Subject: CGRP Receptor Antagonists Oral, Nasal ST with Limit, Post PA Policy 3481-E UDR 06-2024

Drug

ORAL, NASAL CALCITONIN GENE-RELATED PEPTIDE (CGRP) RECEPTOR ANTAGONISTS

NURTEC ODT  (rimegepant)

QULIPTA  (atogepant)

UBRELVY  (ubrogepant)

ZAVZPRET  (zavegepant)

Policy:

FDA-APPROVED INDICATIONS
Nurtec ODT
Acute Treatment of Migraine
Nurtec ODT is indicated for the acute treatment of migraine with or without aura in adults.
Preventive Treatment of Episodic Migraine
Nurtec ODT is indicated for the preventive treatment of episodic migraine in adults.

Qulipta
Qulipta is indicated for the preventive treatment of migraine in adults.

Ubrelvy
Ubrelvy is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Ubrelvy is not indicated for the preventive treatment of migraine.

Zavzpret
Zavzpret is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Zavzpret is not indicated for the preventive treatment of migraine.


INITIAL STEP THERAPY with QUANTITY LIMIT* For Ubrelvy and Zavzpret
*Include Rx and OTC products unless otherwise stated.

If the patient has filled a prescription for at least a 30 day supply of two triptan 5-HT1 receptor agonists (include combinations) within the past 180 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit.** If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

**If the patient meets the initial step therapy criteria, then the initial limit criteria will apply. If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that a PA is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.


INITIAL STEP THERAPY with QUANTITY LIMIT* For Nurtec ODT
*Include Rx and OTC products unless otherwise stated.

If the patient has filled a prescription for at least a 30 day supply of two triptan 5-HT1 receptor agonists (include combinations) within the past 180 days OR at least a 56 day supply of divalproex sodium, topiramate, valproate sodium, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, candesartan, amitriptyline, or venlafaxine within the past 730 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit.** If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

**If the patient meets the initial step therapy criteria, then the initial limit criteria will apply. If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that a PA is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.


INITIAL STEP THERAPY with QUANTITY LIMIT* For Qulipta
*Include Rx and OTC products unless otherwise stated.

If the patient has filled a prescription for at least a 56 day supply of divalproex sodium, topiramate, valproate sodium, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, candesartan, amitriptyline, or venlafaxine within the past 730 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit.** If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

**If the patient meets the initial step therapy criteria, then the initial limit criteria will apply. If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that a PA is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

**INITIAL LIMIT QUANTITY      Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength.      PLEASE NOTE: Since manufacturer package sizes may vary, it is the discretion of the dispensing pharmacy to fill quantities per package size up to these      quantity limits. In such cases, the filling limit and day supply may be less than what is indicated.
Drug	1 Month Limit*	3 Month Limit*
Nurtec ODT (rimegepant)	16 orally disintegrating tablets / 25 days	48 orally disintegrating tablets / 75 days
Qulipta 10 mg, 30 mg, 60 mg (atogepant)	30 tablets / 25 days	90 tablets / 75 days
Ubrelvy 50 mg, 100 mg (ubrogepant)	16 tablets / 25 days	48 tablets / 75 days
Zavzpret (zavegepant)	6 nasal spray units / 18 days	24 nasal spray units / 75 days
*The duration of 18 days is used for a 21-day fill period, 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

 

COVERAGE CRITERIA

Acute Treatment of Migraine
Authorization may be granted when the requested drug is being prescribed for the acute treatment of migraine in an adult patient when ALL of the following criteria are met:
     •   The request is for Nurtec ODT, Ubrelvy, or Zavzpret
     •   The patient meets ONE of the following criteria:
               °   The patient experienced an inadequate treatment response or an intolerance to TWO
                    triptan 5-HT1 receptor agonists
     •   The patient has a contraindication that would prohibit a trial of triptan 5-HT1 receptor agonists

Preventive Treatment of Episodic Migraine
Authorization may be granted when the requested drug is being prescribed for the preventive treatment of episodic migraine in an adult patient when ALL of the following criteria are met:
     •   The request is for Nurtec ODT
     •   The patient has NOT received at least 3 months of treatment with the requested drug

Preventive Treatment of Migraine
Authorization may be granted when the requested drug is being prescribed for the preventive treatment of migraine in an adult patient when ALL of the following criteria are met:
     •   The request is for Qulipta
     •   The patient has NOT received at least 3 months of treatment with the requested drug


CONTINUATION OF THERAPY

Acute Treatment of Migraine
All patients (including new patients) requesting authorization for continuation of therapy must meet ALL requirements in the coverage criteria section.

Preventive Treatment of Episodic Migraine
Authorization may be granted when the requested drug is being prescribed for the preventive treatment of episodic migraine in an adult patient when ALL of the following criteria are met:
     •   The request is for Nurtec ODT
     •   The patient has received at least 3 months of treatment with the requested drug
     •   The patient had a reduction in migraine days per month from baseline

Preventive Treatment of Migraine
Authorization may be granted when the requested drug is being prescribed for the preventive treatment of migraine in an adult patient when ALL of the following criteria are met:
     •   The request is for Qulipta
     •   The patient has received at least 3 months of treatment with the requested drug
     •   The patient had a reduction in migraine days per month from baseline


QUANTITY LIMITS APPLY
Ubrelvy: 16 tablets per month, 48 tablets per 3 months
Nurtec ODT: 16 tablets per month, 48 tablets per 3 months
Qulipta: 30 tablets per month, 90 tablets per 3 months
Zavzpret: 6 nasal spray units per 3 weeks, 24 nasal spray units per 3 months

*The duration of 18 days is used for a 21-day fill period, 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

 

DURATION OF APPROVAL (DOA)

     •   3481-E:
               °   Nurtec ODT, Ubrelvy, Zavzpret (Acute Treatment): DOA: 12 months
               °   Nurtec ODT, Qulipta (Preventive Treatment): Initial therapy DOA: 3 months; Continuation
                    of therapy DOA: 12 months

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nurtec ODT [package insert]. New Haven, CT: Biohaven Pharmaceuticals, Inc; April 2023.
2. Qulipta [package insert]. Madison, NJ: Allergan USA, Inc.; June 2023.
3. Ubrelvy [package insert]. Madison, NJ: Allergan USA, Inc.; June 2023.
4. Zavzpret [package insert]. New York, NY: Pfizer Las Division of Pfizer Inc.; March 2023.
5. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed April 11, 2024.
6. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 04/11/2024).
7. American Headache Society. The American Headache Society Position Statement on Integrating New Migraine Treatments into Clinical Practice. Headache 2019; 59:1-18.
8. Marmura M, Silberstein S, Schwedt T. The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies.  Headache 2015;55:3-20.
9. Ailani J, Burch RC, Robbins MS et al. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021; 61:1021-1039.
10. Silberstein S, Holland S, Freitag F, et al. Evidence-Based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults: Report of the Quality and the American Headache Society Standards Subcommittee of the American Academy of Neurology. Neurology 2012;78;1337-1345.
11. Silberstein S, Holland S, Freitag F, et al. Evidence-Based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults: Report of the Quality and the American Headache Society Standards Subcommittee of the American Academy of Neurology. Neurology 2013;80;871
12. Charles A, Digre K, Goadsby P, et al. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024; 00:1-9.
13. American Academy of Neurology. Update: Pharmacologic Treatments for Episodic Migraine Prevention in Adults. Available at: https://www.aan.com/Guidelines/Home/GetGuidelineContent/545. Accessed April 2024.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

September 29, 2024