CurrentUnitedHealthcarePolicy 2026 P 2180-9

Trikafta (elexacaftor/tezacaftor/ivacaftor) prior authorization

Prior authorization and medical necessity criteria for Trikafta for UnitedHealthcare members with cystic fibrosis; defines initial authorization, reauthorization, prescriber requirements, and documentation expectations.

Policy Summary

PayerUnitedHealthcare

PolicyTrikafta (elexacaftor/tezacaftor/ivacaftor) prior authorization

Policy CodePolicy 2026 P 2180-9

Change TypeRoutine review — no material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit laboratory results documenting at least one responsive CFTR mutation and documentation of cystic fibrosis diagnosis for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum patient age for coverage

12 moauthorization duration

1+required responsive mutation

2019–2026P&T review history

Coverage Criteria for Trikafta

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Initial Authorization

Covered when ALL of the following are met

Initial authorization: Member has a diagnosis of cystic fibrosis (CF).

Initial authorization: Patient is ≥ 2 years of age.age >=2 yrs

Initial authorization: Submission of laboratory results documenting that the patient has at least one responsive CFTR gene mutation: (1) F508del OR (2) a mutation responsive based on clinical data OR (3) a mutation responsive based on in vitro data OR (4) a mutation responsive based on extrapolated data.

Complete, up-to-date list of responsive mutations referenced in the Trikafta Prescribing Information; clinical/in vitro/extrapolated support defined in footnotes.

Initial authorization: Prescribed by or in consultation with a provider who specializes in the treatment of cystic fibrosis.

Reauthorization

Covered when ALL of the following are met

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

Reauthorization: Authorization will be issued for 12 months.authorization period = 12 months

State mandates, federal requirements, member benefit plan, and other utilization management programs may apply.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required — Initial Authorization

Prior authorization is required for initial Trikafta therapy. Submit documentation of the diagnosis of cystic fibrosis and laboratory results confirming at least one responsive CFTR mutation. If the patient's CFTR genotype is unknown, an FDA-cleared CF mutation test should be used to confirm presence of at least one indicated mutation.

Required: documentation of CF diagnosis (ICD-10 code) and lab report showing ≥1 responsive CFTR mutation (e.g., F508del or mutation responsive per clinical, in vitro, or extrapolated data).
If genotype unknown, submit results from an FDA-cleared CF mutation test.
Prescriber must be a provider who specializes in the treatment of cystic fibrosis or be in consultation with a CF specialist.

Documentation Required

Reauthorization Requirements

For reauthorization, provide objective documentation of clinical benefit from Trikafta therapy. Approval is contingent on evidence that the patient is experiencing a positive clinical response.

Acceptable documentation: improved or stable lung function (e.g., FEV1), clinician progress notes, pulmonary function test results, or other objective measures demonstrating clinical response.
Authorizations are issued for 12 months; reauthorization requires submission of the clinical response documentation prior to renewal.

Denial Risk

Documentation and Denial Risk

Lack of a documented diagnosis of cystic fibrosis or absence of laboratory results confirming a responsive CFTR mutation will result in denial or additional review. UnitedHealthcare may use automated approval based on prior claim/medication history and diagnosis codes for some programs, but missing required documentation may still trigger manual review or denial.

No CF diagnosis on record or no genetic test results demonstrating at least one responsive mutation → denial or request for additional information.
Automated approvals may occur in some programs based on claims history or ICD-10 codes, but submission of required lab and clinical documentation is the provider's responsibility to avoid delays or denials.
Supply limits and other utilization management programs may apply; check member-specific benefits and state/federal mandates.

Definitions

Responsive CFTR mutation — definition and acceptable evidence

DefinitionA CFTR gene mutation documented as responsive to Trikafta based on clinical trial data, in vitro assay results (e.g., FRT or HBE), or extrapolation; includes F508del and other mutations listed in the Trikafta Prescribing Information.

Required evidence — Clinical trial dataMutation documented as responsive based on clinical data (clinical trial evidence of benefit).

Required evidence — In vitro assayMutation shown to be responsive based on in vitro data (laboratory assay demonstrating drug responsiveness).

Required evidence — Extrapolated dataMutation considered responsive based on extrapolated data when direct clinical or in vitro evidence supports inference of responsiveness.

Acceptable documentationSubmission of laboratory results confirming at least one responsive CFTR mutation (one or more of: F508del, mutation responsive by clinical data, by in vitro data, or by extrapolated data).

OpenPayer

Trikafta (elexacaftor/tezacaftor/ivacaftor) prior authorization

Coverage Criteria for Trikafta

Provider Actions and Documentation Requirements

Definitions

Background