CurrentMedical Mutual - OhioPolicy N/A

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) — Coverage Criteria

Defines prior authorization, coverage criteria, and approval durations for Alyftrek for treatment of cystic fibrosis in eligible patients; applies to Medical Mutual - Ohio pharmacy benefit review.

Policy Summary

PayerMedical Mutual - Ohio

PolicyAlyftrek (vanzacaftor/tezacaftor/deutivacaftor) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 19, 2026

Key ActionPrior authorization is recommended for pharmacy benefit coverage; approval is recommended for patients meeting specified criteria including age, prescriber specialty, genotype, and clinical evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6min patient age

6 moinitial approval

1 yrextended approval

PA recommendedauth requirement

manyresponsive variants

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Coverage Criteria for Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

Initial Therapy

Covered when ALL of the following are met

Initial Use (FDA-Approved Indication): A) Patient is ≥ 6 years of age; AND B) medication is prescribed by or in consultation with a pulmonologist or physician who specializes in cystic fibrosis; AND C) patient has at least ONE pathogenic or likely pathogenic CFTR variant from the listed responsive mutations; AND D) patient meets at least ONE: positive newborn screening test OR family history of cystic fibrosis OR clinical presentation consistent with signs and symptoms of cystic fibrosis (examples include but are not limited to meconium ileus, persistent cough, wheezing, obstructive PFTs, excess sputum production, bronchiectasis, sinusitis, failure to thrive, pancreatic insufficiency); AND E) evidence of abnormal CFTR function demonstrated by at least ONE: elevated sweat chloride test OR two CF-causing CFTR mutations OR abnormal nasal potential difference.

Approve for 6 months (can be extended to 12 months based on patient's response).

Continuation Therapy

Continuation of therapy covered when ALL of the following are met

Continuation of Therapy: A) Patient continues to meet all criteria for new starts (see Initial Use); AND B) patient has been using Alyftrek for at least 6 months; AND C) patient has experienced an adequate response to therapy (e.g., improvement in FEV1 and/or other lung function tests, improvement in sweat chloride, decrease in pulmonary exacerbations or infections, increase in weight, decrease in hospitalizations) compared to baseline.>= 6 months use

Continuation of Therapy

Covered when ALL of the following are met

Continuation Criteria: A. Patient continues to meet all criteria in (1) above for new starts; AND B. The patient has been using Alyftrek for at least 6 months; AND C. The patient has experienced an adequate response to therapy (e.g. improvement in FEV1 and/or other lung function tests, improvement in sweat chloride, decrease in pulmonary exacerbations or infections, increase in weight, decrease in hospitalizations) compared to baseline.6 months use; documented clinical improvement

Must have met initial-start criteria prior to continuation

Conditions not recommended for approval are listed after the recommended authorization criteria and represent situations where evidence is limited, absent, or safety concerns do not support general coverage. Requests for uses not listed in this policy will be reviewed for evidence of efficacy and medical necessity on a case-by-case basis and may be denied if criteria are not met. Initial approvals require prescription by or consultation with a physician who specializes in cystic fibrosis or pulmonology, and continuation of therapy requires documented response to treatment unless otherwise noted.

Coverage is not recommended for patients with an unknown CFTR gene mutation; an FDA-cleared cystic fibrosis mutation test should be used to detect at least one indicated mutation prior to use. Coverage is also not recommended for combination therapy with other CFTR modulators that contain tezacaftor or overlapping components (examples include Symdeko®, Trikafta®, Kalydeco®, Orkambi®).

Requests for uses not listed in this policy (including indications outside the FDA‑approved cystic fibrosis indication) will be reviewed on a case-by-case basis and may be considered not medically necessary if there is insufficient evidence of efficacy or medical necessity.

Specific examples of situations where coverage is not recommended include: patients with an unknown CFTR mutation (perform an FDA‑cleared mutation test to confirm an indicated mutation before prescribing) and use of Alyftrek in combination with other CFTR modulators (for example, combining with products that include tezacaftor or other listed modulators such as Symdeko®, Trikafta®, Kalydeco®, Orkambi®). Coverage is also not recommended for infertility or for circumstances not listed in the Recommended Authorization Criteria.

Coding and Usage Minimums

Minimum prior use — Continuation criteria

Minimum prior use before continuation review>= 6 months of Alyftrek use

Context for requirementContinuation criteria require prior meeting of initial-start criteria and documented adequate response compared to baseline

Examples of adequate responseImprovement in FEV1/other lung function, improved sweat chloride, fewer exacerbations/infections, increased weight, decreased hospitalizations

Prescriber & Authorization Actions

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Alyftrek. Approval is recommended for patients who meet the conditions of coverage in the Criteria and Initial/Extended Approval sections. Initial approval requires the medication be prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Initial approval: 6 months (may be extended to 12 months based on response)
Prescriber specialty required: pulmonologist or physician specializing in cystic fibrosis

Prior Authorization

Continuation Authorization Requirements

Continuation authorization requires that the patient has met all initial-start criteria, has been using Alyftrek for at least 6 months, and has demonstrated an adequate response to therapy (for example: improvement in FEV1 or other lung function tests, improvement in sweat chloride, decreased pulmonary exacerbations or infections, increased weight, or decreased hospitalizations).

Must have used Alyftrek ≥ 6 months

Background on Alyftrek and Indication

Alyftrek is a triple‑combination CFTR modulator composed of deutivacaftor, tezacaftor, and vanzacaftor. It is indicated for the treatment of cystic fibrosis in patients aged ≥ 6 years who have at least one F508del or another responsive CFTR mutation. If genotype is unknown, an FDA‑cleared cystic fibrosis mutation test should be used to confirm an indicated mutation prior to therapy. Because of the specialized evaluation and monitoring required, initial therapy should be prescribed by or in consultation with a physician experienced in cystic fibrosis care.

Definitions and Testing Requirements

Definition: CFTR

TermCFTR — Cystic Fibrosis Transmembrane Conductance Regulator

Role in diseaseTarget of CFTR modulators; mutations in CFTR cause cystic fibrosis

Relevance to policyResponsive CFTR mutations determine eligibility for Alyftrek therapy

CFTR mutation testing requirement

When to testRequired prior to use of Alyftrek if genotype is unknown

PurposeTo detect presence of at least one F508del or other responsive CFTR mutation that supports treatment