ModifiedHealth NetPolicy CP CPA.349

Erenumab-aooe (Aimovig) for migraine prophylaxis

Defines medical necessity criteria, prior authorization and continuation requirements for Aimovig (erenumab-aooe) for prevention of migraine in adults for Health Net/Centene-affiliated health plans.

Policy Summary

PayerHealth Net

PolicyErenumab-aooe (Aimovig) for migraine prophylaxis

Policy CodePolicy CP CPA.349

Change TypeConcurrent-use and coding revisionsCA plan exception clarified

Effective Date12.01.20

Next Review Date

Key ActionObtain prior authorization with documentation of ≥4 migraine days/month for ≥3 months and failure of ≥2 oral preventive therapies (each ≥8 weeks) before prescribing Aimovig.

SourceLink

POLICY UPDATE CHANGES

Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden.

Revised requirement on concurrent use with other CGRP inhibitors to include oral products (Nurtec, Ubrelvy) and clarified CA continuity exception.

Clarified continuation of therapy requirement that concurrent use prohibition does not apply to California if member was previously approved via Centene benefit.

Added HCPCS code C9399 for unclassified drugs or biologicals.

Updated concurrent-use language to include oral CGRP inhibitors (examples: Nurtec, Ubrelvy) and added Zavzpret to list of CGRP inhibitors that should not be prescribed concurrently with Aimovig.

Added clarification that criteria do NOT apply to California Commercial Exchange Plans and that those requests should be reviewed using California Exchange Plan processes.

≥4migraine days per month required for initial approval

2oral preventive therapy failures required

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70 / 140 mgapproved monthly dosing options (SC)

3 monthsinitial approval duration

6 monthscontinuation approval duration

J3490, J3590, C9399HCPCS / unclassified codes referenced

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial migraine prophylaxis criteria: 1) Diagnosis of episodic or chronic migraine; 2) Age requirement as documented in the medical record; 3) Provider attestation that the member experiences >= 4 migraine days per month for at least 3 months; 4) Failure of at least 2 oral migraine preventive therapies, each tried for >= 8 weeks and from different therapeutic classes (unless clinically significant adverse effects or contraindications exist) (examples: antiepileptic drugs such as divalproex sodium or topiramate; beta-blockers such as metoprolol, propranolol, timolol; antidepressants such as amitriptyline, venlafaxine); 5) Failure of Ajovy and Emgality unless clinically significant adverse effects are experienced or both are contraindicated (prior authorization may be required); 6) Aimovig is not prescribed concurrently with other CGRP inhibitors (injectable, oral, or nasal formulations) unless exceptions below are met; 7) If concurrent use with Botox for migraine prophylaxis is requested (i.e., not switching agents), ALL of the following must be provided: a) evidence from at least two high-quality, published studies or evidence-based clinical practice guidelines that adequately represent the member's clinical characteristics, prescribed regimen, and clinically meaningful outcomes; b) documentation that the member experienced and maintained a >= 30% reduction in migraine days per month from baseline following at least 2 quarterly Botox injections (6 months) of Botox monotherapy; c) despite Botox monotherapy, the member continues to experience >= 4 migraine days per month and/or severe migraine headaches causing disability/functional impairment; 8) Dose does not exceed one of the following: a) 70 mg (1 injection) once monthly; b) 140 mg (1 injection) once monthly if medical justification is provided.

Approval duration: 3 months

Continuation Therapy

Covered when ALL of the following are met:

Continuation therapy: 1) Member is currently receiving medication via a Centene benefit OR has previously met initial approval criteria (or is enrolled in a state/product with applicable continuity of care regulations as documented); 2) Provider attestation that the member has experienced and maintained a positive response to therapy as evidenced by a reduction in migraine days per month from baseline; 3) Member is currently stable on therapy; 4) Aimovig is not prescribed concurrently with other CGRP inhibitors (examples: Ajovy, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret); this concurrent-use prohibition does not apply for California if the member was previously approved via a Centene benefit (CA exception as documented); 5) If request is for a dose increase, the new dose does not exceed 70 mg once monthly or 140 mg once monthly (140 mg requires medical justification).

Approval duration: 6 months

Concurrent-use and plan exception criteria (partial)

Coverage includes restrictions on concurrent use with other CGRP inhibitors and Botox; California Exchange Plans are excluded from these criteria.

Concurrent use restrictions: Erenumab (Aimovig) should not be prescribed concurrently with other CGRP pathway agents, including injectable and oral CGRP inhibitors; Zavzpret (nasal formulation) is explicitly included in the list of agents that should not be used concurrently. Exceptions: concurrent use with Botox may be considered only when supportive evidence (at least two high-quality published studies or evidence-based clinical practice guidelines) is provided, the member had a documented >= 30% reduction in migraine days with Botox monotherapy after at least 2 quarterly injections, and the member continues to have >= 4 migraine days/month or disabling migraine despite Botox. Additionally, the concurrent-use prohibition may not apply for California Commercial Exchange members who were previously approved via a Centene benefit (see plan-specific continuity/exception documentation).

Exceptions/clarifications exist for members previously approved via Centene benefit and for concurrent use with Botox when supportive evidence exists.

California Exchange Plans: These criteria do NOT apply to California Commercial Exchange Plans; requests for those plans should be reviewed using California Exchange Plan processes and HIM PA.SP65 as applicable.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless there is sufficient documentation of efficacy and safety in accordance with the Health Net off‑label use policy CP.CPA.09.

These criteria do not apply to California Commercial Exchange Plans. Requests for members covered under California Exchange Plans must be reviewed using the plan‑specific prior authorization processes described for those products.

Requests for indications or uses that lack sufficient evidence per the off‑label use policy will be considered not medically necessary and are not authorized for coverage.

Within the provided excerpt there is no standalone, explicitly worded section that labels specific uses as “not medically necessary.” Instead, the policy cross‑references off‑label use procedures and coding guidance as the mechanisms by which non‑covered or insufficiently supported indications are identified.

Billing and Code References

HCPCS Codes referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Referenced HCPCS / unclassified codesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs

Minimum monthly migraine days

Minimum monthly migraine days≥ 4 migraine days per month (documented for at least 3 months)

Application contextRequired for initial approval of migraine prophylaxis (episodic or chronic)

Documentation neededProvider attestation of frequency for the specified duration

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Aimovig (erenumab) will be considered medically necessary only when the documented clinical criteria in this policy are met and prior authorization is obtained. Inclusion or exclusion of codes in policy documents does not guarantee coverage; claims must be submitted with appropriate coding and adhere to plan terms.

Prior authorization required for Aimovig per policy CP CPA.349.
Providers must submit supporting clinical documentation as described below with the PA request.
Use current professional coding guidance when submitting claims; referenced codes are informational only.

Documentation Required

Required Clinical Documentation

Providers must document and attest to the required clinical information when requesting authorization. Insufficient documentation may result in denial.

Clinical Background

Erenumab‑aooe (Aimovig) is a human monoclonal antibody that acts as a CGRP receptor antagonist and is approved for preventive treatment of migraine in adults. Clinical trial evidence and defined trial endpoints (for example, definitions of qualified migraine days) are referenced in the policy to support coverage decisions and to inform concurrent‑use determinations.

Definitions and Terms

High-quality* (study descriptor)

Preferred study typesRandomized, prospective controlled trials are considered the standard for high-quality evidence

Acceptable supportive designsNon-randomized prospective trials with substantial subject numbers may provide supportive evidence

Not considered high-qualityCase reports and chart reviews are not considered high-quality evidence

Qualified migraine headache

DefinitionQualified migraine headache: a migraine with or without aura lasting ≥ 30 minutes

Associated symptom criteriaMust meet at least one of: nausea/vomiting, photophobia, or phonophobia

Document Revision History

2024-07-15revised

Updated list of CGRP inhibitors to add Zavzpret (nasal) and removed references to CGRP as Zavzpret is a nasal product; updated HCPCS code J3490.

2023-09-21clarified

Clarified that these criteria do NOT apply to California Commercial Exchange Plans and directed requests for those plans to be reviewed using California Exchange Plan processes.

2023-06-29annual_review

4Q 2023 annual review: added HCPCS code C9399 for unclassified drugs or biologicals and reviewed references (no significant clinical changes).

Policy Summary

PayerHealth Net

PolicyErenumab-aooe (Aimovig) for migraine prophylaxis

Policy CodePolicy CP CPA.349

Change TypeConcurrent-use and coding revisionsCA plan exception clarified

Effective Date12.01.20

Next Review Date

Key ActionObtain prior authorization with documentation of ≥4 migraine days/month for ≥3 months and failure of ≥2 oral preventive therapies (each ≥8 weeks) before prescribing Aimovig.

SourceLink

On This Page

Provider attestation that the member experiences 4 migraine days per month for at least 3 months.

Documented diagnosis of episodic or chronic migraine.

Documentation of failure (or intolerance/contraindication) of at least 2 oral preventive migraine therapies, each tried for at least 8 weeks and from different therapeutic classes (examples: antiepileptics such as topiramate or divalproex; beta-blockers such as propranolol or metoprolol; antidepressants such as amitriptyline or venlafaxine).

If applicable, documentation of prior trial and failure or contraindication to other CGRP monoclonal antibodies (Ajovy, Emgality) when required by the policy.

If concurrent use with onabotulinumtoxinA (Botox) is requested, provide evidence per policy (see concurrent therapy criteria) including supporting published studies/guideline citations and documentation of response to Botox monotherapy.

Step Therapy

Required Prior Therapies / Step Therapy

Step therapy/required prior therapies must be documented. Failure to document required prior therapies or to meet step-therapy requirements may result in denial of the request.

Failure of 2 oral preventive agents, each for 8 weeks and from different therapeutic classes, unless clinically significant adverse effects or contraindications exist.
Examples of acceptable oral preventive classes: antiepileptics (e.g., topiramate, divalproex), beta-blockers (e.g., propranolol, metoprolol), antidepressants (e.g., amitriptyline, venlafaxine).
Policy may require prior trials of other CGRP inhibitors (Ajovy, Emgality) as specified; document trials, durations, and reasons for discontinuation if applicable.

Denial Risk

Concurrent Therapy Considerations

Concurrent use restrictions apply. Requests for concurrent therapy must meet the specific policy criteria and be supported by clinical justification; otherwise concurrent use will not be authorized.

Aimovig is not to be prescribed concurrently with other CGRP pathway inhibitors, including injectable (Ajovy, Emgality, Vyepti), oral (Nurtec ODT, Ubrelvy, Qulipta), or nasal (Zavzpret) CGRP-targeted products, unless the policy's concurrent-use criteria are met.
Concurrent use with onabotulinumtoxinA (Botox) is restricted: when requested, provide evidence from at least two high-quality published studies or evidence-based clinical practice guidelines, documentation of an adequate representation of the members clinical characteristics and prescribed regimen, demonstration of clinically meaningful outcomes, and evidence the member had a positive response to Botox monotherapy (≥ 30% reduction in migraine days/month after at least 2 quarterly injections) but continues to have 4 migraine days/month or disabling migraines.
If the member is currently stable on combined oral and injectable CGRP inhibitors under an existing approval, document stability and prior approval details; plan-specific exceptions (e.g., California Exchange plans) may apply.

Billing Rule

Coding Implications and Denial Risk

Coding references in this policy are informational only. Use appropriate HCPCS/NDC/CPT codes when submitting claims and be aware unclassified drug/biologic codes may be required for certain products. Lack of appropriate coding or failure to follow plan billing guidance may result in claim denial or delayed payment.

Commonly referenced codes (informational): J3490 (unclassified drugs), J3590 (unclassified biologics), C9399 (unclassified drugs or biologicals).
Inclusion or exclusion of codes in this policy does not guarantee coverage; always reference up-to-date professional coding resources when filing claims.
Providers are responsible for submitting accurate codes and documentation to support medical necessity for reimbursement.

Note

Clinical Policy and Coverage Documentation

This clinical policy is a guide to medical necessity and coverage decisions. Providers should apply clinical judgment and consider plan-specific terms, member benefit documents, and applicable policies when requesting authorization. Coverage decisions remain subject to the members benefits and the Health Plan's terms.

Policy content was developed by clinical experts and is current as of the effective date; it is not a substitute for individualized clinical judgment.
Authorization decisions are subject to the members benefit plan, evidence requirements, and applicable Centene/Health Net policies (including CP.CPA.09 for off-label uses).
For California Commercial Exchange Plans, follow plan-specific prior authorization processes (see HIM PA.SP65 or plan instructions) as the standard criteria in this document may not apply.

Clinical trial useA qualified migraine headache defines any calendar day counted as a migraine day in trials

California Exchange Plans

Review processCalifornia Commercial Exchange Plans: requests should be reviewed using plan-specific prior authorization processes (HIM PA.SP65)

Scope of policyThese policy criteria do NOT apply to California Exchange Plans

Related guidanceSee HIM PA.SP65 and applicable California Exchange Plan procedures for coverage determinations

2022-07-19material_added

4Q 2022 annual review: added criteria permitting concurrent use with Botox only when supported by published studies or guidelines, required documented positive response to Botox monotherapy, and added unclassified drugs HCPCS code.

2021-06-28revised

Revised concurrent-use requirement to explicitly include oral CGRP products (examples: Nurtec, Ubrelvy) and added clarification that the concurrent-use prohibition does not apply to California if member was previously approved via Centene benefit.

2020-10-07createdLatest

Policy created (adapted from CP PHAR.128) with prescriber requirements removed and prior authorization clarified.