CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Symdeko (tezacaftor/ivacaftor) for cystic fibrosis — Coverage Criteria

Covers use of Symdeko for treatment of cystic fibrosis in members meeting genotype, age, prescriber, and documentation requirements; governs prior authorization and reauthorization for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySymdeko (tezacaftor/ivacaftor) for cystic fibrosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain and submit genetic testing report confirming the appropriate CFTR mutation with initial prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

>=6 yrsminimum age

requiredgenotype requirement

pulmonologistprescriber specialty

Coverage Criteria for Symdeko (tezacaftor/ivacaftor)

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Initial Authorization for Cystic Fibrosis: Genetic testing was conducted to detect a mutation in the CFTR gene with documentation provided (for initial requests, submit genetic testing report confirming the presence of the appropriate CFTR gene mutation).

If genotype is unknown, use an FDA‑cleared CF mutation test with follow-up sequencing when recommended.

Genotype requirement

Option 1: Member is homozygous for the F508del mutation.
Mutation list in policy must match member genotype.
Option 2: Member has at least one CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro or clinical evidence (see policy mutation list).
Mutation list provided in policy must match member genotype.

Age: Member is at least 6 years of age.>= 6 years

Prescriber: Drug is prescribed by or in consultation with a pulmonologist.

Concomitant therapy: Symdeko is not prescribed in combination with other medications containing ivacaftor.

inv-02: Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation of Therapy: Authorization of up to 12 months may be granted for continued treatment for members previously approved for an indication listed in the policy who are experiencing benefit from therapy, evidenced by disease stability or improvement (e.g., improvement in FEV1 from baseline).Authorization up to 12 months

Reauthorization requires documentation of clinical benefit (e.g., measures of stability or improvement).

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization may be granted for up to 12 months when criteria are met; reauthorization may be approved for 12 months when the member is experiencing benefit from therapy as evidenced by disease stability or improvement (e.g., improvement in FEV1 from baseline).

Authorization duration: up to 12 months for initial approval
Reauthorization: up to 12 months when benefit demonstrated

Documentation Required

Required Documentation

For initial requests, submit a genetic testing report confirming the presence of the appropriate CFTR gene mutation. If the patient’s genotype is unknown, use an FDA-cleared CF mutation test and verify with bi-directional sequencing when recommended by the test instructions for use.

Note

Concomitant Therapy Restriction

Symdeko must not be used in combination with other medications containing ivacaftor.

Denial Risk

Denial Triggers

Requests lacking documentation of an appropriate CFTR mutation (or genetic testing report), or requests for indications outside FDA‑approved or compendial uses, may be denied.

Background

Symdeko (tezacaftor/ivacaftor) is indicated for the treatment of cystic fibrosis in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one CFTR mutation shown to be responsive to tezacaftor/ivacaftor based on in vitro data or clinical evidence. If a patient’s genotype is unknown, an FDA‑cleared CF mutation test should be used with verification by bi‑directional sequencing when recommended. Indications outside these FDA‑approved or compendial uses are considered experimental/investigational and not medically necessary.

Definitions and FDA-Approved Indications

FDA‑approved indication

Indication summaryTreatment of cystic fibrosis in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one CFTR mutation responsive to tezacaftor/ivacaftor based on in vitro or clinical evidence.

Age requirement>= 6 years of age.

Genotype requirementMember must be homozygous for F508del OR have at least one CFTR mutation shown to be responsive to tezacaftor/ivacaftor.

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

LimitationsAll other indications are considered experimental/investigational and are not medically necessary.