Overview

This document addresses the use of Vyepti (eptinezumab), a calcitonin gene-related peptide (CGRP) inhibitor agent for migraine prophylaxis. The CGRP system is involved with vascular homeostasis. During a migraine, CGRP levels increase resulting in vasodilation, pro-inflammatory effects and pain signaling. Vyepti is FDA approved for the prophylaxis of migraine headaches. Please refer to the following clinical criteria for additional information:

• Self-Injected Calcitonin Gene-Related Peptide (CGRP) Agents
• Calcitonin Gene-Related Peptide (CGRP) Step Therapy

Vyepti is an infused agent that requires administration via healthcare professional every 3 months. The dose recommendation per label for Vyepti is 100 mg every 3 months. However, the label indicates that some patients may benefit from a dosage of 300 mg.

Clinical Criteria

When a drug is being reviewed for coverage under a member's medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Vyepti (eptinezumab)

Initial requests for Vyepti (eptinezumab) may be approved when the following criteria are met:

1. Individual has a diagnosis of one of the following:
   • Episodic migraine defined as at least 4 and fewer than 15 migraine days per month and fewer than 15 headache days per month on average during the previous 3-month period; OR
   • Chronic migraine defined as a headache occurring on 15 or more days per month for more than 3 months, which, on at least 8 days per month, has features of a migraine headache (ICHD-3); AND
2. Individual is using Vyepti for migraine prophylaxis; AND
3. Individual has had a trial of and inadequate response to a 2-month trial at target or usual effective dose or intolerance to two agents for migraine prophylaxis (at least one agent in any two of the following classes) or has a contraindication to all of the following medications (AAN/AHA 2012/2015, Level A and B evidence; ICSI 2013, high quality evidence, AHS 2021):
   • The following antidepressants: amitriptyline, venlafaxine, nortriptyline, duloxetine; OR
   • One of the following beta blockers: Metoprolol, propranolol, timolol (oral), nadolol, atenolol, nebivolol; OR
   • One of the following antiepileptic agents: valproate sodium, divalproex sodium, topiramate, gabapentin; OR
   • The following calcium channel blocker: verapamil; OR
   • Botox (for chronic migraine); AND
4. If individual is also currently using botulinum toxin for prophylaxis and is going to be using Vyepti and botulinum toxin together (i.e., not switching from one agent to another), the following must apply:
   • Individual has had a reduction in the overall number of migraine days or reduction in number of severe migraine days per month with the initial agent; AND
   • Individual continues to experience a significant number of migraine headache days or severe migraine days per month requiring additional therapy for migraine prevention.

Renewal requests for Vyepti (eptinezumab) may be approved when the following criteria are met:

1. Individual has a reduction in the overall number of migraine days or reduction in number of severe migraine days per month; AND
2. Individual has obtained clinical benefit deemed significant by individual or prescriber including any of the following (AHS 2021):
   • 50% reduction in frequency of days with headache or migraine; OR

Significant decrease in attack duration; OR

• Significant decrease in attack severity; OR
• Improved response to acute treatment; OR

Improvements in migraine-related outcomes may include, but are not limited to:

• Reduction in migraine-related disability and improvements in functioning in important areas of life; OR
• Improvements in health-related quality of life and reduction in psychological stress due to migraine;

AND

If individual is using concurrently with botulinum toxin, the following must apply:

1. Individual has had further reduction in the overall number of migraine days or reduction in number of severe migraine days per month compared to monotherapy with the initial agent (either botulinum toxin or Vyepti).

Vyepti (eptinezumab) may not be approved for the following:

• Individual is using in combination with another prophylactic CGRP agent (Ajovy, Aimovig, Emgality, Qulipta or prophylactic use of Nurtec ODT).

Approval duration:

• Initial request: 6 months (two injection cycles)
• Renewal requests: 1 year

Step Therapy

Note: When a calcitonin gene-related peptide (CGRP) inhibitor is deemed approvable based on the clinical criteria above, the benefit plan may have additional criteria requiring the use of a preferred¹ agent or agents.

Calcitonin Gene-Related Peptide (CGRP) Inhibitor Step Therapy

A list of the preferred calcitonin gene-related peptide (CGRP) inhibitors is available here. Requests for a non-preferred calcitonin gene-related peptide (CGRP) inhibitor may be approved when the following criteria are met:

1. Individual has had a trial of and inadequate response or intolerance to one preferred CGRP agent;

Quantity Limits

Vyepti (eptinezumab) Quantity Limit

Vyepti (eptinezumab) 100 mg/mL vial

Drug

• 1 vial (100 mg)

Limit per 3 months

• Individuals who have had an inadequate response to 100 mg dose may be approved for 3 vials (300 mg) every 3 months

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J3032
Injection, eptinezumab-jjmr, 1 mg (Effective 10/1/2020)

ICD-10 Diagnosis

• G43.001-G43.919 Migraine, unspecified

Document History

Reviewed: 09/11/2023