Pharmacy Prior Authorization Criteria

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

For diagnosis of Cystic Fibrosis (CF)
Indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in 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 production of CFTR protein.

Prior Authorization

Length of Approval: When approved; no reauthorization required

AND

Presence of at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as detected by an FDA-cleared cystic fibrosis mutation test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

AND

AND

AND

2026-04-29, 2026-02-04, 2025-05-01, 2025-04-30, 2025-03-25, 2025-03-05

Alyftrek Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. March 2026.

2026-04-29: Criteria updated to align with updated indication. Now indicated in patients with at least one variant in CFTR gene that is responsive based on clinical/in vitro data or results in production of CFTR protein. Reference updated.
2026-02-04: 2026 Annual Review. No clinical criteria changes. Background updates.
2025-05-01: Approval length updated to "Approved- no reauthorization required"
2025-04-30: Removing reauthorization requirement as part of extended reauthorization program.
2025-03-25: Removing reauthorization requirement as part of extended reauthorization program.
2025-03-05: New program.