ModifiedmhnPolicy CP.CPA.344

Galcanezumab-gnlm (Emgality) coverage for migraine and episodic cluster headache

Defines medical necessity criteria, dosing limits, and prior authorization/continuation requirements for Emgality for adults with migraine prophylaxis or episodic cluster headache for health plans affiliated with Centene Corporation (commercial line).

Policy Summary

Payermhn

PolicyGalcanezumab-gnlm (Emgality) coverage for migraine and episodic cluster headache

Policy CodePolicy CP.CPA.344

Change TypeOperational revisions to durations, concurrent-use, and failure-threshold language

Effective DateMar 1, 2020

Next Review DateN/A

Key ActionPrior authorization required and must document diagnosis, age ≥18, ≥2 failed oral preventive therapies (8 weeks each, different classes), and requested duration consistent with policy (e.g., 6 months).

SourceLink

POLICY UPDATE CHANGES

Added Zavzpret to list of CGRP inhibitors that should not be prescribed concurrently with Emgality and removed references to 'injectable or oral CGRP' since Zavzpret is a nasal product.

Modified initial and continuation approval durations for migraine prophylaxis to 6 months or to the member's renewal date, whichever is longer; episodic cluster headache initial approval changed from 3 to 6 months.

Revised initial criteria for migraine prophylaxis redirection to oral preventive therapies from 'failure of at least two' to 'failure of two of the following'.

Clarification that California Exchange Plans should not be approved using these criteria and refer to a state-specific criteria set.

≥4minimum migraine days/month required

2failed oral preventives required

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120 mgmigraine maintenance dose (max)

300 mgcluster headache monthly dose (max)

6 moinitial approval duration

Zavzpretnew concurrent-use product listed

Coverage Criteria

Initial Therapy Criteria

Initial Approval — Migraine Prophylaxis (covered when ALL of the following are met):

Diagnosis of episodic or chronic migraine

Frequency: Provider attests member experiences >= 4 migraine days per month for at least 3 months>=4 days/month for >=3 months

Age >= 18 years>=18

Prior therapy: Failure of two of the following oral migraine preventive therapies, each for 8 weeks and from different therapeutic classes, unless contraindicated or intolerant (examples: antiepileptics, beta-blockers, antidepressants)2 therapies, 8 weeks each

Concurrent Botox: If requesting concurrent use with Botox, provide required high-quality evidence AND member must have had >=30% reduction in migraine days from baseline after at least 2 quarterly (6 months) Botox injections but continue to have >=4 migraine days/month or disabling migraines>=30% reduction after 2 quarterly Botox injections; persistent >=4 days/month

Detailed evidentiary criteria in policy

CGRP exclusivity: Emgality is not prescribed concurrently with other CGRP inhibitors (examples include Aimovig, Ajovy, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret)

Dose limits: Dose does not exceed loading dose 240 mg once and maintenance dose 120 mg once monthlyloading 240 mg; maintenance 120 mg/month

Approval duration: 6 months or to member renewal date, whichever is longer

Initial Therapy - Episodic Cluster Headache Criteria

Initial Approval — Episodic Cluster Headache (covered when ALL of the following are met):

Diagnosis of episodic cluster headaches

Cluster history: Provider attests history of >= 2 cluster periods lasting 7 days to 1 year each and separated by >= 3 months>=2 cluster periods

Age >= 18 years>=18

Verapamil failure: Failure of verapamil at a dose of 360 mg/day unless contraindicated or intolerantverapamil 360 mg/day trial

Continuation Therapy - Migraine Prophylaxis Criteria

Continuation Therapy — Migraine Prophylaxis (must meet ALL):

Eligibility: Member currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies)

Response: Member has experienced and maintained positive response as evidenced by provider attestation of reduction in migraine days per month from baselinedocumented reduction

CGRP exclusivity: Emgality is not prescribed concurrently with other CGRP inhibitors (this requirement does not apply in CA for members previously approved and stable on therapy)

CA exception described in policy

Dose ceiling: If request is for a dose increase, new dose must not exceed 120 mg once monthly

Continuation Therapy - Episodic Cluster Headache Criteria

Continuation Therapy — Episodic Cluster Headache (must meet ALL):

Eligibility: Member currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies)

Response: Member is responding positively as evidenced by provider attestation of reduction in cluster headache attack frequencydocumented reduction

Duration limits: Member has not received more than 12 months of consecutive treatment OR it has been at least 3 months since the member last received Emgality<=12 months consecutive or >=3 months since last dose

CGRP exclusivity:

Updated approval durations and concurrent-use criteria

Policy coverage includes updated duration and concurrent-use criteria:

Migraine approval duration: Initial and continuation approval for migraine prophylaxis are for 6 months or to the member's renewal date, whichever is longer.6 months or to member renewal date

chunk 24

Episodic cluster approval duration: Initial approval duration for episodic cluster headache changed from 3 months to 6 months.6 months

chunk 24

Concurrent use restrictions: Emgality should not be prescribed concurrently with other CGRP inhibitors; Zavzpret was explicitly added to the list and route-based language was removed to account for the nasal formulation; concurrent use with Botox requires supportive evidence per policy.N/A

Coverage is not authorized for non‑FDA approved indications unless there is sufficient documentation of safety and efficacy in accordance with the off‑label use policy (CP.CPA.09) or other evidence of coverage documentation. In particular, chronic cluster headache is explicitly excluded from coverage under this policy.

These criteria do not apply to members covered under California Exchange Plans. For California Exchange Plans, refer to the state‑specific galcanezumab (Emgality) criteria: HIM.PA.SP67 rather than using this policy's criteria.

Use of Emgality for chronic cluster headache is considered not medically necessary and is not authorized based on the policy's exclusion for non‑FDA indications and the clinical trial evidence showing lack of demonstrated efficacy for chronic cluster headache.

Emgality should not be prescribed concurrently with other CGRP pathway agents. The policy was updated to explicitly include Zavzpret on the list of CGRP products to avoid concurrent prescribing and to remove route‑based language (to account for nasal formulations). Concurrent use with other CGRP inhibitors or Botox requires supporting documentation per policy and may trigger denial if not justified.

Coding and Billing

Product CodesNDC

NDC	Product billing via NDC implied (product availability listed)

HCPCS referenced codesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

inv-12: Minimum migraine days per month requirement (value badge)

Minimum migraine days per month>= 4 migraine days per month (for at least 3 months)

Evidence durationAttestation must state frequency for >= 3 months

Applies toEpisodic or chronic migraine diagnoses for adults (age >= 18)

inv-13: Minimum prior oral preventive therapies failed (>= 2, 8 weeks each, different classes)

Minimum prior oral preventive therapies failed>= 2 oral migraine preventive therapies

Trial durationEach therapy tried for 8 weeks unless contraindicated or intolerant

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required for initial and continued therapy. Providers must document diagnosis, prior therapy trials, attestations, and any supportive evidence for concurrent therapies. Requests lacking required documentation or requesting concurrent CGRP therapies or coverage for unsupported indications may be denied.

Applies to Emgality (galcanezumab) requests for migraine prophylaxis and episodic cluster headache
Approval duration: initial and continued — 6 months or to the member's renewal date, whichever is longer (episodic cluster = 6 months initial)
Do not prescribe concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret) unless documentation supports concurrent use

Documentation Required

Initial Authorization — Migraine Prophylaxis

Initial authorization for migraine prophylaxis is approved only when ALL listed criteria are met. Providers must attest to migraine frequency, age, prior oral preventive therapy failures (two different classes, 8 weeks each unless contraindicated), and dosing limits. For requests that involve concurrent Botox and Emgality (not a switch), submit high-quality evidence, proof of prior Botox response, and documentation that migraine burden remains ≥ 4 days/month or causes significant disability despite Botox.

Background

Emgality (galcanezumab‑gnlm) is a monoclonal antibody targeting the calcitonin gene‑related peptide (CGRP) pathway indicated for preventive treatment of migraine and for episodic cluster headache in adults. Dosing varies by indication (loading and monthly maintenance regimens described in the prescribing information), and clinical trials demonstrated reductions in monthly migraine days for patients receiving the product. The policy references the Emgality Prescribing Information and clinical trial/guideline literature as the primary sources for dosing and efficacy details.

Definitions and References

inv-26: Definition — 'Migraine day' (short clinical definition)

Definition — Migraine dayAny calendar day with a headache lasting >= 2 consecutive hours meeting ICHD-3 migraine or probable migraine criteria, or any day a headache of any duration is treated with a migraine-specific medication (triptan or ergot)

Source criteriaDefinition consistent with clinical trial outcome measures (EVOLVE-1/2, REGAIN)

Use in attestationProviders must attest to migraine day frequency when documenting eligibility

inv-27: Definition — Episodic vs Chronic Cluster Headache distinctions

Episodic vs Chronic cluster distinctionEpisodic: cluster periods lasting 7 days to 1 year separated by >= 3 months of remission; Chronic: >1 year without remission or with remissions < 3 months

Clinical relevance

Revision History

2024-07-15operational_update

Added Zavzpret to the list of CGRP inhibitors that should not be prescribed concurrently with Emgality and removed route-specific language to account for Zavzpret’s nasal formulation.

2025-06-10operational_update

Clarified that California Exchange Plans should not be approved using these criteria and directed reviewers to the state-specific HIM.PA.SP67 criteria for Emgality.

2025-07-11operational_updateLatest

Policy Summary

Payermhn

PolicyGalcanezumab-gnlm (Emgality) coverage for migraine and episodic cluster headache

Policy CodePolicy CP.CPA.344

Change TypeOperational revisions to durations, concurrent-use, and failure-threshold language

Effective DateMar 1, 2020

Next Review DateN/A

SourceLink

On This Page

CGRP exclusivity: Emgality is not prescribed concurrently with other CGRP inhibitors (examples include Aimovig, Ajovy, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret)

Dose limits: Dose does not exceed 300 mg once monthly (administered as three 100 mg injections)300 mg/month

Approval duration: 6 months

Approval duration: 6 months or to member renewal date, whichever is longer

Emgality is not prescribed concurrently with other CGRP inhibitors (this requirement does not apply in CA for members previously approved and stable on therapy)

CA exception described in policy

Dose ceiling: If request is for a dose increase, new dose must not exceed 300 mg once monthly (3 injections)<=300 mg/month

Approval duration: 6 months (up to 12 months per cluster period)

Prior therapy wording update: Initial criteria for migraine prophylaxis redirection to oral preventive therapies updated from 'failure of at least two' to 'failure of two of the following'.failure of two

chunk 23

Therapeutic classesMust be from different classes (examples: antiepileptics, beta-blockers, antidepressants)

inv-14: Initial/continuation approval duration (6 months or to member renewal date)

Initial/continuation approval duration6 months or to the member's renewal date, whichever is longer

Episodic cluster initial approvalInitial approval for episodic cluster headache changed to 6 months (previously 3 months)

Continuation review intervalContinuation approvals aligned to 6-month authorization periods per policy

Diagnosis: episodic or chronic migraine
Provider attestation: ≥ 4 migraine days per month for at least 3 months
Age ≥ 18 years
Failure of two oral migraine preventive therapies from different classes, each trialed for 8 weeks unless contraindicated or intolerant (examples: antiepileptics like topiramate or valproate; beta-blockers like propranolol or metoprolol; antidepressants like amitriptyline or venlafaxine)
If concomitant Botox use is requested: provide (a) ≥2 high-quality published studies or guidelines supporting concurrent use (case reports/chart reviews are not high-quality), (b) documentation of ≥30% reduction in migraine days after at least 2 quarterly Botox injections (6 months) demonstrating prior response to Botox monotherapy, and (c) evidence that member continues to have ≥4 migraine days/month or disabling headaches despite Botox

Documentation Required

Initial Authorization — Episodic Cluster Headache

Initial authorization for episodic cluster headache requires documentation of diagnosis and cluster history, age, and failure of verapamil at adequate dose unless contraindicated. Dose and injection limits must be observed.

Diagnosis: episodic cluster headaches
Provider attestation: history of ≥2 cluster periods lasting 7 days to 1 year each, separated by ≥3 months
Age ≥ 18 years
Failure of verapamil at 360 mg/day (unless contraindicated or intolerant)
Dose limits: 300 mg once monthly administered as three consecutive 100 mg injections; maximum 3 injections once monthly

Documentation Required

Required Documentation and Provider Attestations

Required documentation must be submitted with the PA request. This includes prior therapy dates and durations, provider attestations of response or failure, rationale for concurrent therapies, and supporting evidence when applicable. Lack of sufficient documentation may trigger denial.

Dates and duration of prior oral preventive therapy trials and reason for discontinuation (ineffectiveness, intolerance, or contraindication)
Provider attestation of baseline and on-treatment migraine days per month (for initial and continuation requests)
If concurrent Botox and Emgality is requested, include supporting publications/guidelines and documentation of prior Botox response (≥30% reduction in migraine days after ≥6 months of Botox monotherapy)
If requesting deviation from step therapy (e.g., missing two oral trials), provide clinical justification and documentation of contraindications or intolerances

Step Therapy

Step Therapy / Prior Drug Trials

Step therapy: For migraine prophylaxis, members must have failed two of the specified oral preventive therapies from different classes before approval, unless contraindicated. Each oral trial should be at least 8 weeks. Exceptions require documentation of contraindication or intolerable adverse effects.

Failure of two of the following (from different therapeutic classes) is required prior to approval: antiepileptic drugs (e.g., topiramate, divalproex/valproate), beta-blockers (e.g., propranolol, metoprolol, timolol), antidepressants (e.g., amitriptyline, venlafaxine)
Each oral preventive therapy trial should be ≥ 8 weeks unless stopped earlier for adverse effects or documented contraindication
If prescriber documents contraindication or intolerance to one or more classes, indicate which agents are contraindicated and provide supporting clinical rationale

Denial Risk

Unsupported Indications / Not Authorized

Unsupported or non‑FDA indications are not covered under this policy unless supported by off‑label use policies or evidence. Chronic cluster headache is explicitly not authorized.

Non‑FDA-approved indications require sufficient documentation of efficacy and safety per off‑label use policies (e.g., CP.CPA.09) or evidence of coverage documents
Chronic cluster headaches: coverage NOT authorized under this policy

Denial Risk

Denial Triggers and Operational Notes

Denial triggers: concurrent prescribing with other CGRP therapies or Botox without the required supportive documentation, insufficient prior therapy documentation, missing provider attestations, or requests for non‑covered indications may lead to denial.

Concurrent use with other CGRP inhibitors (Aimovig, Ajovy, Nurtec ODT, Qulipta, Ubrelvy, Vyepti, Zavzpret) without documentation justifying concurrent therapy — denial risk
Requests that do not document two adequate oral preventive therapy trials (or documented contraindications) — denial risk
Requests lacking provider attestations of baseline migraine frequency or clinical response — denial risk
Requests for chronic cluster headache — not covered

Emgality has demonstrated efficacy only in episodic cluster headache; chronic cluster headache use not authorized

Documentation requirementProvider must attest to history of >= 2 cluster periods for episodic cluster initial requests

inv-28: Definition — Prescribing Information as primary product reference

Primary product referenceEmgality Prescribing Information (FDA label) — Emgality Prescribing Information. Eli Lilly and Company; March 2025

Content coveredContains dosing regimens, loading and maintenance doses, and formulation details

Reference URLFDA label available via accessdata.fda.gov as listed in policy references

inv-29: Guideline and trial evidence — professional society guidelines and pivotal trials referenced

Professional society guidelinesReferences include American Academy of Neurology, American Headache Society, and American College of Physicians guidance relevant to migraine and cluster headache management

Pivotal trialsKey trials cited: EVOLVE-1, EVOLVE-2, REGAIN (galcanezumab pivotal studies)

Evidence summaryGuidelines and pivotal trial results inform dosing recommendations and efficacy—maintenance 120 mg monthly supported by trials

Modified initial and continuation approval durations for migraine prophylaxis to 6 months or to the member's renewal date, whichever is longer, and changed episodic cluster headache initial approval from 3 months to 6 months.