CurrentMass General Brigham Health PlanPolicy N/A

CGRP inhibitors for migraine and cluster headache prophylaxis

Defines prior authorization, coverage criteria, and quantity limits for CGRP monoclonal antibodies (Aimovig, Ajovy, Emgality, Vyepti) for migraine prevention and Emgality for episodic cluster headache for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCGRP inhibitors for migraine and cluster headache prophylaxis

Policy CodePolicy N/A

Change TypeCriteria revisedproduct added

Effective DateApr 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document two different AAN Level A/B prophylactic medication trials (each ≥60 days) and ≥4 migraine days/month; physician assessment required for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Criteria for prophylactic treatment of migraines changed to require TWO prophylactic medication trials (rather than three) from AAN Level A or B within the past 3 years.

Removed prior requirement related to Botox treatment timing for migraines.

Vyepti (eptinezumab) was added to the criteria and is covered under the medical benefit.

>=4migraine days per month required

2required prior prophylactic medication trials

Initial:3m; Reauth:12mapproval durations

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Coverage Criteria for CGRP Monoclonal Antibodies

Prophylactic Treatment of Migraines

Authorizations may be granted when ALL of the following are met for prophylactic migraine treatment:

Prophylactic migraine criteria: 1. Member is >=18 years of age; 2. Member has >=4 migraine days per month; 3. Member has had inadequate response to a trial of at least TWO different prophylactic migraine medications, each with a different mechanism of action, with each trial of at least 60 days' duration within the past 3 years; both trials must be from AAN Level A or B categories; 4. Member is not currently using any other CGRP for the treatment of migraines.see node text

Triptans will not be considered as prophylactic options.

Episodic Cluster Headaches

Authorizations for Emgality for episodic cluster headache may be granted when ALL of the following are met:

Episodic cluster headache criteria: 1. Member is >=18 years of age; 2. Member has experienced at least 5 cluster headache episodes within the past 12 months; 3. Member had inadequate response to a trial of injectable sumatriptan or intranasal sumatriptan or intranasal zolmitriptan.see node text

Emgality only for episodic cluster headache per policy.

Continuation and Quantity Limits

Reauthorization and product-specific quantity limits:

Continuation of therapy (reauthorization): Physician assessment documenting improvement (decrease in frequency and severity of migraines or cluster headaches) is required for reauthorization.improvement documented

Initial approvals: up to 3 months; reauthorizations: 12 months.

Quantity limits: Product-specific quantity limits apply: Aimovig 70 mg or 140 mg: 1 pen per 30 days; Ajovy 225 mg: options of 1 syringe/autoinjector per 30 days or 3 syringes (675 mg) every 90 days; Emgality for migraine: initial 240 mg (two 120 mg injections) then 120 mg monthly; Emgality for episodic cluster headache: loading dose of three 100 mg consecutive doses then 300 mg every 4 weeks maintenance; Vyepti dosing per medical benefit (IV).see text

Exact numeric formulations as specified in policy limitations.

Note: triptans will not be considered as prophylactic options for migraine prevention under this policy. Triptans are excluded from the required prior medication trials used to establish inadequate response when evaluating eligibility for CGRP monoclonal antibody therapy.

Requests that do not meet the policy criteria are not supported. Specifically, authorization will not be approved when the member is under 18 years of age, or when the member has fewer than 4 migraine days per month. Requests lacking documentation of inadequate response to the required prior trials — at least TWO different prophylactic migraine medications (different mechanisms, each tried ≥60 days within the past 3 years, from AAN Level A or B) — will be denied. Additionally, requests for use concurrent with another CGRP for migraine treatment are not supported. Prior authorization is required for these products and approvals may be granted only when the stated criteria are met or when members are already receiving the requested medication at plan entry.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Certain migraine and cluster headache therapies require prior authorization. Determine benefit pathway (pharmacy vs medical) based on the product and submit prior auth per plan procedures.

Affected products: CGRP inhibitors and Emgality for episodic cluster headache
New members: authorization may be granted if currently receiving the medication (excludes samples/PAP)

Step Therapy

Required Prior Medication Trials

Required prior medication trials: For prophylactic migraine treatment, the member must have tried at least TWO different prophylactic migraine medications with different mechanisms of action, each for a minimum of 60 days, within the past 3 years. Both trials must be from AAN Level A or Level B recommended medications. Triptans are not acceptable as prophylactic options.

Total required trials: 2 distinct agents with different mechanisms of action
Trial duration: each >= 60 days

Product and Coding Information

Covered productsmixedCovered

Aimovig (erenumab-aooe)	pharmacy benefit; Aimovig 70mg and 140mg pens
Ajovy (fremanezumab-vfrm)	pharmacy benefit; 225mg pre-filled syringe/autoinjector
Emgality (galcanezumab-gnlm)	pharmacy benefit; dosing differs for migraine vs cluster headache
Vyepti (eptinezumab-jjmr)	medical benefit; IV infusion

Numeric eligibility thresholds for migraine and cluster headache

Migraine frequency threshold>= 4 migraine days per month

Cluster headache episode threshold>= 5 cluster headache episodes within the past 12 months

Age requirementMember is >= 18 years of age

Concurrent CGRP use exclusionMember is not currently using any other CGRP for treatment of migraines

Background and Indications

Calcitonin gene-related peptide (CGRP) monoclonal antibodies included in this policy are Aimovig (erenumab-aooe), Ajovy (fremanezumab-vfrm), Emgality (galcanezumab-gnlm), and Vyepti (eptinezumab-jjmr). These agents are indicated for the prophylactic treatment of migraine in adults. Emgality additionally has an indication for the treatment of episodic cluster headache and is the only product covered for that diagnosis under this policy.

Definitions

Calcitonin gene-related peptide (CGRP) monoclonal antibodies — definitions / listing

Included agents (CGRP monoclonal antibodies)Aimovig (erenumab-aooe); Ajovy (fremanezumab-vfrm); Emgality (galcanezumab-gnlm); Vyepti (eptinezumab-jjmr)

Route / benefitAimovig, Ajovy, Emgality: subcutaneous (pharmacy benefit); Vyepti: intravenous infusion (medical benefit)

Indications in policyIndicated for prophylactic treatment of migraines in adults; Emgality additionally indicated for episodic cluster headache