CurrentHighmark Blueshield NenyPolicy N/A

Emgality (galcanezumab) prior authorization form for migraine/cluster headache prophylaxis

A medication prior authorization form used by Highmark BlueShield for Emgality (galcanezumab) to document clinical indications, prior therapeutic failures/intolerance, dosing (including loading dose), concurrent CGRP use, and reauthorization effectiveness criteria for episodic migraine, chronic migraine, and episodic cluster headache.

Policy Summary

PayerHighmark Blueshield Neny

PolicyEmgality (galcanezumab) prior authorization form for migraine/cluster headache prophylaxis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must complete and submit a separate Emgality prior authorization form (one per medication) including diagnosis, prior treatment failures/intolerance, baseline headache frequency, and other required fields to Highmark via fax 1-866-240-8123 or mail to SPECARE, 120 Fifth Avenue, Pittsburgh, PA 15222.

POLICY UPDATE CHANGES

No material clinical/coverage changes

3Covered Indications (listed on form)

6Prior preventive medication classes listed

3Reauthorization improvement criteria options

Coverage Summary

Coverage stance: covered_with_criteria. This Highmark prior authorization form establishes coverage for Emgality (galcanezumab) with specific documented clinical criteria required for initiation and continuation of therapy.

Thresholds

Episodic migraine4-14 headache days per month

Chronic migraine15 or more headache days per month, of which 8 or more are migraine days

Medication overuse threshold>18 doses per month of narcotics or triptans

Reauthorization - general response>= 50% reduction in migraine days per month compared to start of therapy

Reauthorization - episodic migraineReduction of at least 4 monthly migraine days since start of therapy

Reauthorization - chronic migraineReduction of at least 5 monthly migraine days since start of therapy

Episodic cluster attack frequencyAt least one attack every other day during a cluster period

Initial Therapy Criteria (Prior Authorization Form Requirements)

Initial Authorization - Indications and Required Clinical Information

Form collects diagnosis and documents required clinical criteria and prior treatment failures for initiation of Emgality.

ALL of the following

Diagnosis selection
- Episodic Migraine Prophylaxis (4-14 headache days per month)4-14 days per month
- Chronic Migraine Prophylaxis (15 or more headache days per month, of which 8 or more are migraine days)>= 15 days per month with >= 8 migraine days
- Episodic Cluster Headache (severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes when left untreated)
  For episodic cluster headache, question 7 applies
- Other (please list diagnosis and/or ICD-10 code)
Baseline frequency: Baseline average number of migraine days per month documented (prior to starting Emgality)
Numeric entry requested
Medication rebound/overutilization: Headaches are not primarily caused by medication rebound/overutilization (>18 doses per month of narcotics or triptans) or lifestyle factors>18 doses per month
Yes/No checkbox; presence of rebound/overuse should be documented
Prior therapeutic failure or intolerance: Documentation of therapeutic failure or intolerance to one or more relevant preventive agents (select ALL that apply from list: anti-epileptics, beta-blockers, calcium-channel blockers, SNRIs, TCAs, Botox, alpha-agonists, ACEi/ARBs, other)
Form asks to select ALL that apply; prior failure/intolerance must be indicated
Loading dose: Does the member need a loading dose of 240 mg (2 syringes/pens of Emgality 120 mg)?240 mg = 2 x 120 mg
Yes/No checkbox
Concurrent CGRP inhibitor use
- Concurrent acute CGRP inhibitor use: Will Emgality be used for migraine prevention in combination with another CGRP inhibitor that will be used for acute use (e.g., rimegepant - Nurtec ODT, ubrogepant - Ubrelvy)?
  Yes/No checkbox
- Prescriber attestation for concurrent use: If YES: Do the benefits of therapy outweigh the risks of concurrent use of both medications?
  Yes/No checkbox; prescriber attestation required if concurrent use
Episodic cluster frequency: For episodic cluster headache only: member experiencing attack frequency of at least one attack every other day during a cluster periodAt least one attack every other day during a cluster period
Yes/No checkbox (question 7)

Continuation / Reauthorization Criteria

Reauthorization / Continuation Criteria

Reauthorization requires documentation of clinical response since start of therapy.

ALL of the following

Overall response: Member has experienced at least a 50% reduction in the number of migraine days per month compared to the start of therapy>= 50% reduction in migraine days per month
Yes/No checkbox
Condition-specific improvement thresholds
- Episodic migraine threshold: If episodic migraine: reduction of at least 4 monthly migraine days since start of therapy>= 4 fewer monthly migraine days
  Yes/No checkbox
- Chronic migraine threshold: If chronic migraine: reduction of at least 5 monthly migraine days since start of therapy>= 5 fewer monthly migraine days
  Yes/No checkbox
- Episodic cluster threshold: If episodic cluster headache: reduction in the number of mean weekly cluster headaches from baselinereduction in mean weekly cluster headaches
  Yes/No checkbox

Documentation Required

Document response for reauthorization

For reauthorization, document the member's response compared to baseline headache frequency. Record whether the member has achieved at least a 50% reduction in migraine days per month or the applicable condition-specific threshold (episodic migraine: ≥4 fewer monthly migraine days; chronic migraine: ≥5 fewer monthly migraine days; episodic cluster headache: reduction in mean weekly cluster headaches). Document the baseline average number of migraine days per month and the current frequency so the percent and absolute change can be calculated and compared to these thresholds.

Contraindications, Exclusions, and Other Clinical Considerations

Exclusions/contraindications noted on the form include headaches primarily caused by medication rebound/overutilization, defined as taking narcotics or triptans exceeding more than 18 doses per month, or headaches due to lifestyle factors (e.g., sleep patterns, caffeine use). The form asks the provider to indicate whether headaches are caused by these factors.

Concurrent CGRP use: the form asks whether Emgality will be used for migraine prevention in combination with another CGRP inhibitor used for acute treatment (examples listed). If YES, the prescriber must indicate whether the benefits outweigh the risks of concurrent use (attestation).

Loading dose note: the form requires the provider to indicate if the member needs a 240 mg loading dose (2 syringes/pens of Emgality 120 mg).

Provider Actions & Submission Requirements

Prior Authorization

Submit completed prior authorization form

Submit a completed Emgality prior authorization form (one form per medication) including diagnosis, prior treatment failures/intolerance, baseline headache frequency, and all required fields. Fax submissions to 1-866-240-8123 or mail to SPECARE, 120 Fifth Avenue, Pittsburgh, PA 15222.

Documentation Required

Document prior therapeutic failures/intolerance

Document which preventive agent classes were tried and either failed or were not tolerated. Select from the provided classes (anti-epileptics; beta-blockers; calcium-channel blockers; SNRIs; TCAs; Botox; alpha-agonists; ACE inhibitors/ARBs; other) and include specifics to support medical necessity.

Billing Rule

Loading dose specification

Indicate on the form if the member requires a 240 mg loading dose (equivalent to 2 syringes or pens of Emgality 120 mg).

Clinical Evidence / Rationale

Clinical intent: the form documents indications and baseline severity by requiring selection of diagnosis (episodic migraine, chronic migraine, episodic cluster headache, or other) and the baseline average number of migraine days per month prior to starting Emgality.

The form captures prior therapeutic trials or intolerance by asking providers to select all preventive agent classes that have failed or were not tolerated (anti-epileptics, beta-blockers, calcium-channel blockers, SNRIs, TCAs, Botox, alpha-agonists, ACEi/ARBs, other).

Contraindicating factors and treatment details: the form documents medication overuse/rebound status (>18 doses/month of narcotics or triptans), lifestyle contributors, need for a 240 mg loading dose, and concurrent CGRP use with a required prescriber attestation if used together. For reauthorization, the form requires documentation of clinical response (overall ≥50% reduction in migraine days or condition-specific thresholds).

Background

This is a Highmark medication prior authorization form for Emgality (galcanezumab) to capture clinical details for initiation and continuation of therapy for episodic migraine, chronic migraine, and episodic cluster headache.

The form collects: baseline frequency (average migraine days per month prior to starting Emgality), prior treatment trials or intolerances (selection of preventive agent classes), contraindicating factors such as medication overuse/rebound (>18 doses/month of narcotics or triptans) and lifestyle contributors, need for a 240 mg loading dose, concurrent CGRP use questions with prescriber attestation, and reauthorization response metrics (≥50% reduction overall or condition-specific thresholds).

Definitions

Medication rebound/overutilizationTaking narcotics or triptans exceeding more than 18 doses per month

Loading dose (Emgality)240 mg = 2 syringes or pens of Emgality 120 mg