Last Review Date: 01/05/2023

Date of Origin: 04/01/2020

Dates Reviewed: 04/2020, 10/2020, 04/2021, 04/2022, 01/2023

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Vyepti 100 mg/mL solution single-dose vial: 1 vial per 84 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 100 billable units every 84 days

3. Initial Approval Criteria ^1,6

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., Headache Impact Test [HIT]; monthly headache day [MHD]; Migraine Disability Assessment [MIDAS]; Migraine Physical Function Impact Diary [MPFID]); AND

Universal Criteria ^1,4-9

• Other causes of headaches have been ruled out; AND
• Not used in combination with prophylactic calcitonin gene-related peptide (CGRP) inhibitors (e.g., eptinezumab, erenumab, galcanezumab, fremanezumab, etc.) [Note: This does not include CGRP inhibitors used for acute treatment (i.e., ubrogepant)]; AND

• Patient is not on concurrent treatment with a botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, etc.) [Note: This does not apply when the botulinum toxin is used for an indication other than prevention of chronic migraines]; AND  

• Patient is utilizing prophylactic intervention modalities (e.g., pharmacotherapy, behavioral therapy, physical therapy, etc.); AND

Preventative Treatment of Migraines † ^1-9

• Patient has a diagnosis of chronic migraines defined as 15 or more headache (tension-type-like and/or migraine-like) days per month for > 3 months*; AND
  • Patient has had at least five attacks with features consistent with migraine (with and/or without aura)§; AND
  • On at least 8 days per month for > 3 months:
    • Headaches have characteristics and symptoms consistent with migraine§; OR
    • Patient suspected migraines are relieved by a triptan or ergot derivative medication; AND
• ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Patient has failed at least an 8-week trial of an oral medication for the prevention of migraines (see list of prophylactic medications below for examples ±) prior to initiation of eptinezumab; AND
• Patient had an inadequate response (or unable to tolerate) a minimum trial of at least two doses of a botulinum toxin; OR
• •  
• Patient has a diagnosis of frequent episodic migraines defined as at least 5 headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated)*; AND
  • Headaches have characteristics and symptoms consistent with migraine without aura§; AND
  • Medication overuse headache has been ruled out by trial and failure of titrating off acute migraine treatments in the past

† FDA Approved Indication; ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,4,6

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, etc.; AND
• Disease response as evidenced by the following:

• Reduction in mean monthly headache days of  ≥50% relative to the pretreatment baseline; OR
• A clinically meaningful improvement in ANY of the following validated migraine-specific patient-reported outcome measures:
  • • Reduction of ≥5 points when baseline score is 11–20 OR Reduction of ≥30% when baseline scores >20 in the MIDAS scores; OR
    • Reduction of ≥5 points in the MPFID score; OR
    • Reduction of ≥5 points in the HIT-6 score

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J3032 – Injection, eptinezumab-jjmr, 1 mg: 1 billable unit = 1 mg

NDC:

• Vyepti 100 mg/mL solution for injection; single-dose vial: 67386-0130-xx

7. References

1. Vyepti [package insert].  Bothell, WA; Lundbeck Seattle BioPharm., Inc; October 2022. Accessed December 2022.
2. Modi S, Lowder DM. Medications for migraine prophylaxis. Am Fam Physician. 2006 Jan 1; 73(1):72-8.
3. Pringheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can Jneurol Sci. 2012 Mar; 39(2 Suppl 2):S1-S9.
4. The International Classification of Headache Disorders, 3rd edition. Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018; 38(1):1-211.
5. Garza I, Schwedt TJ. (2022) Chronic Migraine. In Swanson JW (Ed). UpToDate. Last updated: November 28, 2022. Accessed on December 1, 2022. Available from https://www.uptodate.com/contents/chronic-migraine?search=chronic%20migraine&source=search_result&selectedTitle=1~67&usage_type=default&display_rank=1
6. American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019 Jan;59(1):1-18. doi: 10.1111/head.13456. Epub 2018 Dec 10.
7. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Feb 19:333102420905132. doi: 10.1177/0333102420905132. [Epub ahead of print]
8. Cady R, McGill L, Hirman J, et al. Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment With Eptinezumab (S38.009). Neurology Apr 2019, 92 (15 Supplement) S38.009;
9. Kudrow D, Lipton R, Silberstein S, et al. Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy–2) Trial (P2.10-006). Neurology Apr 2019, 92 (15 Supplement) P2.10-006;

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/ LCA): N/A