CurrentUnitedHealthcarePolicy 2026 P 1301-9

Trikafta® (elexacaftor/tezacaftor/ivacaftor) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

UnitedHealthcare prior authorization/notification policy for Trikafta for commercial plans governing initial authorization and reauthorization criteria for members aged ≥2 years with cystic fibrosis and responsive CFTR mutations, including genotype documentation and approval duration.

Policy Summary

PayerUnitedHealthcare

PolicyTrikafta® (elexacaftor/tezacaftor/ivacaftor) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 1301-9

Change TypeAnnual review (no coverage changes)

Effective DateMay 1, 2026

Next Review Date

Key ActionTrikafta requires prior authorization/notification for UnitedHealthcare commercial plans; members must meet the listed initial or reauthorization clinical criteria.

SourceLink

POLICY UPDATE CHANGES

Annual review on 2/2026 with no changes to coverage criteria.

Effective date updated to 5/1/2026 in program header.

≥2Minimum age (years)

12Authorization duration

ManyResponsive CFTR mutations

2019-2026Policy review history

Coverage summary

Coverage stance: covered_with_criteria for UnitedHealthcare commercial plans. Scope: UnitedHealthcare prior authorization/notification policy for Trikafta governing initial authorization and reauthorization criteria for members aged ≥2 years with cystic fibrosis and responsive CFTR mutations. Effective date: 5/1/2026.

Initial authorization criteria

Reauthorization (continuation) criteria

Authorizations are issued for 12 months. UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or automated claim logic per program implementation; when automated approval is not applied, providers must supply required documentation. For reauthorization, documentation must show a positive clinical response (for example, improved or stable lung function), which is used operationally to review continued medical necessity and support issuance of a subsequent 12‑month authorization.

Exclusions / unproven uses

The policy brief does not list additional unproven or excluded indications; it refers clinicians to the Trikafta prescribing information for the complete and up‑to‑date list of responsive CFTR mutations and mutation‑specific guidance.

Applicable codes

ICD-10 / diagnosis reference (used for automated approvals)ICD-10

No codes listed

Provider actions & requirements

Prior Authorization

Prior authorization required

Trikafta requires prior authorization/notification for UnitedHealthcare commercial plans; members must meet the listed initial or reauthorization clinical criteria.

Documentation Required

Genotype documentation

Document presence of at least one responsive CFTR mutation using an FDA-cleared CF mutation test if the patient’s genotype is unknown; reference the current Trikafta prescribing information for the complete, up-to-date list of responsive mutations.

Clinical evidence & references

Key evidence cited includes Trials 1 (NCT03525444), 2 (NCT03525548), and 5 (NCT05274269), and the Trikafta prescribing information: Trikafta [Package Insert], Vertex Pharmaceuticals; September 2025.

Evidence

Key trials referencedTrials 1 (NCT03525444), 2 (NCT03525548), and 5 (NCT05274269)

Prescribing informationTrikafta [Package Insert], Vertex Pharmaceuticals; September 2025

Background & definitions

Trikafta (elexacaftor/tezacaftor/ivacaftor) is indicated for treatment of cystic fibrosis in patients aged 2 years and older who have at least one F508del mutation or another CFTR mutation responsive based on clinical, in vitro, or extrapolated data; if genotype is unknown, an FDA‑cleared CF mutation test should be used to document at least one indicated mutation.

Definitions

Responsive mutationA CFTR gene mutation shown to be responsive to Trikafta based on clinical data, in vitro data, or extrapolation; full list is in Trikafta prescribing information.

Revision history

2026-02-01revised

Annual review on 2/2026 with no changes to coverage criteria. Change Control notes annual review; prior updates include expanded indications and mutation list updates across 2019-2025.

2026-05-01addedLatest

Effective date updated to 5/1/2026 in program header. Program Number 2026 P 1301-9 listed in header metadata.