Vyepti

Eptinezumab

• Brand(s): Vyepti
• Dosage Form/Strength: 100 mg/mL, 300 mg/3 mL Vial for Injection
• Effective date: August 4, 2023
  Updated: October 29, 2024 (new dosage format)

Initiation Criteria

For the prophylaxis of headaches in adults meeting the following criteria:

1. The patient has a diagnosis of either episodic or chronic migraine according to the International Headache Society criteria, defined as:
   a. Episodic migraine: <15 headache days per month for more than 3 months, of which ≥4 days per month are with migraine
   b. Chronic migraine: ≥15 headache days per month for more than 3 months, of which ≥8 days per month are with migraine..
   AND
2. The patient has experienced an inadequate response¹, intolerance, or contraindication to 2 or more oral prophylactic migraine medications²;
   AND
3. Eptinezumab is not used in combination with onabotulinum toxin A or another Calcitonin gene-related peptide (CGRP) receptor antagonist;
   AND
4. Request must be provided by a physician or nurse practitioner with experience in the management of migraine headaches.

¹Inadequate response is defined as no therapeutic or unsatisfactory effect (<30% reduction in frequency of headache days) to an adequate dose and duration of 2 oral prophylactic medications² where both medications must be of different types/classes.

Contraindication or intolerable side effects necessitating discontinuation will be considered for 1 of the 2 drugs only.

²Oral prophylactic therapy types/classes to be considered include:
• Beta blockers
• Tricyclic antidepressants
• Verapamil or flunarizine
• Sodium valproate (or divalproex sodium)
• Topiramate
• Gabapentin

Initial requests should contain the following information:

• Objective measures of baseline migraine headache days (e.g. headache diary) and/or baseline disability measures (i.e., Six-Item Headache Impact Test [HIT-6] score).
• List of previously trialed oral prophylactic medications, including dosing regimen, duration of treatment, treatment response and reasons for discontinuation.
• Confirmation that the patient is under the care of a physician or nurse practitioner with experience in the management of migraine headaches

Renewal criteria

Objective evidence demonstrating that the patient has achieved or maintained an adequate treatment response, defined as:

1. A reduction of ≥ 50% in frequency of migraine headache days per month compared with baseline;
   OR
2. A reduction of ≥ 30% in frequency of migraine headache days per month compared with baseline AND an improvement of ≥ 5 points in the HIT-6 score compared with baseline.

Renewal requests should contain the following information:

• Outcome measures (i.e., headache diary, HIT-6 score) of the patient’s response to epitinezumab therapy.

Approved dosage: 100 mg every 12 weeks IV up to 300 mg every 12 weeks

Duration of Approval of Initials and Renewals: 6 months