CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0090Q

Vyepti (eptinezumab) — medical benefit coverage criteria for migraine prevention

Clinical policy governing medical benefit coverage criteria for Vyepti (eptinezumab) as a preventive treatment for migraine in adults; specifies initial and continuation authorization requirements and exclusions.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVyepti (eptinezumab) — coverage criteria for migraine prevention

Policy CodePolicy CS2026D0090Q

Change TypeTemplate update — removed state-specific language

Effective DateApril 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of migraine diagnosis, required prior therapy trials or contraindications, and dosing per FDA labeling; authorization limited to 12 months.

SourceLink

POLICY UPDATE CHANGES

Template Update — Removed content/language pertaining to the state of Louisiana

100; 300 mgFDA doses

12Max authorization (months)

≥4/dayEpisodic threshold

≥8/dayChronic threshold

J3032Billing code

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Coverage Criteria for Vyepti (eptinezumab)

Initial Therapy

Covered when ALL of the following are met:

Initial therapy: Diagnosis of migraine consistent with the International Classification of Headache Disorders, 3rd edition; AND one of the documented frequency groups: both 4 to 7 migraine days per month and either <15 headache days per month or provider attests migraine is the member's predominant headache diagnosis; AND trial and failure (after a trial of at least 2 months), contraindication, or intolerance to two listed conventional prophylactic therapies (see policy list); AND trial and failure (after a trial of at least 3 months), contraindication, or intolerance to two CGRP-targeted preventive therapies (Aimovig, Ajovy, Emgality [120 mg strength], or an oral CGRP receptor antagonist such as rimegepant or atogepant); AND medication will not be used in combination with another biologic CGRP antagonist or inhibitor used for migraine prevention; AND dosing is in accordance with FDA‑approved labeling; AND authorization will be issued for no more than 12 months.see text

See policy for the specific list of required conventional prophylactic therapies (tricyclics, beta‑blockers, candesartan, divalproex, onabotulinumtoxinA, topiramate, SNRIs) and required trial durations.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation: Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; AND medication will not be used in combination with another biologic CGRP antagonist or inhibitor used for the preventive treatment of migraines; AND dosing is in accordance with FDA‑approved labeling; AND reauthorization will be issued for no more than 12 months.

Document clinical response when requesting reauthorization.

Unproven / Not Medically Necessary

Unproven/Not medically necessary: Use of Vyepti for acute attack of migraine OR for episodic cluster headache.

These indications are explicitly listed as unproven and not medically necessary.

Use of Vyepti (eptinezumab) for the acute attack of migraine and for episodic cluster headache is explicitly listed as an exclusion in this coverage policy and is not considered an appropriate preventive indication.

Policy revision effective April 1, 2026: template update removed content and language specific to the state of Louisiana. The previous policy version CS2025D0090P has been archived.

Vyepti is considered unproven and not medically necessary when used for the acute treatment of migraine attacks or when used to treat episodic cluster headache; these uses are outside the preventive indications supported by the evidence cited in this policy.

Billing and Diagnosis Codes

Applicable HCPCS/CPT CodesHCPCS

J3032

Injection, eptinezumab-jjmr, 1 mg.

Applicable ICD-10 Diagnosis CodesICD-10

G43.001	Migraine without aura, not intractable, with status migrainosus.
G43.009	Migraine without aura, not intractable, without status migrainosus.
G43.011	Migraine without aura, intractable, with status migrainosus.
G43.019	Migraine without aura, intractable, without status migrainosus.
G43.101	Migraine with aura, not intractable, with status migrainosus.
G43.109	Migraine with aura, not intractable, without status migrainosus.
G43.111	Migraine with aura, intractable, with status migrainosus.
G43.119	Migraine with aura, intractable, without status migrainosus.
G43.401	Hemiplegic migraine, not intractable, with status migrainosus.
G43.409	Hemiplegic migraine, not intractable, without status migrainosus.

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1/5

Migraine days per month thresholds — episodic and chronic

Episodic migraine threshold4–14 headache days per month with at least 4 migraine days/month (PROMISE‑1 inclusion: ≤14 headache days/month with ≥4 migraine days).

PROMISE‑1 enrollment floorMinimum of ≥4 migraine days/month required for episodic migraine trial inclusion (PROMISE‑1).

Chronic migraine threshold≥15 headache days per month with at least 8 migraine days/month (PROMISE‑2 inclusion: ≥15 headache days/month with ≥8 migraine days).

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization required — document diagnosis, prior trials, and required elements.

Document diagnosis consistent with International Classification of Headache Disorders, 3rd edition (ICHD-3).
Include frequency of migraine days per month and confirmation of predominant headache diagnosis if applicable.
Provide documentation of trials, failures, contraindications, or intolerances to required prophylactic therapies (see step therapy items).
Authorization typically issued for up to 12 months; reauthorization requires demonstration of positive response (reduction in frequency and/or intensity).

Step Therapy

Step Therapy Requirements

Step therapy requirements: trial and failure (or contraindication/intolerance) of specified conventional prophylactic agents and prior biologic/oral CGRP agent trials are required before approval.

Trial and failure (after a trial of at least two months), contraindication, or intolerance to two of the following conventional prophylactic therapies: one tricyclic antidepressant (amitriptyline or nortriptyline); one beta-blocker (atenolol, metoprolol, nadolol, propranolol, or timolol); candesartan; divalproex sodium (Depakote/Depakote ER); onabotulinumtoxinA (Botox) — trial of at least two quarterly injections (6 months); topiramate; or one SNRI (duloxetine or venlafaxine).

Background on Vyepti (eptinezumab)

Vyepti (eptinezumab) is a humanized IgG1 monoclonal antibody that binds the calcitonin gene-related peptide (CGRP) ligand and prevents its receptor binding; it is indicated for the preventive treatment of migraine in adults with dosing per FDA labeling. Clinical efficacy for migraine prevention has been demonstrated in phase 3 trials (PROMISE‑1 and PROMISE‑2) supporting use in episodic and chronic migraine. This policy limits coverage to preventive indications and excludes use for acute migraine attacks and episodic cluster headache. Policy updates effective 04/01/2026 reflect administrative template changes; prior version CS2025D0090P was archived.

Definitions and Trial Evidence

Eptinezumab (Vyepti) — key attributes

Drug class and mechanismHumanized IgG1 monoclonal antibody that binds the calcitonin gene-related peptide (CGRP) ligand and blocks its receptor binding.

Brand and generic namesVyepti (eptinezumab).

IndicationPreventive treatment of migraine in adults per prescribing information.

Dosing form and administrationIntravenous infusion given once every 12 weeks (per clinical trials and prescribing information).

PROMISE trials — episodic vs chronic trial definitions

PROMISE‑1 (episodic) — designPhase 3 randomized, double-blind, placebo-controlled trial of eptinezumab (30, 100, 300 mg) IV every 12 weeks in patients with ≤14 headache days/month and ≥4 migraine days/month.

Policy Revision History

2026-04-01template_updateLatest

Template update: removed content/language pertaining to the state of Louisiana and archived previous policy version CS2025D0090P.