UBRELVY (ubrogepant)

UBRELVY (ubrogepant)

Self-Administration – Oral

Indications for Prior Authorization:

• Acute Treatment of Migraine - indicated for the acute treatment of migraine with or without aura in adults.
  • Limitations of Use: Not indicated for the preventive treatment of migraine.

Coverage Criteria:

For acute treatment of migraine:

• Patient is 18 years of age or older; AND
• Documented trial and failure or intolerance to TWO triptan medications, or a contraindication to all triptan drugs (i.e., sumatriptan, rizatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, zolmitriptan); AND
• Average number of migraine headaches experienced per month is confirmed by medical records; AND
• If patient experiences 4 or more migraine headaches days per month, then one of the following:
  • Patient has experienced an inadequate response (minimum two-month trial) to at least TWO prophylactic medications used for migraine headaches, each from a different pharmacologic class supported by the American Academy of Neurology, American Headache Society (AAN/AHS), or a contraindication to all medications listed for migraine headache prophylaxis:
    • Antiepileptic drugs (i.e., divalproex sodium, sodium valproate, topiramate, carbamazepine)
    • Beta-blockers (i.e., metoprolol, propranolol, timolol, atenolol, nadolol, nebivolol, pindolol)
    • Antidepressants (i.e., amitriptyline, venlafaxine)
    • Blood pressure drugs (i.e., lisinopril, candesartan)
    • Alpha-agonists (i.e., clonidine, guanfacine)
    • Antihistamines (i.e., cyproheptadine)
  • The patient is currently using one of the oral medications supported by AAN/AHS for migraine headache prophylaxis; AND
• Will not be used in combination with another oral CGRP inhibitor or 5-HT-1F agent.

Reauthorization Criteria:

For acute treatment of migraine:

• Documentation of positive clinical response to therapy; AND
• Not being used in combination with another oral CGRP inhibitor or 5-HT-1F agent.

Dosing:

• The recommended dose is 50 mg or 100 mg taken by mouth as needed.
  • If needed, a second dose may be administered at least 2 hours after the initial dose.
• The maximum dose in a 24-hour period is 200 mg.
• The safety of treating more than 8 migraines in a 30-day period has not been established.
• The quantity limit for Ubrelvy is 16 tablets per 30-day period.

Coverage Duration:

• Initial: 3 months
• Reauthorization: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• The recommended dose of Ubrelvy is 50 mg or 100 mg orally with or without food.  If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
• Dose adjusted for concomitant use of specific drugs and for patients with hepatic or renal impairment (see manufacturer’s package insert for details).
• Avoid use with strong CYP3A4 inducers.
• Avoid use in end-stage renal disease (CrCl <15 mL/min).
• Contraindicated with concomitant use of strong CYP3A4 inhibitors.

Policy Updates:

• 05/19/2020 – New policy approved by P&T.
• 08/28/2020 – Removed trial and failure of Nurtec ODT from criteria, quantity limits (QL) changed to 10 per month
• 10/19/2021– Prophylactic pharmacologic therapy trial and failure criteria updated; combination CGRP inhibitor criteria updated; reauthorization criteria created; coverage duration updated to initial 3 months.
• 12/01/2023 - Update QL to allow up to 16 doses per month for acute treatment of migraines (P&T 11/14/2023). 

References:

1. American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18.
2. Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019 Jul 1;142(7):1894-1904. 
3. Gronseth GS, Woodroffe LM, Getchius TS, et al; for the American Academy of Neurology. Clinical Practice Guideline Process Manual, 11th edition. 2011. Available at: http://tools.aan.com/globals/axon/assets/9023.pdf. Accessed June 28, 2021.
4. International Headache Society (IHS); Headache Classification Committee. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33: 629-808.
5. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015 Mar;55 Suppl 2:103-22.
6. Nurtec ODT Prescribing Information. Biohaven Pharmaceuticals, Inc. New Haven, CT. May 2021.
7. Reyvow Prescribing Information. Lilly USA, LLC Indianapolis, IN. August 2021.
8. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26.
9. The International Classification of Headache Disorders 3rd edition. Trigeminal autonomic cephalgias (TACs). Available at: https://ichd-3.org/3-trigeminal-autonomic-cephalalgias/3-1-cluster-headache/3-1-1-episodic-cluster-headache/. Accessed on June 14, 2021.
10. Ubrelvy Prescribing Information. Allergan USA, Inc. Madison, NJ. March 2021.
11. United Council for Neurologic Subspecialties website. www.ucns.org. Accessed June 14, 2021.