Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) prior authorization
Customize your policy alerts
Sign up for all UnitedHealthcare policy alerts
Know when UnitedHealthcare releases new policies or updates existing guidance.
Monitor payer policy activity
Defines UnitedHealthcare prior authorization, initial authorization, and reauthorization criteria for Alyftrek for members with cystic fibrosis aged 6 years and older, including required CFTR mutation documentation and duration of authorization.
UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.
Medical necessity and supply limits may be in place.
Updated list of eligible CFTR mutations and background; no changes to coverage criteria noted during annual review.
Coverage Criteria for Alyftrek
Initial Authorization
Covered when ALL of the following are met
Clinical data sources: Trials NCT05033080 and NCT05076149; in vitro assay notes (FRT/HBE) and extrapolation rules described in policy.
Initial Therapy
Initial authorization criteria
Clinical trial support: NCT05033080 and NCT05076149; assay details (FRT, HBE) and extrapolation notes in policy.
Reauthorization / Continuation
Covered when ALL of the following are met
Authorization will be issued for 12 months.
Continuation therapy
Reauthorization requirements
Reauthorization period: 12 months.
Coverage quantity for Alyftrek may be limited by supply limits. Medical necessity determinations remain applicable and supply limits may restrict coverage quantity for this medication.
Provider Actions, Documentation & Authorization Rules
Prior authorization required for initial therapy
Prior authorization is required for initial Alyftrek therapy. Initial approval is granted only when all coverage criteria are met, including a clinical diagnosis of cystic fibrosis, documentation of at least one responsive CFTR mutation, and patient age ≥ 6 years; authorization is issued for 12 months when criteria are satisfied.
- Diagnosis of cystic fibrosis must be documented.
- Documentation confirming at least one responsive CFTR mutation (F508del OR mutation responsive by clinical, in vitro, or extrapolation data).
- Patient must be ≥ 6 years of age.
- Authorization period: 12 months.
Prior authorization/notification rules
Prior authorization/notification programs may use prior claims, medication history, ICD-10 diagnosis codes, and claim logic to approve initial and reauthorization requests; medical necessity determinations and supply limits may also apply.
- Programs may approve based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.
- Medical necessity and supply limits may restrict coverage quantity.
Program-level automated approval note
UnitedHealthcare may use program-level automated processes to approve initial and reauthorization requests based on prior claim/medication history, diagnosis codes, and claim logic; use of automated approval and re-approval processes varies by program and therapeutic class.
- Automated approvals may rely solely on prior claim/medication history, ICD-10 codes, and claim logic.
- Use of automated processes varies by program and therapeutic class.
Automated/program note
(No additional program-specific step therapy sequence specified in the policy text.)
Required clinical and genotype documentation
Document the clinical diagnosis of cystic fibrosis and confirm the presence of at least one responsive CFTR variant (e.g., F508del or a mutation responsive by clinical, in vitro, or extrapolation data). If genotype is unknown, obtain an FDA-cleared CF mutation test to confirm a responsive variant.
- Confirm clinical diagnosis of CF in the medical record.
- Provide genotype documentation showing at least one responsive CFTR mutation (F508del or other responsive mutations listed in policy).
- If genotype is unknown, use an FDA-cleared CF mutation test to confirm a responsive variant.
Required documentation
Ensure ICD-10 diagnosis coding accurately reflects clinical cystic fibrosis and maintain medication and claim history to support authorization decisions; these data may be used by programs for automated approvals.
- Use accurate ICD-10 coding for cystic fibrosis on claims and authorization requests.
- Maintain prior medication and claim history to support approvals and reauthorizations.
Genotype documentation required
Requests lacking documentation of at least one responsive CFTR variant — or with unknown genotype without confirmation via an FDA-cleared CF mutation test — may be denied.
- Absence of documented responsive CFTR mutation or unknown genotype without an FDA-cleared test confirmation can trigger denial.
Automated approval/denial triggers
Requests may be denied if prior claim/medication history, diagnosis codes (ICD-10), or claim logic do not support approval when automated or program-specific review is applied.
- Automated/programmatic review may deny requests when claim history, ICD-10 diagnosis, or claim logic do not support approval.
Definitions and Key Terms
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 who have at least one responsive CFTR variant. Clinical evidence supporting responsive mutations includes data from trials (e.g., NCT05033080, NCT05076149) and in vitro assays (FRT or HBE); extrapolation from related mutations is applied where appropriate. The prescribing information (Alyftrek package insert, March 2026) is the referenced source for detailed mutation listings and clinical prescribing details.
Quantity and Supply Limits
Revision History
Updated list of eligible CFTR mutations and background; references updated and package insert cited (March 2026).
Program established as Prior Authorization/Notification for Alyftrek (initial program creation noted).
Program creation entry recorded (program metadata: new program noted).
Operational note: use of automated approval and re-approval processes varies by program; UnitedHealthcare may approve based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.
Medical necessity determinations and supply limits may be in place.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.