CurrentUnitedHealthcarePolicy 2025 P 1160-13

Orkambi (lumacaftor/ivacaftor) prior authorization

Prior authorization and reauthorization requirements for Orkambi (lumacaftor/ivacaftor) for treatment of cystic fibrosis in eligible members; applies to UnitedHealthcare pharmacy clinical programs and prescribers seeking coverage.

Policy Summary

PayerUnitedHealthcare

PolicyOrkambi (lumacaftor/ivacaftor) prior authorization

Policy CodePolicy 2025 P 1160-13

Change TypeAuthorization duration clarifiedreauthorization criteria revised

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of CF diagnosis and confirmation the patient is homozygous for the F508del mutation; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Initial authorization duration increased to 12 months.

Reauthorization criteria simplified to require documentation of positive clinical response.

Effective date set to 9/1/2025 and P&T approvals updated through 6/2025.

12 monthsauthorization duration (initial and reauth)

>=1 yrminimum patient age

homozygous F508delrequired CFTR genotype

2025 P 1160-13program identifier

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Coverage Criteria for Orkambi (lumacaftor/ivacaftor)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization: Diagnosis of cystic fibrosis (CF).

Initial Authorization: Documentation confirming the patient is homozygous for the F508del mutation in the CFTR gene.

Initial Authorization: Patient meets the minimum age requirement per policy (patients 1 years of age or older).

Authorization will be issued for 12 months.

Reauthorization

Covered when ALL of the following are met

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

Authorization will be issued for 12 months.

Use of Orkambi in patients with cystic fibrosis who are not homozygous for the F508del mutation is not established. The policy limits coverage to individuals meeting the specified genotype requirement; members must meet the coverage criteria to be eligible for authorization.

Orkambi is not established for use in patients with cystic fibrosis other than those who are homozygous for the F508del CFTR mutation. Providers should confirm genotype documentation before seeking coverage under this policy.

Initial Therapy

Initial therapy criteria (covered when ALL of the following are met):

Initial Therapy: Diagnosis of cystic fibrosis (CF).

Authorization will be issued for 12 months.

Initial Therapy: Documentation confirming the patient is homozygous for the F508del mutation in the CFTR gene.

Initial Therapy: Patient meets the policy age requirement (patients 1 years of age or older).

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Reauthorization/continuation criteria (covered when ALL of the following are met):

Continuation: Documentation of positive clinical response to Orkambi (e.g., improved or stable lung function).

Authorization duration: 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Orkambi (lumacaftor/ivacaftor). Initial approvals require documentation of a cystic fibrosis (CF) diagnosis and confirmation that the patient is homozygous for the F508del mutation by an FDA‑cleared CF mutation test when genotype is unknown. Authorizations are issued for 12 months.

Prior authorization required for Orkambi (lumacaftor/ivacaftor).
Initial approval prerequisites: documented diagnosis of cystic fibrosis (CF); documentation confirming patient is homozygous for the F508del mutation in the CFTR gene (use an FDA‑cleared CF mutation test if genotype is unknown); patient meets age requirement (≥ 1 year).
Initial and reauthorizations are issued for 12 months.

Documentation Required

Documentation Requirements

Documentation must clearly include a CF diagnosis and genetic confirmation of homozygous F508del status. Lack of documentation of homozygous F508del on both alleles, absence of a CF diagnosis, incorrect genotype, or age noncompliance may lead to denial of the request.

Definitions

Homozygous F508del

DefinitionPresence of the F508del (also shown as FSO8del in source text) mutation on both alleles of the CFTR gene.

How detectedAs determined by an FDA‑cleared CF mutation test that demonstrates F508del on both alleles.

Clinical implicationRequired genotype for coverage: patients must be homozygous for F508del to meet Orkambi eligibility under this policy.

Background

Orkambi is a combination of lumacaftor and ivacaftor indicated for treatment of cystic fibrosis in patients who are homozygous for the F508del CFTR mutation. The agent targets the CFTR protein defect; when genotype is unknown, an FDA‑cleared CF mutation test should be used to confirm the presence of F508del on both alleles prior to authorization.

Policy Summary

PayerUnitedHealthcare

PolicyOrkambi (lumacaftor/ivacaftor) prior authorization

Policy CodePolicy 2025 P 1160-13

Change TypeAuthorization duration clarifiedreauthorization criteria revised

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of CF diagnosis and confirmation the patient is homozygous for the F508del mutation; approvals issued for 12 months.

SourceLink

On This Page

Required documentation: CF diagnosis and documentation confirming homozygous F508del mutation (both alleles) — use an FDA‑cleared CF mutation test if genotype unknown.
Denial risk includes: missing or incomplete documentation of homozygous F508del, no documented CF diagnosis, incorrect genotype, or patient below age requirement.

Note

Utilization Management

UnitedHealthcare may use automated approvals or prior-authorization decisions based on previous claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits, medical-necessity rules, and other utilization management programs may also apply.

Automated approval or re-approval may be granted based on prior claim/medication history and diagnosis codes (ICD-10).
Supply limits and other utilization management programs (e.g., medical necessity review) may apply.

Denial Risk

Denial Conditions

Denials will be issued when required documentation is not provided or criteria are not met. Providers should ensure all required documentation (CF diagnosis, FDA‑cleared genetic test confirming homozygous F508del, patient age) is included with the request to avoid denial.

Denial conditions: lack of required documentation (including homozygous F508del confirmation), absence of documented CF diagnosis, incorrect genotype, or noncompliance with age criteria.