DraftColorado Rocky Mountain Health PlansPolicy IEXD0090.10

Vyepti (eptinezumab) — Medical Benefit Drug Policy (migraine prevention, individual exchange)

Medical benefit drug policy governing coverage and prior authorization criteria for intravenous eptinezumab (Vyepti) for preventive treatment of migraine in individual exchange plans (excludes MA, NV, NY). Affects prescribers and prior authorization reviewers for affected members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVyepti (eptinezumab) — Medical Benefit Drug Policy (migraine prevention, individual exchange)

Policy CodePolicy IEXD0090.10

Change TypeCoding additionscontent updates

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document ICHD‑3 diagnosis, migraine-day frequency, and required prior prophylactic therapy trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 diagnosis codes G43.A0, G43.A1, G43.B0, G43.B1, G43.D0, and G43.D1 to applicable codes.

Updated Background, Clinical Evidence, and References sections to reflect the most current information.

100 mg; 300 mgFDA‑recommended dosing options (IV q3 months)

J3032HCPCS billing code

PROMISE-1, PROMISE-2Key phase 3 trials

≤12 moAuthorization duration

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Preventive migraineIndication

Coverage Criteria for Vyepti (eptinezumab)

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial coverage criteria

Migraine frequency options: Either episodic or chronic criteria metEpisodic: 4–7 migraine days/month and <15 headache days/month OR provider attests migraine is the member's predominant headache diagnosis; Chronic: (criteria for chronic migraine applied by provider per ICHD-3)
chunk support [5],[1]
Required prior prophylactic therapy trials: Trial and failure (or contraindication/intolerance) to the required prophylactic therapies. For initial therapy this includes: trial and failure (after a trial of at least two months), contraindication, or intolerance to two of the following: a tricyclic antidepressant (amitriptyline or nortriptyline), a beta-blocker (atenolol, metoprolol, nadolol, propranolol, or timolol), candesartan, divalproex sodium, onabotulinumtoxinA (trial of at least 2 quarterly injections/6 months), topiramate, or an SNRI (duloxetine or venlafaxine); and, when required by criteria, trial and failure (after a trial of at least three months), contraindication, or intolerance to one of the following anti-CGRP monoclonal antibodies: Aimovig (erenumab), Emgality (galcanezumab), or Ajovy (fremanezumab).two months for some agents; three months for anti-CGRP agents
chunk support [1],[6]

Dosing and combination restrictions: Dosing must follow FDA-approved labeling (e.g., 100 mg IV every 3 months; some patients may benefit from 300 mg IV every 3 months). Medication must not be used concurrently with another biologic CGRP antagonist or inhibitor for migraine prevention.FDA-labeled dosing

chunk support [6],[19]

Continuation Therapy

Covered for continuation when ALL of the following are met:

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

chunk support [6]

Unproven / Not Medically Necessary

Unproven / NMN uses: Use of Vyepti for acute attacks of migraine; Episodic cluster headache.

chunk support [7]

Evidence and Indications (informational)

Contextual coverage considerations and clinical evidence summary

Professional Society Evidence: CGRP has strong human evidence as a fundamental mechanism of migraine; CGRP-targeting therapies are migraine-specific with substantial efficacy, safety, and tolerability data and are FDA-approved for episodic and chronic migraine in many cases.

Supports clinical rationale for coverage in appropriate patients; not an explicit coverage rule.

Vyepti Indication: Vyepti (eptinezumab) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults. Recommended dosing is 100 mg administered by intravenous infusion every 3 months; some patients may benefit from 300 mg IV every 3 months.

FDA approval is informational; member-specific benefit plan governs coverage decisions.

Evidence of benefit in specific populations: CGRP therapies demonstrate efficacy in patients with multiple prior preventive treatment failures, in those with acute medication overuse, and across aura status; there is at least one head-to-head study showing superiority of a CGRP-targeting therapy (erenumab) over topiramate.

Use of Vyepti (eptinezumab) for the acute attack of migraine and for episodic cluster headache is considered unproven and not medically necessary.

The policy reiterates that FDA approval alone is not a basis for coverage; coverage determinations must reference the member-specific benefit plan and any applicable federal or state mandates when deciding coverage.

For clarity, Vyepti is unproven and not medically necessary when used to treat the acute migraine attack or for episodic cluster headache, and such uses are excluded from coverage under this policy.

This document is provided for informational purposes and does not itself constitute a coverage determination. Reviewers must consult the member-specific benefit plan document to determine actual coverage; in the event of conflict, the member-specific plan governs.

Coding and Billing

HCPCSHCPCS

J3032

Injection, eptinezumab-jjmr, 1 mg

Applicable ICD-10 Codes (partial list continued)ICD-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

1–10 of 19

1/2

Added ICD-10 Diagnosis CodesICD-10

G43.A0	Cyclical vomiting, in migraine, not intractable
G43.A1	Cyclical vomiting, in migraine, intractable
G43.B0	Ophthalmoplegic migraine, not intractable
G43.B1	Ophthalmoplegic migraine, intractable
G43.D0	Abdominal migraine, not intractable
G43.D1	Abdominal migraine, intractable

Drug dosing/administration notesmixed

N/A	Vyepti dosing & administration: 100 mg IV every 3 months; some patients may benefit from 300 mg IV every 3 months

Migraine day thresholds

Episodic migraine threshold4–7 migraine days per month with <15 headache days per month (or provider attestation that migraine is the predominant headache diagnosis)

Episodic additional requirementAt least 4 migraine days per month (ICHD‑3 criteria referenced)

Chronic migraine threshold (migraine days)≥8 migraine days per month

Chronic migraine threshold (headache days)≥15 headache days per month (of which ≥8 meet migraine criteria)

Vyepti dosing interval

Standard FDA-recommended dosing interval

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyepti (eptinezumab). Decisions should be informed by the member-specific benefit plan and may use third‑party clinical criteria tools (for example, InterQual®) to assist in administering benefits. Authorization will be issued for no more than 12 months for initial and reauthorization requests; review member plan for benefit limits.

Prior authorization required for Vyepti (eptinezumab).
Third‑party decision tools (e.g., InterQual®) may be used to inform determinations.
Authorizations limited to ≤12 months; check member plan for variations.

Denial Risk

Denial Triggers

Denial is likely if documentation does not show a diagnosis consistent with the International Classification of Headache Disorders, 3rd edition (ICHD‑3), or if migraine frequency thresholds for episodic or chronic migraine are not met. Denial may also occur if required prior medication trials (or documented contraindication/intolerance) are not met, if the medication would be used in combination with another biologic CGRP antagonist/inhibitor, or if dosing is not in accordance with FDA labeling.

Background and Mechanism

Eptinezumab (Vyepti) is a humanized IgG1 monoclonal antibody that binds the calcitonin gene-related peptide (CGRP) ligand and prevents receptor binding. It is indicated for the preventive treatment of migraine in adults and is administered by intravenous infusion, with a recommended dosage of 100 mg every 3 months (some patients may benefit from 300 mg every 3 months).

Key Definitions

Vyepti (eptinezumab) — key facts

Mechanism of actionHumanized IgG1 monoclonal antibody that binds the CGRP ligand and blocks receptor binding

Route and frequencyIntravenous infusion every 3 months (administered once every 12 weeks)

FDA‑approved dosing100 mg IV every 3 months; some patients may receive 300 mg IV every 3 months

Indication summaryIndicated for preventive treatment of migraine in adults (evaluated in episodic and chronic migraine trials)

Episodic migraine

Definition≤14 headache days per month with at least 4 migraine days per month (ICHD‑3 criteria referenced)

Policy Revision History

2025-09-01codes_addedLatest

Added ICD-10 diagnosis codes G43.A0, G43.A1, G43.B0, G43.B1, G43.D0, and G43.D1 to the applicable codes list.

2025-09-01content_updated

Updated Background, Clinical Evidence, and References sections to reflect the most current information.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVyepti (eptinezumab) — Medical Benefit Drug Policy (migraine prevention, individual exchange)

Policy CodePolicy IEXD0090.10

Change TypeCoding additionscontent updates

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document ICHD‑3 diagnosis, migraine-day frequency, and required prior prophylactic therapy trials or contraindications.

SourceLink

On This Page

Clinical evidence cited but not translated into explicit coverage criteria.

100 mg IV every 3 months

Higher-dose optionSome patients may benefit from 300 mg IV every 3 months

Route and frequency noteAdministered by intravenous infusion once every 12 weeks

Missing ICHD‑3 consistent diagnosis — denial risk.
Migraine frequency thresholds not met (e.g., episodic vs chronic) — denial risk.
Required prior medication trials not documented (or no contraindication/intolerance) — denial risk.
Concurrent use with another biologic CGRP antagonist/inhibitor — denial risk.
Dosing not consistent with FDA labeling (see prescribing information) — denial risk.

Note

Member‑Specific Plan Governs

The member‑specific benefit plan governs coverage decisions. This policy is informational and may differ from the member's plan; in the event of conflict, the member specific benefit plan document controls. Verify federal/state mandates and the member’s benefit language before approving or denying coverage.

Reference the member specific benefit plan document — it governs in case of conflict.
Check for applicable federal or state mandates that may affect coverage.

Documentation Required

Required Documentation

Document the diagnosis and clinical data supporting medical necessity. Required documentation must include a diagnosis consistent with ICHD‑3, migraine-day frequency (e.g., 4–7 migraine days/month for certain episodic criteria or ≥15 headache days/month with ≥8 migraine days for chronic migraine), prior medication trials with dates/durations and outcomes (trial and failure, intolerance, or contraindication), and that Vyepti will not be used with another biologic CGRP agent. For step‑therapy, document trials and failures (or contraindication/intolerance) of required oral prophylactic agents or prior CGRP biologics as specified.

Diagnosis consistent with ICHD‑3.
Migraine-day and headache-day frequency (numeric documentation).
Prior medication trials: agents, durations, and outcomes (failure, intolerance, or contraindication).
Statement that Vyepti will not be used concurrently with another biologic CGRP antagonist/inhibitor.

Documentation Required

Vyepti Indication and Dosing Documentation

Vyepti is indicated for preventive treatment of migraine in adults. Dosing must follow FDA labeling: recommended 100 mg IV infusion every 3 months; some patients may benefit from 300 mg IV every 3 months. Include the indication (preventive migraine), chosen dose (100 mg or 300 mg), and planned infusion schedule in the request.

Indication: preventive treatment of migraine in adults.
Dose: 100 mg IV every 3 months (recommended); 300 mg IV every 3 months for some patients.
Include planned infusion schedule and rationale for dose selection.

Step Therapy

Step Therapy Context

Step‑therapy context: Professional societies recognize CGRP‑targeting therapies as migraine‑specific and support their use broadly; some guidelines support CGRP agents after failure of conventional oral prophylactics, while others acknowledge CGRPs as reasonable options earlier in therapy. This policy requires documented trials of specified oral prophylactic agents (or prior biologic CGRP trial where applicable) unless there is documented contraindication or intolerance. Examples of required prior therapies include trials of beta‑blockers, tricyclic antidepressants, topiramate, valproate/divalproex, candesartan, duloxetine/venlafaxine, and onabotulinumtoxinA when applicable.

Professional societies describe CGRP therapies as migraine‑specific and support broad use, including after prior treatment failures or in some cases earlier in therapy.
Step therapy requires documented trials and failures (or contraindication/intolerance) of specified oral prophylactics or a prior CGRP biologic trial per policy.
Examples of prophylactic agents: beta‑blockers (metoprolol, propranolol, atenolol, nadolol, propranolol, timolol), amitriptyline/nortriptyline, topiramate, divalproex/valproate, candesartan, duloxetine/venlafaxine, and onabotulinumtoxinA (trial of at least 2 quarterly injections when indicated).

PROMISE‑1 enrolled patients with ≤14 headache days/month and ≥4 migraine days/month

Coverage contextEpisodic criteria used for initial therapy eligibility when frequency thresholds and documentation met

Chronic migraine

Definition≥15 headache days per month, of which ≥8 meet criteria for migraine

Use in trialsPROMISE‑2 enrolled patients with ≥15 headache days/month and ≥8 migraine days/month

Coverage contextMeets chronic migraine threshold for initiation when documented per ICHD‑3 and other criteria

Vyepti (eptinezumab) — indication and dosing

Drug class and targetCalcitonin gene‑related peptide (CGRP) ligand antagonist (humanized IgG1 monoclonal antibody)

IndicationIndicated for preventive treatment of migraine in adults

Recommended dosing per FDA label100 mg IV every 3 months; some patients may receive 300 mg IV every 3 months

Route and administrationIntravenous infusion administered once every 12 weeks