Subject: Trikafta SGM 3374-A P2026a

Drug

TRIKAFTA  (elexacaftor/tezacaftor/ivacaftor)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indication¹

Trikafta is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the CFTR gene that is responsive based on clinical and/or in vitro data or results in the production of CFTR protein.

If the patient’s genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in the production of CFTR protein.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

·        Genetic testing report confirming the presence of the appropriate CFTR gene variant.

·        Chart notes, laboratory values, medical records confirming a clinical diagnosis of CF.

Prescriber Specialties

This medication must be prescribed by or in consultation with a pulmonologist or a prescriber specialized in the treatment of cystic fibrosis.

Coverage Criteria

Cystic Fibrosis^1,2

Authorization of 12 months may be granted for treatment of cystic fibrosis when all of the following criteria are met:

·        The member has a confirmed clinical cystic fibrosis diagnosis (e.g., sweat chloride testing, CFTR physiological testing).

·        Genetic testing was conducted to detect a variant in the CFTR gene that meets either of the following:

§  The CFTR gene variant is responsive based on clinical and/or in vitro data

§  The CFTR gene variant results in the production of CFTR protein

·        The member is at least 2 years of age.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria who are experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., improvement in forced expiratory volume 1 [FEV1] from baseline).

Other

Trikafta will not be used in combination with another CFTR modulator for the treatment of cystic fibrosis (e.g., Alyftrek, Kalydeco).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Trikafta [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; March 2026.

2.     Farrel PM, White TB, Ren CL et al. Diagnosis of cystic fibrosis: consensus guidelines from cystic fibrosis foundation. The J of Pediatrics. 2017; 181S: S4-S15.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 29, 2026