CurrentBlue Cross Blue Shield - IowaPolicy 05.02.49

Injectable CGRP Antagonist Drugs (Aimovig, Ajovy, Emgality, Vyepti) — Coverage Criteria

Policy governs prior authorization, coverage criteria, and continuation requirements for FDA‑approved injectable CGRP antagonists (Aimovig, Ajovy, Emgality, Vyepti) for preventive treatment of chronic and episodic migraine and episodic cluster headache in adults for Wellmark/BCBS Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyInjectable CGRP Antagonist Drugs — Coverage Criteria

Policy CodePolicy 05.02.49

Change TypeNo material changes

Effective DateSep 8, 2023

Next Review DateJun 1, 2025

Key ActionPrior approval is required; submit a prior approval/treatment request and document trials or contraindications to preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4CGRP agents addressed

6 monthsInitial approval period

12 monthsContinuation approval period

18+Adults only

J3032Vyepti billing code

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Injectable CGRP Antagonists

Initial Approval — Aimovig when preferred drugs tried or contraindicated

A Criteria for initial approval for Aimovig (erenumab) will only apply when the following criteria are met:

Aimovig initial criteria: (1) The patient has had an inadequate response to treatment, an intolerable adverse event, or has a contraindication to therapy with BOTH preferred products Ajovy (fremanezumab) and Emgality (galcanezumab).

Approval will be for 6 months

Current therapy exception: (2) The patient is currently receiving therapy with Aimovig through insurance (excludes samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.

Approval will be for 6 months

Initial Approval — Chronic migraine (Aimovig, Ajovy, Emgality)

May be considered medically necessary when ALL of the following are met:

Chronic migraine initial: (1) Diagnosis of chronic migraine defined as headache on ≥15 days per month for >3 months, with ≥8 migraine days per month.

Prophylactic trials: (2) Trial of at least TWO medications from the listed migraine prophylactic classes (e.g., anticonvulsants, beta blockers, antidepressants) with inadequate response, OR documented intolerance/contraindication/hypersensitivity to alternatives, OR currently receiving the requested product through insurance (excludes samples/manufacturer assistance) with documented benefit.

Each trial defined as ≥8 weeks at maximum tolerated dose with adherence during the trial.

Medication overuse evaluation: (3) The patient has been evaluated for and does not have medication‑overuse headache.

See Appendix B for diagnostic criteria.

Contributing conditions treated: (4) Other conditions or aggravating factors contributing to chronic migraine (e.g., dental/jaw problems, muscle tension, depression, fibromyalgia, sleep disorders, smoking) are being treated when applicable.

Concurrent botulinum toxin use: (5) If the patient is also currently receiving onabotulinumtoxinA for chronic migraine and will use the requested CGRP agent together (i.e., not switching), BOTH of the following must apply: (a) prior reduction in overall migraine days or severe migraine days with botulinum toxin; and (b) the patient continues to experience a significant number of migraine or severe migraine days per month requiring additional preventive therapy.

No combination CGRP agents: (6) The requested medication will not be used in combination with another CGRP antagonist or inhibitor being used for preventive treatment of migraine.

Examples include Vyepti and Qulipta.

Initial Approval — Episodic migraine (Aimovig, Ajovy, Emgality)

May be considered medically necessary when ALL of the following are met:

Episodic migraine initial: (1) Diagnosis of episodic migraine defined as at least 4 and fewer than 15 migraine days per month and fewer than 15 headache days per month on average during the prior 3‑month period.

Each trial defined as ≥8 weeks at maximum tolerated dose with adherence during the trial.

Medication overuse evaluation: (3) The patient has been evaluated for and does not have medication‑overuse headache.

See Appendix B for diagnostic criteria.

Initial Approval — Episodic cluster headache (Emgality)

Emgality may be considered medically necessary when ALL of the following are met:

Episodic cluster initial: (1) Diagnosis of episodic cluster headache as defined (severe unilateral orbital, supraorbital and/or temporal pain lasting 15–180 minutes, occurring at least every other day and up to eight times per day).

Medication overuse evaluation: (2) The patient has been evaluated for and does not have medication‑overuse headache.

See Appendix B for diagnostic criteria.

No concurrent CGRP receptor antagonist: (3) Emgality will not be used concurrently with another CGRP receptor antagonist for preventive treatment.

Initial Approval — Vyepti (eptinezumab) for chronic and episodic migraine

Vyepti may be considered medically necessary when ALL of the following are met:

Vyepti chronic initial: (1) Diagnosis of chronic migraine defined as headache on ≥15 days per month for >3 months, with ≥8 migraine days per month.

Vyepti prophylactic trials (chronic): (2) Trial of at least ONE medication in each of the listed migraine prophylactic agent classes (e.g., anticonvulsants, beta blockers, antidepressants) with inadequate response, OR documented intolerance/contraindication/hypersensitivity, OR currently receiving Vyepti through insurance (excludes samples/manufacturer assistance) with documented benefit.

Each trial defined as ≥8 weeks at maximum tolerated dose with adherence during the trial.

Vyepti episodic initial: (3) For episodic migraine: diagnosis of 4–14 migraine days/month and <15 headache days/month on average during the prior 3 months, and trial of at least ONE medication in each prophylactic class as described above with inadequate response or documented intolerance/contraindication, OR current receipt with benefit.

Continuation of Therapy — Aimovig, Ajovy, Emgality, Vyepti

May be considered medically necessary for continuation when ALL of the following are met:

Response to therapy: Patient's condition has responded as defined by ONE of the following: (a) achieved or maintained ≥50% reduction in monthly headache frequency or severity with medical records supporting benefit; OR (b) reduction in days of use of acute migraine‑specific medications from baseline with documentation; OR (c) reduction in headache frequency/severity resulting in improved productivity/attendance with documentation.>=50% reduction option

Approval for continuation is typically 12 months

Continuation other requirements: The patient has been evaluated for and does not have medication‑overuse headache; other contributing/aggravating conditions are being treated when applicable; the requested medication will not be used in combination with another biologic CGRP antagonist/inhibitor for prevention. If the patient is receiving botulinum toxin and will use both agents together (not switching), the botulinum toxin criteria regarding prior benefit and continued burden apply.

Approval will be for 12 months

Non‑Formulary Exception / Approval Criteria

Coverage for non‑formulary medications when ALL of the following are met

Non‑Formulary Exception Criteria - Indication: 1) The requested drug is used for an FDA‑approved indication or an indication supported in accepted compendia (e.g., AHFS, Micromedex); diagnostic testing/lab results required when applicable.

Members receiving samples or manufacturer assistance must still meet initial approval criteria.

Dosage within accepted limits: 2) The prescribed dose and quantity must fall within FDA‑approved labeling or dosing guidelines found in accepted compendia and evidence‑based practice guidelines.

Approvals may be subject to dosing/quantity limits (see Quantity Limits).

Formulary alternatives exhausted: 3) All covered formulary alternative drugs on any tier are ineffective, were ineffective, would not be as effective, or caused adverse effects; documentation required (chart notes indicating prior treatment failure, severity of adverse event, and dosage/duration of prior treatment, or contraindication).

Documentation required to support non‑formulary exception.

Evidence for Eptinezumab (Vyepti)

Coverage for Vyepti (eptinezumab) supported when trial data align with indication

Vyepti efficacy evidence: PROMISE‑1 (episodic) and PROMISE‑2 (chronic) randomized, placebo‑controlled trials demonstrated that eptinezumab (100 mg and 300 mg) reduced mean monthly migraine days versus placebo; effects were observed as early as day 1 and primary efficacy was assessed at 12 weeks. PROMISE‑1 enrolled episodic migraine patients (4–14 headache days/month) and PROMISE‑2 enrolled chronic migraine patients (15–26 headache days/month).

Trials administered IV every 3 months; primary endpoint measured at 12 weeks.

The safety and effectiveness of using multiple CGRP antagonists together for preventive treatment of migraine have not been evaluated. Requests that propose concurrent use of more than one CGRP antagonist or inhibitor for migraine prevention are not supported by the evidence in this policy and are restricted accordingly.

When the requested medication is not on the plan formulary, coverage requires meeting the Non‑Formulary Exception Criteria. This includes that the drug is used for an FDA‑approved indication or an indication supported in accepted compendia, the prescribed dose/quantity falls within FDA‑approved labeling or compendia dosing, and documentation that all covered formulary alternatives were ineffective, not tolerated, or contraindicated (chart notes documenting prior treatment failure, adverse events, dosage and duration, or contraindication are required).

The requested CGRP antagonist will not be used in combination with another CGRP antagonist or inhibitor for preventive treatment of migraine (examples include Aimovig, Ajovy, Emgality, Vyepti, Nurtec ODT, Qulipta). Use in combination with another biologic CGRP agent for prevention is explicitly disallowed by the policy and would be considered not medically necessary.

Use that exceeds the listed product quantity limits may be considered not medically necessary and subject to denial. Quantity limits in this policy include product‑specific limits such as Aimovig 70 mg/1 mL per 28 days, Aimovig 140 mg/1 mL per 28 days, Ajovy 225 mg/1.5 mL — 3 syringes/autoinjectors per 84 days, and specified limits for Emgality formulations.

Procedures, Codes, and Quantity Limits

Procedures and billing codesHCPCS

J3032

Injection, eptinezumab-jjmr, (Vyepti) mg

Covered HCPCS CodesHCPCSCovered

J3032

Injection, eptinezumab-jjmr, (Vyepti) mg

Product quantity limits (per-product dosing/limits summary)

Aimovig 70 mg70 mg/1 mL autoinjector — 1 autoinjector per 28 days

Aimovig 140 mg140 mg/1 mL autoinjector — 1 autoinjector per 28 days

Ajovy (fremanezumab) 225 mg225 mg/1.5 mL prefilled syringe/autoinjector — 3 syringes or autoinjectors per 84 days

Emgality (galcanezumab) 120 mg120 mg/mL prefilled syringe/pen — 1 prefilled syringe or pen per 28 days

Emgality (galcanezumab) 100 mg100 mg/mL prefilled syringe/pen — 3 prefilled syringes or pens per 28 days

Required Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for all injectable CGRP antagonist therapies covered by this policy. Submit a prior approval/treatment request before initiating therapy to avoid denial of the claim.

Prior approval required for Aimovig, Ajovy, Emgality, and Vyepti
Failure to obtain prior approval may result in denial

Documentation Required

Documentation of Trials or Current Therapy Required for Initial Approvals

Document trials of preferred products or current therapy when requesting initial approval. For Aimovig initial requests, the patient must have an inadequate response to, intolerance of, or contraindication to BOTH preferred products (Ajovy and Emgality), unless the patient is currently receiving Aimovig through insurance and demonstrating benefit. For all initial approvals, provide chart notes showing trials of at least two prophylactic agents from listed classes (or intolerance/contraindication) with trial durations and adherence noted.

Background

FDA‑approved injectable CGRP antagonists addressed in this policy include erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti). These agents are approved for preventive treatment of migraine in adults; galcanezumab additionally has an indication for episodic cluster headache. The policy is intended to ensure appropriate patient selection consistent with product labeling, clinical trial evidence, and guideline recommendations, and to direct utilization toward preferred products where applicable.

Key Definitions and Diagnostic Criteria

Definition — Chronic migraine

DefinitionHeadache occurring on 15 or more days per month for more than 3 months, which, on at least 8 days per month, has features of a migraine headache.

Age groupAdults (18 years of age and older)

Approval contextUsed as indication for preventive treatment with Aimovig, Ajovy, or Emgality when other criteria met; initial approval typically for 6 months.

Definition — Episodic migraine

DefinitionAt least 4 and fewer than 15 migraine days per month and fewer than 15 headache days per month on average during the previous 3-month period.

Age groupAdults (18 years of age and older)

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyInjectable CGRP Antagonist Drugs — Coverage Criteria

Policy CodePolicy 05.02.49

Change TypeNo material changes

Effective DateSep 8, 2023

Next Review DateJun 1, 2025

Key ActionPrior approval is required; submit a prior approval/treatment request and document trials or contraindications to preferred products.

SourceLink

On This Page

Contributing conditions treated: (4) Other conditions or aggravating factors contributing to episodic migraine (e.g., dental/jaw problems, muscle tension, depression, fibromyalgia, sleep disorders, smoking) are being treated when applicable.

No combination CGRP agents: (5) The requested medication will not be used in combination with another CGRP antagonist or inhibitor being used for preventive treatment of migraine (e.g., Vyepti, Nurtec ODT, Qulipta).

Medication overuse evaluation: (4) The patient has been evaluated for and does not have medication‑overuse headache.

See Appendix B for diagnostic criteria.

Contributing conditions treated: (5) Other contributing or aggravating conditions are being treated when applicable.

Concurrent botulinum toxin use: (6) If also receiving onabotulinumtoxinA and using Vyepti together (not switching), BOTH of the following must apply: prior reduction in migraine days with botulinum toxin, and the patient continues to experience significant migraine burden requiring additional therapy.

No combination CGRP agents: (7) Vyepti will not be used in combination with another CGRP antagonist or inhibitor being used for preventive treatment of migraine.

Document prior trials of Ajovy and Emgality (preferred) for Aimovig requests

Include dates, doses, duration (generally ≥8 weeks at max tolerated dose), adherence, and reason for discontinuation (inefficacy, adverse event, contraindication)

Current therapy: if patient is already receiving the requested product through insurance and demonstrating positive therapeutic outcome, document ongoing benefit

Prior Authorization

Prior Authorization and Dosing Limits

Approvals are subject to dosing and quantity limits consistent with FDA labeling and the policy's quantity limits. Provide dosing information on the prior authorization request and ensure requested dose/quantity falls within labeled guidelines.

Approvals may be subject to dosing limits per FDA labeling, compendia, and evidence-based guidelines
Quantity limits example: Aimovig 70 mg or 140 mg per 28 days; Ajovy 225 mg three syringes/84 days; Emgality 120 mg 1 syringe/28 days or 100 mg three syringes/28 days

Billing Rule

Billing Code for Vyepti (eptinezumab) Must Be Reported as J3032

Use the HCPCS code J3032 when billing for Vyepti (eptinezumab). Claims for eptinezumab that do not report J3032 may be denied.

Report Vyepti (eptinezumab) as J3032
Claims for eptinezumab may be denied if J3032 is not used

Denial Risk

Failure to Demonstrate Inadequate Response / Non‑Formulary Exception Denial Triggers

Failure to demonstrate inadequate response to both preferred products (Ajovy and Emgality) for Aimovig requests may lead to denial. For non‑formulary exception requests, insufficient documentation of prior treatment failure, adverse events, dose, or duration may result in denial.

Aimovig requests require documentation of inadequate response/intolerance/contraindication to BOTH Ajovy and Emgality unless currently benefiting from Aimovig under insurance
Non‑Formulary Exception denials may be triggered by dosing/quantity outside labeling or inadequate documentation of prior therapy failure or adverse events

Documentation Required

Medical Records Must Document Therapeutic Benefit for Continuation

Medical records must document therapeutic benefit for continuation approvals. Acceptable documentation includes at least ONE of: ≥50% reduction in monthly headache frequency or severity, reduction in days of acute migraine-specific medication use from baseline, or improvement in productivity/attendance supported by medical records.

Continuation approvals require medical records supporting benefit (e.g., ≥50% reduction in monthly headache frequency or severity)
Also acceptable: documented reduction in acute medication use or improved function/productivity

Step Therapy

Non‑Formulary Exception Documentation Requirements

When requesting a non‑formulary exception, include chart notes or documentation indicating prior treatment failure, severity of any adverse events, dosage and duration of prior treatments, or contraindications to formulary alternatives. The prescribed dose/quantity must align with FDA labeling or accepted compendia.

Chart notes must document prior treatment failure or adverse events and include dose and duration
Requested dose/quantity must fall within FDA-approved labeling or compendia guidance

Billing Rule

Coding and Documentation — Use Appropriate CPT/HCPCS/Revenue/ICD Codes When Reporting Eptinezumab

Use appropriate CPT, HCPCS, revenue, and ICD codes when reporting services. For eptinezumab (Vyepti), report J3032. Accurate coding and documentation on claims help prevent denials.

Report eptinezumab as J3032 (Injection, eptinezumab-jjmr, (Vyepti))
Include relevant CPT, revenue, and ICD-10 diagnosis codes when billing
Claims may be denied for incorrect coding or missing documentation

Step Therapy

Preferred Product Requirement — Use Preferred Products Before Aimovig Unless Exceptions Met

Preferred product requirement: the plan's preferred products are Ajovy and Emgality. Use these preferred agents before requesting Aimovig unless there is documented intolerance, contraindication, or failure to both preferred products, or the member is already receiving Aimovig through insurance with documented benefit. Vyepti is excluded from the preferred product requirement.

Preferred products: Ajovy (fremanezumab) and Emgality (galcanezumab)
Aimovig requires prior failure/intolerance/contraindication to BOTH preferred products unless currently receiving Aimovig with benefit
Vyepti is excluded from the preferred product step

Note

Provider Action Checklist

Provider action summary: ensure prior authorization is obtained, include full documentation of prior trials or current therapy, request doses within labeling, use proper billing codes (J3032 for Vyepti), and supply medical records demonstrating therapeutic benefit for continuation. Missing or insufficient documentation, or requests for doses/quantities outside labeling, may lead to denial.

Obtain prior authorization prior to treatment initiation
Attach chart notes documenting prior therapies, trial durations, adherence, and reasons for discontinuation
Verify dose/quantity requested aligns with policy limits and FDA labeling
Use J3032 for Vyepti and include appropriate CPT/ICD codes
Provide documentation of therapeutic benefit for continuation (e.g., ≥50% reduction in headache frequency)

Approval contextCriteria for Aimovig, Ajovy, Emgality, and Vyepti preventive treatment; initial approval typically for 6 months when prophylactic trial requirements met.

Definition — Episodic cluster headache

DefinitionSevere or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15–180 minutes (when untreated), occurring at least every other day and up to eight times per day.

Associated featuresIpsilateral autonomic signs (e.g., conjunctival injection, lacrimation, nasal congestion, eyelid edema) or sense of restlessness/agitation.

Approval contextEmgality (galcanezumab) may be considered medically necessary for episodic cluster headache in adults when criteria met; initial approval for 6 months.

Episodic vs Chronic Migraine / ICHD‑3 distinction

ICHD‑3 distinctionEpisodic migraine: fewer than 15 monthly migraine or headache days; Chronic migraine: at least 15 monthly headache days with ≥8 migraine days per month (over >3 months).

Diagnostic basisClassification follows International Classification of Headache Disorders (ICHD‑3) criteria; see Appendix for full diagnostic content.

Clinical relevanceFrequency thresholds determine eligibility for preventive CGRP antagonist therapy per policy criteria (initial approval and continuation).

Medication‑overuse headache (ICHD‑3 beta) definition

DefinitionHeadache present on ≥15 days/month and regular overuse for >3 months of one or more drugs taken for acute/symptomatic treatment of headache (includes triptans, ergotamine, opioids, combination analgesics, acetaminophen/NSAIDs thresholds as specified).

Overuse thresholdsExamples: regular intake of triptans or ergotamine ≥10 days/month for >3 months; acetaminophen/NSAIDs or other non‑opioid analgesics ≥15 days/month for >3 months; opioids or combination analgesics ≥10 days/month for >3 months.

Policy implicationPatients must be evaluated for and not have medication‑overuse headache before initiating or continuing CGRP antagonist preventive therapy.

References — clinical citations, package inserts, and guidelines

Product package insertsAimovig, Ajovy, Emgality, and Vyepti package inserts (Amgen, Teva, Eli Lilly, Lundbeck) cited (March 2025).

Key clinical trialsPROMISE‑1 and PROMISE‑2 (eptinezumab); EVOLVE‑1/2 and other randomized trials for galcanezumab, fremanezumab, erenumab referenced in bibliography.

Guidelines and society statementsInternational Headache Society ICHD‑3, AHS and AAN guideline documents and IHS trial guidance cited as supporting references.