Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)
Indications for Prior Authorization
Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)
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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. For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039
Prior Authorization
Length of Approval: When approved; no reauthorization required
- 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^
- 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
P & T Revisions
2025-05-01, 2025-04-30, 2025-03-25, 2025-03-05
References
- Alyftrek Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. January 2025.
Revision History
- 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.
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