Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) prior authorization
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Defines prior authorization criteria, approval duration, and reauthorization requirements for Alyftrek for treatment of cystic fibrosis in patients aged 6 years and older, as used by West Virginia Bureau for Medical Services.
No material clinical or coverage changes in this revision.
Coverage Criteria for Alyftrek
inv-01: Initial Therapy
Covered when ALL of the following are met:
Initial approval duration: six months for the first year, then annual prior authorization thereafter.
inv-02: Continuation/Reauthorization
Reauthorization covered when ALL of the following are met:
Documentation of monitoring per schedule is required for reauthorization.
Coverage for Alyftrek requires a confirmed diagnosis of cystic fibrosis and documentation that the patient meets FDA‑label age criteria. In addition, the patient must have genetic testing confirming at least one F508del mutation or another responsive CFTR mutation as verified by an FDA‑approved CF mutation test. Baseline laboratory and clinical data must be submitted with the prior authorization request, including baseline liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) and, for patients six years of age and older, baseline FEV1. Patients under 18 must have a baseline ophthalmic examination documented.
Use of Alyftrek is not supported when there is no confirmed diagnosis of cystic fibrosis or when CFTR genotype testing does not demonstrate at least one F508del or another responsive mutation as confirmed by an FDA‑approved test. Lack of required baseline documentation (age per FDA label, genotype confirmation, baseline LFTs, and required baseline FEV1 or ophthalmic exam where applicable) may result in denial of the request.
Initial Therapy Criteria
inv-14: Initial Therapy
Initial approval duration: 6 months for the first year, then annual prior authorization.
Reauthorization / Continuation Criteria
inv-15: Reauthorization
Failure to document monitoring per schedule may result in denial of reauthorization.
Laboratory and Safety Limits
Provider Actions, Documentation & Prior Authorization
Prior authorization and approval duration
Prior authorization is required. Initial approval will be for six months for the first year, followed thereafter by an annual prior authorization.
No step therapy required
No step therapy requirements or prior medication failure steps are specified in this policy.
Required documentation for initial request
Provide documentation with the prior authorization request showing the patient meets FDA‑label age, has a confirmed diagnosis of cystic fibrosis, and CFTR mutation test results confirming at least one F508del or another responsive mutation; include baseline liver function tests (ALT, AST, alkaline phosphatase, bilirubin) and, for patients six years and older, baseline FEV1.
Ophthalmic exam requirements for patients <18
For patients under 18, include a baseline ophthalmic examination with the initial prior authorization; for reauthorization, provide documentation of follow‑up ophthalmic exams at least annually.
Denial risk for missing core evidence
Requests may be denied if the request does not document FDA‑label age, a confirmed cystic fibrosis diagnosis, or CFTR genotype showing at least one F508del or other responsive mutation, or if baseline LFTs and (when applicable) baseline FEV1 are not provided.
Reauthorization denial risk for missing LFT monitoring
For reauthorization, failure to document the required LFT monitoring schedule (monthly during the first 6 months, then every 3 months for the next 12 months, then at least annually) or to show ALT/AST and bilirubin values meeting the policy thresholds may result in denial.
- LFT schedule: monthly x6, then every 3 months x12, then at least annually.
- Thresholds to document: ALT or AST < 5× ULN OR ALT or AST < 3× ULN with bilirubin < 2× ULN.
Definitions
Background
Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) is a triple‑combination CFTR modulator indicated for treatment of cystic fibrosis in patients meeting FDA labeling. Because of potential hepatotoxicity and ophthalmic effects in children, the policy requires baseline and ongoing monitoring—specifically baseline liver function tests and, for patients under 18, a baseline ophthalmic exam—documented with the prior authorization request.
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