CurrentHighmark Blueshield NenyPolicy N/A

Emgality (galcanezumab) prior authorization for migraine/cluster headache

This form governs prior authorization requests for Emgality (galcanezumab) for migraine prophylaxis and episodic cluster headache for Highmark BlueShield members; it affects prescribing providers submitting authorization forms and documentation.

Policy Summary

PayerHighmark Blueshield Neny

PolicyEmgality (galcanezumab) prior authorization for migraine/cluster headache

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with clinical documentation including diagnosis, baseline migraine frequency, prior therapy failures/intolerances, and response data for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

50%reduction threshold (general)

4 daysepisodic reduction

5 dayschronic reduction

240 mgloading dose

Coverage Criteria for Emgality (galcanezumab)

Policy Summary

PayerHighmark Blueshield Neny

PolicyEmgality (galcanezumab) prior authorization for migraine/cluster headache

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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ALL of the following

Documented diagnosis of one of the following: Episodic migraine (4–14 headache days per month), Chronic migraine (≥15 headache days per month, with ≥8 migraine days), or Episodic cluster headache (severe unilateral orbital, supraorbital, and/or temporal pain lasting 15–180 minutes)
Baseline documentation of average number of migraine or headache days per month prior to starting Emgality
Record numeric value in chart or prior auth form
Therapeutic failure or intolerance to ≥1 preventive agent
- Anti-epileptic drug (e.g., topiramate, valproic acid, divalproex, carbamazepine)
- Beta-blocker (e.g., propranolol, timolol, metoprolol)
- Calcium-channel blocker (e.g., verapamil, amlodipine)
- Serotonin-norepinephrine reuptake inhibitor (e.g., venlafaxine, duloxetine)
- Tricyclic antidepressant (e.g., amitriptyline, nortriptyline)
- Botox (onabotulinumtoxinA)
- Other preventive agents (specify)
  Provider must indicate agent and intolerance or failure reason
Member is not primarily experiencing medication overuse or rebound headache due to overutilization of acute agents (e.g., narcotics or triptans >18 doses/month) or unmanaged lifestyle contributors unless clinician documents that Emgality is still clinically appropriate
If medication overuse is present, document rationale and plans to address overuse
Concurrent CGRP-targeted therapy
- If Emgality will be used concurrently with another CGRP-targeted medication for acute use (e.g., rimegepant, ubrogepant), provider attests that the benefits of concurrent use outweigh the risks
  Yes response required to approve concurrent use
- If NO concurrent CGRP therapy, this criterion is met
Loading dose
- Provider documents need for 240 mg loading dose (2 × 120 mg syringes/pens) if clinically indicated
  Select Yes to authorize loading dose
- No loading dose requested

Reauthorization Criteria

Reauthorization is approved when ANY of the following response thresholds (matched to diagnosis) are met:

ALL of the following

Primary reauthorization response criteria
- For all diagnoses: ≥50% reduction in monthly migraine days compared with baseline
  Documentation of baseline and current monthly migraine days required
- For episodic migraine: reduction of ≥4 monthly migraine days from baseline
  Provider must report baseline and current monthly migraine days
- For chronic migraine: reduction of ≥5 monthly migraine days from baseline
  Provider must report baseline and current monthly migraine days
- For episodic cluster headache: reduction in mean weekly cluster attacks from baseline
  Provider must report baseline and current mean weekly cluster attack frequency
Provider attests to clinical benefit (reduced severity, improved functioning, or decreased acute medication use) if numeric thresholds are not fully met
Clinical justification must be documented in chart notes

Query regarding medication overuse / rebound headache: The prescriber must indicate whether the member's headaches are caused by medication overuse or rebound (defined as use of narcotics or triptans exceeding more than 18 doses per month) or by modifiable lifestyle factors (e.g., sleep patterns, caffeine use). If medication overuse is present, document the plan to address overuse and rationale for initiating or continuing Emgality despite overuse; untreated medication overuse may affect coverage decisions.

Migraine Definitions and Dosing

Migraine days per month

Episodic migraine4–14 headache days per month

Chronic migraine15 or more headache days per month (of which a number are migraine days)

Assessment requiredDocument average migraine days per month prior to starting Emgality

Loading dose

Loading dose amount240 mg total (two 120 mg syringes or pens)

Provider questionIndicate whether member needs a 240 mg loading dose (Yes/No)

Administration detailLoading dose described as 2 syringes or pens of Emgality 120 mg

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required for this medication. Submit the completed prior authorization form for review; the request must include the member diagnosis and all applicable clinical fields from the form.

Submit one form per medication request.
Include diagnosis (select applicable: episodic migraine, chronic migraine, episodic cluster headache, or other with ICD-10).
Include completed clinical fields (migraine days per month, prior preventive therapy history, medication details, and responses to all clinical questions).

Documentation Required

Prior Preventive Therapy Documented

Document and submit evidence of therapeutic failure or intolerance to prior preventive agents before initial approval will be considered. The form requires indication of prior preventive therapies tried and whether each produced therapeutic failure or intolerance. Please select all that apply and provide specifics when applicable.

Anti-epileptic agents (e.g., topiramate, valproic acid, divalproex sodium, carbamazepine)
Beta-blockers (e.g., propranolol, timolol, metoprolol)
Calcium-channel blockers (e.g., verapamil, amlodipine)
SNRIs (e.g., venlafaxine, duloxetine)
Tricyclic antidepressants (e.g., amitriptyline, nortriptyline)
Botox
Alpha-agonists (e.g., clonidine, guanfacine)
ACE inhibitors/ARBs (e.g., lisinopril, candesartan)
Other — specify agent, dates of therapy, and reason for discontinuation (failure or intolerance)

Documentation Required

Required Documentation and Submission

To ensure timely review, submit the completed form along with supporting clinical documentation. Include member and provider information, medication details, and clinical responses to the form questions.

Completed prior authorization form with all fields filled out.
Member information: name, DOB, subscriber ID, group number, contact phone, address.
Provider information: physician name, NPI, phone, fax, address, and signature with date.
Medication information: drug name, strength, requested quantity and days supply, directions, and whether a loading dose is requested.
Clinical information: diagnosis, baseline migraine/cluster frequency (days per month or attacks per week), evidence of prior preventive therapy failure/intolerance, reasons headaches are not due to medication overuse, and outcomes for reauthorization (e.g., ≥50% reduction in migraine days or specified reduction thresholds by diagnosis).
Attach relevant clinical notes, headache diaries, prior medication records, and objective documentation supporting response to therapy for reauthorization requests.

Denial Risk

Authorization and Payment Eligibility

Authorization is a review decision and does not guarantee payment. Payment remains subject to member eligibility, benefits, and coverage rules at the time of claim adjudication.

Ensure member eligibility and benefits are verified at time of service.
Authorization determination does not override benefit limitations, formulary restrictions, or eligibility status.

Background

This prior authorization form covers use of Emgality (galcanezumab) for prevention of migraine and for episodic cluster headache. The diagnosis options listed are episodic migraine prophylaxis (4–14 headache days per month), chronic migraine prophylaxis (≥15 headache days per month), and episodic cluster headache (defined on the form as severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes when untreated). The form also captures baseline average monthly migraine days and asks whether a 240 mg loading dose is required and whether concurrent use with another CGRP-targeting medication is planned.

Definitions

Episodic Migraine Prophylaxis

DefinitionEpisodic Migraine Prophylaxis defined as 4–14 headache days per month

Baseline requirementForm asks for average days per month prior to starting Emgality

Medication-overuse screeningForm queries whether headaches are caused by medication rebound or overutilization

Chronic Migraine Prophylaxis

DefinitionChronic Migraine Prophylaxis defined as 15 or more headache days per month (of which a number are migraine days)

Reauthorization response targetFor chronic migraine, reauthorization requires a reduction of at least 5 monthly migraine days since start of therapy

Baseline requirementForm requests documentation of average headache days per month prior to therapy

Episodic Cluster Headache

DefinitionEpisodic Cluster Headache: severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes when untreated

Separate question setFor this diagnosis only, the form directs the provider to question 7

Attack-frequency assessmentQuestion 7 asks whether the member is experiencing at least one attack every other day during a cluster period