CurrentmhnPolicy CP.CPA.346

Fremanezumab-vfrm (Ajovy)

Defines medical necessity criteria, dosing, duration, concomitant therapy restrictions, and documentation requirements for Ajovy (fremanezumab-vfrm) for commercial lines of business (excludes California Exchange Plans). Includes initial and continuation criteria, non-covered indications, dosing, HCPCS coding, and appendices.

Policy Summary

Payermhn

PolicyFremanezumab-vfrm (Ajovy)

Policy CodePolicy CP.CPA.346

Change TypeClarifications and criteria additions

Effective DateOct 1, 2020

Next Review Date

Key ActionProviders must obtain prior authorization and provide attestation of diagnosis, migraine-day frequency (≥4/month for ≥3 months), trial/failure documentation of required preventive therapies (per age group), weight for pediatric patients, and dosing not to exceed policy limits.

SourceLink

POLICY UPDATE CHANGES

Clarified that criteria do NOT apply to California Exchange Plans; requests for California Exchange Plans should be reviewed using HIM.PA.SP66.

Added criteria for concurrent use with Botox requiring supportive evidence, positive response to Botox monotherapy, and continued migraine burden.

Modified initial and continuation approval duration to 6 months or to the member's renewal date, whichever is longer.

Added pediatric extension for episodic migraine (ages 6-17) requiring redirection to topiramate for ages 12-17.

Added Zavzpret to list of CGRP inhibitors that should not be prescribed concurrently with Ajovy.

2FDA approved indications (adult, pediatric ≥45kg)

Key initial approval criteria (age, frequency, trials, dosing)

1Non-covered indication (cluster headaches)

Coverage Summary

Coverage stance: covered with criteria for fremanezumab-vfrm (Ajovy) aligned to FDA-approved indications: preventive treatment of migraine in adults and preventive treatment of episodic migraine in pediatric patients age 6 to 17 years weighing ≥ 45 kg. Scope: applies to commercial lines of business and excludes California Exchange Plans. Policy effective date: 10.01.20; last review date: 11.25.

Thresholds

Migraine days per month≥ 4 migraine days per month for at least 3 months

Pediatric weightFor ages 6 to 17 years: current weight ≥ 45 kg

Botox response threshold≥ 30% reduction in migraine days per month from baseline after at least 2 quarterly injections (6 months) of Botox monotherapy

Approval durationApproval duration: 6 months or to the member's renewal date, whichever is longer

Initial Therapy Criteria — Migraine Prophylaxis

Initial Approval Criteria - Migraine Prophylaxis

Must meet ALL of the following:

ALL of the following

Diagnosis
- Age ≥ 18 years: episodic or chronic migraine
- Age 6 to 17 years: episodic migraine
Provider's attestation that member experiences ≥ 4 migraine days per month for at least 3 months≥ 4 migraine days per month for at least 3 months
Age ≥ 6 years≥ 6 years

Other / Off-Label Initial Requests

Other diagnoses/indications (Initial)

If the requested use is not listed under the approved criteria

Label change: If the drug had a recent label change within last 6 months not reflected in this policy, follow the applicable no-coverage or non-formulary policy (CP.CPA.190)within last 6 months
Off-label referral: If requested use is not listed in policy section III and no recent label change applies, refer to off-label use policy CP.CPA.09

Continuation Therapy Criteria

Continued Therapy - Migraine Prophylaxis

Must meet ALL of the following:

ALL of the following

Member continuity/previous approval
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Response attestation: Member has experienced and maintained positive response to therapy as evidenced by provider's attestation of a reduction in migraine days per month from baseline
Provider attestation required

Unproven / Exclusions

Diagnoses/Indications NOT authorized

ALL of the following

Non-FDA indications: Non-FDA approved indications not addressed in this policy, unless sufficient documentation per off-label policy CP.CPA.09
Refer to CP.CPA.09 for commercial off-label uses
Cluster headaches
Not authorized

Applicable Codes

HCPCS - drug codeHCPCS

J3031

Injection, fremanezumab-vfrm, 1 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with documentation

Providers must obtain prior authorization and submit documentation including: attestation of migraine diagnosis; documentation that the member experiences ≥ 4 migraine days per month for at least 3 months; trial/failure documentation of required preventive therapies per age group (adults: failure of at least 2 oral preventive therapies from different classes each for 8 weeks; ages 12–17: failure of an 8-week trial of topiramate unless contraindicated); current pediatric weight for ages 6–17 (≥ 45 kg); and confirmation that requested dosing does not exceed policy limits.

Affected HCPCS code: J3031

Documentation Required

Documentation for concurrent Botox use

For requests to use Ajovy concurrently with Botox, submit supportive evidence of concurrent use including at least two high-quality, published studies or evidence-based clinical practice guidelines that adequately represent the member and regimen and report clinically meaningful outcomes. Provide documentation that the member experienced and maintained a positive response to Botox monotherapy evidenced by ≥ 30% reduction in migraine days per month from baseline after at least 2 quarterly injections (6 months). Also document that despite Botox monotherapy the member continues to have ≥ 4 migraine days per month and/or severe, disabling migraine headaches.

Clinical Evidence & References

Evidence sources referenced in the brief include the Ajovy Prescribing Information, Teva Pharmaceuticals, August 2025 and guideline citations (AAN, AHS, ACP and other guideline references cited in the policy).

The policy requires supportive evidence for certain uses (for example, concurrent use with Botox) from at least two high-quality, published studies or evidence-based clinical practice guidelines.

The policy defines High-quality evidence as randomized, prospective controlled trials or robust non-randomized prospective trials and explicitly states that case reports and chart reviews are not considered high-quality evidence.

Background

Background: Fremanezumab-vfrm (Ajovy) is a CGRP receptor antagonist indicated for preventive treatment of migraine in adults and for episodic migraine in pediatric patients age 6–17 years who weigh ≥ 45 kg, consistent with FDA-approved indications.

Policy alignment and requirements: The policy aligns coverage to FDA indications and requires documentation of migraine frequency—provider attestation of ≥ 4 migraine days per month for at least 3 months—and, for adults, documentation of failure of at least 2 different oral preventive therapies (each for 8 weeks unless contraindicated). For ages 12–17 additional redirection to topiramate is specified per recent updates. The policy also requires documentation of current weight for pediatric patients and that dosing does not exceed the policy limits (e.g., 225 mg once monthly or 675 mg every 3 months for adults).

Scope clarification: The policy applies to commercial lines and explicitly does not apply to California Exchange Plans; requests for those plans should be reviewed using HIM.PA.SP66.

Definitions

Migraine day (definition)Any calendar day with headache lasting ≥2 consecutive hours meeting ICHD-3 criteria for migraine or probable migraine, or any duration headache treated with migraine-specific medications (triptans or ergots).

High-quality evidence (definition)Randomized, prospective controlled trials or robust non-randomized prospective trials; case reports and chart reviews are not considered high-quality.

Revision History

07.10.25addedLatest

Added pediatric extension for episodic migraine (ages 12-17) requiring failure of an 8-week trial of topiramate unless contraindicated; modified initial and continuation approval duration to 6 months or to the member's renewal date, whichever is longer.

07.15.24added

Added Zavzpret to the list of CGRP inhibitors that should not be prescribed concurrently with Ajovy and removed references to 'injectable or oral CGRP' to reflect Zavzpret as a nasal product.

07.19.22added

Policy Summary

Payermhn

PolicyFremanezumab-vfrm (Ajovy)

Policy CodePolicy CP.CPA.346

Change TypeClarifications and criteria additions

Effective DateOct 1, 2020

Next Review Date

SourceLink

On This Page

ALL of the following

Therapeutic classes (examples): Antiepileptic drugs (e.g., divalproex sodium, sodium valproate, topiramate)
Therapeutic classes (examples): Beta-blockers (e.g., metoprolol, propranolol, timolol)
Therapeutic classes (examples): Antidepressants (e.g., amitriptyline, venlafaxine)

For members age 12 to 17 years: Failure of an 8-week trial of topiramate, unless contraindicated or clinically significant adverse effects are experienced8 weeks

Pediatric-specific requirement

Botox concurrent-use

Evidence requirement: Sufficient evidence is provided from at least two high-quality, published studies or evidence-based clinical practice guidelines that adequately represent the member and regimen and report clinically meaningful outcomesat least two high-quality published studies
Case reports/chart reviews are not high-quality
Botox response: Member has experienced and maintained positive response to Botox monotherapy as evidenced by a ≥ 30% reduction in migraine days per month from baseline following at least 2 quarterly injections (6 months) of Botox monotherapy≥ 30% reduction after ≥ 6 months (2 quarterly injections)
Residual burden: Despite Botox monotherapy, member continues to experience ≥ 4 migraine days per month and/or severe migraine headaches that result in disability and functional impairment≥ 4 migraine days per month

Concurrent CGRP prohibition: Ajovy is not prescribed concurrently with other CGRP inhibitors (eg, Aimovig, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret)

Pediatric weight: For members age 6 to 17 years, current weight is ≥ 45 kg≥ 45 kg

Pediatric weight requirement

Dose limits

225 mg (1 injection) once monthly225 mg monthly
Age ≥ 18 years: 675 mg (3 injections) every 3 months675 mg every 3 months

Concurrent CGRP prohibition: Ajovy is not prescribed concurrently with other CGRP inhibitors (eg, Aimovig, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret)

This requirement does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors

Dose increase limits

225 mg (1 injection) once monthly225 mg monthly
Age ≥ 18 years: 675 mg (3 injections) every 3 months675 mg every 3 months

Billing Rule

Dose limits

Dose limits: do not exceed 225 mg (one injection) once monthly, or 675 mg (three injections) every 3 months for adults.

HCPCS: J3031

Denial Risk

Concurrent CGRP agents prohibited

Ajovy should not be prescribed concurrently with other CGRP inhibitors. Prohibited agents include Aimovig, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, and Zavzpret. Note: the concurrent-CGRP prohibition does not apply for a California continuity exception if the member was previously approved via the Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors.

Prohibited agents: Aimovig, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret

Added criteria for concurrent use with Botox requiring submission of at least two high-quality published studies or evidence-based guidelines, documentation of a ≥30% reduction in migraine days per month after at least 2 quarterly (6 months) Botox injections, and evidence the member continues to have ≥4 migraine days per month or disabling severe migraines.

07.19.22revised

Revised initial approval duration for every-3-month dosing to 6 months (approval duration: 6 months or to the member's renewal date, whichever is longer).

09.21.23clarified

Clarified that these criteria do NOT apply to California Exchange Plans; requests for California Exchange Plans should be reviewed using HIM.PA.SP66.