CurrentNeighborhood Health Plan of Rhode IslandPolicy 3374-A

Trikafta (elexacaftor/tezacaftor/ivacaftor) coverage

Defines coverage and authorization criteria for Trikafta (elexacaftor/tezacaftor/ivacaftor) for treatment of cystic fibrosis for members aged 2 years and older with specified CFTR mutations, plus documentation, prescriber specialty, duration, continuation criteria, and exclusion of combination use with other CFTR modulators.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrikafta (elexacaftor/tezacaftor/ivacaftor) coverage

Policy CodePolicy 3374-A

Change TypeClarified

Effective Date

Next Review Date

Key ActionPrior authorization is required; submit genetic testing confirming an appropriate CFTR mutation (or use an FDA-cleared CF mutation test if genotype unknown); reauthorization requires evidence of clinical benefit.

POLICY UPDATE CHANGES

FDA-cleared CF mutation test required if genotype unknown to confirm presence of at least one indicated mutation.

12 monthsAuthorization duration (initial and continuation)

>=2Minimum age

PulmonologistRequired prescriber specialty

Coverage Summary

policy_number: 3374-A; coverage_stance: covered_with_criteria. Trikafta (elexacaftor/tezacaftor/ivacaftor) is covered for FDA-approved and compendial uses when all specified criteria are met. The policy applies to treatment of cystic fibrosis in members aged >= 2 years who have at least one F508del mutation or another CFTR mutation shown to be responsive. Uses that are not FDA-approved or compendial are considered investigational and not medically necessary.

Initial Therapy Criteria (Authorization)

Authorization of 12 months may be granted for treatment of cystic fibrosis when ALL of the following criteria are met:

ALL of the following

Genetic testing was conducted to detect a mutation in the CFTR gene.
The member has one of the following mutations in the CFTR gene: at least one F508del mutation OR another CFTR mutation that is an indicated/label-supported responsive mutation (per FDA-approved labeling or supportive clinical/in‑vitro data).
The medication is prescribed by or in consultation with a pulmonologist.
Prescriber specialty required: pulmonologist
If the patient's genotype is unknown, an FDA-cleared CF mutation test must be used to confirm the presence of at least one indicated mutation.
Use an FDA-cleared CF mutation test when genotype unknown.

Documentation Required

Genetic testing documentation

Genetic testing report confirming the presence of an appropriate CFTR mutation is required for initial authorization. If the patient's genotype is unknown, an FDA-cleared CF mutation test must be performed and submitted.

FDA-cleared CF mutation test

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Previous authorization: Member was previously authorized for an indication listed in the coverage criteria section.
Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., improvement in FEV1 from baseline).

Documentation Required

Evidence for clinical benefit

For reauthorization, include evidence of disease stability or improvement (for example, improvement in FEV1 from baseline).

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization required; initial and continuation authorizations may be granted for 12 months when clinical criteria are met.

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a pulmonologist.

Clinical Evidence & References

Primary reference: Trikafta [package insert], Vertex Pharmaceuticals; December 2024. As context, Trikafta is FDA-approved for treatment of cystic fibrosis in patients aged 2 years and older with at least one F508del or other CFTR mutation that is responsive based on clinical and/or in vitro data. The policy evidence section relies on this approval and related compendial uses when criteria are satisfied.

Background & Definitions

Trikafta is FDA-approved for the treatment of cystic fibrosis in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene or a CFTR mutation that is responsive based on clinical and/or in vitro data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm presence of an indicated mutation. The policy covers FDA-approved and compendial uses when the authorization criteria are met, requires genetic testing documentation for initial requests, limits prescription to or in consultation with a pulmonologist, authorizes initial and continuation approvals for 12 months, and does not allow Trikafta to be used in combination with another CFTR modulator.

Term	Definition
CFTR mutation test	An FDA-cleared cystic fibrosis mutation test used to confirm presence of indicated CFTR mutations. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrikafta (elexacaftor/tezacaftor/ivacaftor) coverage

Policy CodePolicy 3374-A

Change TypeClarified

Effective Date

Next Review Date

On This Page

OpenPayer

Trikafta (elexacaftor/tezacaftor/ivacaftor) coverage

Coverage Summary

Initial Therapy Criteria (Authorization)

Continuation Therapy Criteria (Reauthorization)

Not Medically Necessary / Experimental

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History