ModifiedCentenePolicy HIMPA.SP64

Clinical Policy: Eptinezumab‑jjmr (Vyepti) — Coverage Criteria

Covers medical necessity and authorization criteria for Vyepti (eptinezumab‑jjmr) as preventive treatment for episodic or chronic migraine in adults for Centene‑affiliated health plans.

Policy Summary

PayerCentene

PolicyEptinezumab‑jjmr (Vyepti) — Coverage Criteria

Policy CodePolicy HIMPA.SP64

Change TypeMaterial updates to concurrent‑use restrictions and approval duration

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit HCPCS code J3032 with documentation of ≥4 monthly migraine days and required prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

Zavzpret was added to the list of CGRP inhibitors that should not be prescribed concurrently with Vyepti.

Concurrent use restrictions were clarified to state Vyepti should not be prescribed concurrently with Botox or other injectable, oral, or nasal CGRP inhibitors unless specific criteria for concurrent Botox use are met.

Initial approval duration was revised from 3 months to 6 months.

Requirement on concurrent use with other CGRP inhibitors revised to include oral products (Nurtec, Ubrelvy) and later expanded to include Zavzpret (nasal).

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; initial approval duration revised.

100 mgstandard recommended dose

300 mgmaximum/recommended higher dose

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Coverage Criteria for Eptinezumab (Vyepti)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Migraine Prophylaxis: 1) Diagnosis of episodic or chronic migraine; 2) Age ≥ 18 years; 3) Provider attestation that member experiences ≥4 migraine days per month for at least 3 months; 4) Failure of at least 2 oral migraine preventive therapies from different therapeutic classes, each tried for ≥8 weeks unless clinically significant adverse effects or contraindications; 5) Failure of Aimovig and Emgality unless clinically significant adverse effects are experienced or both are contraindicated; 6) Vyepti is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Qulipta, Ubrelvy, Zavzpret) unless criteria for concurrent Botox use are met; 7) Dose for initial approval does not exceed 100 mg IV once every 3 months.

Approval duration: 6 months

Concurrent Botox Use

For requests to use Vyepti concurrently with on‑label Botox for migraine, ALL of the following must be met:

Concurrent Botox criteria: a) Sufficient evidence is provided from at least two high‑quality, published studies in reputable peer‑reviewed journals or from evidence‑based clinical practice guidelines supporting concurrent use (case studies/chart reviews do not qualify); b) Member experienced and maintained a positive response to Botox monotherapy defined as ≥30% reduction in migraine days per month from baseline after at least 2 quarterly Botox injections (minimum 6 months); c) Despite Botox monotherapy, member continues to experience ≥4 migraine days per month and/or severe disabling migraine causing functional impairment.

Case reports or chart reviews are not considered high‑quality evidence

Continuation Therapy

Continued therapy is covered when ANY of the following apply and specific criteria are met:

Continued therapy options: a) Member is currently receiving Vyepti via a Centene benefit OR member previously met initial approval criteria; OR b) Member is currently receiving Vyepti and is in a state/product with continuity of care regulations; AND member has experienced and maintained a positive response to therapy as evidenced by provider attestation of a reduction in migraine days per month from baseline.

If request is for a dose increase, new dose must not exceed 100 mg once every 3 months, or 300 mg once every 3 months if medical justification for higher dose is provided. Approval duration: 6 months.

Concurrent therapy restrictions

Concurrent use of eptinezumab with other CGRP inhibitors or Botox is restricted and requires meeting specified conditions.

Concurrent CGRP inhibitor restriction: Eptinezumab should not be prescribed concurrently with other CGRP inhibitors; policy examples include Nurtec, Ubrelvy, and Zavzpret (also includes Aimovig, Emgality, Ajovy, Qulipta).

Zavzpret was added to the list in 4Q 2024; prior revisions added oral products such as Nurtec and Ubrelvy.

Concurrent use with Botox: Concurrent use of Vyepti with Botox requires supportive evidence from published studies or evidence‑based clinical practice guidelines, documentation of positive response to Botox monotherapy (≥30% reduction in migraine days after at least 2 quarterly injections), and documentation of continued migraine burden to justify addition of eptinezumab.

Prior authorization may be required; documentation and supportive evidence must be supplied per policy.

Requests for use of Vyepti for indications that are not FDA‑approved are not authorized by this policy unless the provider supplies sufficient supporting documentation per the off‑label use policy HIM.PA.154. Absent evidence meeting that off‑label standard (efficacy and safety documentation), coverage for non‑FDA indications may be denied.

Vyepti should not be prescribed concurrently with other CGRP pathway therapies unless the policy’s concurrent‑use criteria are met. Examples of CGRP inhibitors specifically listed in the policy include Nurtec, Ubrelvy, and (as of 4Q 2024) Zavzpret. Prior authorization and documentation requirements apply when concurrent therapy is requested; providers should follow the policy’s specified supportive evidence and documentation pathways for consideration.

Concurrent administration of Vyepti with other CGRP inhibitors or with on‑label Botox is restricted. The policy specifies that Vyepti should not be prescribed concurrently with other CGRP inhibitors (examples: Aimovig, Emgality, Ajovy, Nurtec ODT, Qulipta, Ubrelvy, Zavzpret) and that requests to add Vyepti to ongoing Botox therapy require meeting the policy’s Botox concurrent‑use criteria. For concurrent Botox use the policy requires supportive evidence from published studies or guidelines, documentation of a prior positive response to Botox monotherapy, and ongoing migraine burden to justify adding eptinezumab.

Within the provided document segments there is no single explicit standalone statement formatted as a categorical 'not medically necessary' phrase; however, the policy does state that concurrent prescription of Vyepti with other CGRP inhibitors or Botox without meeting the specified concurrent‑use criteria may be considered not medically necessary and may lead to denial when required documentation or criteria are not met.

Coding and Billing References

HCPCS CodesHCPCS

J3032

Injection, eptinezumab-jjmr, 1 mg

HCPCS Codes (informational)HCPCS

J3032

Injection_eptinezumab-jjmg_Lmg_

Monthly migraine days — threshold for eligibility

Monthly migraine days threshold≥4 days per month for at least 3 months (provider attestation required)

Documentation periodAttestation must reflect migraine frequency for a minimum duration of 3 months

Age associated with thresholdApplies to adults (age ≥ 18 years) per initial approval criteria

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for eptinezumab (Vyepti) per this policy. Providers should note that prior authorization may also be required for alternative CGRP-targeted therapies when redirection is requested.

Prior authorization required for eptinezumab (HCPCS J3032)
PA may be required for alternative CGRP redirections

Step Therapy

Step Therapy Requirements

Step therapy: Member must have trial and failure of at least two oral migraine preventive therapies from different therapeutic classes, each taken for a minimum of 8 weeks, unless clinically significant adverse effects occur or therapies are contraindicated. Additionally, failure of Aimovig (erenumab) and Emgality (galcanezumab) is required unless these agents produced clinically significant adverse effects or are contraindicated.

Trial and failure of ≥2 oral preventive therapies (different classes) each ≥8 weeks (examples: antiepileptics, beta‑blockers, antidepressants)

Background and Clinical Context

Eptinezumab (Vyepti) is an intravenous monoclonal antibody that targets the calcitonin gene‑related peptide (CGRP) pathway and is indicated for preventive treatment of migraine in adults. The recommended dosing for migraine prophylaxis is 100 mg IV every 3 months, with some patients potentially benefiting from 300 mg every 3 months when medically justified. Clinical trial programs (for example, PROMISE‑1 and PROMISE‑2 as referenced in the policy background) demonstrated reductions in monthly migraine days supporting its use as a preventive therapy.

Definitions and Contraindications

Contraindication — Serious hypersensitivity to eptinezumab‑jjmr or any excipients

Contraindication (primary)Serious hypersensitivity to eptinezumab-jjmr

Contraindication (excipients)Serious hypersensitivity to any of the excipients in the eptinezumab formulation

Boxed warning statusNo boxed warnings reported

J3032 — HCPCS code referenced for injection eptinezumab; informational

HCPCS codeJ3032 — Injection, eptinezumab-jjmg_Lmg_ (listed for informational purposes)

Coding purposeCode referenced for claim submission and authorization processing (informational)