CurrentColorado Rocky Mountain Health PlansPolicy N/A

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) prior authorization

Prior authorization and medical necessity criteria for Alyftrek for treatment of cystic fibrosis in members of Colorado Rocky Mountain Health Plans; applies to prescribers requesting coverage for patients aged 6 years and older with responsive CFTR mutations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlyftrek prior authorization — coverage criteria for cystic fibrosis (age ≥6, responsive CFTR mutation)

Policy CodePolicy N/A

Change TypeClarified and revised (annual reviewprior 4/2025 revision added Trikafta requirement)

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization with documentation of CF diagnosis, CFTR mutation proof, age ≥6, and trial/failure/contraindication/intolerance to Trikafta or qualifying mutation or current Alyftrek use.

SourceLink

POLICY UPDATE CHANGES

Updated criteria to require history, contraindication, or intolerance to Trikafta or current Alyftrek therapy for initial approval (added previously in 4/2025).

Updated references; annual review noted no changes to coverage criteria.

≥6minimum age for therapy

12 moauthorization duration

CFTR requiredgenotype documented

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2/2025,4/2025,2/2026

Coverage Criteria for Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

Initial Therapy — Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Patient has a diagnosis of cystic fibrosis (CF).

Initial Authorization: Submission of laboratory results documenting that the patient has at least one responsive CFTR gene mutation (examples include F508del, mutations responsive based on clinical, in vitro, or extrapolated data); the complete, up-to-date list is referenced in the Alyftrek prescribing information.

Initial Authorization: Patient is ≥ 6 years of age.

Initial Authorization

ONE of: (1) Submission of medical records demonstrating a history of trial and failure, contraindication, or intolerance to Trikafta (elexacaftor/tezacaftor/ivacaftor).
ONE of: (2) Patient has a documented CFTR gene mutation that is responsive to Alyftrek but is not responsive to Trikafta (see Trikafta prescribing information for a current list).
ONE of
- Patient is currently on Alyftrek therapy as documented by claims history or submission of medical records (include date and duration of therapy).
- Patient did not establish current use via a manufacturer-supplied sample or any form of assistance from the Vertex GPS or other Vertex co-pay assistance programs (e.g., sample card redeemed at pharmacy).

Initial Authorization: Medication is prescribed by or in consultation with a provider who specializes in the treatment of cystic fibrosis.

Continuation Therapy / Reauthorization

Reauthorization — Covered when ALL of the following are met:

Reauthorization: Documentation of positive clinical response to Alyftrek therapy (e.g., improved or stable lung function).

Reauthorization: Authorization will be issued for 12 months on approval.

Patients who were established on Alyftrek therapy solely through receipt of manufacturer‑supplied samples or any form of Vertex co‑pay assistance (including the Vertex GPS™ Guidance & Patient Support program or sample cards redeemed at a pharmacy) are not automatically treated as continuing users. Such patients must meet the initial authorization criteria and will be reviewed as if they are new to therapy.

Use of Alyftrek without documentation of a diagnosis of cystic fibrosis, without laboratory confirmation of at least one responsive CFTR mutation, or in patients below the policy minimum age is not supported. The policy requires a documented CF diagnosis, demonstration of a responsive CFTR mutation, and that the patient be ≥ 6 years of age for approval.

Coding and Authorization Details

Diagnosis codes referencedICD-10

ICD-10

Diagnosis codes for cystic fibrosis referenced generally for automated approvals

Authorization duration / Age

Authorization duration12 months

Minimum age>= 6 years

Reauthorization requirementDocumentation of positive clinical response to Alyftrek for continued approval

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required — Initial authorization requirements

Prior authorization required. Initial authorization will be approved only when all required clinical criteria are met, including documentation of diagnosis, genotype, age, and prior therapy or exception criteria. Prescriptions must be written by or in consultation with a cystic fibrosis specialist.

Alyftrek is approved only for patients ≥ 6 years with documented CF and at least one responsive CFTR mutation.
Submit medical records showing trial and failure, contraindication, or intolerance to Trikafta unless an exception applies.
If the patient is currently on Alyftrek, provide claims history or medical records documenting date and duration of therapy and confirm no manufacturer assistance was used to establish current use.

Documentation Required

Required documentation for prior authorization

Documentation requirements: prior authorization requests must include medical records and laboratory evidence that support the diagnosis and eligibility criteria for Alyftrek. Incomplete requests lacking the items below will be denied or returned for additional information.

Definitions

Responsive CFTR mutation (Alyftrek PI definition)

Definition (per prescribing information)A CFTR gene mutation listed in the Alyftrek prescribing information as responsive based on clinical data, in vitro data, or extrapolated data (includes F508del and other specified mutations)

Clinical-data responsive mutationMutations supported by clinical trial evidence as listed in the Alyftrek PI (e.g., F508del)

In vitro–responsive mutationMutations predicted responsive based on validated in vitro assays (FRT or HBE as noted; e.g., N1303K responsive only by HBE assay) as listed in the PI

Extrapolated-response mutationsCertain non‑canonical splice mutations for which efficacy is extrapolated because clinical trials are infeasible, per the PI

Background

Alyftrek is a triple‑combination CFTR modulator composed of deutivacaftor, tezacaftor, and vanzacaftor indicated for the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del or other CFTR mutation listed as responsive in the Alyftrek prescribing information.

Revision History and Policy Changes

2026-02annual_reviewLatest

Annual review completed; no changes to coverage criteria and references updated.

2025-04criteria_revision

Coverage criteria updated to require history of trial/failure, contraindication, or intolerance to Trikafta or current use of Alyftrek for initial approval; references updated.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlyftrek prior authorization — coverage criteria for cystic fibrosis (age ≥6, responsive CFTR mutation)

Policy CodePolicy N/A

Change TypeClarified and revised (annual reviewprior 4/2025 revision added Trikafta requirement)

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

SourceLink

On This Page

Medical record confirming diagnosis of cystic fibrosis.
Laboratory results from an FDA-cleared CF mutation test documenting at least one responsive CFTR mutation (e.g., F508del or other mutation responsive by clinical, in vitro, or extrapolated data).
Patient age (must be ≥ 6 years).
If applicable, medical records documenting a trial and failure, contraindication, or intolerance to Trikafta (elexacaftor/tezacaftor/ivacaftor).
If requesting exemption from Trikafta trial, documentation that the patient’s CFTR mutation is responsive to Alyftrek but not to Trikafta (reference Trikafta prescribing information for mutation responsiveness).
If the patient is currently on Alyftrek, claims history or medical records documenting date and duration of therapy and documentation that the patient did not establish therapy via manufacturer-provided samples or Vertex assistance/copay programs.
Documentation that the prescriber is a CF specialist or that consultation with a CF specialist occurred.

Denial Risk

Documentation deficiency — missing diagnosis or genotype

Requests missing documentation of diagnosis or genotype will be denied or held pending completion. Ensure CFTR mutation test results are included; if genotype is unknown, submit results from an FDA-cleared CF mutation test.

Absence of documented CF diagnosis and CFTR genotype will result in denial or request for additional information.
If genotype is unknown at time of request, include results from an FDA-cleared CF mutation test confirming at least one indicated mutation.
Provide full mutation documentation when relying on clinical, in vitro, or extrapolated evidence of responsiveness.