CurrentUnitedHealthcarePolicy N/A

Symdeko (tezacaftor/ivacaftor) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity requirements for Symdeko for members with cystic fibrosis, including initial and reauthorization criteria and prescriber requirements.

Policy Summary

PayerUnitedHealthcare

PolicySymdeko (tezacaftor/ivacaftor) prior authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit laboratory results documenting CF diagnosis and CFTR genotype showing homozygous F508del or at least one mutation responsive to Symdeko and ensure prescription is by or in consultation with a CF specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

≥6 yrsminimum age

homozygous F508del or ≥1 responsive mutationgenotype requirement

CF specialist requiredprescriber requirement

6/2025P&T review thru

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Coverage Criteria for Symdeko (tezacaftor/ivacaftor)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization

Diagnosis: Member has a diagnosis of cystic fibrosis (CF).
Submit clinical documentation of CF diagnosis as part of authorization request
Genotype evidence
- Homozygous F508del: The patient is homozygous for the F508del mutation in the CFTR gene.
  Provide laboratory report showing homozygous F508del
- At least one responsive mutation: The patient has at least one CFTR mutation that is responsive to Symdeko per prescribing information.
  Submit laboratory documentation identifying the responsive CFTR mutation(s); reference prescribing information for the list of responsive mutations
Prescriber requirement: Medication is prescribed by or in consultation with a provider who specializes in the treatment of cystic fibrosis.
Include documentation of specialist involvement with the prescription

Operational note: Authorization decisions require submission of the documents referenced above; lack of adequate diagnostic or genotype documentation may result in denial.

See provider documentation requirements for acceptable laboratory testing methods and reports

Continuation Therapy

Reauthorization:

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

Authorization, when approved, will be issued for 12 months.

Use of Symdeko is limited to individuals with a diagnosis of cystic fibrosis and a CFTR genotype that is known to be responsive to tezacaftor/ivacaftor. Treatment of patients who do not have cystic fibrosis or who do not have a CFTR mutation shown to be responsive to tezacaftor/ivacaftor per the product labeling is not supported by this policy. Members must meet the stated coverage criteria before therapy will be authorized.

Authorization requires submission of laboratory documentation confirming the member’s CFTR genotype. Acceptable evidence includes documentation that the patient is homozygous for the F508del mutation or has at least one CFTR mutation responsive to Symdeko as specified in the product information. If the genotype is unknown, an FDA‑cleared CF mutation test should be used with verification by bi‑directional sequencing when recommended by the test instructions; absence of genotype documentation demonstrating either criterion will result in the request being not authorized.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Initial Documentation Requirements

Initial prior authorization is required. Submit documentation that the member has a confirmed diagnosis of cystic fibrosis and genotype evidence demonstrating eligibility for Symdeko. Include lab reports showing either homozygosity for F508del or presence of at least one CFTR mutation known to be responsive to tezacaftor/ivacaftor (refer to the current Symdeko Prescribing Information for the up-to-date responsive mutation list).

Required: documented diagnosis of cystic fibrosis (CF).
Required: laboratory/genetic test results showing either: (1) homozygous F508del or (2) at least one CFTR mutation responsive to Symdeko (see Prescribing Information).
If genotype is unknown, submit results of an FDA-cleared CF mutation test; follow with bidirectional sequencing when recommended by the test instructions.
Prescriber: must be a CF specialist or submit documentation of consultation with a CF specialist.

Denial Risk

Background

Symdeko is a combination of tezacaftor and ivacaftor indicated for treatment of patients with cystic fibrosis age 6 years and older who are either homozygous for the F508del mutation or have at least one CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro data or clinical evidence. When genotype is not documented, an FDA‑cleared CF mutation test with bi‑directional sequencing verification when recommended should be used to establish eligibility.

Definitions

Responsive CFTR mutation

DefinitionA CFTR gene mutation shown to be responsive to tezacaftor/ivacaftor per the Symdeko prescribing information or supported by in vitro data or clinical evidence.

Source for responsive-mutation listRefer to the Symdeko prescribing information for the complete, up‑to‑date list of CFTR mutations responsive to tezacaftor/ivacaftor.

Action when genotype unknownIf genotype is unknown, use an FDA‑cleared CF mutation test and verify results with bi‑directional sequencing when recommended by the test instructions.

Coverage implicationOnly patients with at least one CFTR mutation responsive to tezacaftor/ivacaftor (or homozygous F508del) meet the genotype requirement for coverage under this policy.

Evidence basisResponsiveness is established by in vitro data and/or clinical evidence cited in the Symdeko prescribing information.

Policy Summary

PayerUnitedHealthcare

PolicySymdeko (tezacaftor/ivacaftor) prior authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Insufficient Diagnostic/Genotype Documentation — Denial Risk

Lack of adequate diagnostic or genotype documentation may result in denial of the request. Ensure submitted genetic test reports clearly identify the mutation(s) and testing method; vague statements or absence of mutation-specific results increase denial risk.

Denial risk if documentation does not show homozygous F508del or a responsive CFTR mutation.
Denial risk if testing method or results are not included (e.g., only clinical suspicion without genetic report).
If prior test used a panel that does not sequence all CFTR exons, provide follow-up sequencing or an FDA-cleared test report as indicated.

Documentation Required

Prescriber Specialty Documentation Required

Prescriptions should be written by a provider who specializes in CF or include documentation that the prescriber consulted with a CF specialist. Medical records should indicate the specialist’s involvement.

Acceptable documentation: prescription from a CF specialist, clinic notes from a CF center, or a consult note confirming specialist input.
If prescribed by a non-specialist, include evidence of specialist consultation and agreement with the treatment plan.

Note

Utilization Management and Supply Limits

Utilization management rules and program-level limits may apply. UnitedHealthcare may use automated approval based on prior claims/medication history and diagnosis coding; supply limits could restrict quantity or duration.

Automated approval/re-approval: may be granted based on prior claim/medication history and ICD-10 diagnosis codes depending on program.
Supply limits: quantity limits or duration-of-therapy restrictions may be enforced; verify plan-specific limits.
Operational note: program-level utilization management practices vary by therapeutic class and benefit program.