CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Symdeko (tezacaftor/ivacaftor) — Coverage Criteria for Cystic Fibrosis

Covers authorization, documentation, and clinical criteria for Symdeko (tezacaftor/ivacaftor) to treat cystic fibrosis in eligible members, including required genetic testing and prescriber specialty; applies to Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySymdeko (tezacaftor/ivacaftor) — Coverage Criteria for Cystic Fibrosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with genetic testing report confirming the appropriate CFTR mutation and ensure prescribing by or in consultation with a pulmonologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

>=6 yrsminimum age

homozygous F508del or ≥1 responsivegenotype requirement

pulmonologistrequired prescriber

Coverage Criteria for Symdeko (tezacaftor/ivacaftor)

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Initial Therapy

Covered when ALL of the following are met

Genetic testing performed: Genetic testing was conducted to detect a mutation in the CFTR gene.

Evidence: genetic testing report is required for initial requests; if genotype is unknown use an FDA-cleared CF mutation test with verification as recommended.

Genotype eligibility: Member is homozygous for the F508del mutation OR member has at least one CFTR mutation responsive to tezacaftor/ivacaftor (see policy mutation list).

Includes FDA‑approved responsive mutations and additional listed mutations.

Age and concomitant therapy: Member is at least 6 years of age AND Symdeko will not be used in combination with other medications containing ivacaftor.age >= 6 years

Continuation Therapy

Covered when ALL of the following are met

Existing indication: Member requests reauthorization for an indication listed in Section IV (cystic fibrosis meeting initial criteria).

Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., improvement in FEV1 from baseline).

Reauthorization may be granted for 12 months.

Not Medically Necessary / Experimental

Unapproved indications: All indications other than FDA‑approved indications and compendial uses are considered experimental/investigational and not medically necessary.

Use of Symdeko (tezacaftor/ivacaftor) for indications other than the FDA‑approved indications and compendial uses is considered experimental/investigational and is not medically necessary. This policy follows the FDA‑approved indication which limits therapy to patients meeting the specified genotype and age criteria; requests for other diagnoses or off‑label uses will be denied as not medically necessary.

All other indications not explicitly listed in the FDA‑approved indication are considered experimental/investigational and are not medically necessary. Coverage is limited to cystic fibrosis meeting the genotype and age requirements described in the FDA‑approved labeling.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be granted for up to 12 months when genotype, age, and other criteria are met for treatment of cystic fibrosis.

Authorization duration: up to 12 months when criteria satisfied
Clinical requirements: genotype and age criteria must be met

Documentation Required

Required Documentation

For initial prior authorization requests, submit a genetic testing report confirming the presence of the appropriate CFTR gene mutation. Lack of this documentation will delay review and may result in denial.

Required for initial requests: genetic testing report showing CFTR mutation

Denial Risk

Denial Risk if Criteria Not Met

Requests that do not meet all clinical criteria (including confirmed CFTR mutation, member age ≥ 6 years, and absence of concurrent ivacaftor-containing therapy) or that lack required documentation may be denied.

Denial risk if genotype not confirmed by testing report
Denial risk if member is younger than 6 years
Denial risk if used with other ivacaftor-containing medications

Note

Provider Actions

Provider action: ensure genetic testing demonstrates one of the covered CFTR mutations (including F508del or listed eligible mutations), confirm member is ≥6 years old, and verify Symdeko will not be combined with other ivacaftor-containing products before submitting the PA.

Confirm mutation: homozygous F508del or one of the enumerated CFTR mutations
Confirm age: member is at least 6 years old
Verify no combination with other ivacaftor-containing medications
Attach genetic test report to initial request

Definitions

CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence

DefinitionCFTR mutation responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence

FDA‑approved contextSymdeko is indicated for patients age ≥ 6 years who are homozygous for F508del or who have at least one CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence

Testing recommendationIf genotype is unknown, use an FDA‑cleared CF mutation test and verify with bi‑directional sequencing when recommended by the test instructions

Coverage implicationPresence of a responsive CFTR mutation is required for coverage; all other indications are experimental/investigational and not medically necessary

Background

Symdeko (tezacaftor/ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) modulator indicated for the treatment of cystic fibrosis in patients aged 6 years and older who are either homozygous for the F508del mutation or who have at least one CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. If the patient’s genotype is unknown, an FDA‑cleared CF mutation test should be used to detect the presence of a CFTR mutation, with verification by bi‑directional sequencing when recommended by the test instructions.