CurrentCignaPolicy N/A

Emgality (galcanezumab) prior authorization for migraine and episodic cluster headache

Prior authorization policy describing medical necessity criteria, coverage limits, and exclusions for Emgality (galcanezumab-gnlm) for migraine prevention and episodic cluster headache for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEmgality (galcanezumab) prior authorization for migraine and episodic cluster headache

Policy CodePolicy N/A

Change TypeApproval duration and criteria clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Emgality; approvals for covered indications are granted for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Episodic Cluster Headache Treatment: Approval duration was changed from 6 months to 1 year.

Migraine Headache Prevention criteria now approve for 1 year when patient is ≥18, has ≥4 migraine days/month prior to initiating preventive medication, and current users must have significant clinical benefit.

The policy expanded the examples of standard prophylactic therapies for cluster headache and clarified that examples do not include oral or injectable CGRP inhibitors in earlier history notes.

1 yearapproval duration for covered indications

≥4minimum migraine days/month for migraine prevention coverage

≥18minimum age for covered indications

Policy Summary

PayerCigna

PolicyEmgality (galcanezumab) prior authorization for migraine and episodic cluster headache

Policy CodePolicy N/A

Change TypeApproval duration and criteria clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Emgality; approvals for covered indications are granted for 1 year when criteria are met.

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

FDA-Approved Indications

Covered when ALL of the following are met for the indicated FDA-approved use

Episodic Cluster Headache Treatment: Approve for 1 year if ALL of the following are met:

Episodic Cluster Headache Treatment - Criteria: A) Patient is ≥ 18 years of age; AND B) Patient has between one headache every other day and eight headaches per day; AND C) Patient has tried at least one standard prophylactic (preventive) pharmacologic therapy for cluster headache (examples: lithium, verapamil, melatonin, frovatriptan, prednisone, suboccipital steroid injection, topiramate, valproate); AND D) According to the prescriber, the patient had inadequate efficacy or experienced adverse events severe enough to warrant discontinuation of the standard prophylactic therapy.

Approval duration: 1 year.

Migraine Headache Prevention: Approve for 1 year if ALL of the following are met:

Migraine Headache Prevention - Criteria: A) Patient is ≥ 18 years of age; AND B) Patient has ≥ 4 migraine headache days per month (prior to initiating a migraine‑preventive medication); AND C) If the patient is currently taking Emgality, the patient has had a significant clinical benefit from the medication as determined by the prescriber (examples: reduction in overall number of migraine days per month or reduction in number of severe migraine days per month).

Approval duration: 1 year.

Coverage does not include concurrent use of Emgality with another calcitonin gene‑related peptide (CGRP) inhibitor for migraine prevention or with Nurtec ODT when Nurtec is being used as a preventive therapy. Requests for combined CGRP‑directed therapies will be considered not medically necessary and may be denied. The policy specifically notes injectable CGRP preventive agents (Aimovig, Ajovy, Emgality, Vyepti) and the oral preventive agent Qulipta, and states these agents have not been studied in combination with one another.

Providers should also follow the applicable benefit plan document and prior authorization processes. Approvals for FDA‑approved indications are provided for the durations specified in the policy when all coverage criteria are met; documentation must support the clinical rationale for therapy and any prior treatment trials or demonstrated clinical benefit as applicable.

Emgality has not been studied for the acute treatment of migraine. Use of Emgality to treat acute migraine attacks is not supported by the evidence referenced in this policy and is listed among the conditions considered not medically necessary.

Use of Emgality for any indication not specified in this policy is considered not medically necessary. This explicitly includes acute migraine treatment, concurrent use with another CGRP inhibitor for migraine prevention, and concurrent preventive use with Nurtec ODT. The policy clarifies that multiple injectable CGRP preventive agents (Aimovig, Ajovy, Emgality, Vyepti) and the oral preventive Qulipta have not been studied in combination, and concurrent prescribing of these agents is not covered.

Coding and Clinical Thresholds

Minimum monthly migraine days

Minimum monthly migraine days>= 4 migraine headache days per month (prior to initiating a migraine‑preventive medication)

Minimum age for migraine preventionPatient is >= 18 years of age

Approval duration for covered indicationApprove for 1 year when criteria are met

Prior Authorization, Documentation, and Provider Steps

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for prescription benefit coverage of Emgality. All approvals are provided for 1 year when criteria are met.

Emgality® (galcanezumab-gnlm subcutaneous injection)

Documentation Required

General documentation and billing guidance

Provider must submit requests consistent with the member's benefit plan. Use the most appropriate and current diagnosis and procedure/drug codes when billing. Claims submitted for services not accompanied by covered code(s) under the applicable coverage policy will be denied as not covered.

Ensure documentation supports the medical necessity criteria (diagnosis, frequency/severity, prior therapies tried, and prescriber justification).
When billing, use the most appropriate codes as of the service date. Unsupported or non-covered diagnosis/procedure codes will result in denial.

Drug Background and Context

Emgality (galcanezumab‑gnlm) is a monoclonal antibody that targets the calcitonin gene‑related peptide (CGRP) pathway and is indicated in adults for migraine prevention and for episodic cluster headache. The policy notes that Emgality is not studied for acute migraine treatment. Migraine is classified as episodic (<15 days/month) or chronic (≥15 days/month with ≥8 migraine days/month), and cluster headache is characterized by severe unilateral orbital/supraorbital/temporal pain lasting 15–180 minutes and occurring from once every other day up to eight times daily.

Clinical Definitions

Migraine classification — thresholds

Chronic migraineHeadache occurring on >= 15 days/month for > 3 months with migraine features on >= 8 days/month

Episodic migraineHeadaches that occur < 15 days/month

Clinical relevanceEpisodic migraine is more common; chronic migraine has greater personal and societal burden

Cluster headache — definition and attack features

DefinitionSevere, strictly unilateral orbital, supraorbital, and/or temporal pain lasting 15–180 minutes per attack

Attack frequencyOccurs from once every other day up to eight times a day