Prior Authorization/Medical Necessity - CGRP antagonists (Aimovig, Ajovy, Emgality)

Coverage Summary

Scope: Prior authorization / medical necessity criteria for Aimovig (erenumab), Ajovy (fremanezumab), and Emgality (galcanezumab) for prevention of migraine in adults and Emgality 100 mg for episodic cluster headache. Coverage stance: covered_with_criteria. Status: MODIFIED. Subject: CGRP antagonist therapies for migraine and episodic cluster headache (Aimovig, Ajovy, Emgality).

Authorization duration: 12 months for initial approvals and reauthorizations. Key thresholds summary: migraine frequency thresholds of either 4–7 migraine days per month (with <15 headache days/month or provider attestation that migraine is the predominant diagnosis) or ≥8 migraine days per month; required prior prophylactic trials of at least ≥2 agents (general initial requirement) with special rules for Ajovy requiring prior trials of specified CGRP agents for ≥3 months; cluster criteria require at least 2 cluster periods lasting 7–365 days separated by ≥3 months pain-free. State-specific exceptions and footnotes (e.g., Connecticut/Kentucky/Mississippi reduced trial duration; California trial not required) apply.

Initial Therapy — Aimovig and Emgality (120 mg) for Migraine

Initial Therapy - Aimovig or Emgality (120 mg) for migraine

Covered when ALL of the following are met:

ALL of the following

Diagnosis of migraine consistent with The International Classification of Headache Disorders, 3rd edition (ICHD-3).
One of the following:
- 4 to 7 migraine days per month and at least one of the following:
  - 4 to 7 migraine days per month
  - ANY of the following
    Less than 15 headache days per month
    operational
    Provider attests this is the member's predominant headache diagnosis (i.e., primary driver of headaches is not a different, non-migrainous condition)
- Greater than or equal to 8 migraine days per month>= 8 migraine days/month
Prophylactic therapy trials
- Failure (after a trial of at least two months), contraindication, or intolerance to two of the following prophylactic therapies (document name and date tried):
  For Connecticut, Kentucky and Mississippi business, only a 30-day trial will be required. For California business a trial of non-CGRP preventive treatments will not be required.
- ANY of the following
  - One of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol
  - Candesartan (Atacand)
  - Divalproex sodium (Depakote/Depakote ER)
  - OnabotulinumtoxinA (Botox). Note: Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements.
Medication will not be used in combination with another CGRP antagonist or inhibitor used for the preventive treatment of migraines (e.g., Ajovy, Nurtec ODT, Qulipta, Vyepti).
Includes oral and injectable CGRP-targeting therapies; document concurrent therapy status.

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization duration is 12 months unless state-specific rules apply.

Prior authorization required for Aimovig and Emgality (120 mg). Authorization issued for 12 months (state exceptions below).
Document prior prophylactic therapy trials including drug name(s) and dates tried; include documentation of diagnosis consistent with ICHD-3.
Step therapy / prior trial requirements: trial of at least two months for listed prophylactic agents (30 days for CT, KY, MS; California: non-CGRP preventive trial not required).

Documentation Required

Document prior prophylactic therapy trials

Documentation required. Providers must document ICHD-3 consistent migraine diagnosis and the names and dates of prior prophylactic therapy trials. Note state-specific trial duration exceptions.

Diagnosis consistent with The International Classification of Headache Disorders, 3rd edition (ICHD-3) is required.
Document name and date tried for at least two prophylactic therapies from the policy list (or note contraindication/intolerance).
State-specific exceptions: Connecticut, Kentucky, Mississippi — 30-day trial acceptable; California — trial of non-CGRP preventive treatments not required.

Step Therapy

Step therapy / prior trial requirements

Step therapy / prior trial requirements. Approval requires failure, contraindication, or intolerance to two prophylactic agents (trial durations as noted). Authorization duration is 12 months; follow state-specific exceptions.

Required trials: two prophylactic therapies from the listed options (beta-blocker, candesartan, divalproex, onabotulinumtoxinA, SNRI, topiramate, tricyclic antidepressant).
Trial length: generally at least two months per agent; CT/KY/MS: 30-day trial; CA: non-CGRP preventive trial not required.
Do not use in combination with another CGRP antagonist/inhibitor for migraine prevention (e.g., Ajovy, Nurtec ODT, Qulipta, Vyepti).

Initial Therapy — Ajovy for Migraine

Initial Therapy - Ajovy for migraine

Covered when ALL of the following are met:

ALL of the following

Diagnosis of migraine consistent with The International Classification of Headache Disorders, 3rd edition
One of the following migraine frequency presentations
- 4 to 7 migraine days per month
  - AND at least one of
    Less than 15 headache days per month< 15 headache days per month

Reauthorization — Aimovig, Ajovy, Emgality (120 mg) for Migraine

Reauthorization - Aimovig, Ajovy, Emgality (120 mg) for migraine

Covered when ALL of the following are met:

ALL of the following

Positive response to therapy: Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity
Authorization will be issued for 12 months
Combination CGRP exclusion: Medication will not be used in combination with another CGRP antagonist or inhibitor used for the preventive treatment of migraines (examples: Nurtec ODT, Qulipta, Vyepti)
Claims may be denied if combined

ref

Initial Therapy — Emgality (100 mg) for Episodic Cluster Headache

Initial Therapy - Emgality (100 mg) for episodic cluster headache

Covered when ALL of the following are met:

ALL of the following

Diagnosis of episodic cluster headache
Providers must attest diagnosis is consistent with ICHD-3
Cluster period frequency and duration: Patient has experienced at least 2 cluster periods lasting from 7 days to 365 days, separated by pain-free periods lasting at least three monthsat least 2 cluster periods of 7-365 days separated by >= 3 months pain-free
Authorization will be issued for 12 months
Combination CGRP exclusion:

Reauthorization — Emgality (100 mg) for Episodic Cluster Headache

Reauthorization - Emgality (100 mg) for episodic cluster headache

Covered when ALL of the following are met:

ALL of the following

Positive response to therapy: Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity
Authorization will be issued for 12 months
Combination CGRP exclusion: Medication will not be used in combination with another CGRP antagonist or inhibitor used for the preventive treatment of migraines (examples: Aimovig, Ajovy, Nurtec ODT, Qulipta, Vyepti)
Claims may be denied if combined

ref

Combination Therapy Exclusions and Non-Combination Rule

Policy prohibits concurrent use of more than one CGRP antagonist/inhibitor for preventive treatment of migraine or episodic cluster headache. The policy explicitly states that the medication "will not be used in combination with another CGRP antagonist or inhibitor used for the preventive treatment of migraines" and repeats this prohibition across initial and reauthorization criteria for Aimovig, Ajovy, Emgality (120 mg) and Emgality (100 mg) for cluster headache.

Examples of CGRP agents listed as not to be combined include: Aimovig, Ajovy, Nurtec ODT, Qulipta (oral atogepant), Vyepti (eptinezumab), and Emgality. The policy notes that claims may be denied if medication is used in combination with another CGRP antagonist or inhibitor used for preventive migraine treatment.

Denial Risk

Combination CGRP therapy prohibited

Use of CGRP antagonists in combination with another preventive CGRP product is prohibited and may result in claim denial. Examples of implicated products include Aimovig, Ajovy, Emgality, Nurtec ODT, Qulipta, and Vyepti.

Impacted products (examples): Aimovig; Ajovy; Emgality (all strengths); Nurtec ODT; Qulipta; Vyepti

Applicable Drugs / Referenced Products

Referenced drugs / productsmixedCovered

Aimovig	erenumab (CGRP receptor antagonist) — preventive treatment of migraine in adults; covered per criteria
Ajovy	fremanezumab (CGRP antagonist) — preventive treatment of migraine in adults; typically excluded from benefit coverage (note in policy) but PA criteria provided
Emgality 120 mg	galcanezumab 120 mg — preventive treatment of migraine in adults; covered per criteria
Emgality 100 mg	galcanezumab 100 mg — indicated for episodic cluster headache in adults; covered per criteria
Nurtec ODT	rimegepant (CGRP antagonist) — listed as another CGRP not to be combined
Qulipta	atogepant (oral CGRP) — listed as another CGRP not to be combined
Vyepti	eptinezumab-jjmr — IV CGRP; may be subject to additional benefit/coverage review requirements
OnabotulinumtoxinA	Botox — listed as a prophylactic option; coverage may be subject to additional review

Provider Actions and Operational Notes

Step Therapy

Step therapy / prior trial requirements

Members must fail, be intolerant to, or have contraindications to required prophylactic therapies prior to approval. General initial prophylactic trial requirement is >=2 months for two agents; Ajovy requires >=3 months for prior CGRP agents (Aimovig, Emgality 120 mg, Nurtec ODT, Qulipta). State exceptions: Connecticut/Kentucky/Mississippi = 30 days; California = no non‑CGRP preventive trial required.

Initial general prophylactic trial duration: >=2 months for two agents
Ajovy prior CGRP trial duration: >=3 months for listed CGRPs
CT/KY/MS: 30-day trial
California: trial of non‑CGRP preventives not required

Operational note: UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic; authorization will be issued for 12 months when criteria are met. Providers must document prior prophylactic therapy trials (name and date tried) as specified by the policy.

Clinical Evidence & Background

Background: Aimovig, Ajovy and Emgality (120 mg) are calcitonin gene-related peptide (CGRP) antagonists indicated for preventive treatment of migraine in adults; Emgality 100 mg is indicated for episodic cluster headache in adults.

Mechanism and guidance alignment: These therapies target the CGRP pathway for migraine prevention, and the policy states that prior authorization criteria require diagnoses consistent with The International Classification of Headache Disorders, 3rd edition (ICHD-3). The policy and references align with ICHD-3 diagnostic standards and relevant guideline statements.

Evidence / Definitions

P&T approval historyMultiple reviews from 6/2018 through 2/2025; effective date 5/1/2025

Key referencesAimovig package insert (Aug 2024); Ajovy package insert (Oct 2022); Emgality package insert (Mar 2021); ICHD-3; AHS Consensus Statement 2024

Predominant headache diagnosis (definition)Provider attestation that the primary driver of headaches is migraine rather than a different non-migrainous condition

Key Thresholds & Parameters

Thresholds and Durations

Migraine days per month - lower range4 to 7 migraine days per month

Migraine days per month - higher threshold>= 8 migraine days per month

Headache days per monthLess than 15 headache days per month (when 4-7 migraine days)

Cluster period duration (episodic)At least 2 cluster periods lasting 7 to 365 days, separated by >= 3 months pain-free

Initial prophylactic trial duration (general)>= 2 months

Initial prophylactic trial duration (CT, KY, MS)Only a 30-day trial required for Connecticut, Kentucky and Mississippi

Initial prophylactic trial duration (CA)

Revision History

2025-05-01material_changeLatest

Effective 5/1/2025: Added oral CGRP (Qulipta) to the list of required options for Ajovy; added California footnote and updated list of potential prophylactic therapies. Removed prior notation that Qulipta was typically excluded; updated referenced prophylactic therapies and list of non-combinable CGRPs.

03/2024policy_revision

3/2024 review: Initial authorization duration standardized/updated to 12 months (applies to initial and reauthorization).

addition