Vyepti (eptinezumab-jjmr) for migraine prevention — Coverage Criteria
Defines UnitedHealthcare coverage criteria for Vyepti (eptinezumab-jjmr) for prevention of migraine in applicable members, including initial and continuation authorization requirements and excluded indications.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial therapy
Medication must not be used in combination with another biologic CGRP antagonist or inhibitor used for preventive treatment of migraines (e.g., Aimovig, Emgality, Nurtec ODT, Qulipta)
Continuation Therapy
Covered for continuation when ALL of the following are met
Not Medically Necessary / Unproven
These uses are listed as unproven and not medically necessary
The following uses are explicitly listed as unproven and not medically necessary: acute attack of migraine and episodic cluster headache. These indications are excluded from coverage and may be denied if billed for Vyepti for these purposes.
Vyepti (eptinezumab) is considered unproven and not medically necessary when used for the treatment of acute migraine attacks and for episodic cluster headache. Providers should not submit requests for Vyepti authorization for these indications as they do not meet medical necessity criteria.
Coding and Diagnosis Codes
| J3032 | Injection, eptinezumab-jjmr, 1 mg |
| 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. |
Provider Actions and Requirements
Prior authorization required for initial therapy
Prior authorization is required for initial Vyepti (eptinezumab‑jjmr) therapy. Authorization for initial therapy is granted only when the member has a diagnosis of migraine consistent with ICHD‑3 and meets the migraine frequency criteria (either 4 to 7 migraine days per month with <15 headache days per month or provider attestation that migraine is the predominant headache diagnosis, or the alternate ≥8 migraine days pathway with required prior trials). Dosing must follow FDA‑approved labeling and initial authorization is limited to no more than 12 months.
- Diagnosis must be consistent with The International Classification of Headache Disorders, 3rd edition (ICHD‑3).
- One frequency pathway: 4 to 7 migraine days/month AND less than 15 headache days/month OR provider attests migraine is predominant diagnosis.
- Alternate pathway references ≥8 migraine days/month with associated prior-trial requirements (see step therapy).
- Dosing per FDA labeling; authorization issued for up to 12 months.
Required prior trial and failure of listed prophylactic therapies
Initial therapy requires documented prior trial and failure, intolerance, or contraindication to specified preventive therapies before Vyepti is authorized. Trials and minimum durations vary by agent class and pathway, including at least two months for certain oral/systemic prophylactics and at least three months for a prior CGRP monoclonal antibody where specified.
- For the ≥8 migraine days/month pathway: trial and failure (after a trial of at least two months), contraindication, or intolerance to two listed prophylactic therapies (examples: amitriptyline/nortriptyline; beta‑blockers; candesartan; divalproex; topiramate; duloxetine/venlafaxine; OnabotulinumtoxinA with at least 2 quarterly injections = 6 months).
- For other pathways: trial and failure (after a trial of at least three months), contraindication, or intolerance to one of the listed CGRP monoclonal antibodies (Aimovig, Emgality, Ajovy).
- Medication must not be used in combination with another biologic CGRP antagonist/inhibitor.
Required clinical documentation to support authorization
Providers must document an ICHD‑3 consistent migraine diagnosis, the member's migraine day frequency, and evidence of prior preventive therapy trials (including agent names, trial durations, and intolerance/contraindication when applicable) to support authorization.
- Document diagnosis consistent with The International Classification of Headache Disorders, 3rd edition.
- Record migraine days per month and headache days per month or provider attestation that migraine is the predominant headache diagnosis.
- Provide documentation of prior trial(s) including agents used, duration (e.g., ≥2 months for some oral/systemic prophylactics; ≥3 months for prior CGRP mAb where required), and reason for failure/intolerance/contraindication.
Excluded indications — acute migraine attack and episodic cluster headache
Use of Vyepti for acute migraine attacks or for episodic cluster headache is considered unproven and not medically necessary and may be denied.
- Do not submit authorization requests for Vyepti for treatment of an acute attack of migraine.
- Do not submit authorization requests for episodic cluster headache; these uses are listed as not medically necessary.
Background
Eptinezumab (Vyepti) is an intravenous monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) pathway and is indicated for preventive treatment of migraine. Phase 3 trials (including PROMISE-1 and related studies) demonstrated reductions in monthly migraine days in episodic migraine populations, with onset of benefit observed as early as day 1 and a tolerability profile similar to placebo.
Definitions
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