Alyftrek™

Drug - Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor) [Vertex Pharmaceuticals, Inc.]

July 2025

Therapeutic Area - Cystic fibrosis, Oral

Initial approval criteria

  • Age ≥ 6 years; AND
  • Diagnosis of cystic fibrosis (CF); AND
  • Patient has ≥ 1 F508del mutation or other responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, as confirmed by genetic testing (medical records required); AND
  • Alyftrek will NOT be used in combination with another CFTR modulator; AND
  • Liver function tests (e.g., alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, bilirubin) have been assessed prior to initiation of Alyftrek and will be monitored regularly during treatment; AND
  • Patient does NOT have severe hepatic impairment (Child-Pugh Class C); AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., CF, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
  • Initial approval is for 6 months

Transition criteria

  • If patient is currently stable on another CFTR modulator, request to transition to Alyftrek may be approved if all of the following conditions are met:
    • the patient meets initial approval criteria AND
    • approved request for Alyftrek will not be effective until at least 85% of patient’s current supply of another CFTR modulator has been depleted (based on pharmacy claims data)
  • Transition approval is for 6 months

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient must have disease improvement or stabilization with treatment (e.g., improvement or stabilization of any of the following: forced expiratory volume in one second [FEV1], sweat chloride concentration, weight/body mass index [BMI], Cystic Fibrosis Questionnaire-Revised [CFQ-R] respiratory domain score, respiratory symptoms related to cystic fibrosis [e.g., cough, sputum production, difficulty breathing], number of pulmonary exacerbations); AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., severe liver injury or liver failure, severe hypersensitivity reactions).
  • Renewal approval is for 12 months

Quantity limits

  • vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg tablets: 84 tablets per 28 days
  • vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg tablets: 56 tablets per 28 days

Questions

Provider Call Center (844) 575-7887