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
- 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:
- 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:
- American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18.
- 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.
- 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.
- International Headache Society (IHS); Headache Classification Committee. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33: 629-808.
- 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.
- Nurtec ODT Prescribing Information. Biohaven Pharmaceuticals, Inc. New Haven, CT. May 2021.
- Reyvow Prescribing Information. Lilly USA, LLC Indianapolis, IN. August 2021.
- 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.
- 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.
- Ubrelvy Prescribing Information. Allergan USA, Inc. Madison, NJ. March 2021.
- United Council for Neurologic Subspecialties website. www.ucns.org. Accessed June 14, 2021.
Last review date: December 1, 2023