Pharmacy Prior Authorization Criteria

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

Indications for Prior Authorization

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

• For diagnosis of Cystic Fibrosis (CF)
  Indicated for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.

Criteria

Alyftrek

^Please consult Background section for table of CFTR gene mutations responsive to Alyftrek.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of cystic fibrosis (CF)
AND
• Presence of at least one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as detected by a U.S. Food and Drug Administration (FDA)-cleared cystic fibrosis mutation test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA):
• F508del mutation
• A mutation in the CFTR gene that is responsive based on clinical, in vitro, or extrapolated data^
AND
• Patient is 6 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Specialist affiliated with a CF care center

Alyftrek

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., stable or improved lung function [percent predicted forced expiratory volume in one second {PPFEV1}], decreased number of pulmonary exacerbations)

P & T Revisions

2025-03-05

References

1. Alyftrek Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. January 2025.

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Revision History

• 2025-03-05: New program.

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