CurrentCignaPolicy N/A

Migraine – Calcitonin Gene-Related Peptide Inhibitors – Ajovy - (IP0504)

Cigna coverage policy for prior authorization and medical necessity criteria for Ajovy (fremanezumab-vfrm) for preventive treatment of migraine in adults and preventive treatment of episodic migraine in pediatric patients (6–17 years, ≥45 kg). Includes covered indications, not-covered uses, coding, and authorization duration.

Policy Summary

PayerCigna

PolicyMigraine – Calcitonin Gene-Related Peptide Inhibitors – Ajovy - (IP0504)

Policy CodePolicy N/A

Change TypeCriteria revisions, pediatric indication added, coding updated

Effective Date

Next Review Date

Key ActionProviders must obtain prior authorization for Ajovy; approvals are for 1 year when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

Removed requirement to try Botox or at least two standard prophylactic pharmacologic therapies prior to approval.

Initial approval duration updated from 6 months to 1 year.

Preventive treatment of episodic migraine in pediatric patients (ages 6–17) added as an approval condition.

Added HCPCS code J3031 to coding table.

Reformatted adult and pediatric requirements into separate Initial Therapy and Continuation of Therapy sets.

Updated policy title from 'Fremanezumab' to 'Migraine - Calcitonin Gene-Related Peptide Inhibitors - Ajovy'.

2Covered indications (adult, pediatric episodic)

1Approval duration (years)

Coverage Summary

This policy covers Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults and for preventive treatment of episodic migraine in pediatric patients ages 6–17 (weighing ≥ 45 kg). Prior authorization is required for benefit coverage, and approvals are issued for 1 year when the clinical criteria are met. The coverage stance is covered with criteria, with specific age and monthly migraine day thresholds defining initial and continuation approvals.

Migraine Headache Prevention in Adults — Medical Necessity Criteria

Migraine Headache Prevention in Adults

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- Patient has ≥ 4 migraine headache days per month (prior to initiating a migraine-preventive medication)≥ 4 migraine headache days per month
B) Patient is Currently Receiving Ajovy
- Patient is ≥ 18 years of age
- Patient has ≥ 4 migraine headache days per month (prior to initiating a migraine-preventive medication)≥ 4 migraine headache days per month
- Patient has had a significant clinical benefit from the medication, as determined by the prescriber

Preventive Treatment of Episodic Migraine in Pediatric Patients (ages 6-17) — Medical Necessity Criteria

Preventive Treatment of Episodic Migraine in Pediatric Patients (ages 6-17)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 6 years of age and < 18 years of age
- Patient has ≥ 4 and < 15 migraine headache days per month (prior to initiating a migraine-preventive medication)≥ 4 and < 15 migraine headache days per month
B) Patient is Currently Receiving Ajovy

Prior Authorization and General Requirements

General Prior Authorization Requirement

Prior Authorization is required for benefit coverage of Ajovy. All approvals are provided for the duration noted below.

ALL of the following

Prior Authorization required
Approval duration: 1 year1 year

Prior Authorization

Obtain prior authorization for Ajovy

Providers must obtain prior authorization for Ajovy; approvals are for 1 year when clinical criteria are met.

Not Medically Necessary / Conditions Not Covered

Ajovy for any other use is considered not medically necessary, including (not all inclusive):

ALL of the following

Acute treatment of migraine (Ajovy has not been studied for acute treatment of migraine)
Cluster headache, treatment or prevention (not effective in Phase III trials for episodic and chronic cluster headache)
Concurrent use with another CGRP inhibitor being prescribed for migraine headache prevention (not studied in combination)
Concurrent use with Nurtec ODT (rimegepant) when used as a preventive treatment of migraine

Coding

Covered HCPCS for Ajovy when criteria metHCPCSCovered

J3031

Injection, fremanezumab-vfrm, 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

Background, Evidence, and Definitions

Ajovy is a CGRP-targeting monoclonal antibody indicated for prevention of migraine in adults and for preventive treatment of episodic migraine in pediatric patients 6–17 years who weigh ≥ 45 kg. The policy references American Headache Society (AHS) guidance noting that CGRP-targeting therapies have substantial and consistent evidence for efficacy and tolerability and are considered first-line options for migraine prevention; the AHS position informs placement of Ajovy as a first-line preventive therapy in this policy.

The AHS evidence base and position statements (2018, 2021, and 2024 update) indicate robust, consistent efficacy and tolerability for CGRP-targeting therapies. This policy incorporates that evidence by allowing Ajovy as a covered preventive option with defined criteria (age and monthly migraine-day thresholds) for initial and continuation approvals and by removing prior requirements to trial Botox or two different classes of oral preventives, aligning coverage with the AHS recommendation that CGRP-targeting therapies can be used as first-line preventive treatments.

Term	Definition
Chronic migraine	Headache occurring on ≥ 15 days/month for > 3 months with features of migraine on ≥ 8 days/month.
Episodic migraine	Headaches that occur < 15 days/month.
Significant clinical benefit	Reduction in overall number of migraine days per month or reduction in number of severe migraine days per month as determined by prescriber.

Revision History

07/15/2024added

Added HCPCS code J3031 to coding table (HCPCS: J3031, Effective Date = 07/15/2024).

05/30/2024revised

Updated coverage policy title from 'Fremanezumab' to 'Migraine - Calcitonin Gene-Related Peptide Inhibitors - Ajovy' and removed requirement to try Botox or at least two standard prophylactic pharmacologic therapies prior to approval.

07/01/2025revised

Authorization duration updated from 6 months to 1 year (Initial approval duration updated from 6 months to 1 year).