Vyepti (eptinezumab-jjmr) intravenous for migraine prevention

Coverage Summary

Scope: This policy governs coverage, clinical criteria, dosing, renewal, units, billing codes, and required prior trials for Vyepti (eptinezumab-jjmr) for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island. Coverage stance: covered_with_criteria (coverage provided when the policy's clinical criteria are met). Covered indication: preventive treatment of migraine in adults. Dosing cadence and administration: Vyepti is administered intravenously every 3 months with an initial dosing option of 100 mg and an escalation option to 300 mg if criteria are met. Covered ages and payer applicability: policy applies to members aged 18+ and to Medicaid, Commercial, and Medicare populations. Policy limits: maximum of 300 billable units every 84 days (100 units = 100 mg dose; 300 units = 300 mg dose).

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

ALL of the following
- Member must be 18 years or older
- Prescriber is a neurologist or headache specialist, or in consultation with a neurologist or headache specialist
- Universal Criteria
  - Other causes of headaches have been ruled out
  - Vyepti is not used in combination with other prophylactic calcitonin gene-related peptide (CGRP) antagonists (examples: Aimovig [erenumab], Ajovy [fremanezumab], Emgality [galcanezumab], Nurtec ODT [rimegepant], Qulipta [atogepant])
  - Member will continue to utilize prophylactic intervention modalities (i.e., pharmacotherapy, behavioral therapy, physical therapy, etc.)
  - Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., HIT-6; monthly headache day [MHD]; MIDAS; MPFID)
  - Member has been fully equipped with abortive migraine therapy, if appropriate, and has had inadequate relief
- Indication-specific (ONE of chronic migraine OR frequent episodic migraine)
  - Preventative Treatment of Chronic Migraines
    Member has a diagnosis of chronic migraines defined as 15 or more headache (tension-type-like and/or migraine-like) days per month for > 3 months
    Member has had at least five attacks with features consistent with migraine (with and/or without aura)
    On at least 8 days per month for > 3 months, headaches have characteristics and symptoms consistent with migraine OR suspected migraines are relieved by a triptan or ergot derivative medication
    Headaches have characteristics and symptoms consistent with migraine
    Member suspected migraines are relieved by a triptan or ergot derivative medication
- Members new to therapy must initiate treatment at the 100 mg dose before increasing to the 300 mg dose if required
- For Medicare members ONLY, failure of one formulary CGRP inhibitor is required (instead of two)

Continuation / Renewal Criteria

Provider Actions & Billing Requirements

Prior Authorization

Prior authorization required with documentation

Prescriber must provide documentation to support prior authorization, including patient age, involvement of a neurologist or headache specialist (or documentation of consultation), baseline objective measure of disease severity (e.g., HIT-6, MIDAS, MPFID, monthly headache days), prior trials and failures of specified oral prophylactics, prior trials and failures of preferred injectable CGRP inhibitors and botulinum toxin as required by indication, and documentation of clinical response (baseline and follow-up measures) as applicable.

Age (must be ≥18 years)
Prescriber is a neurologist/headache specialist or consultation noted
Baseline objective measure (HIT-6, MIDAS, MPFID, or monthly headache days)
Prior trials and failures of two oral prophylactic medications (3 months each)
Prior trials and failures of two preferred injectable CGRP inhibitors (≥12 weeks each) when required
Prior trials and failures of botulinum toxin (two quarterly injections = 6 months) when required
Documentation of clinical response or inadequate response (change in frequency, duration, severity; validated PROs or headache diary)

Applicable Codes

HCPCS (billing unit)HCPCSCovered

J3032

Injection, eptinezumab-jjmr, 1 mg

NDCNDCCovered

67386-0130-xx

Vyepti 100 mg/mL solution for injection; single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

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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Clinical Evidence

100 mg -3.9 dPROMISE-1 (episodic migraine): 100 mg reduced MMD by 3.9 days; 300 mg reduced MMD by 4.3 days vs placebo

300 mg -4.3 dPROMISE-1 (episodic migraine): 100 mg reduced MMD by 3.9 days; 300 mg reduced MMD by 4.3 days vs placebo

100 mg -7.7 dPROMISE-2 (chronic migraine): 100 mg reduced MMD by 7.7 days; 300 mg reduced MMD by 8.2 days vs placebo

300 mg -8.2 dPROMISE-2 (chronic migraine): 100 mg reduced MMD by 7.7 days; 300 mg reduced MMD by 8.2 days vs placebo

Vyepti is an intravenous calcitonin gene-related peptide (CGRP) antagonist with efficacy demonstrated in randomized, placebo-controlled trials for both episodic and chronic migraine. In the episodic migraine trial, the 100 mg dose reduced mean monthly migraine days (MMD) by 3.9 days and the 300 mg dose by 4.3 days versus placebo. In the chronic migraine trial, the 100 mg dose reduced MMD by 7.7 days and the 300 mg dose by 8.2 days. Both studies used IV administration every 3 months.

Background & Definitions

Background: Vyepti (eptinezumab-jjmr) is an intravenous CGRP antagonist indicated for the preventive treatment of migraine in adults. It is administered by intravenous infusion with a recommended dosage of 100 mg every 3 months, with some patients benefiting from a 300 mg every 3 months dose per the policy criteria.

Term	Definition
Chronic migraine
15 or more headache days per month for >3 months (tension-type-like and/or migraine-like)
Frequent episodic migraine
At least 5 headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
CGRP inhibitors (preferred injectable) examples
Examples include Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)

Key thresholds & units

Renewal response thresholdReduction in mean monthly headache days ≥50% relative to pretreatment baseline

MIDAS thresholdsReduction ≥5 points when baseline MIDAS is 1-20 OR reduction ≥30% when baseline MIDAS >20

MPFID thresholdReduction of ≥5 points

HIT-6 thresholdReduction of ≥5 points

Dosage units / billing period100 billable units every 84 days for 100 mg dose; 300 billable units every 84 days for 300 mg dose

Revision History

2020-07-01effective

Policy effective date per document header (Effective Date: 07/01/2020).

2026-03-03last_reviewLatest

Most recent review date listed in document Dates Reviewed (03/03/2026); changes list in brief is empty.