Eptinezumab-Jjmr (Vyepti™)

Corporate Medical Policy: Eptinezumab-jjmr (Vyepti™)

Restricted Product(s):

• eptinezumab-jjmr (Vyepti™) intravenous infusion for administration by a healthcare professional FDA Approved Use: • For preventive treatment of migraines in adults

Criteria for Medical Necessity: The restricted product(s) may be considered medically necessary when the following criteria are met: Initial Criteria for Approval: 1. The patient is 18 years of age or older; AND 2. The patient has been diagnosed with chronic migraine and over the last 3 months the patient has experienced both of the following: a. Greater than or equal to 15 headache days per month; AND b. Greater than or equal to 8 migraine days per month; OR 3. The patient has been diagnosed with episodic migraine and over the last 3 months the patient has experienced the following: a. Less than or equal to 14 headache days per month of which at least 4 are migraine days; OR b. Migraine attacks that are attributed to a diminished quality of life despite the use of acute rescue medications; OR c. The patient has contraindications to acute therapies; OR d. The patient has tried and had an inadequate response to acute therapies; OR e. The patient has serious side effects to acute therapies; OR f. The patient is at risk of medication overuse headache without preventative therapy; AND 4. The patient has had an adequate trial (i.e., at least 4-6 weeks) and was adherent to (i.e., a PDC of ≥80%) at least two of the distinct categories of migraine prophylaxis treatment options including [medical record documentation required]: a. Beta blockers b. Antidepressants c. Anticonvulsants; OR 5. The patient has a clinical contraindication or intolerance to all of the following: beta blocker, antidepressant, and an anticonvulsant [medical record documentation required]; AND

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6. The patient has tried and had an inadequate response to BOTH erenumab (Aimovig) AND galcanezumab (Emgality) [medical record documentation required]; OR 7. The patient has a clinical contraindication or intolerance to BOTH erenumab (Aimovig) AND galcanezumab (Emgality) that is not expected to occur with the requested agent [medical record documentation required]; AND 8. The patient will not be starting therapy with a botulinum toxin agent and has not been treated with a botulinum toxin agent within the last 4 months for migraine prophylaxis; AND 9. The requested agent will not be used in combination with another calcitonin gene-related peptide (CGRP) receptor antagonist indicated for migraine prophylaxis (e.g., erenumab, fremanezumab, galcanezumab); OR 10. If using another CGRP receptor antagonist, the patient will discontinue the other CGRP prior to starting the requested agent; AND 11. The patient does not have other reasons to explain headache/migraine frequency including history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, or cerebrovascular disease.

Initial Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 2. The patient would have met initial criteria for approval at the time they started therapy [medical record documentation required]; AND 3. The patient is using the requested agent for prevention of migraine; AND 4. If eptinezumab (Vyepti) 100 mg strength is being requested: a. The patient has had a positive clinical response with eptinezumab treatment, demonstrated by the following: i. A decrease from baseline in the number of migraine days per month or migraine frequency [medical record documentation required]; AND ii. A reduction in the need for migraine rescue medications (i.e., NSAIDs, triptans, ergot derivatives); OR 5. If eptinezumab (Vyepti) 300 mg strength is being requested: a. The patient has not been previously approved for 300 mg strength; AND b. The patient has had an adequate trial (at least 3 months) and had an inadequate response to the 100 mg strength [medical record documentation required]; OR c. The patient was previously approved through Blue Cross NC for the 300 mg strength; AND i. The patient has had a positive clinical response with eptinezumab (Vyepti) 300 mg strength treatment, demonstrated by the following:

1. A decrease from baseline in the number of migraine days per month or migraine frequency [medical record documentation required]; AND 2. A reduction in the need for migraine rescue medications (i.e., NSAIDs, triptans, ergot derivatives); AND 6. The patient will not be starting therapy with a botulinum toxin agent and has not been treated with a botulinum toxin agent within the last 4 months for migraine prophylaxis; AND 7. The patient is not using the requested agent at the same time as another calcitonin gene-related peptide (CGRP) receptor antagonist indicated for migraine prophylaxis (e.g., erenumab, fremanezumab, galcanezumab).

Duration of Approval: 365 days (1 year)

FDA Label Reference Medication Indication Dosing HCPCS Maximum Units*

Initial: 200** 100 mg via IV infusion every 3

Eptinezumab-jjmr (Vyepti™) Preventive treatment of migraine in months. Continuation: 400; adults J3032 1200 if approved for Some patients may benefit from a intravenous (IV) infusion 300 mg dose*** dosage of 300 mg**

*Maximum units allowed for duration of approval

**300 mg strength is not eligible for approval on initial review ***See continuation criteria for approval for requests for 300 mg strength dosing

References: all information referenced is from FDA package insert unless otherwise noted below.

1. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study: PROMISE-1. Cephalalgia. 2020;40(3):241-254. 2. Evers S, Afra J, Frese A, et al. EFNS guideline on the drug treatment of migraine – revised report of an EFNS task force. Eur J Neurol. 2009 Sep;16(9):968-81. 3. Headache Classification Committee of the International Headache Society (HIS). The International Classification of Headache Disorders; 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. 4. Katsarava Z, Buse DC, Manack AN, et al. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92. 5. Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar;94(13):e1365-e1377. 6. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1337-45. 7. Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62.

Policy Implementation/Update Information:

June 2021: Criteria change: Added maximum units and removed review of 300 mg strength in initial criteria; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. *Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.

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