Neighborhood Health Plan RI Vyepti Coverage Update

Coverage Criteria for Vyepti (eptinezumab-jjmr)

Initial Approval Criteria

Covered when ALL of the following are met

Age and prescriber: Patient is 18 years or older AND prescriber is a neurologist or headache specialist or the prescriber is in consultation with a neurologist or headache specialist.

Baseline and exclusions: Other causes of headache have been ruled out; Vyepti is not used in combination with other prophylactic CGRP antagonists; patient will continue appropriate prophylactic modalities; physician has assessed baseline disease severity with an objective tool (e.g., HIT-6, MHD, MIDAS, MPFID); and patient has abortive migraine therapy if appropriate with inadequate relief documented.

Indication-specific: Chronic migraine: Diagnosis of chronic migraine defined as ≥15 headache days per month for >3 months with ≥5 attacks with migraine features and ≥8 days/month with migraine characteristics (or relief with a triptan/ergot); AND documented inadequate response to a 3-month trial of two oral preventive medications from two different classes; AND inadequate response or intolerance to at least two quarterly (6 months) botulinum toxin injections with documentation of change in headache frequency, duration and/or severity from baseline; AND inadequate response or intolerance to a minimum 12-week trial of two preferred injectable CGRP inhibitors with documentation of clinical response.

Patients new to therapy must initiate treatment at 100 mg before increasing to 300 mg; MMP members required to fail only one formulary CGRP inhibitor.

Indication-specific: Frequent episodic migraine: Diagnosis of frequent episodic migraine (at least 5 attacks lasting 4–72 hours) with headache features consistent with migraine without aura and medication-overuse headache ruled out; AND documented inadequate response to a 3-month trial of two oral preventive medications from two different classes; AND inadequate response or intolerance to a minimum 12-week trial of two preferred injectable CGRP inhibitors with documentation of clinical response.

Patients new to therapy must initiate treatment at 100 mg before increasing to 300 mg.

Renewal Criteria

Renewal covered when ALL of the following are met

Continued eligibility: Patient continues to meet the universal and indication-specific criteria and has no unacceptable toxicity to Vyepti (e.g., severe hypersensitivity).

Clinical response: Either a reduction in mean monthly headache days of at least moderate severity by ≥50% from pretreatment baseline (diary documentation or clinician attestation) OR a clinically meaningful improvement in a validated migraine-specific PRO: MIDAS (≥5-point reduction if baseline 1–20 OR ≥30% reduction if baseline >20), OR MPFID (≥5-point reduction), OR HIT-6 (≥5-point reduction).MIDAS: ≥5-point reduction if baseline 1–20 OR ≥30% reduction if baseline >20; MPFID: ≥5-point reduction; HIT-6: ≥5-point reduction

Dose escalation to 300 mg may be considered if initial response followed by loss of response, or inadequate response to 100 mg after a minimum of two doses.

General coverage intent and review

Coverage is subject to the plan's clinical coverage criteria intended to align use with FDA labeling and relevant clinical literature; individual consideration is given for each request.

Plan adoption and intent: The P&T Committee adopted these criteria to ensure use consistent with FDA labeling and relevant clinical literature, to promote medically accepted indications, minimize risk for adverse effects, and encourage cost-effective options where appropriate.

For INTEGRITY (Medicare-Medicaid Plan) members, these criteria apply only in the absence of applicable NCD or LCD; Neighborhood will give individual consideration to each request based on submitted information.

Use of Vyepti concurrently with other prophylactic calcitonin gene-related peptide (CGRP) antagonists is not permitted. Examples of prohibited concurrent agents include Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Qulipta (atogepant). Requests that document combination therapy with other prophylactic CGRP antagonists do not meet the plan's coverage criteria.

These coverage determinations apply to non‑Medicare members. For Medicare beneficiaries, National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) supersede the non‑Medicare policy where applicable. Medicare Part B rules and guidance (including relevant NCDs/LCDs/LCAs and the Medicare Benefit Policy Manual Chapter 15 §50) govern coverage for outpatient drugs administered under Part B.

Initiation of Vyepti requires documentation of prior preventive therapy trials. For chronic migraine, the patient must have an inadequate response to a 3‑month trial of two oral preventive medications from different classes, an inadequate response (or intolerance) to at least two quarterly injections (6 months) of botulinum toxin when indicated, and inadequate response (or intolerance) to at least 12 weeks each of two preferred injectable CGRP inhibitors. Use of Vyepti without documented trials or failures of the required oral agents, botulinum toxin (when required), and preferred injectable CGRP inhibitors is not consistent with the plan's coverage criteria.

Use of Vyepti that is inconsistent with FDA labeling or with these plan clinical coverage criteria may be determined to be not medically necessary after review of the information submitted. The plan will consider prescriber‑submitted documentation and available clinical information in individual case review to determine whether the request meets medical necessity standards.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J3032

Injection, eptinezumab-jjmr, 1 mg

NDCNDCCovered

67386-0130-xx

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

Covered ICD-10 Diagnosis CodesICD-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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Dose and billing unit thresholds

100 mg dosing and billing units100 mg dose = 100 billable units every 84 days (standard initiation dose)

300 mg dosing and billing units300 mg dose = 300 billable units every 84 days (may be used per criteria)

Quantity limit (NDC)Maximum 3 vials per 84 days for Vyepti 100 mg/mL single-dose vials

Maximum billed unitsMaximum 300 billable units per 84 days (HCPCS basis)

Dosing frequencyDoses administered by IV infusion every 3 months (every 84 days)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required per plan criteria. Initial approvals are granted for six months. Dosing and quantity limits apply as specified by the plan (see dosing limits and max units); requests must align with FDA labeling and the plan's coverage criteria.

Initial approval duration: 6 months
Dose limits: 100 mg every 84 days (100 billable units); 300 mg every 84 days (300 billable units)
Quantity limit example: Vyepti 100 mg/mL — 3 vials per 84 days; HCPCS: 300 billable units every 84 days

Step Therapy

Step Therapy and Failure Requirements

Step therapy requirements must be documented. For preventative treatment of migraines, patients must have an inadequate response or intolerance to prior therapies before Vyepti will be approved. The intent is to ensure more cost‑effective options are used first where appropriate.

Documented inadequate response to a 3-month trial of two oral preventive medications from two different drug classes

Definitions

Chronic migraine — definition

Core definitionChronic migraine: ≥15 headache days per month for >3 months with at least five attacks with migraine features and ≥8 days/month with migraine characteristics (or relief with triptan/ergot)

Duration requirementHeadache frequency must be present for greater than 3 months

Attack frequencyAt least five migraine attacks meeting diagnostic features

Migraine-characteristic daysAt least 8 days per month with headache characteristics consistent with migraine for >3 months

Frequent episodic migraine / Migraine without aura — definitions

Frequent episodic migraine — core thresholdAt least 5 headache attacks lasting 4–72 hours (when untreated or unsuccessfully treated)

Background

Vyepti (eptinezumab‑jjmr) is an intravenous monoclonal antibody that targets the calcitonin gene‑related peptide (CGRP) pathway for the preventive treatment of migraine in adults. Clinical trials have demonstrated statistically significant reductions in mean monthly migraine days with both the 100 mg and 300 mg doses administered by intravenous infusion every 84 days, with clinical benefit observed early in the treatment period.

Revision History & Notes

2020-07-01Policy effective date

Policy effective date when coverage criteria for Vyepti (eptinezumab-jjmr) were adopted following P&T Committee review to align use with FDA labeling and relevant clinical literature.

2024-01-04Last reviewLatest

Most recent documented policy review date (last_review) recorded for the Vyepti coverage criteria.

OpenPayer

Vyepti (eptinezumab-jjmr) intravenous for migraine prevention