CurrentUnitedHealthcarePolicy 2025 P 3113-12

Step therapy for CGRP antagonist migraine preventives

Defines UnitedHealthcare's step therapy requirements for coverage of Aimovig (erenumab), Ajovy (fremanezumab), and Emgality (galcanezumab) for migraine prevention, and who must trial lower-cost alternatives first.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for CGRP antagonist migraine preventives

Policy CodePolicy 2025 P 3113-12

Change TypeAdded California exceptionrevised Ajovy prior-therapy requirements

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain and document prior therapy trials (name and dates) and submit prior authorization showing failure, contraindication, or intolerance to required agents for approval.

SourceLink

POLICY UPDATE CHANGES

Added footnote for California specific requirement that a trial of non-CGRP preventive treatments will not be required.

Updated list of potential prophylactic therapies and added oral CGRPs to the required options for Ajovy.

Effective date set to 5/1/2025 and program P&T approvals updated through 2/2025.

12 moauthorization duration

≥2 motrial ≥ 2 months

≥3 motrial ≥ 3 months

3 drugs/classesrequired prior failures

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2025 P 3113-12program id

Coverage Criteria for CGRP Antagonists

inv-01: Aimovig / Emgality (120 mg) Initial Criteria

Covered when ALL of the following are met:

Aimovig/Emgality (120 mg) approval: 1) Failure (after a trial of at least two months), contraindication or intolerance to two of the following prophylactic therapies (document name and date tried): a) one of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol; b) candesartan; c) divalproex sodium; d) onabotulinumtoxinA (Botox); e) an SNRI (duloxetine, venlafaxine); f) topiramate; g) a tricyclic antidepressant (amitriptyline, nortriptyline).two agents failed; each trial >=2 months

Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements.

inv-02: Ajovy Initial Criteria

Covered when ALL of the following are met:

Ajovy initial part 1: 1) Failure (after a trial of at least two months), contraindication or intolerance to two of the following prophylactic therapies (document name and date tried): a) one of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol; b) candesartan; c) divalproex sodium; d) onabotulinumtoxinA (Botox); e) an SNRI (duloxetine, venlafaxine); f) topiramate; g) a tricyclic antidepressant (amitriptyline, nortriptyline).two agents failed; each trial >=2 months

Ajovy initial part 2: 2) Failure (after a trial of at least three months), contraindication or intolerance to two of the following: a) Aimovig; b) Emgality (120 mg); c) Nurtec ODT; d) Qulipta (document date tried).two agents failed; each trial >=3 months

This adds oral CGRPs and other injectables as required prior options for Ajovy.

inv-03: Emgality (100 mg) Approval

Covered when criteria met:

Emgality (100 mg): Emgality 100 mg strength will be approved (indication: episodic cluster headache).

Specific prior therapy requirements are not listed for the 100 mg strength in this section.

State and plan-level requirements can modify the trial durations and prior-therapy requirements described in these criteria. Authorization is issued for 12 months, but state mandates and member-specific benefit plans may change what is required. For example, for Connecticut, Kentucky, and Mississippi business, only a 30‑day trial of prior therapies is required. Separately, for California business a trial of non‑CGRP preventive treatments will not be required.

Ajovy is noted in the policy as typically excluded from benefit coverage. When Ajovy is considered, the approval criteria require documentation of prior therapy trials (or documented contraindication/intolerance) as specified; however, the policy footnote indicates Ajovy is normally not a covered benefit.

Prior Trial Duration and Coding Notes

Prior trial duration

Minimum trial for non-CGRP prophylacticsAt least 2 months trial (failure, contraindication, or intolerance) for each required non‑CGRP prophylactic therapy.

Minimum trial for prior CGRP/oral CGRP agents (Ajovy)At least 3 months trial (failure, contraindication, or intolerance) for each required prior CGRP or oral CGRP agent when part of Ajovy criteria.

Number of non‑CGRP agents required to fail (Aimovig/Emgality/Ajovy part 1)Failure of two different non‑CGRP prophylactic therapies (document name and date tried).

Number of prior CGRP/oral CGRP agents required to fail for AjovyFailure of two agents from the list (Aimovig; Emgality 120 mg; Nurtec ODT; Qulipta), each after at least a 3‑month trial.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Aimovig, Ajovy, and Emgality (120 mg). Approval for Aimovig or Emgality is contingent on documented failure, contraindication, or intolerance to at least two specified prior prophylactic therapies (each trial ≥ 2 months unless otherwise noted). For Ajovy, approval requires the same initial two prior prophylactic therapy trials AND failure/contraindication/intolerance to two listed CGRP-targeted agents (each trial ≥ 3 months) before coverage is authorized.

Prior authorization required for Aimovig, Ajovy, Emgality (120 mg).
Aimovig/Emgality: document failure/contraindication/intolerance to two prophylactic therapies (trial ≥2 months).
Ajovy: document failure/contraindication/intolerance to two prophylactic therapies (trial ≥2 months) AND to two CGRP-targeted agents (trial ≥3 months).
State-specific and plan-specific variations may apply; Ajovy may be excluded from coverage in some benefits.

Step Therapy

Step Therapy Overview

Background

Aimovig (erenumab), Ajovy (fremanezumab), and Emgality (galcanezumab) are calcitonin gene–related peptide (CGRP) pathway–targeted therapies used for preventive treatment of migraine in adults. The policy requires trials of lower‑cost migraine preventives before approval of these agents, with specified minimum durations and documentation of the name and date tried. Emgality at the 100 mg strength is specifically indicated and will be approved for episodic cluster headache per the policy; separate prior therapy requirements for the 100 mg strength are not listed in this section. Authorization for covered CGRP agents is issued for 12 months, subject to state and plan variations.

Definitions

CGRP antagonist

DefinitionCalcitonin gene‑related peptide (CGRP) receptor antagonists used for preventive treatment of migraine.

Examples — monoclonal antibodiesAimovig (erenumab); Ajovy (fremanezumab); Emgality (galcanezumab).

Indications noteAimovig, Ajovy and Emgality 120 mg are indicated for migraine prevention in adults; Emgality 100 mg is indicated for episodic cluster headache.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for CGRP antagonist migraine preventives

Policy CodePolicy 2025 P 3113-12

Change TypeAdded California exceptionrevised Ajovy prior-therapy requirements

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain and document prior therapy trials (name and dates) and submit prior authorization showing failure, contraindication, or intolerance to required agents for approval.

SourceLink

On This Page

Step therapy requires trial of lower-cost migraine preventive medications before coverage of Aimovig, Ajovy, or Emgality (120 mg). Required classes/drugs include: one beta-blocker (atenolol, metoprolol, nadolol, propranolol, timolol), candesartan, divalproex sodium (Depakote/Depakote ER), onabotulinumtoxinA (Botox), an SNRI (duloxetine or venlafaxine), topiramate, or a tricyclic antidepressant (amitriptyline or nortriptyline). The program is intended to encourage use of lower-cost alternatives prior to CGRP-targeted therapies.

Required trial options include: beta-blocker (atenolol, metoprolol, nadolol, propranolol, timolol); candesartan; divalproex sodium; onabotulinumtoxinA (Botox) — may have separate review requirements; SNRI (duloxetine, venlafaxine); topiramate; tricyclic antidepressant (amitriptyline, nortriptyline).
Aimovig/Emgality: two of the above (documented name and date tried).
Ajovy: same two prophylactic therapies required, plus additional CGRP-agent trials (see separate criterion).

Documentation Required

Required Documentation for Prior Therapy Trials

Documentation of prior therapy trials must include the medication name and the date(s) tried. For each agent claimed as failed, contraindicated, or not tolerated, providers must specify whether the reason was treatment failure, intolerance, or a documented contraindication.

Document the name of the prior agent and the date(s) it was tried for each required trial.
State exceptions: Connecticut, Kentucky and Mississippi require only a 30-day trial duration; California does not require a trial of non-CGRP preventive treatments.
If claiming contraindication or intolerance, include clinical rationale or relevant medical record notes.

Denial Risk

Missing or Incomplete Prior Therapy Documentation — Denial Risk

Missing required prior therapy trials or insufficient documentation (e.g., absence of medication name or date tried, or not meeting minimum trial duration) may result in denial of authorization. Providers should ensure records demonstrate the required trial lengths (≥ 2 months for non‑CGRP prophylactics; ≥ 3 months for required CGRP-agent trials for Ajovy) except where state-specific exceptions apply.

Authorization may be denied if prior trials are not documented with medication name and date tried.
Insufficient trial duration (less than required months) or lack of evidence of failure/intolerance/contraindication increases denial risk.
For Connecticut, Kentucky and Mississippi only 30-day trials are acceptable for the non‑CGRP agents; California does not require non‑CGRP preventive trials.

Note

Authorization Length and Plan Variance

Authorization duration is typically 12 months. State mandates, federal regulatory requirements, and member-specific benefit plans may modify prior authorization or step therapy requirements. Ajovy may be excluded from benefit coverage under some plans.

Authorization will generally be issued for 12 months.
State mandates and member-specific benefit plans may alter required trial durations or documentation.
Ajovy is typically excluded from benefit coverage in some benefit designs.