Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.30
    OpenPayerPolicy UpdatesClinical/Medical PolicyAHCA Alyftrek Prior Auth Coverage Update | OpenPay…
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Alyftrek Prior Authorization Criteria

    Customize your policy alerts

    Sign up for all Agency for Health Care Administration policy alerts

    Know when Agency for Health Care Administration releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    This policy establishes prior authorization requirements for Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for patients with cystic fibrosis, including initial and continuation therapy criteria, genetic confirmation, safety monitoring, specialist involvement, treatment response, and authorization duration.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAlyftrek Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming cystic fibrosis, at least one responsive CFTR mutation, liver function monitoring, and applicable initial or continuation criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥ 6 yearsMinimum patient age
    1 yearMaximum authorization duration
    ≥ 1Required responsive CFTR mutations
    2Fixed-dose tablet strengths

    Initial and Continuation Therapy Criteria

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyAlyftrek Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming cystic fibrosis, at least one responsive CFTR mutation, liver function monitoring, and applicable initial or continuation criteria.
    SourceLink
    On This Page
    Initial and Continuation Therapy CriteriaAuthorization, Documentation, and Denial ConditionsTherapy OverviewKey Policy Definitions

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Initial and continuation therapy

    Covered when all applicable initial or continuation review criteria are met.

    Initial therapy

    • Patient eligibility: Patient is at least 6 years of age and has a diagnosis of cystic fibrosis.Age ≥ 6 years
    • Genetic confirmation: Patient has at least one F508del mutation or other responsive mutation in the CFTR gene, confirmed by genetic testing.≥ 1 responsive CFTR mutation

      Medical records are required.

    • Concomitant therapy restriction: Alyftrek will not be used in combination with another CFTR modulator.No concurrent CFTR modulator
    • Liver monitoring: Liver function tests, including ALT, AST, alkaline phosphatase, and bilirubin, have been assessed before initiation and will be monitored regularly during treatment.Baseline assessment and regular monitoring
    • Hepatic safety: Patient does not have severe hepatic impairment classified as Child-Pugh Class C.Not Child-Pugh Class C
    • Specialist involvement: The prescriber is a specialist in the area of the patient's diagnosis, such as cystic fibrosis or pulmonology, or has consulted with an appropriate specialist.Specialist prescriber or consultation
    "{\"operator\":\"all\",\"label\":\"Continuation therapy\",\"text\":\"Patient meets all continuation review requirements.\",\"note\":\"All criteria below must be satisfied.\",\"children\":[{\"operator\":\"all\",\"label\":\"Initial criteria\",\"text\":\"Patient met the initial review criteria.\",\"children\":[]},{\"operator\":\"all\",\"label\":\"Clinical response\",\"text\":\"Patient has disease improvement or stabilization with treatment, demonstrated by improvement or stabilization in one or more relevant measures.\",\"threshold\":\"Improvement or stabilization in ≥ 1 relevant measure\",\"note\":\"Relevant measures may include FEV1, sweat chloride concentration, weight or BMI, CFQ-R respiratory domain score, respiratory symptoms, or number of pulmonary exacerbations.\",\"children\":[]},{\"operator\":\"all\",\"label\":\"Adverse-effect safety\",\"text\":\"Patient has not experienced treatment-restricting adverse effects.\",\"threshold\":\"No treatment-restricting adverse effects\",\"note\":\"Examples include severe liver injury, liver failure, or severe hypersensitivity reactions.\",\"children\":[]},{\"operator\":\"all\",\"label\":\"Dosing appropriateness\",\"text\":\"Dosing is appropriate according to product labeling or is supported by compendia.\",\"threshold\":\"Labeling- or compendia-supported dosing\",\"children\":[]}]}"

    Alyftrek must not be used in combination with another CFTR modulator. Concurrent use with another CFTR modulator is excluded from coverage.

    Patients with severe hepatic impairment classified as Child-Pugh Class C are excluded from coverage for Alyftrek.

    Authorization, Documentation, and Denial Conditions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Alyftrek (vanzacaftor/tezacaftor/deutivacaftor). Authorization may be approved for up to one year.

    • Maximum authorization duration: up to one year.
    Documentation Required

    Initial Approval Requirements

    Initial approval requires that the patient meet all clinical criteria for Alyftrek therapy, including age, cystic fibrosis diagnosis, a responsive CFTR mutation, appropriate hepatic evaluation, and specialist involvement.

    • Patient is 6 years of age or older.
    • Patient has a diagnosis of cystic fibrosis (CF).
    • Patient has at least one F508del mutation or other responsive CFTR mutation.
    • Alyftrek will not be used with another CFTR modulator.
    • Liver function tests have been assessed before initiation and will be monitored regularly during treatment.
    • Patient does not have severe hepatic impairment (Child-Pugh Class C).
    • Prescriber is a specialist in the patient's diagnosis area, such as CF or pulmonology, or has consulted with such a specialist.
    Denial Risk

    Eligibility and Mutation Requirements

    Eligibility requires the patient to be at least 6 years old, have cystic fibrosis, and have genetic confirmation of at least one F508del or other responsive CFTR mutation.

    • CFTR mutation must be confirmed by genetic testing; medical records are required.
    • Patients who do not meet the age, cystic fibrosis diagnosis, or responsive mutation requirements do not qualify for approval.
    Documentation Required

    Initial Clinical Documentation

    Initial requests must include clinical records supporting the diagnosis, mutation status, baseline safety assessment, and appropriate specialist involvement.

    • Medical records documenting cystic fibrosis diagnosis.
    • Genetic testing results confirming at least one F508del or other responsive CFTR mutation.
    • Pre-treatment liver function test results, including testing such as ALT, AST, alkaline phosphatase, and bilirubin.
    • Documentation that the prescriber is a relevant specialist or has consulted with one.
    • Documentation that Alyftrek will not be used in combination with another CFTR modulator and that the patient does not have Child-Pugh Class C hepatic impairment.
    Documentation Required

    Continuation Approval Requirements

    Continuation requests must show that the patient met initial review criteria and is benefiting from or stable on treatment without treatment-restricting safety concerns.

    • Document disease improvement or stabilization, such as in FEV1, sweat chloride concentration, weight or BMI, CFQ-R respiratory domain score, CF-related respiratory symptoms, or number of pulmonary exacerbations.
    • Document absence of treatment-restricting adverse effects, including severe liver injury or liver failure and severe hypersensitivity reactions.
    • Confirm dosing is appropriate according to product labeling or supported by compendia.
    Documentation Required

    Continuation Documentation

    Continuation requests must include records supporting treatment response or stabilization, ongoing safety, and compliant dosing.

    • Provide updated clinical measures or narrative documentation showing improvement or stabilization.
    • Include monitoring results and documentation that no treatment-restricting adverse effects have occurred.
    • Confirm dosing remains consistent with labeling or is supported by compendia.
    Denial Risk

    Eligibility Denial Conditions

    Approval is not available when the patient fails the basic eligibility or mutation requirements.

    • Deny when the patient is younger than 6 years of age.
    • Deny when the patient does not have a cystic fibrosis diagnosis.
    • Deny when genetic testing does not confirm at least one F508del or other responsive CFTR mutation.
    Denial Risk

    Contraindicated Combination or Hepatic Risk

    Alyftrek must not be used with another CFTR modulator and is not approved for patients with severe hepatic impairment.

    • Deny for concurrent use with another CFTR modulator.
    • Deny when the patient has Child-Pugh Class C hepatic impairment.
    Denial Risk

    Continuation Failure

    Continuation approval should be denied when treatment does not produce improvement or stabilization or when treatment must be restricted for safety reasons.

    • Deny when the patient has not demonstrated disease improvement or stabilization with treatment.
    • Deny when treatment-restricting adverse effects occur, including severe liver injury, liver failure, or severe hypersensitivity reactions.
    • Deny when a contraindication prevents continued treatment or dosing is not appropriate under labeling or supported by compendia.

    Therapy Overview

    Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) is a fixed-dose CFTR modulator combination for patients with cystic fibrosis who have at least one responsive CFTR mutation, including F508del or another mutation confirmed by genetic testing.

    Key Policy Definitions

    Responsive CFTR Mutation
    DefinitionA mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Alyftrek.
    Specifically includedAt least one F508del mutation or other responsive CFTR mutation confirmed by genetic testing.
    Documentation requiredMedical records must confirm the responsive mutation through genetic testing.
    Severe Hepatic Impairment
    DefinitionSevere hepatic impairment classified as Child-Pugh Class C.
    Coverage requirementThe patient must not have severe hepatic impairment classified as Child-Pugh Class C.
    Related monitoringLiver function tests, including ALT, AST, alkaline phosphatase, and bilirubin, must be assessed before initiation and monitored regularly during treatment.