ModifiedHealth NetPolicy N/A

Clinical Policy: Atogepant (Qulipta) — migraine prevention

Defines medical necessity criteria, prior authorization expectations, and coverage limits for Qulipta (atogepant) for prevention of episodic and chronic migraine for Health Net/Centene-affiliated lines of business.

Policy Summary

PayerHealth Net

PolicyAtogepant (Qulipta) — migraine prevention

Policy CodePolicy N/A

Change TypeMaterial clinical updates (added drug exclusion, clarified redirection)

Effective Date03.01.22

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals 3 months, continued therapy 6 months; ensure required trials (>=2 oral preventives and a 3-month injectable CGRP trial when redirecting).

SourceLink

POLICY UPDATE CHANGES

Added Zavzpret to list of CGRP inhibitors that should not be prescribed concurrently with Qulipta.

Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden.

Clarified that redirection to injectable CGRP therapy used for migraine prophylaxis requires a 3-month trial of at least one injectable CGRP therapy.

Policy updated to incorporate expanded indication for preventive treatment of chronic migraine.

60 mg/daymaximum daily dose

3 moinitial approval

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Migraine Prophylaxis):

Initial Approval - Migraine Prophylaxis: 1. Diagnosis of episodic or chronic migraine;

Initial Approval - Migraine Prophylaxis: 2. Member experiences >=4 migraine days per month for at least 3 months;

Initial Approval - Migraine Prophylaxis: 3. Age > 18 years;

Initial Approval - Migraine Prophylaxis: 4. Prescribed by or in consultation with a neurologist, headache specialist, or pain specialist;

Initial Approval - Migraine Prophylaxis: 5. Failure of at least 2 oral migraine preventive therapies (each trialed for 8 weeks and from different therapeutic classes) unless clinically significant adverse effects are experienced or all are contraindicated (examples: antiepileptic drugs such as divalproex sodium or topiramate; beta-blockers such as metoprolol, propranolol, timolol; antidepressants such as amitriptyline, venlafaxine);

Initial Approval - Migraine Prophylaxis: 6. Failure of a 3-month trial of at least ONE injectable CGRP therapy used for migraine prophylaxis (unless clinically significant adverse effects are experienced or all are contraindicated);

Initial Approval - Migraine Prophylaxis

Botox concurrent-use requirements: a. Sufficient evidence from at least two high-quality published studies or evidence-based clinical practice guidelines that represent the member and regimen and show clinically meaningful outcomes (case studies or chart reviews are not considered high-quality evidence);
Botox concurrent-use requirements: b. Member experienced and maintained a positive response to Botox monotherapy, defined as >=30% reduction in monthly migraine days from baseline after at least 2 quarterly injections (6 months);
Botox concurrent-use requirements: c. Despite Botox monotherapy, member continues to experience >=4 migraine days per month and/or severe disabling migraines causing functional impairment;

Initial Approval - Migraine Prophylaxis: 8. Qulipta (atogepant) is not prescribed concurrently with other CGRP inhibitors (examples listed: Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti, Zavzpret);

Initial Approval - Migraine Prophylaxis: 9. Dose does not exceed 60 mg/day;

Approval duration: 3 months

Continuation Therapy

Continued therapy covered when:

Continued Therapy - Migraine Prophylaxis: 1. Member is currently receiving medication via Centene benefit or has previously met initial approval criteria;

Continued Therapy - Migraine Prophylaxis: 2. Member has experienced and maintained a positive response to therapy as evidenced by a reduction in migraine days per month from baseline;

Continued Therapy - Migraine Prophylaxis: 3. Qulipta is not prescribed concurrently with other CGRP inhibitors (Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti, Zavzpret) — except this concurrent-use restriction does not apply in CA if the member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors;

Continued Therapy - Migraine Prophylaxis: 4. If request is for a dose increase, the new dose does not exceed 60 mg/day;

Requests for uses of Qulipta (atogepant) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits documentation demonstrating efficacy and safety in accordance with the Health Plan off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or other applicable evidence‑of‑coverage documents.

Qulipta is contraindicated in members with a history of hypersensitivity to atogepant or to any component of the Qulipta formulation.

Qulipta should not be prescribed concurrently with other CGRP inhibitors listed in this policy (for example: Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti, and Zavzpret). This concurrent‑use restriction and related prior authorization expectations were clarified in the 4Q 2024 review.

Use of Qulipta for indications that are not FDA‑approved and that lack sufficient supporting evidence may be considered not medically necessary. Providers seeking coverage for off‑label uses must provide documentation of efficacy and safety consistent with the Health Plan off‑label use policies referenced in this document.

Billing and Coding

Covered CPT Codesmixed

No codes listed

inv-08: Monthly migraine days (MMD)

Monthly migraine days (MMD)Member experiences >=4 migraine days per month for at least 3 months.

Minimum documentation periodMMD documented for at least 3 consecutive months.

ApplicabilityRequired for initial approval of atogepant for episodic or chronic migraine.

inv-19: Episodic vs Chronic Migraine dosing

Episodic migraine dosing options10 mg, 30 mg, or 60 mg PO once daily (maximum 60 mg/day).

Chronic migraine dosing option60 mg PO once daily (maximum 60 mg/day).

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Concurrent CGRP inhibitor conflict

Prior authorization required. Qulipta must not be prescribed concurrently with other CGRP inhibitors (including Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti, and Zavzpret). If a request involves redirection to an injectable CGRP therapy used for migraine prophylaxis, the prescriber must document a 3-month trial of that injectable agent unless an exception is documented. Prior authorization may be required for alternative CGRP redirections; approval duration for initial Qulipta therapy is 3 months.

Do not initiate Qulipta concurrently with other CGRP inhibitors (Aimovig, Ajovy, Emgality, Nurtec ODT, Ubrelvy, Vyepti, Zavzpret).
If redirecting to an injectable CGRP therapy for migraine prophylaxis, document a 3-month trial of the injectable prior to approval for redirection (unless exception applies).
PA may be required for alternative CGRP redirections; initial approval duration = 3 months.

Documentation Required

Provider responsibilities and documentation

Clinical Background

Atogepant (Qulipta) is an oral calcitonin gene‑related peptide (CGRP) receptor antagonist approved for preventive treatment of migraine in adults. It is available as 10 mg, 30 mg, and 60 mg tablets and dosing options include 10 mg, 30 mg, or 60 mg once daily for episodic migraine and 60 mg once daily for chronic migraine; the maximum recommended dose is 60 mg/day. The policy was updated in 4Q 2024 to add Zavzpret to the list of CGRP inhibitors that should not be co‑prescribed with Qulipta and to clarify requirements when redirecting to or from injectable CGRP therapies, including a required 3‑month trial of an injectable CGRP therapy when applicable.

Definitions and Key Terms

inv-18: CGRP

AcronymCGRP = Calcitonin gene-related peptide.

RoleCGRP is the biological target of atogepant (Qulipta).

Mechanism classAtogepant is a CGRP receptor antagonist used for migraine prevention.

inv-19: Episodic vs Chronic Migraine dosing

Summary dosing (episodic)10 mg, 30 mg, or 60 mg PO once daily; maximum 60 mg/day.

Summary dosing (chronic)60 mg PO once daily; maximum 60 mg/day.

Maximum daily dose

Policy Revision History

2024-07-154Q 2024 annual reviewLatest

Added Zavzpret to the list of CGRP inhibitors that should not be prescribed concurrently with Qulipta; clarified redirection to injectable CGRP therapy used for migraine prophylaxis and added requirement for a 3-month trial; clarified continuation exception for CA members previously approved and stable on both oral and injectable CGRP therapies.

2022-11-244Q 2022 annual review

Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, documented positive response to Botox monotherapy, and continued migraine burden.

2023-07-104Q annual review (2023-07-10)