).  Yes: Go to #2

b).  No:  Deny as not meeting criteria.

  1. Has the patient been adherent to therapy and if applicable, has HgA1c been reduced by 0.5% for T2DM?
  2. a) Yes: approve for 6 months.
  3. b) No: deny as criteria not met.

 

Rationale:

To promote value within step therapy management and evidence-based standard of care.  To ensure optimization of least costly formulary alternatives including metformin, other oral glucose lowering agents and basal insulin prior to initiating therapy with more costly SGLT-2 inhibitors. Adherence and dose optimization will be reviewed using prescription refill history for consideration of coverage for SGLT-2 inhibitors.

FDA Approved Indication:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus for all products. See Table 1 for medication specific indications.

References:

  1. American Diabetes Association (ADA). Standards of Medical Care in Diabetes – 2021. Diabetes Care 2021 Jan; 44(Supplement 1): S111-S124.
  2. Invokana Prescribing Information. Revised 8/2020.
  3. Invokamet XR Prescribing Information. Revised 8/2020.
  4. Invokamet Prescribing Information. Revised 8/2020.
  5. Farxia Prescribing Information. Revised 4/2021.
  6. XigduoXR Prescribing Information. Revised 1/2020.
  7. Qtern Prescribing Information. Revised 1/2020.
  8. Jardiance Prescribing Information. Revised 8/2021.
  9. Glyxambi Prescribing Information. Revised 6/2021.
  10. Synjardy XR Prescribing Information. Revised 6/2021.
  11. Synjardy Prescribing Information. Revised 6/2021.
  12. Steglatro Prescribing Information. Revised 9/2021.
  13. Segluromet Prescribing Information. Revised 9/2021.
  14. Steglujan Prescribing Information. Revised 9/2021.
  15. Trijardy Prescrbing Information. Revised 6/2021.
  16. UpToDate: Management of persistent hyperglycemia in type 2 diabetes mellitus. Last updated: January 18, 2022. Accessed January 27, 2022.

Glucose-lowering medication in type 2 diabetes: 2021 ADA Professional Practice Committee (PPC) adaptation of Davies et al. (35) and Buse et al. (36).

Approved by Advanced Health Pharmacy and Therapeutics Committee 9-30-2020, 10-21-20, 10-13-2021, 4-13-2022

Dyslipidemia

Click HERE for a printable PDF

Omega 3 Fatty Acids Drug Use Criteria

Created: 8/18/2019

Reviewed: August 2019, August 2021

Includes:

Vascepa©       Icosapent Ethyl

Lovaza©         Omega-3-Acid Ethyl Esters

Guideline for Use:

For consideration of coverage, refer to the Oregon Medicaid Fee-For-Service (FFS) Drug Use Criteria for Omega-3 Fatty Acids, available at:

https://www.orpdl.org/durm/PA_Docs/omega-3fattyacids.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medications based on the best available evidence and to align coverage with Oregon Medicaid FFS criteria.

References:

Oregon Medicaid FFS Drug Use Criteria. Omega 3 Fatty Acids. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health Pharmacy and Therapeutics Committee 8/21/2019, 10/13/2021

DVT

Click HERE for a printable PDF

Direct Oral Anticoagulants Drug Use Criteria

Created: October 2016

Reviewed: 4/22/19, 12/9/21

Includes:

Xarelto©        Rivaroxaban

Pradaxa©       Dabigatran

Eliquis©          Apixaban

Savaysa©       Edoxaban

This drug use criteria will be used to determine ongoing coverage of the direct oral anticoagulants following the initial three months of therapy allowed through the Advanced Health formulary.

Guideline for Use:

  1. Does the member have an OHP funded condition?
    1. If yes, continue to question 2.
    2. If no, deny as BTL.
  1. Does the member have a diagnosis for any of the recommended FDA approved indications (DVT or PE treatment, secondary prevention of recurrent DVT or PE, prophylaxis of DVT in knee or hip replacement surgery, or prevention of stroke or systemic embolism in nonvalvular atrial fibrillation), AND is the appropriate dose of medication being prescribed consistent with the FDA approved prescribing information?
    1. If yes, continue to question 3
    2. If no, deny as not meeting criteria. Use of medications for off label indications is considered experimental and not a covered benefit on OHP.

**Note to reviewer: Please coordinate with prescriber prior to denying authorization request for inappropriate dosing to change to FDA approved dosing regimen.

Indications and Dosing

Xarelto© Pradaxa© Eliquis© Savaysa©
Deep vein thrombosis (DVT) or pulmonary embolism (PE) treatment 15 mg twice daily for 21 days followed by 20 mg once daily 150 mg twice daily following 5-10 days of parenteral anticoagulation 10 mg twice daily for 7 days followed by 5 mg twice daily 60 mg once daily following 5-10 days of parenteral anticoagulation
Reduction in risk of recurrent DVT/PE 10 mg once daily after initial 6 months of therapy 150 mg twice daily 2.5 mg twice daily after initial 6 months of therapy Not indicated
Nonvalvular atrial fibrillation 20 mg once daily 150 mg twice daily 5 mg twice daily 60 mg once daily
Postoperative DVT prophylaxis (hip and knee replacement surgery) 10 mg once daily

· Knee: 12 days

· Hip: 35 days

110 mg on day 1 then 220 mg once daily (hip replacement only)

· Minimum:10 days

· Maximum: 35 days

Not indicated for knee replacement

2.5 mg twice daily

· Knee: 12 days

· Hip: 35 days

Not indicated
Prophylaxis of VTE in acutely ill patients (not at high risk of bleeding) 10mg once daily

• Total recommended duration of 31 to 39 days

 
Peripheral artery disease, stable or Coronary artery disease, stable 2.5 mg twice daily in combination with 75-100 mg aspirin daily  

Duration of therapy

Provoked DVT/PE

· Surgery

· Nonsurgical transient risk factors: estrogen therapy, pregnancy, leg injury, flight >8h

· 3 months
Unprovoked DVT/PE · Low to moderate bleeding risk: extended               anticoagulation therapy (no stop date)

· High bleeding risk: 3 months

VTE associated with cancer: LMWH is the preferred agent over VKA, Pradaxa, Xarelto, Eliquis, or Savaysa · Extended anticoagulation therapy (no stop date)
  1. Does the member have any conditions in which the DOACs are not recommended or contraindicated? See chart below.
    1. If yes, deny as not meeting criteria. Warfarin or LMWH are alternatives
    2. If no, approve for appropriate duration of therapy for FDA approved indication medication is prescribed to treat.
Xarelto© Pradaxa© Eliquis© Savaysa©
Contraindication -Active bleeding -Active bleeding

-Mechanical prosthetic heart valve

-Active bleeding -Active bleeding
Use not recommended -Age <18-year-old -Prosthetic heart valves -Severe renal impairment (CrCl <15 ml/min) -Hepatic impairment (Child-Pugh B and C) -Hepatic disease associated with coagulopathy -Pregnancy -Nursing mothers -Prosthetic heart valves -Triple positive antiphospholipid syndrome -Bioprosthetic heart valve

-Severe renal impairment (CrCl <15 ml/min) -Pregnancy -Nursing mothers

-Age <18 years old -Prosthetic heart valve -Nursing mothers -Pregnancy -Severe hepatic impairment (Child-Pugh C) -Severe renal impairment (CrCl <15 ml/min) -Age <18 years old -Mechanical heart valve -Moderate to severe mitral stenosis -CrCl >95 ml/min (nonvalvular atrial fibrillation)

-Nursing mothers

-Moderate to severe hepatic impairment (Child-Pugh B and C)

Drug-Drug Interactions -Anticoagulants

-Combined P-gp and strong CYP3A4 inhibitors and inducers

-Anticoagulants

-Rifampin

-P-gp inducers

-Anticoagulants

-Combined strong CYP3A4 and P-gp inhibitors and inducers

-Anticoagulants

-Rifampin

*Example of potential drug-drug interactions:

-Strong CYP3A4 and P-gp Inducers: carbamazepine, phenytoin, rifampin, St. John’s wort

-Strong CYP3A4 and P-gp Inhibitors: cobicistat, conivaptan, danoprevir/ritonavir, elvitegravir/ritonavir, ketoconazole, clarithromycin, diltiazem, quinidine, tacrolimus, grapefruit juice

*Note: The International society on Thrombosis and Haemostatis (ISTH) 2016 guideline suggests avoiding the use of DOACs in patients with BMI >40 kg/m2 or weight >120 kg due to lack of clinical data in this population. If used in patients with BMI >40 kg/m2 or weight >120 kg, ISTH suggests measuring peak and trough levels using an anti-factor Xa assay or mass spectrometry. If drug level is below expected range, ISTH recommends changing to Vitamin K antagonist. Advanced Health will not restrict access to DOAC medication based on BMI or weight, however, a note will be sent to the requesting provider alerting them to the lack of clinical data in this population.

Dosing Adjustments

Xarelto© Pradaxa© Eliquis© Savaysa©
DVT or PE treatment 30 mg once daily (CrCl 15 to 50 ml/min or body weight ≤60 kg)
Reduction in risk of recurrent DVT/PE 15 mg once daily (CrCl 15 to 50 ml/min)
Nonvalvular atrial fibrillation 15 mg once daily (CrCl 15 to 50 ml/min) 75 mg twice daily (CrCL 15-30 ml/min) 2.5 mg twice daily (2 or more of the following: age ≥80, weight ≤60 kg, or serum creatinine ≥1.5 mg/dl) 30 mg once daily (CrCl 15 to 50 ml/min)

 

Rationale:

Due to high cost of therapy and potential for serious adverse events, drug use criteria help to promote safe, evidence-based prescribing of the direct oral anticoagulants.

FDA Approved Indications:

Xarelto© (rivaroxaban) is FDA indicated for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), reduction in the risk of recurrence of DVT and PE, reduction of risk of stroke and systemic embolism in patient with nonvalvular atrial fibrillation, and prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients, and to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease  (CAD) or peripheral artery disease (PAD).

Savaysa© (edoxaban) if FDA indicated for reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and the treatment of DVT and PE following 5-10 days of initial therapy with a parenteral anticoagulant.

Pradaxa© (dabigatran) is FDA indicated in adults for the reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of DVT and PE following 5-10 days of initial therapy with a parenteral anticoagulant, reduction in the risk of recurrence of DVT and PE, and DVT and PE prophylaxis in patients that have undergone hip replacement surgery. Pradaxa© is FDA indicated in pediatric patients 8 to less than 18 years of age for the treatment of venous thromboembolic events who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE.

Eliquis© (apixaban) is FDA indicated for reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery, treatment of DVT and PE, and reduction in the risk of recurrent DVT and PE.

References:

  1. Xarelto© Prescribing Information. Last updated 8/2021
  2. Savaysa© Prescribing Information. Last updated 9/2016
  3. Pradaxa© Prescribing Information. Last updated 6/2021
  4. Eliquis© Prescribing Information. Last updates 7/2016
  5. Kearin C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. CHEST 2016; 149(2):315-352
  6. International Society on Thrombosis Haemostasis (ISTH) 2016 Guideline

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/19, 1/71/21

GERD

Click HERE for a printable PDF

Proton Pump Inhibitors

Created: 3/22/2006

Reviewed: 5/13/2019, 12/2021

Includes:

Aciphex©                                           Rabeprazole

Dexilant©                                           Dexlansoprazole

Kapidex©                                           Dexlansoprazole

Nexium© and Nexium 24HR©          Esomeprazole

Prevacid© and Prevacid 24HR©       Lansoprazole

Prilosec© and Prilosec OTC©           Omeprazole capsules

Protonix©                                          Pantoprazole tablets

*Highlighted agent is available on Advanced Health formulary without a prior authorization.

GUIDELINE FOR USE:

Generic omeprazole capsules and pantoprazole tablets are available on the Advanced Health formulary with no prior authorization required. Non-formulary proton pump inhibitors will be considered for coverage under the following drug use criteria.

Initial Request:

  1. Is the medication being used to treat a condition funded for coverage by Oregon Health Plan?
    1. If yes, continue to 2
    2. If no, deny as below the line.
  2. Has the patient had an adequate trial of all formulary proton pump inhibitors, or does the patient have a documented allergy or contraindication to formulary agents? Adequate trial is defined as consistent prescription fill history for at least 8 weeks. All formulary and least costly alternative agents must be trialed before consideration of more costly non-formulary agents.
    1. If yes, continue to 3
    2. If no, deny as non-formulary with message to please trial formulary alternatives.
  3. Is the medication being prescribed for an indication and dose supported by the FDA approved package insert?
    1. If yes, go to 4
    2. If no, deny as not meeting criteria. Off-label use of medications is not a covered benefit on Oregon Health Plan.
  4. Does the patient meet guideline note 144, Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease (GERD) of the Health Evidence Review Commission Prioritized List of Health Services?
    1. If yes and request is for short term treatment of GERD without Barrett’s, approve for up to 8 weeks. Dosing must be consistent with the FDA approved package insert.
    2. If yes and request is for long term proton pump inhibitor therapy for Barrett’s esophagus, approve for 12 fills or one year of therapy. Dosing must be consistent with the FDA approved package insert.
    3. If no, deny as not meeting criteria with message that request does not meet Guideline Note 144 of the HERC Prioritized List. Long term coverage of PPI therapy for GERD is not a covered benefit on OHP.

Renewal Request:

  1. Is the request for a continuation of therapy for a previously approved non-formulary proton pump inhibitor?
    1. If yes, go to 2
    2. If no, see above for initial prior authorization criteria.
  2. Is there documented improvement in patient’s condition and patient continues to meet guideline note 144 of the Prioritized List?
    1. If yes, approve for 12 fills or one year of therapy
    2. If no, deny as not meeting criteria with message requesting documentation of patient’s response to therapy and/or that request does not meet guideline note 144 of the Prioritized List.

Rationale:

To ensure use of formulary, least costly proton pump inhibitors for conditions intended for coverage by the Health Evidence Review Commission Prioritized List of Health Services. To ensure utilization consistent with Guideline Note 144, Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease. To ensure prescribing consistent with the FDA approved package insert.

FDA Approved Indications:

Drug Name Indications: Dosing
Rabeprazole ·         Healing of erosive or ulcerative GERD: 20mg once daily for 4 to 8 weeks

·         Maintenance of Healing of erosive or ulcerative GERD: 20mg once daily *studied for 12 months

·         Treatment of symptomatic GERD in adults: 20mg once daily for 4 weeks

·         Healing of Duodenal Ulcers: 20mg once daily after morning meal for up to 4 weeks

·         H. Pylori eradication to reduce the risk of duodenal ulcer recurrence: 20mg twice daily with morning and evening meals for 7 days. Taken with Amoxicillin 1000mg and Clarithromycin 500mg.

·         Treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome: Starting dose 60mg once daily then adjust to patient need

·         In adolescent patients 12 years of age and older: short term tx of symptomatic GERD: 20mg once daily for up to 8 weeks

·         In pediatric patients 1 to 11 years of age: tx of GERD: <15 kg- 5mg once daily with option to increase to 10mg once daily. ≥15kg- 10mg once daily for up to 12 weeks

Dexlansoprazole ·         Healing of all grades of erosive esophagitis (EE): 60mg once daily for up to 8 weeks

·         Maintenance of healed EE: 30mg once daily for up to 6 months

·         Symptomatic non-erosive GERD: 30mg once daily for 4 weeks.

Esomeprazole ·         Healing of erosive esophagitis (EE): Adults- 20mg to 40mg once daily for 4 to 8 weeks; 12-17 years- 20mg to 40mg once daily for 4 to 8 weeks; 1 month to 11 years- weight-based dosing and duration

·         Maintenance of Healing of EE: Adults- 20mg once daily for up to 6 months

·         Treatment of symptomatic GERD: Adults- 20mg once daily for 4 to 8 weeks;  12-17 years- 20mg to 40mg once daily for 4 weeks; 1 to 11 years-10mg once daily for up to 8 weeks

·         Risk Reduction of NSAID-Associated Gastric Ulcer: 20mg or 40mg once daily for up to 6 months

·         H. Pylori Eradication (triple therapy): 40mg once daily for 10 days in combination with Amoxicillin 1000mg twice daily for 10 days and Clarithromycin 500mg twice daily for 10 days

·         Pathological hypersecretory conditions: 40mg twice daily

Lansoprazole Adult

·         Duodenal Ulcer: Short-term Treatment- 15mg once daily for 4 weeks. Maintenance of Healed- 15mg once daily

·         H. Pylori Eradication: Triple therapy- 30mg twice daily for 10-14 days in combination with amoxicillin 1 gram and clarithromycin 500mg; Dual therapy; 30mg three times daily for 14 days in combination with amoxicillin 1 gram

·         Benign Gastric Ulcer: 30mg once daily for up to 8 weeks

·         NSAID Induced Gastric Ulcer: Healing-30mg once daily for up to 8 weeks. Risk Reduction- 15mg once daily up to 12 weeks

·         GERD: Short term treatment of symptomatic GERD- 15mg once daily up to 8 weeks. Short term treatment of EE- 30mg once daily up to 8 weeks

Pediatric (1-11 years of age): Short term treatment of symptomatic GERD and Short Term treatment of EE- ≤30 kg- 15mg once daily up to 12 weeks. >30kg- 30mg once daily up to 12 weeks.

Pediatric (12-17 years of age): Short term treatment of symptomatic GERD: Nonerosive GERD-15mg once daily up to 8 weeks. EE-30mg once daily up to 8 weeks

·         Maintenance of Healing EE: 15mg once daily

·         Pathological Hypersecretory Conditions: 60mg once daily

Omeprazole ·         Treatment of active duodenal ulcer: 20mg once daily for 4 weeks. Some patients may require an additional 4 weeks.

·         H. Pylori Eradication: Triple therapy- 20mg twice daily for 10 days in combination with amoxicillin 1 gram and clarithromycin 500mg; Dual therapy; 40mg once daily for 14 days in combination with clarithromycin 500mg

·         Gastric Ulcer: 40mg once daily for 4 to 8 weeks

·         GERD: 20mg once daily for 4 to 8 weeks

·         Maintenance of healing EE: 20mg once daily

·         Pathological Secretory Conditions: 60mg once daily. Varies by individual patient.

·         Pediatric Patients (1 to 16 years of age): GERD, Maintenance of healing EE- Weight Based- 5<10 kg- 5mg once daily, 10<20kg-10mg once daily, ≥20kg-20mg once daily

Pantoprazole ·         Short term treatment of EE associated with GERD: Adults- 40mg once daily up to 8 weeks, Children 5 years and younger: ≥15kg to < 40kg- 20mg once daily for up to 8 weeks; ≥40 kg- 40mg once daily for up to 8 weeks ·         Maintenance of Healing EE: 40mg once daily ·         Pathological Hypersecretory Conditions including Zollinger- Ellison Syndrome- 40mg twice daily

Mechanism of Action and Dosing:

Proton Pump Inhibitor. Suppresses gastric basal and stimulated acid secretion by inhibiting the parietal cell H+/K+ ATP pump.

Contraindications:

Hypersensitivity to any component of the formulation.

References:

  1. The Prioritized List of Health Services. Extracted from the October 1, 2021 Prioritized List. Guideline Note 144, Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease (GERD).
  2. Aciphex Prescribing Information. Revised 6/2018.
  3. Dexilant Prescribing Information. Revised 6/2018.
  4. Nexium Prescribing Information. Revised 10/2020.
  5. Prevacid Prescribing Information. Revised 10/2017.
  6. Prilosec Prescribing Information. Revised 9/2012.
  7. Protonix Prescribing Information. Revised 11/2020.

Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 1/7/21

GUIDELINE NOTE 144, PROTON PUMP INHIBITOR THERAPY FOR GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Lines 314,​380,​513

Short term treatment (up to 8 weeks) of GERD without Barrett’s (ICD-10-CM K20.8, K20.9, K21.0, K21.9) with proton pump inhibitor therapy is included on Line 380.

Long term proton pump inhibitor therapy is included on Line 380 for Barrett’s esophagus (ICD-10-CM K22.70). Long term treatment is included on Line 513 and on Line 314 for Barrett’s esophagus with dysplasia (ICD-10-CM K22.71).

Heart Failure

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Sacubitril/Valsartan Drug Use Criteria

Created: August 2017

Includes:

Entresto©                              Sacubitril / Valsartan

Guideline for Use:

For consideration of coverage, refer to the Oregon Medicaid Fee-For-Service (FFS) Drug Use Criteria for Entresto©, available at:

https://www.orpdl.org/durm/PA_Docs/sacubitrilvalsartan.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medications based on the best available evidence and to align with the Oregon Medicaid Fee for Service Drug Use Criteria.

References:

  1. Oregon Medicaid FFS Drug Use Criteria. Sacubitril / Valsartan. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 10/13/2021

Click HERE for a printable PDF

Sodium-Glucose CoTransporter-2 Inhibitors (SGLT-2 Inhibitors) Drug Use Criteria

Created: August 2020

Reviewed: September 30, 2020, October 2020, September 2021, January 2022

Includes:

Invokana©                              Canagliflozin

Invokamet XR©                      Canagliflozin/Metformin HCI

Invokamet©                             Canagliflozin/Metformin HCI

Farxiga©                                 Dapagliflozin Propanediol

XigduoXR©                              Dapagliflozin/Metformin HCI

Qtern©                                    Dapagliflozin/Saxagliptin HCI

Jardiance©                              Empagliflozin

Glyxambi©                               Empagliflozin/Linagliptin

Synjardy XR©                           Empagliflozin/Metformin HCI

Synjardy©                                Empagliflozin/Metformin HCI

Steglatro©                              Ertugliflozin Pidolate (Preferred for glycemic control)

Segluromet©                           Ertugliflozin/Metformin

Steglujan©                               Ertugliflozin/Sitagliptin

Trijardy XR©                           Empaglifozin/Linagliptin/Metformin

(Bolded items are preferred agents)

GUIDELINE FOR USE:

Initial Request:

  1. Is this a request for renewal of a previously approved prior authorization?
  2. a) Yes: Go the Renewal Criteria
  3. b) No: Go to #2
Drug Name Risk Reduction for major CV events in T2DM and established CV disease Risk Reduction of end-stage kidney disease in patients with T2DM and diabetic nephropathy with albuminuria >300mg/day Risk Reduction of eGFR decline and end-stage kidney disease CV death and hospitalization for HF in patients with CKD at risk of progression HF risk reduction in patients with T2DM and established CV disease or multiple CV risk factors HF risk reduction in patients with HFrEF (NYHA Class II-IV)
Invokana (canagliflozin) X X      
Farxiga (dapagliflozin)     X X X
Jardiance (empagliflozin) X       X
Steglatro (ertugliflozin)          

*Abbreviations: CKD- chronic kidney disease; CV- Cardiovascular; eGFR- estimated glomerular filtration rate; HF- heart failure; HFrEF- heart failure with reduced ejection fraction; NYHA- New York Heart Association; T2DM- Type 2 Diabetes Mellitus

  1. Does the member qualify for the requested therapy based on the diagnoses and requirements in Table 1?
  2. a) Yes: Go to #5
  3. b) No: Go to #3
  1. Does the member have T2DM and an A1c >9%?
  2. a) Yes: Deny as not meeting criteria. SGLT-2 Inhibitors aren’t recommended due to inferior glycemic efficacy and the potential for increasing symptoms from polyuria. Recommend basal insulin and prandial insulin.
  3. b) No: Go to #4.

 

  1. Does the patient have T2DM and has tried and failed metformin and another oral glucose lowering agent, have contraindications to these treatments or is the request for use of a SGLT-2 inhibitor with metformin and an oral glucose lowering agent? (Please document dose optimization, medication adherence, and/or clinical contraindications, if any e.g., heart failure). For dose optimization of oral glucose lowering agents, has member trialed maximum dose supported by manufacturer labeling or highest tolerated dose? For dose optimization of basal insulin, has member trialed at least 80 units per day of basal insulin?
  2. a) Yes: go to question #5
  3. b) No and not on basal insulin: Deny and recommend trial of metformin, other oral glucose lowering agents (sulfonylurea, pioglitazone, or alogliptin), or basal insulin (Semglee).

c). No and on basal insulin:  Go to #5

  1. Is the request for the following treatments (including combination products) with an associated estimated glomerular filtration rate (eGFR):
  • Canagliflozin and eGFR <30 mL/min/ 1.73 m2, or
  • Empagliflozin and eGFR <30 mL/min/1.73 m2, or
  • Dapagliflozin and eGFR <25 mL/min/1.73 m2, or
  • Ertugliflozin and eGFR <60 mL/min/1.73 m2?

*Additional manufacturer labeling information will be used on an individual basis.

  1. a) Yes: Deny as criteria not met. Use is not recommended per manufacturing labeling.
  2. b) No: Approve for 3 months. Please submit follow-up chart note evaluating response to treatment, including HgA1c level after treatment was initiated.

Renewal Request:

  1. Does member still meet initial criteria?

a).  Yes: Go to #2

b).  No:  Deny as not meeting criteria.

  1. Has the patient been adherent to therapy and if applicable, has HgA1c been reduced by 0.5% for T2DM?
  2. a) Yes: approve for 6 months.
  3. b) No: deny as criteria not met.

 

Rationale:

To promote value within step therapy management and evidence-based standard of care.  To ensure optimization of least costly formulary alternatives including metformin, other oral glucose lowering agents and basal insulin prior to initiating therapy with more costly SGLT-2 inhibitors. Adherence and dose optimization will be reviewed using prescription refill history for consideration of coverage for SGLT-2 inhibitors.

FDA Approved Indication:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus for all products. See Table 1 for medication specific indications.

References:

  1. American Diabetes Association (ADA). Standards of Medical Care in Diabetes – 2021. Diabetes Care 2021 Jan; 44(Supplement 1): S111-S124.
  2. Invokana Prescribing Information. Revised 8/2020.
  3. Invokamet XR Prescribing Information. Revised 8/2020.
  4. Invokamet Prescribing Information. Revised 8/2020.
  5. Farxia Prescribing Information. Revised 4/2021.
  6. XigduoXR Prescribing Information. Revised 1/2020.
  7. Qtern Prescribing Information. Revised 1/2020.
  8. Jardiance Prescribing Information. Revised 8/2021.
  9. Glyxambi Prescribing Information. Revised 6/2021.
  10. Synjardy XR Prescribing Information. Revised 6/2021.
  11. Synjardy Prescribing Information. Revised 6/2021.
  12. Steglatro Prescribing Information. Revised 9/2021.
  13. Segluromet Prescribing Information. Revised 9/2021.
  14. Steglujan Prescribing Information. Revised 9/2021.
  15. Trijardy Prescrbing Information. Revised 6/2021.
  16. UpToDate: Management of persistent hyperglycemia in type 2 diabetes mellitus. Last updated: January 18, 2022. Accessed January 27, 2022.

Glucose-lowering medication in type 2 diabetes: 2021 ADA Professional Practice Committee (PPC) adaptation of Davies et al. (35) and Buse et al. (36).

Approved by Advanced Health Pharmacy and Therapeutics Committee 9-30-2020, 10-21-20, 10-13-2021, 4-13-2022

Hepatitis C

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Direct Acting Antivirals for Treatment of Hepatitis C Drug Use Criteria

Created: October 2016

Revised: February 2019, August 2021

Includes:

Mavyret©                              Glecaprevir/Pibrentasvir

Vosevi©                                  Sofosbuvir/Velpatasvir/Voxilaprev

Epclusa© and generic            Sofosbuvir/Velpatasvir

Zepatier©                               Elbasvir/Grazoprevir

Harvoni© and generic           Ledipasvir/Sofosbuvir

Viekira Pak©                          Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir

Sovaldi©                                Sofosbuvir

Preferred agents on FFS Preferred Drug List

GUIDELINE FOR USE:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria for Hepatitis C Direct Acting Antivirals available at:

https://www.orpdl.org/durm/PA_Docs/HCV_directactingantivirals.pdf

Rationale:

To ensure medically appropriate, cost effective use of medications based on the best available evidence. To align with FFS Preferred Drug List (PDL) and drug use criteria consistent with requirements for the Oregon Health Authority Hepatitis C Risk Corridor.

References:

  1. Oregon Medicaid FFS Drug Use Criteria. Hepatitis C Direct Acting Antivirals (Effective March 1, 2019). Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Western Oregon Advanced Health Pharmacy and Therapeutics Committee 10/28/2016

Approved by Advanced Health Pharmacy and Therapeutics Committee 2/18/2019, 10/13/2021

HIV

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Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/19

Migraine

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Sumatriptan Injection and Nasal Spray Drug Use Criteria

Created: May 2017

Reviewed: May 2019, December 2021

Includes:

Imitrex Injection©                 Sumatriptan Injection

            Imitrex Nasal Spray©            Sumatriptan Nasal Spray

GUIDELINE FOR USE:

Initial Request:

  1. Is the medication being used for treatment of migraine headaches?
    1. If yes, continue to 2
    2. If no, deny as not meeting criteria. Off label use of medication is not a funded benefit on Oregon Health Plan.
  1. Has the patient trialed optimized dosing of formulary sumatriptan tablets or rizatriptan tablets? supported by prescription fill history review in MedAccess?
    1. If yes, go to 3.
    2. If no, deny as not meeting criteria. Please trial formulary, least costly alternatives of sumatriptan or rizatriptan tablets.
  1. Does the patient have any contraindications to sumatriptan therapy? (see below contraindications from FDA approved package insert)
    1. If yes, deny as not meeting criteria. Off label use of medication is not a covered benefit on OHP.
    2. If no, go to 4
  1. Is the requested dose of medication consistent with the FDA approved prescribing information?
    1. If yes, approve for 3 fills with limit of one box of #2 injections per 30-day supply. Monthly quantity limits are in place to prevent over-use or rebound headaches.
    2. If no, deny as not meeting criteria. Off label use of medication is not a covered benefit on OHP.

Renewal Request:

  1. Is there clinical documentation supporting response to therapy?
    1. If yes, approve for requested duration of therapy up to 12 fills with a limit of one box of #2 injections per 30-day supply.
    2. If no, deny as not meeting criteria. Documented effectiveness of therapy is required for continued coverage.

Rationale:

To promote use of the least costly formulary products for acute treatment of migraine.

FDA Approved Indication:

Generic Name (Brand Name) FDA Approved Indications
Sumatriptan Injection (Imitrex©) Acute treatment of migraine with or without aura in adults; Acute treatment of cluster headache in adults
Sumatriptan Nasal Spray (Imitrex©) Acute treatment of migraine with or without aura in adults

Mechanism of Action:

Sumatriptan is a serotonin (5-HT 1B/1D) receptor agonist (triptan).

Dosing:

Sumatriptan Nasal Spray may be administered as a single dose of 5mg, 10mg, or 20

  1. A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. Maximum dose in 24-hour period is 40mg.

Sumatriptan Injection is indicated for subcutaneous use only. A single dose of 1mg to 6mg for acute treatment of migraine headache. Single dose of 6mg for acute treatment of cluster headache. Maximum dose in a 24-hour period is 12mg separate doses by at least 1 hour.

Contraindications:

  • History of coronary artery disease or coronary artery vasospasm
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorder
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic Bowel Disease
  • Uncontrolled Hypertension
  • Recent (within 24 hours) use of another 5-HT1 agonist or of an ergotamine containing medication
  • Concurrent or recent (past 2 weeks) use of MOA-inhibitor
  • Hypersensitivity to sumatriptan (angioedema or anaphylaxis seen)
  • Severe hepatic impairment

References:

  1. Imitrex© (sumatriptan succinate) Injection Prescribing Information. Revised 7/2018. Accessed 12/20/2021.
  2. Imitrex© (sumatriptan) Nasal Spray Prescribing Information. Revised 12/2017. Accessed 12/20/2021.
  3. Oregon Administrative Rule 410-120-1200(2)(n)

Approved by WOAH Pharmacy and Therapeutics Committee 5/22/17

Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 1/7/21

Click HERE for printable PDF

Calcitonin Gene-Related Peptide (CGRP) Antagonist Drug Use Criteria

Created: October 2018

Reviewed: August 2020, August 2021

Includes:

Preventative Migraine Therapy

Aimovig©       Erenmab-aooe

Ajovy©           Fremanezumab-vfrm

Emgality©      Galcanezumab-gnlm   (migraine and cluster headache preventatives)                    

Vyepti©          Eptinezumab jjmr

Nurtec©         Rimegepant

Acute Migraine Therapy

Nurtec©         Rimegepant

            Ubrelvy©        Ubrogepant

Guideline for Use:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria at:

https://www.orpdl.org/durm/PA_Docs/CGRPinhibitors.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medication based on the best available evidence.

References:

1)  Oregon Medicaid FFS Drug Use Criteria. Calcitonin Gene-Related Peptide (CGRP) Antagonists. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health Pharmacy and Therapeutics Committee August 28,2020, 10/13/2021

Multiple Sclerosis

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Tecfidera (dimethyl fumarate) Drug Use Criteria

Created: July 13, 2021

Reviewed:

Includes:

Brand©                       Generic

Tecfidera                     dimethyl fumarate 120mg, 240mg capsules

GUIDELINE FOR USE:

Initial Request:

  1. Is medication being prescribed by or in consultation with a neurologist?
  2. Yes, go to #2.
  3. No, deny as criteria not met. Please resubmit prior authorization request with current neurology note.
  1. Is medication to be used to treat a relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and is member 18 years or older?
  2. Yes, go to #3.
  3. No, and deny as criteria not met. Off-label use of a medication is not a covered benefit on OHP.
  1. Is member on concurrent treatment with a disease modifying drug (i.e interferon beta-1b, glatiramer acetate, interferon beta-1a, natalizumab, ofatumumab, ocrelizumab, or mitoxantrone)?
  2. Yes, deny as criteria not met. Dimethyl fumarate is not to be used with other disease modifying drugs for MS.
  3. No, go to #4.
  1. Have baseline safety assessments been completed (i.e Does documentation include liver function tests and a baseline CBC with lymphocyte count greater than 500/μL)?
  2. Yes, approve for 6 months. Initial dose: dimethyl fumarate 120mg #14/7day supply. Maintenance dose: dimethyl fumarate 240mg #60/30 day supply.
  3. No, deny as criteria not met. Please resubmit request with current CBC results, including lymphocyte count and/or liver function test.

 

 

Renewal Request:

 

  1. Has the member’s condition improved as assessed by the prescribing physician and physician attests to patient’s improvement?
  2. Yes, approve for 12 months.
  3. No, forward to MD for review.

Fumarate Salts (Dimethyl Fumarate, Monomethyl Fumarate, Diroximel Fumarate) Clinical Notes:

  • Fumarate salts may decrease a patient’s white blood cell count. In the clinical trials the mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. The incidence of infections (60% vs. 58%) and serious infections (2% vs. 2%) was similar in patients treated with dimethyl fumarate or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8 x103 cells/mm3 (equivalent to <0.8 cells/μL). A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
  • Fumarate salts should be held if the WBC falls below 2 x103 cells/mm3 or the lymphocyte count is below 0.5 x103 cells/mm3 (cells/μL) and permanently discontinued if the WBC did not increase to over 2 x103 cells/mm3 or lymphocyte count increased to over 0.5 x103 cells/mm3 after 4 weeks of withholding therapy.
  • Patients should have a CBC with differential monitored every 6 to 12 months.

Rationale:

FDA Approved Indication:  Multiple sclerosis, relapsing: Treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Mechanism of Action: Dimethyl fumarate and its active metabolite, monomethyl fumarate (MMF), have been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in cellular response to oxidative stress. The mechanism by which dimethyl fumarate (DMF) exerts a therapeutic effect in MS is unknown, although it is believed to result from its anti-inflammatory and cytoprotective properties via activation of the Nrf2 pathway.

Dosing: Multiple sclerosis, relapsing: Oral: Initial: 120 mg twice daily; after 7 days, increase to the maintenance dose: 240 mg twice daily.

Contraindications:  Known hypersensitivity (eg, anaphylaxis, angioedema) to dimethyl fumarate or any component of the formulation.

References:

  1. American Academy of Neurology.  https://www.aan.com/Guidelines/home/GuidelineDetail/898
  2. https://www.uptodate.com/contents/indications-for-switching-or-stopping-disease-modifying-therapy-for-multiple-sclerosis?search=multiple%20sclerosis%20treatment&topicRef=129091&source=see_link
  3. Oregon Medicaid FFS Drug Class List – Dimethyl fumarate. https://www.orpdl.org/durm/PA_Docs/multiplesclerosisoralagents.pdf
  4. Drug information: Tecfidera FDA-approved prescribing information. https://www.tecfidera.com/content/dam/commercial/tecfidera/pat/en_us/pdf/full-prescribing-info.pdf

Approved by Advanced Health Pharmacy and Therapeutics Committee 10/13/2021

Click HERE for printable PDF

Ocrevus Drug Use Criteria

Created: October 2017

Reviewed: May 2019, August 2021

Includes:

Ocrevus©                   Ocrelizumab

GUIDELINE FOR USE:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria for Ocrevus© available at:

https://www.orpdl.org/durm/PA_Docs/ocrelizumab.pdf

Rationale:

To ensure medically appropriate, cost effective use of medications based on the best available evidence and to align with the Oregon Medicaid FFS Drug Use Criteria.

References:

  1. Oregon Medicaid FFS Drug Use Criteria. Ocrelizumab (Ocrevus©) Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by WOAH Pharmacy and Therapeutics Committee 10/23/17; Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 10/13/2021

Narcolepsy

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Short Acting Stimulant Drug Use Criteria for Adult Advanced Health Members ≥ 23 Years of Age

 

Created: 10/2015

Revised: 8/2018, 6/2019, 12/2021

 

Includes:

Adderall©                   amphetamine/dextroamphetamine

            Focalin ©                     dexmethylphenidate

Dexedrine©                dextroamphetamine

Ritalin©                      methylphenidate

GUIDELINE FOR USE:

Initial Request:

  1. Is the patient being treated for a funded condition by Oregon Health Plan?
    1. If yes, go to 2
    2. If no, deny as Below the Line. The condition being treated is below the funded line for Oregon Health Plan and is therefore not a covered benefit.
  1. Is the patient being treated for attention deficit disorder with or without hyperactivity or narcolepsy?
    1. If ADHD, go to 3
    2. If narcolepsy, go to 5
    3. If no, deny as Criteria Not Met. Stimulant therapy will be provided as a covered benefit for FDA approved indications supported by the medication package insert. Off label use of medication is not a covered benefit on Oregon Health Plan.

 

  1. Has the patient been evaluated and diagnosed with ADHD with or without hyperactivity and have co-morbid conditions that may contribute to ADHD symptoms been addressed (eg depression, anxiety, etc). Please provide documentation of assessment such as Adult ADHD Self-Report Scale (ASRS v1.1), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), clinical and historical interview. Demonstrated impairments should be present across multiple environmental domains (school, work, home, etc) and they should have been present since childhood/adolescence.
    1. If yes, go to 4
    2. If no, deny as Criteria Not Met. An evaluation and diagnosis of ADHD is required for coverage of stimulant therapy, including co-morbid conditions that may contribute to ADHD symptoms be addressed. Please submit documentation such as ASRS, PHQ-9, GAD-7, clinical and historical interview.
  1. Does the patient have a continued need for focus including school, work, or volunteer activities?
    1. If yes, go to 5
    2. If no, deny as Criteria Not Met. Patients should have a documented need for focus for coverage of stimulant therapy.

 

  1. Does the patient have a history of substance abuse?
    1. If yes, deny as Criteria Not Met. Schedule II stimulant medications have a high potential for abuse, misuse, and diversion. Use of stimulants are contraindicated in patients with a history of drug abuse. Consider therapy with a tricyclic antidepressant (desipramine or nortriptyline) or atomoxetine (Strattera). Buproprion is also an alternative if patients do not tolerate TCA therapy.
    2. If no, go to 6
  1. Is the patient using any other medications that have a potential for causing sedation or lack of focus? (e.g. opioid pain medications, marijuana, alcohol, benzodiazepines, etc). Urine drug screen should be provided that is negative for illicit substances.
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not indicated for treatment of sedation, fatigue, or lack of focus due to side effects of concomitant therapies.
    2. If no, go to 7

 

  1. Does the patient have blood pressure that is currently well controlled? (Chart notes documenting blood pressure will be required, and readings greater than 140/90 will not be approved for stimulant therapy)
    1. If yes, go to 8
    2. If no, deny as Criteria Not Met. Elevated blood pressure and heart rate are common side effects of stimulant therapy. Moderate to severe hypertension are contraindications to stimulant therapy. Consider therapy with clonidine for patients with ADHD and hypertension.

 

  1. Does the patient have preexisting structural cardiac abnormalities or other serious cardiac problems?
    1. If yes, deny as Criteria Not Met. Use of stimulant therapy has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems. Stimulants should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that can increase the risk of sudden death.
    2. If no, go to 9
  1. Does the patient have obstructive sleep apnea (OSA)?
    1. If no, go to 10
    2. If yes, is OSA managed with continuous positive airway pressure therapy (CPAP) or alternative therapies such as oral appliances?
      1. If yes, go to 10
      2. If no, deny as Criteria not Met. Untreated OSA is associated with poor concentration, excessive daytime sleepiness, and fatigue, which may impair daily function or induce/exacerbate cognitive deficits. OSA should be adequately controlled prior to initiating treatment with stimulants.

 

  1. Does the patient have bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, narrow angle or angle closure glaucoma, or hyperthyroidism?
    1. If yes, deny as Criteria Not Met. Stimulant therapy is not recommended in patients with bipolar disorder, preexisting psychosis, anxiety disorder, agitated state, glaucoma, or hyperthyroidism.

Note to reviewer: TCAs have been shown to be efficacious in adult ADHD.  TCAs have also been shown in clinical trials to reduce anxiety in patients with ADHD and comorbid anxiety.  Stimulants may exacerbate symptoms of behavior and thought disorder.  Stimulants may induce mixed/manic episodes in patients with bipolar disorder.  New onset psychosis or mania may also occur with stimulant use

  1. If no, go to 11
  1. Is the patient taking a MAO inhibitor, or quit taking a MAO inhibitor within 14 days of starting stimulant therapy? (e.g. isocarboxazid, phenelzine, tranylcypromine, or selegeline)
    1. If yes, deny as Criteria Not Met. Concomitant use of stimulants and MAO inhibitor therapy, or discontinuation within 14 days, is contraindicated due to increased risk of hypertensive crisis.
    2. If no, go to 12
  1. Has the provider documented that the Prescription Drug Monitoring Program (PDMP) has been queried?
    1. If yes, go to 13
    2. If no, request attestation that PDMP has been checked. If no attestation is available, deny as not meeting criteria. Attestation of PDMP check is required for coverage of C2 medications.

 

  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, approve for the requested duration of therapy up to 12 months
    2. If no, deny as Criteria Not Met. Doses above those supported by the FDA approved package insert are not a covered benefit on Oregon Health Plan.

 

 

Renewal Request:

  1. Does the above criteria continue to be met and do chart notes support positive response to therapy?
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, deny as not meeting criteria.

Rationale:

Stimulants used for the treatment of narcolepsy and attention deficit disorder with or without hyperactivity have a high propensity for abuse and diversion. Drug shortages of several stimulant medications have resulted in price increases for this class of drugs. Therefore, drug use criteria for stimulant therapy in adults is necessary to ensure appropriate patient selection, safety, and cost-effective management of ADHD and narcolepsy. Stimulant medications will not be approved for conditions not funded for coverage by Oregon Health Plan. Long acting stimulants will not be approved for members 23 years of age or older as they do not meet the least costly alternative rule for Oregon Health Plan. Short acting stimulants will be a plan benefit if the above drug use criteria are met.

FDA Approved Indication and Dosing:

Drug FDA Approved Indication Maximum Daily Dose

Adult/Pediatric

Duration of Action
amphetamine/dextroamphetamine

(mixed amphetamine salts)

ADHD, narcolepsy ADHD (≥6yo) 40mg/day

Narcolepsy 60mg/day

5 to 8 hours (duration increases with increased dose)
Dexmethylphenidate ADHD 20mg/day 4 to 5 hours
Dextroamphetamine ADHD, narcolepsy 40mg/day 4 to 6 hours
Methylphenidate ADHD, narcolepsy 60mg/day

Peds: NTE 2mg/kg/day

3 to 5 hours

Accepted Symptom Checklists and Questionnaire Links:

  • Adult ADHD Self-Report Scale (ASRS v1.1): http://www.mentalhealthprofessionalsinc.com/Forms/Adult_ADHD_Self-Report_Scale_(ASRS-v1.1).pdf
  • Patient Health Questionnaire (PHQ-9): http://www.agencymeddirectors.wa.gov/Files/AssessmentTools/13-PHQ-9%20form.pdf
  • Generalized Anxiety Disorder 7-item (GAD-7):

https://med.dartmouth-hitchcock.org/documents/GAD-7-anxiety-screen.pdf

References:

  1. Brent MD, David, Bukstein MD, Oscar, Solanto PhD, Mary. Treatment of attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  2. Bukstein MD, Oscar. Attention deficit hyperactivity disorder in adults: Epidemiology, pathogenesis, clinical features, course, assessment, and diagnosis. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  3. Bukstein MD, Oscar. Pharmacotherapies for attention deficit hyperactivity disorder in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  4. Clinical Resource, Comparison of ADHD Medications. Pharmacist’s Letter/Prescriber’s Letter. September 2021. Accessed December 20, 2021.
  5. Ritalin Prescribing Information. Novartis Pharmaceuticals Corporation. Revised 6/2021.
  6. Micromedix Healthcare Series Database 2.0. DrugDex Evaluation: Methylphenidate.
  7. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine.
  8. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dexmethylphenidate.
  9. Micromedix Healthcare Series Database 2.0 DrugDex Evaluation: Dextroamphetamine/Amphetamine.
  10. Adderall Prescribing Information. Shire Pharmaceuticals. Reference ID: 4036383. Revised date January 2017. Accessed December 20, 2021.
  11. Dexedrine Prescribing Information. GlaxoSmithKline. Revised date February 2018. Accessed December 20, 2021.
  12. Kline MD, Lewi. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Literature review current Nov 2021. Accessed December 20, 2021.
  13. Kryger MD FRCPS, Meir H, Malhotra MD, Atul. Management of obstructive sleep apnea in adults. UpToDate. Literature review current through Nov 2021. Accessed December 20, 2021.
  14. OAR 410-141-3855(15)
  15. 42 USC 1396w-3a

Approved by Managed Care Committee 4/27/12

Approved by WOAH Pharmacy and Therapeutics Committee 10/26/15

Approved by Advanced Health Pharmacy and Therapeutics Committee 8/27/18, 6/17/19, 1/7/21, 2/9/22

Click HERE for printable PDF

Long-Acting Stimulant Criteria for patients 6-22 years old

 

Created: 7/2013

Reviewed: 5/2019, 12/2021, 1/2022

 

Includes:

Adderall XR©                                                 amphetamine/dextroamphetamine

Focalin XR ©                                                   dexymethylphenidate

Dexedrine ER©                                               dextroamphetamine

Vyvanse©                                                       lisdexamfetamine

Ritalin LA©                                                     methylphenidate LA

Methylin ER©/Ritalin SR©/Metadate ER© methylphenidate

Metadate CD©                                               methylphenidate

*Includes any other non-formulary extended-release stimulants not listed

GUIDELINE FOR USE:

 

Initial Request:

  1. Is the patient being treated for attention deficit disorders with or without hyperactivity?
    1. If yes, go to 2
    2. If no, deny as below the line.
  1. Is the prescribed dose supported by the FDA approved package insert dosing guideline for the prescribed product?
    1. If yes, go to 2
    2. If no, deny as not meeting criteria. Off label use of medication is not a covered benefit on OHP.
  1. Has the patient failed therapy with the formulary agent, methylphenidate extended-release tablets (generic Methylin ER, Ritalin SR, Metadate ER)? Trial defined as at least 2 weeks of therapy at optimal dosing.
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, go to 4.

 

  1. Is the patient unable to swallow tablets?
    1. If yes, approve for requested duration of therapy up to 12 months for a product that is able to be sprinkled.
    2. If no, go to 5
  1. Has the patient experienced adverse side effects to methylphenidate therapy (e.g. appetite suppression and/or weight loss, mood changes, tics, insomnia).
    1. If yes, Approve for requested duration of therapy up to 12 months.
    2. If no, go to 6
  1. Is the patient in a residential treatment program, or a patient of the CDRC, and is stable on a non-formulary agent?
    1. If yes, approve for requested duration of therapy up to 12 months.
    2. If no, go to 7
  1. Has the patient been stable on therapy greater than 2 years?
    1. If yes, approve as an exception for 12 months.
    2. If no, go to 8
  1. Has the provider documented that the Prescription Drug Monitoring Program (PDMP) has been queried?
    1. If yes, go to 9
    2. If no, request attestation that PDMP has been checked. If no attestation is available, deny as not meeting criteria. Attestation of PDMP check is required for coverage of C2 medications.
  1. Is the patient new on Advanced Health and therapy is already established with a non-formulary agent?
    1. If yes, approve as an exception for 3 months with coordination of care with new PCP to trial methylphenidate ER tablets.
    2. If no, deny as non-formulary and request trial of formulary alternative.
Brand Name

(Generic Name)

FDA Approved Indication Maximum Daily Dose

Adult/Pediatric

Duration of Action
Adderall XR Capsule

(amphetamine/dextroamphetamine)

ADHD ADHD (≥6yo) 30mg/day 10 hours
Focalin XR Tablet

(dexmethylphenidate)

ADHD Adult 40mg/day

Pediatric 30mg/day

8 to 12 hours
Dexedrine ER Spansule

(dextroamphetamine)

ADHD, narcolepsy 40mg/day 6 to 8 hours
Vyvanse Capsule

(lisdexamfetamine)

ADHD 70mg/day 10 to 12 hours (up to 14 hrs in adults)
Ritalin LA Capsule

(methylphenidate LA)

ADHD, narcolepsy 60mg/day 6 to 9 hours
Methylin ER/ Ritalin SR/

 Metadate ER TABLET

(methylphenidate)

ADHD, narcolepsy 60mg/day 2 to 8 hours (dose QD or BID)
Metadate CD Capsule

(methylphenidate)

ADHD, narcolepsy 60mg/day 6 to 9 hours

 

Rationale:

To promote use of the least costly extended-release stimulant, methylphenidate extended release tablets, for management of ADHD in children and adolescents aged 6 to 22 years of age. To ensure dosing consistent with the FDA approved prescribing information.

References:

  1. Adderall XR Prescribing Information. Revised October 2021. Accessed December 20, 2021.
  2. Focalin XR Prescribing Information. Revised June 2021. Accessed December 20, 2021.
  3. Dexedrine Prescribing Information. Revised October 2020. Accessed December 20, 2021.
  4. Vyvanse Prescribing Information. Revised July 2021. Accessed December 20, 2021.
  5. Ritalin LA Prescribing Information. Revised June 2021. Accessed December 20, 2021.
  6. Metadate CD Prescribing Information. Reference ID 3303893. Accessed December 20, 2021.
  7. Ritalin SR Prescribing Information. Revised January 2019. Accessed December 20, 2021.
  8. OAR 410-141-3855(15)
  9. 42 USC 1396w-3a

Approved by WOAH Pharmacy and Therapeutics Committee 7/9/13

Approved by Advanced Health Pharmacy and Therapeutics Committee 5/13/19, 1/7/21, 2/9/22

Opioid Use Disorder

Click HERE for a printable PDF

Buprenorphine/Naloxone or Buprenorphine for Opioid Use Disorder Drug Use Criteria

Created: 06/2015

Updated: 02/17, 05/17, 08/17, 10/23/17, 08/23/18, 02/18/19, 4/22/19, 05/21/21, 10/7/21

Includes:

Suboxone© Sublingual Tablet, Sublingual film  Buprenorphine/naloxone

Zubsolv© Sublingual Tablet                                        Buprenorphine/naloxone (nonformulary)

Bunavail© Buccal Film                                                  Buprenorphine/naloxone (nonformulary)

Subutex© Sublingual Tablet                                       Buprenorphine

                Sublocade© Injection                                                   Buprenorphine

*All formulations of buprenorphine and buprenorphine/naloxone will require a prior authorization after the initial 30 days for consideration of coverage by Advanced Health.

GUIDELINE FOR USE:

  1. Does the prescriber have a ‘X’ waivered DEA license to prescribe buprenorphine products for opioid use disorder?
    1. If yes, continue to 2.
    2. If no, deny as not meeting criteria. An ‘X’ waiver is required for legal prescribing of buprenorphine products for opioid use disorder.
  1. Does the patient have a documented diagnosis of moderate to severe opioid use disorder (defined as ≥4 use disorder criteria by DSM-V)? *Chart notes from initial diagnosis must support diagnosis of opioid use disorder. See the attached DSM-5 Opioid Use Disorder Checklist on page 5.
    1. If yes, continue to 6.
    2. If no, continue to 3.
  1. Is the buprenorphine product being prescribed for documented diagnosis of mild opioid disorder (defined as 2-3 use disorder criteria by DSM-V)?
    1. If yes, continue to 4.
    2. If no, continue to 5.
  1. Is there rationale to why naltrexone (either long-acting injection or oral) or psychosocial treatment alone cannot be used?
    1. If yes, continue to 6.
    2. If no, approve for up to 30 days Request a taper plan of buprenorphine product and recommend change to naltrexone and/or psychosocial treatment. Per UpToDate first-line medication for mild opioid use disorder is long-acting naltrexone rather than an opioid agonist. Psychosocial treatment alone is a reasonable alternative for highly motivated patients who prefer nonmedication treatment, but since naltrexone is a generally safe and well-tolerated medication, working with such patients to encourage its use is advisable. Per the American Society of Addictive Medicine, pharmacologic treatment may not be appropriate for all patients along the entire opioid use disorder continuum (i.e., for individuals with new onset, mild opioid use disorder).
  1. Is the buprenorphine product being prescribed for a painful condition?
    1. If yes, and there is a well-documented opioid tapering plan failure for a patient that was previously on opioids with an MED ≥90, send for MD review. (OMB Policy State on chronic pain management).
    2. If yes, and the patient is not at MED ≥90, may approve for up to 30 days. Please provide a taper plan. Without a taper plan in place with the next prior authorization request, we will be unable to continue coverage of this medication. The buprenorphine products in this drug use are not FDA approved for chronic pain and opiates for chronic low back pain are not a covered benefit under the Oregon Health Plan. Please see Guideline Note 56 Non-Interventional Treatments for Conditions of the Back and Spine and Guideline Note 60 Opioids for Conditions of the Back and Spine.
    3. If no, deny as not meeting criteria. The buprenorphine products listed in this drug use criteria are only FDA-approved for opioid use disorder. Off-label use of medication is not a covered benefit under the Oregon Health Plan.
  1. Is the patient currently taking opioid analgesics or other controlled substances or illicit drugs?
    1. If yes, continue to 7.
    2. If no, continue to 8.
  1. Has a controlled substance taper plan, other than opioid analgesics, been submitted and honored with PA request or is there clinical rationale and/or behavioral health involvement that supports the benefit of concurrent therapy outweighing the risk?
    1. If yes, continue to 8.
    2. If yes, concurrent use of opioid and buprenorphine containing product is requested, has referral been made to ADAPT/OTP?
      1. If yes, approve up to 30 days, dependent on patient enrollment in program. *Note: enrollment may be problematic in areas of our network.
      2. If no, approve for up to 14 days. Request a referral be made to ADAPT/OTP. Referral will be required for consideration of ongoing coverage.
    3. If no, approve for up to 30 days. Request a taper plan and/or behavioral health consult/assessment for consideration of ongoing coverage.
  1. Is the patient 16 years old or younger?
    1. If yes, send for MD review.
    2. If no, continue to 9.
  1. Is the requested medication Sublocade (buprenorphine injection)?
    1. If yes, continue to 10.
    2. If no, continue to 12.
  1. Is the prescribed signed up for the Sublocade REMS program and has provided attestation that they will follow proper storage and administration?
    1. If yes, continue to 11.
    2. If no, deny as not meeting criteria. The prescriber must be signed up for the Sublocade REMS program. Storage requirements include refrigeration that is locked and only accessible by the prescriber. There needs to be policies and procedures in place to ensure medication is only dispensed to the healthcare provider.
  1. Has the patient had at least 7-days of a transmucosal buprenorphine product?
    1. If yes, continue to 14.
    2. If no, is there a plan to ensure patient has had the minimum 7-days of transmucosal buprenorphine product?
  1. If yes, continue to 14.
  2. If no, deny as not meeting criteria. FDA labeling states Sublocade is indicated to treat moderate to severe OUD in patients who have initiated treatment with a buprenorphine containing product, followed by dose adjustment for a minimum of 7 days.
  1. Is the dose of transmucosal buprenorphine prescribed ≤ 24 mg/day?
    1. If yes, continue to 13.
    2. If no, and request if for more than 24mg/day, submit for MD review. FDA approved prescribing information supports a maximum dose of 24mg/day. Doses higher than buprenorphine 24mg/naloxone 6mg have not been demonstrated to provide clinical advantage.
  1. Is the quantity limited to no more than 3 tablets/films per day?
    1. If yes, continue to 14.
    2. If no, is the patient stable on therapy?
  1. If yes, continue to 14.
  2. If no, approve up to 30 days and request change to different dosage form to be less than 3 tablets/films per day.
  1. Has a current urine drug screen (within 90 days) been submitted with the request and are the results consistent to prescription medication? *If positive for illicit drugs, will require UDS looking for buprenorphine.
    1. If yes, are there any positive results that are not explained by a prescription?
  1. If yes, approve for up to 30 days and request detailed urine drug screen looking for buprenorphine (and naloxone, if applicable).
  2. If no, continue to 15.
    1. If no, approve for up to 30 days and request a current urine drug screen.
  1. Is there documentation of the Oregon Prescription Drug Monitoring Program being queried to ensure no concurrent dispensing other controlled substances (stimulants, opioids, benzodiazepines, hypnotic sedatives)?
    1. If yes, continue to 16.
    2. If no, approve for up to 30 days. PDMP check is a requirement for consideration of ongoing coverage.
  1. Is the patient enrolled in the ADAPT Motivational Stepped Care Model or comparable behavioral health support for opioid use disorder?
    1. If yes, continue to 17.
    2. If no, approve for up to 30 days and recommend patient engage with behavioral health and/or ADAPT.
  1. Is the patient filling prescriptions at more than one pharmacy?
    1. If yes, approve for up to 30 days and request provider and member determine single pharmacy for prescription dispensing.
    2. If no, approve for up to 90 days.

*Renewal PA required after 90 days to ensure continued engagement with the ADAPT Motivational Stepped Care Model or comparable behavioral health support for opioid use disorder and that member continues to meet criteria for coverage. There is no duration of therapy limit on buprenorphine/naloxone therapy for patients that continue to meet criteria.

Renewals:

  1. Does the patient still meet all the criteria stated above?
    1. If yes, continue to 2.
    2. If no, approve for up to 30 days and request a taper plan.
  1. Has a current urine drug screen (within the past year) been submitted to ensure member is abstaining from other controlled/illicit substances and to support continued use of buprenorphine?
    1. If yes, may approve up to 12 months on a case-by-case basis.
    2. If no, approve for up to 30 days. Current urine drug screen is required.

*There is no duration of therapy limit on buprenorphine/naloxone therapy for patients that continue to meet criteria.

Rationale:

Due to the potential for diversion, misuse, and prescribing restriction for buprenorphine products, drug use criterion was developed to promote safe, evidence-based prescribing of buprenorphine and buprenorphine/naloxone for opioid use disorder and to align treatment with Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction and ADAPT Medication Assisted Treatment Protocol.

FDA Approved Indications:

-The FDA approved indication of buprenorphine sublingual tablet is for the treatment of opioid use disorder.

-The FDA approved indication of buprenorphine/naloxone sublingual tablet is for the maintenance treatment of opioid use disorder.

-The FDA approved indication of buprenorphine/naloxone sublingual film is for the treatment of opioid use disorder.

-The FDA approved indication of Sublocade is for the treatment of moderate to severe opioid use disorder.

*Of note, the FDA approved prescribing information for buprenorphine/naloxone and buprenorphine supports use as part of a complete treatment plan to include counseling and psychosocial support.

Opioid Use Disorder

Diagnostic Criteria

  1. A problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least two of the following, occurring within a 12-month period:
    1. Opioids are often taken in larger amounts or over a longer period than was intended.
    2. There is a persistent desire or unsuccessful efforts to cut down or control opioid use.
    3. A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects.
    4. Craving, or a strong desire or urge to use opioids.
    5. Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home.
    6. Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids.
    7. Important social, occupational, or recreational activities are given up or reduced because of opioid use.
    8. Recurrent opioid use in situations in which it is physically hazardous.
    9. Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance.
    10. Tolerance, as defined by either of the following:
      1. A need for markedly increased amounts of opioids to achieve intoxication or desired effect.
      2. A markedly diminished effect with continued use of the same amount of an opioid.
      3. Note: This criterion is not considered to be met for those taking opioids solely under appropriate medical supervision.
    11. Withdrawal, as manifested by either of the following:
      1. The characteristic opioid withdrawal syndrome (refer to Criteria A and B of the criteria set for opioid withdrawal, pp. 547–548).
      2. Opioids (or a closely related substance) are taken to relieve or avoid withdrawal symptoms.
      3. Note: This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision.

Specify if:

  • In early remission: After full criteria for opioid use disorder were previously met, none of the criteria for opioid use disorder have been met for at least 3 months but for less than 12 months (with the exception that Criterion A4, “Craving, or a strong desire or urge to use opioids,” may be met).
  • In sustained remission: After full criteria for opioid use disorder were previously met, none of the criteria for opioid use disorder have been met at any time during a period of 12 months or longer (with the exception that Criterion A4, “Craving, or a strong desire or urge to use opioids,” may be met).

Specify if:

  • On maintenance therapy: This additional specifier is used if the individual is taking a prescribed agonist medication such as methadone or buprenorphine and none of the criteria for opioid use disorder have been met for that class of medication (except tolerance to, or withdrawal from, the agonist). This category also applies to those individuals being maintained on a partial agonist, an agonist/antagonist, or a full antagonist such as oral naltrexone or depot naltrexone.
  • In a controlled environment: This additional specifier is used if the individual is in an environment where access to opioids is restricted.

Coding based on current severity /remission : Note for ICD-10-CM codes: If an opioid intoxication, opioid withdrawal, or another opioid-induced mental disorder is also present, do not use the codes below for opioid use disorder. Instead, the comorbid opioid use disorder is indicated in the 4th character of the opioid-induced disorder code (see the coding note for opioid intoxication, opioid withdrawal, or a specific opioid-induced mental disorder). For example, if there is comorbid opioid-induced depressive disorder and opioid use disorder, only the opioid-induced depressive disorder code is given, with the 4th character indicating whether the comorbid opioid use disorder is mild, moderate, or severe: F11.14 for mild opioid use disorder with opioid-induced depressive disorder or F11.24 for a moderate or severe opioid use disorder with opioid-induced depressive disorder.

Specify current severity /remission :

  • 50 (F11.10) Mild: Presence of 2–3 symptoms.
  • (F11.11) Mild, In early remission
  • (F11.11) Mild, In sustained remission
  • 00 (F11.20) Moderate: Presence of 4–5 symptoms.
  • (F11.21) Moderate, In early remission
  • (F11.21) Moderate, In sustained remission
  • 00 (F11.20) Severe: Presence of 6 or more symptoms.
  • (F11.21) Severe, In early remission
  • (F11.21) Severe, In sustained remission

References:

  1. Subutex© Prescribing Information. Updated 2/2018
  2. Zubsolv© Prescribing Information. Updated 3/2021
  3. Suboxone© Prescribing Information. Updated 3/2021
  4. Bunavail© Prescribing Information. Updated 2/2018
  5. Sublocade© Prescribing Information. Updated 6/2021
  6. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. 2004
  7. Brooner, R. K. and M. Kidorf (2002). “Using behavioral reinforcement to improve methadone treatment participation.” Sci Pract Perspect 1(1): 38-47.
  8. ADAPT Motivation Stepped Care (MSC): A protocol for office based buprenorphine assisted recovery from opioid use disorder.
  9. ADAPT Motivational Stepped Care graphic
  10. The American Society of Addiction Medicine (ASAM) National Practice Guideline for the Treatment of Opioid Use Disorder.  https://www.asam.org/Quality-Science/quality/2020-national-practice-guideline
  11. Substance Abuse and Mental Health Services Administration (SAMHSA) Medications for Opioid Use Disorder for Healthcare and Addiction Professionals, Policymakers, Patients, and Families Updated 2020 Treatment Improvement Protocol (TIP) 62. https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP20-02-01-006_508.pdf
  12. UpToDate Approach to treating opioid use disorder. Literature current through April 2021. Topic last updated May 5, 2021. Accessed 5/21/21.
  13. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Section II: Diagnostic Crtieria and Codes. Substance-Related and Addictive Disorders. Opioid Use Disorder. Accessed 9/16/2021.
  14. Oregon Medical Board: Pain Management. https://www.oregon.gov/omb/board/Philosophy/Pages/Pain-Management.aspx Accessed 9/28/21.

Approved by Advanced Health Pharmacy and Therapeutics Committee on 08/28/2017, 10/23/17, 08/27/2018, 02/18/19, 4/22/19, 6/9/2021, 10/13/2021

GUIDELINE NOTE 175, MEDICATION-ASSISTED TREATMENT OF OPIOID DEPENDENCE

Lines 1,​4

In patients who meet criteria for opioid use disorder, programs that offer treatment of opioid use disorder must offer patients a variety of evidence-based interventions including behavioral interventions, social support, and Medication Assisted Treatment (MAT) and are individualized to the patient’s needs. Intensive programs, such as inpatient residential treatment programs, are required to inform patients about MAT and to offer access to and support for MAT (including at least one form of opioid substitution therapy) if patients elect to receive it, to be included on this line.

MAT includes pharmacotherapy with opioid substitution therapy (methadone and buprenorphine) and opioid antagonists (naltrexone).

Detoxification alone is likely ineffective for producing long-term benefit and should be followed by a formal substance use disorder individualized treatment plan.

In pregnant women with opioid dependence, comprehensive treatment (including opioid substitution therapy) is included on this line.

Phenylketonuria

Click HERE for a printable PDF

Phenylketonuria Drug Criteria

Created: October 2018

Reviewed: May 2019, August 2021

Includes:

Palynzig©                   Pegvaliase

            Kuvan©                      Sapropterin

GUIDELINE FOR USE:

For consideration of coverage, refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria at:

https://www.orpdl.org/durm/PA_Docs/phenylketonuria.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medication based on the best available evidence and to align with the Oregon Medicaid Fee for Service Drug Use Criteria.

References:

  • Oregon Medicaid FFS Drug Use Criteria. Phenylketonuria. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Pulmonary Arterial Hypertension

Click HERE for a printable PDF

Pulmonary Hypertension Oral and Inhaled Drug Use Criteria

Created: October 2018

Reviewed: May 2019, August 2021

Includes:

Tracleer©                               Bosentan

Revatio©                                Sildenafil

Adcirca©                                Tadalafil

Letairis©                                 Ambrisentan

Ventavis©                              Ilporst Tromethamine

Opsumit©                              Macitentan

Adempas©                             Riociguat

Uptravi©                                Selexipag

Orenitram ER©                      Tretrostinil

Tyvaso©                                 Tretrostinil

GUIDELINE FOR USE:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria at:

https://www.orpdl.org/durm/PA_Docs/pulmonaryhypertension_oral_inhaled.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medication based on the best available evidence and to align with the Oregon Medicaid Fee for Service Drug Use Criteria.

References:

  1. Oregon Medicaid FFS Drug Use Criteria. Pulmonary Arterial Hypertension Oral and Inhaled Drugs. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health Pharmacy and Therapeutics Committee on February 18, 2019, May 13, 2019, 10/13/2021

Seizures

Click HERE for a printable PDF

Calcitonin Gene-Related Peptide (CGRP) Antagonist Drug Use Criteria

Created: October 2018

Reviewed: August 2020, August 2021

Includes:

Preventative Migraine Therapy

Aimovig©       Erenmab-aooe

Ajovy©           Fremanezumab-vfrm

Emgality©      Galcanezumab-gnlm   (migraine and cluster headache preventatives)                    

Vyepti©          Eptinezumab jjmr

Nurtec©         Rimegepant

Acute Migraine Therapy

Nurtec©         Rimegepant

            Ubrelvy©        Ubrogepant

Guideline for Use:

For consideration of coverage refer to the Oregon Medicaid Fee-For-Service Drug Use Criteria at:

https://www.orpdl.org/durm/PA_Docs/CGRPinhibitors.pdf

Rationale:

To ensure medically appropriate, cost-effective use of medication based on the best available evidence.

References:

1)  Oregon Medicaid FFS Drug Use Criteria. Calcitonin Gene-Related Peptide (CGRP) Antagonists. Drug Use Research and Management. Health Systems Division. Oregon Health Authority.

Approved by Advanced Health Pharmacy and Therapeutics Committee August 28,2020, 10/13/2021

Click HERE for printable PDF

Levetiracetam XR Drug Use Criteria

Created: September 2015

Revised: April 2019, 12/10/21

Includes:

Keppra XR©               Levetiracetam XR

*Please note generic Levetiracetam immediate release tablets are available on the Advanced Health formulary without a prior authorization.

GUIDELINE FOR USE:

Initial Request:

  1. Is the patient being treated for epilepsy or a seizure disorder?
    1. If yes, go to 2
    2. If no, deny as criteria not met. The use of this medication is reserved for members with FDA approved indications of epilepsy or seizure disorder. Off-label use of medication is not a covered benefit on OHP.
  2. Does the patient have any contraindications to levetiracetam therapy?
    1. If yes, deny as not meeting criteria. Off-label use of medication is not a covered benefit on OHP.
    2. If no, go to 3
  3. Is the dose prescribed consistent with the FDA approved prescribing information?
    1. If yes, go to 4
    2. If no, deny as not meeting criteria. Off-label use of medication is not a covered benefit on OHP.
  4. Has the patient failed an adequate trial of immediate-release levetiracetam?
    1. If yes, approve for requested duration of therapy up to 1 year.
    2. If no, deny as not meeting criteria. A trial of immediate-release levetiracetam is recommended prior to the use of levetiracetam XR.

Renewal Request:

  1. Is the patient stable on the prescribed regimen and are they filling medication consistently?
    1. If yes, approve for requested duration of therapy up to 1 year as continued therapy.
    2. If no, approve for one month and coordinate with provider regarding therapy change or adherence strategies to optimize patient outcome.

Rationale:

To ensure use consistent with FDA approved package insert and trial of least costly alternative agent.

FDA Approved Indication:

Adjunctive therapy in the treatment of partial onset seizure in patients 12 years of age and older with epilepsy.

Mechanism of Action:

The precise mechanism of action by which levetiracetam exerts its antiepileptic effect is unknown.

Dosing:

Initial treatment with a dose of 1000mg once daily. Increase by 1000mg every 2 weeks to a maximum recommended dose of 3000mg once daily.

Contraindications:

  • Known hypersensitivity to levetiracetam

References:

  1. Keppra XR© Package insert. Revised date 10/2020.

Approved by Managed Care 708/11

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/19, 1/7/21

Severe Acne

Click HERE for a printable PDF

Drospirenone Containing Oral Contraceptives Drug Use Criteria

Created: October 2014

Reviewed: September 2015, April 2019

Includes:

Yaz©                           Ethinyl Estradiol and Drospirenone

            Yasmin©                     Ethinyl Estradiol and Drospirenone

Zarah©                       Ethinyl Estradiol and Drospirenone

Vestura©                    Ethinyl Estradiol and Drospirenone

Syeda©                       Ethinyl Estradiol and Drospirenone

Ocella©                      Ethinyl Estradiol and Drospirenone

Nikki©                         Ethinyl Estradiol and Drospirenone

Loryna©                     Ethinyl Estradiol and Drospirenone

Gianvi©                      Ethinyl Estradiol and Drospirenone

            Zumandimine©         Ethinyl Estradiol and Drospirenone

            Jasmiel©                     Ethinyl Estradiol and Drospirenone

**or any other brand or generic formulation of oral contraceptive containing drospirenone.

Guideline for Use:

  1. Is the patient being treated for a funded condition by Oregon Health Plan?
    1. If yes, go to 2
    2. If no, deny as Below the Funded Line for Oregon Health Plan.
  1. Does the patient have Polycystic Ovary Syndrome (PCOS) supported in the chart notes submitted for review?
    1. If yes, approve for 12 fills.
    2. If no, go to 3
  1. Does the patient have Premenstrual Dysphoric Disorder (PMDD) supported in the chart notes submitted for review?
    1. If yes, approve for 12 fills.
    2. If no, deny as not meeting criteria. Please use formulary alternative.

 

Rationale:

Drospirenone containing oral contraceptives have been associated with an increased risk of thromboembolic events; therefore, in order to ensure the safest and most cost-effective oral contraceptive preparations are utilized for Advanced Health members, the above drug use criteria was developed. Acne must meet Guideline Note 132: Acne Conglobata and Acne Fulminans or Guideline Note 65: Severe Cystic Acne of the Prioritized List of Health Services to be considered a covered comorbid condition.

 

FDA Approved Indications: Indicated for the prevention of pregnancy, treatment of premenstrual dysphoric disorder (PMDD), and treatment of acne.

References:

 

Lexicomp. Ethinyl Estradiol and Drospirenone: Drug Information. Last updated 12/7/21.

Health Evidence Review Commission Prioritized List of Health Services. Guideline Note 132: Acne Conglobata and Acne Fulminans and Guideline Note 65: Severe Cystic Acne. October 1, 2021 Prioritized List.

Approved by DOCS/WOAH Pharmacy and Therapeutics Committee on 10/27/2014

Approved by Advanced Health Pharmacy and Therapeutics Committee on 4/22/19, 1/22/20, 1/7/21

Click HERE for a printable PDF

Coverage of Acne Medications for Members < 18 years of age

Created: March 14, 2022

Reviewed:

Includes:

Preferred medications:

Claravis©                                                            isotretinoin                                                        

Myorisan©                                                        isotretinoin

Zenatane©                                                        isotretinoin

*All other formulations prescribed for treatment of acne will be considered non-formulary.

* Benzoyl peroxide 2.5%, 5% or 10% gel #60 grams is a covered benefit when billed with doxycycline.  Quantity limit of #180 grams per 12-months.

*Please send in prior authorization request prior to prescribing to ensure member is eligible for medication according to timeframes specified in I-Pledge program. (If you or the member need help signing up for I-Pledge, please contact Advanced Health.)

GUIDELINE FOR USE:

  1. Is diagnosis funded by OHP or has provider submitted documentation supporting moderate acne and that acne has caused a profound psychological impact, contributing to low self-esteem, depression, and anxiety?
    1. If yes, then go to #2.
    2. If no, deny as BTL.
  1. Is medication FDA-approved for condition and has member trialed at least 90 days of formulary alternatives, doxycycline with topical benzoyl peroxide gel, and adapalene, or has provider submitted clinical rationale for why formulary alternatives cannot be trialed or optimized?
  2. If yes, then approve for 90 days.
  3. If no, deny as criteria not met/non-formulary. Please trial at least 90 days of doxycycline plus topical benzoyl peroxide gel.

Renewal Criteria: 

  1. Has condition improved and does documentation support continued therapy?
    1. If yes, approve for 90 days.
    2. If no, deny as criteria not met. Please submit current chart note evaluating response to requested medication.

Rationale:  To ensure there is a funded condition, treatments are used appropriately, and formulary alternatives have been utilized prior to advancing treatment for acne in member under the age of 18.

FDA Approved Indication:

Isotretinoin: Acne, severe recalcitrant nodular: Treatment of severe recalcitrant nodular acne unresponsive to conventional therapy (including systemic antibiotics).

Mechanism of Action:

Reduces sebaceous gland size and reduces sebum production in acne treatment; in neuroblastoma, decreases cell proliferation and induces differentiation.

Dosing: Acne vulgaris, severe recalcitrant nodular: Children ≥12 years and Adolescents:

Softgel capsule (eg, generics, Amnesteem, Claravis, Myorisan, Zenatane) or hard-gelatin capsule (Absorica):

Initial: Oral: 0.5 mg/kg/day in 2 divided doses for 4 weeks, then increase dose to 1 mg/kg/day in 2 divided doses (AAD [Zaenglein 2016]; AAP [Eichenfield 2013]); for severe extensive cases (involving trunk, nuchal region, lower back, buttocks, thighs) may require higher doses up to 2 mg/kg/day in 2 divided doses (manufacturer labeling).

Duration of therapy: Typically 15 to 20 weeks depending upon daily dose; a target cumulative dose range of 120 to 150 mg/kg has been recommended based on observed lower relapse rates with courses ≥120 mg/kg and the plateau effect observed with higher cumulative total doses of >150 mg/kg (AAD [Zaenglein 2016]).

Repeat course: In older adolescents who have completed skeletal growth, a second course of isotretinoin may be repeated after a period of ≥2 months off therapy for persistent or recurring severe nodular acne; for younger patients who have not completed skeletal growth, the optimal interval before retreatment has not been defined.

Contraindication:

Hypersensitivity to isotretinoin or any component of the formulation; sensitivity to parabens (Zenatane only) or vitamin A; pregnancy.

References:

  1. Up To Date Acne vulgaris: Management of moderate to severe acne.Literature review current through: Feb 2022. This topic last updated: Feb 17, 2021. Accessed March 14, 2022.
  2. Up To Date Acne vulgaris: Overview of management. Literature review current through:Feb 2022.  This topic last updated: Oct 26, 2021.  Accessed March 14, 2022.
  3. Isotretinoin prescribing information.
  4. Journal of the American Academy of Dermatology. Guidelines of care for the management of acne vulgaris. https://www.jaad.org/article/S0190-9622(15)02614-6/fulltext#secsectitle0055.
  5. American Academy of Dermatology Association. https://www.aad.org/member/clinical-quality/guidelines/acne.
  6. Restricted Distribution is the US: refer to ipledgeprogram.com for more information.

Approved by Advanced Health Pharmacy and Therapeutics Committee 6/8/22

Click HERE for a printable PDF

Coverage of Acne Medications for Members < 18 years of age

Created: March 14, 2022

Reviewed:

Includes:

Preferred medications:

Differin© 0.1% gel 15 grams              adapalene      

                        Clindamycin 0.1% solution 60 grams

*All other formulations prescribed for treatment of acne will be considered non-formulary.

* Benzoyl peroxide 2.5%, 5% or 10% gel #60 grams is a covered benefit when billed with doxycycline.  Quantity limit of #180 grams per 12-months.

GUIDELINE FOR USE:

  1. Does the member have moderate to severe acne?
    1. If yes, go to 2.
    2. If no, deny as below the Oregon Health Plan funded line.
  1. Has the member trialed and failed use of first step agents (doxycycline with or without benzoyl peroxide) or has clinical rationale been submitted explaining why first step agents cannot be utilized?
  2. If yes, then approve for 90 days.
  3. If no, deny as not meeting criteria. Trial of doxycycline with or without benzoyl peroxide is required or clinical rationale to why first step agents cannot be used.

Renewal Criteria: 

  1. Has condition improved and does documentation support continued therapy? (Of note – topical therapies can accomplish continued efficacy months after discontinuation of systemic antibiotics).
  2. If yes, then approve for 90 days.
  3. If no, deny as criteria not met. Please submit current chart note evaluating response to requested medication.

Rationale:  To ensure there is a funded condition, treatments are used appropriately, and formulary alternatives have been utilized prior to advancing treatment for acne in member under the age of 18.

FDA Approved Indication:

Differin:  Treatment of acne vulgaris.

Mechanism of Action:

Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris

Dosing: Acne vulgaris, treatment: Children ≥7 years and Adolescents: Limited data available in ages <12 years.

Topical: Apply once daily; cream, gel, or solution should be applied in the evening (at bedtime). Note: During the initial 2 weeks of therapy, it may appear that acne worsens; full effect may take up to 8 to 12 weeks of therapy.

Contraindication:

Hypersensitivity to adapalene or any component of the formulation.

FDA Approved Indication:

Clindamycin: Acne vulagris

Mechanism of Action:

Reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism.

Dosing:

Acne: Topical: Gel (Cleocin T, ClindaMax), pledget, lotion, solution: Apply a thin film twice daily.

Contraindication:

Hypersensitivity to clindamycin, lincomycin, or any component of the formulation; history of antibiotic-associated colitis, regional enteritis, ulcerative colitis.

References:

  1. Up To Date Acne vulgaris: Management of moderate to severe acne.Literature review current through: Feb 2022. This topic last updated: Feb 17, 2021. Accessed March 14, 2022.
  2. Up To Date Acne vulgaris: Overview of management. Literature review current through:Feb 2022.  This topic last updated: Oct 26, 2021.  Accessed March 14, 2022.
  3. Clindamycin solution prescribing information.
  4. Adapalene prescribing information.
  5. Journal of the American Academy of Dermatology. Guidelines of care for the management of acne vulgaris. https://www.jaad.org/article/S0190-9622(15)02614-6/fulltext#secsectitle0055.
  6. American Academy of Dermatology Association. https://www.aad.org/member/clinical-quality/guidelines/acne.

Approved by Advanced Health Pharmacy and Therapeutics Committee 6/8/22

GUIDELINE NOTE 65, SEVERE CYSTIC ACNE

Lines 453,​522

Acne is only included on Line 453 if it is severe, defined as the presence of the following characteristics: persistent or recurrent inflammatory nodules and cysts AND ongoing scarring. Otherwise, acne diagnoses are included on Line 522.

Note that acne with recurrent abscesses or communicating sinuses is covered according to Guideline Note 132 ACNE CONGLOBATA AND ACNE FULMINANS.

Sinusitis

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Intranasal Corticosteroids Drug Use Criteria

Created: 6/9/10

Revised: 9/23/15, 5/21/17, 5/28/2021

Includes:

Beconase AQ©, QNasal©                              Beclomethasone

            Rhinocort©, Rhinocort Allergy©                  Budesonide

            Omnaris©, Zetonna©                                   Ciclesonide

            Nasalide©, Nasarel©                                     Flunisolide

            Veramyst©                                                     Fluticasone furoate

            Nasonex©                                                      Mometasone

            Nasacort©, Nasacrot Allergy 24HR©           Triamcinolone

*Highlighted in yellow is preferred agent after fluticasone propionate (Flonase©)

*Generic fluticasone propionate nasal spray is a covered benefit without a prior authorization (16 gram only). Nasacort Allergy 24HR© (triamcinolone) may be considered as a second line agent for those patients unable to tolerate generic fluticasone nasal spray and meeting the below drug use criteria.

Guideline for Use:

  1. Is the patient being treated for an above the line diagnosis for which a substantial body of evidence exists to support use of intranasal corticosteroids?
    1. If yes, continue to 2
    2. If no, deny as below the line
  2. Has there been a trial and failure or contraindication for preferred fluticasone propionate?
    1. If yes, go to 3
    2. If no, deny as not meeting criteria. Trial/failure or contraindication of fluticasone propionate is required.
  3. Does the patient have a funded condition such as chronic sinusitis, acute sinusitis, or sleep apnea for which a substantial body of evidence exists to support use of intranasal corticosteroids?
    1. If yes, approve for requested duration of therapy up to 6 months for chronic sinusitis or sleep apnea and approve for 30 days for acute sinusitis.
    2. If no, go to 4

*Please note there is insufficient evidence supporting use of intranasal corticosteroids for COPD.

  1. Does the patient have a diagnosis of asthma or reactive airway disease, or a covered comorbid condition?
    1. If yes, approve for requested duration of therapy up to 6 months
    2. If no, deny as not meeting criteria
  2. Is there a clinical rationale for use of a nonformulary agent (e.g. documented intolerance to formulary agent, etc.)?
    1. If yes and request is for Nasacort Allergy 24HR©, approve for the requested duration of therapy up to 6 months
    2. If yes and request is for nonformulary agent, and documented failure or intolerance to both fluticasone propionate and Nasacort Allergy 24HR© has been substantiated in the chart note and prescription fill history, review price comparison of intranasal steroids and recommend use of next least costly option. If next least costly alternative prescribed, approve for 6 months. Otherwise deny as not meeting criteria; does not meet the least costly alternative rule for OHP

Rationale: To promote the use of intranasal corticosteroids for conditions funded for coverage by Oregon Health Plan and where there is evidence of benefit. Treatment for allergic or non-allergic rhinitis is only funded for coverage when it exacerbates asthma, sinusitis, or obstructive sleep apnea. Evidence is insufficient to draw any conclusions about comparative effectiveness, efficacy, or safety between intranasal corticosteroid formulations for management of asthma-related outcomes, obstructive sleep apnea, acute sinusitis and chronic rhinosinusitis, therefore the least costly formulations will be covered. Also, to align coverage with the State FFS drug use criteria for intranasal corticosteroids.

FDA Approved Indication: Generic Name (Brand Name) FDA Approved Indications
Beclomethasone (Beconase AQ©) Allergic, non-allergic rhinitis ≥ 6yo
Beclomethasone (QNASL©) Allergic rhinitis ≥ 4 yo
Budesonide (Rhinocort Aqua, Rhinocort Allergy) Allergic rhinitis ≥ 6 yo
Ciclesonide (Omnaris) Allergic rhinitis ≥ 12yo
Ciclesonide (Zetonna) Allergic rhinitis ≥12 yo
Flunisolide Allergic rhinitis ≥ 6 yo
Fluticasone furoate (Veramyst) Allergic rhinitis ≥ 2 yo
Fluticasone propionate (Flonase, Flonase Allergy Relief) Allergic rhinitis ≥ 4yo
Mometasone (Nasonex) Allergic rhinitis ≥ 2yo, Nasal polyps ≥18 yo
Triamcinolone (Nasacort AQ, Nasacort Allergy 24HR) Allergic rhinitis ≥ 2 yo

References:

  1. Intranasal Allergy Drug Class Review. Oregon State University Drug Use Research and Management Program. July 2015. http://www.orpdl.org/durm/meetings/meetingdocs/2015_07_30/archives/2015_07_30_IntranasalAllergyDrugsClassReview_FINAL.pdf
  2. Advanced Health Drug Use Criteria. Last updated 09/23/2015.
  3. Beconase AQ© Prescribing Information. Revised 2/2021
  4. QNASL© Prescribing Information. Revised 3/2018
  5. Rhinocort Aqua© Prescribing Information. Revised 12/2010
  6. Omnaris© Prescribing Information. Revised 10/2019
  7. Zetonna© Prescribing Information. Revised 1/2012
  8. Veramyst© Prescribing Information. Revised 4/2007
  9. Flonase© Prescribing Information. Revised 1/2015
  10. Nasonex© Prescribing Information. Revised 1/2011
  11. Nasacort AQ© Prescribing Information. Revised 2008
  12. Oregon Administrative Rule 410-120-1200 (2)(n)
  13. Oregon Administrative Rule 410-141-0480 (8)(a)(C)

Approved by WOAH P&T on 5/22/2017

Approved by Advanced Health Pharmacy and Therapeutics Committee 4/22/2019, 6/9/2021

Tobacco Cessation

Click HERE for a printable PDF

Tobacco Cessation Drug Criteria

 

Created: February 2016

Revised: October 2018, May 2019, December 2021

 

Includes:

Nicotine Inhaler

Nicotine Nasal Spray

Please Note: Nicotine patches, nicotine gum, nicotine lozenges, bupropion SR 150mg tablets, and varenicline tablets are available on the Advanced Health formulary without a prior authorization for up two quit attempts per year as outlined by the Oregon Health Authority Cigarette Smoking Prevalence (Bundled Measure) and the Prioritized List of Health Services Guideline Note 4: Tobacco Dependence, Including During Pregnancy. See Minimum Quantities Table below. For additional information on the Tobacco Cessation metric see:

http://www.oregon.gov/oha/analytics/CCOData/CigaretteSmokingPrevalenceBundle

GUIDELINE FOR USE:

  1. Has the patient attended a tobacco cessation course within the past 3 months, or are they engaged with behavioral health therapy? (Exception to attendance of tobacco cessation course allowed for members that live in areas where no tobacco cessation course is offered, or member has a physical or mental health condition that restricts their participation in a tobacco cessation course. Documentation from the provider must be provided to support the need for an exception.)
    1. If yes, go to step 2
    2. If no, deny as Criteria Not Met. Member must attend tobacco cessation course for coverage of Nicotine Inhaler or Nicotine Nasal Spray. Nicotine patches, gum, lozenge, bupropion SR 150mg tablets, and varenicline are available without a prior authorization for up to two quit attempts per year on formulary. Use of behavioral health supports with medication therapy optimizes cessation outcomes.
  2. Has the patient trialed nicotine patches, nicotine gum, nicotine lozenges, bupropion SR 150mg tablets, and varenicline within the past 12 months or have a contraindication to the above listed therapies?
    1. If yes, approve for 3 months of therapy based on quantity limits outlined below.
    2. If no, deny as Criteria not met. Nicotine patches, gum, lozenge, bupropion SR 150mg tablets, and varenicline are available without a prior authorization for up to two quit attempts per year on formulary.

Rationale:

To promote utilization of the most cost-effective medication therapies available for tobacco cessation and to encourage participation in behavioral supports to improve outcomes of tobacco cessation efforts for Advanced Health members.

Minimum Quantities Table for Cessation Benefit from CCO Incentive Measure Specification Sheet

for Cigarette Smoking Prevalence:

References:

  1. Oregon Health Authority. CCO Incentive Measure Specification Sheet for 2016 Measurement Year: Cigarette Smoking Prevalence (Bundled Measure).
  2. Health Evidence Review Commission Prioritized List of Health Services. Guideline Note 4: Tobacco

Dependence, Including during pregnancy. October 1, 2021.

Approved by Western Oregon Advanced Health Pharmacy and Therapeutics Committee on 3/29/16

Approved by Advanced Health Pharmacy and Therapeutics Committee on 10/22/18, 5/13/19, 1/7/21

GUIDELINE NOTE 4, TOBACCO DEPENDENCE, INCLUDING DURING PREGNANCY

Lines 1,​5

Pharmacotherapy (including varenicline, buproprion and all five FDA-approved forms of nicotine-replacement therapy) and behavioral counseling are included on this line, alone or in combination, for at least two quit attempts per year. At least two quit attempts per year must be provided without prior authorization, and each attempt can include both pharmacotherapy and behavioral counseling.  Combination drug therapy (i.e. two forms of NRT or NRT plus buproprion) is also included with each quit attempt without prior authorization. However, nicotine inhalers and sprays may be subject to prior authorization.

A minimum of four counseling sessions of at least 10 minutes each (group or individual, telephonic or in person) are included for each quit attempt. More intensive interventions and group therapy are likely to be the most effective behavioral interventions. During pregnancy, additional intensive behavioral counseling is strongly encouraged. All tobacco cessation interventions during pregnancy are not subject to quantity or duration limits.

Inclusion on this line follows the minimum standard criteria as defined in the Oregon Public Health Division “Standard Tobacco Cessation Coverage” (based on the Patient Protection and Affordable Care Act), available here: https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/TOBACCOPREVENTION/Documents/tob_cessation_coverage_standards.pdf. The USPSTF has also made “A” recommendations for screening, counseling, and treatment of pregnant and nonpregnant adults, included in Guideline Note 106.

The development of this guideline note was informed by a HERC coverage guidance. See https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx