CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trikafta (elexacaftor/tezacaftor/ivacaftor)

Policy governs Medicaid coverage criteria, initial and continuation authorization, age and genetic mutation requirements, quantity limits, and prescribing/consultation requirements for Trikafta for treatment of cystic fibrosis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrikafta (elexacaftor/tezacaftor/ivacaftor)

Policy CodePolicy N/A

Change TypeReviewed (dates updated)

Effective DateApr 1, 2020

Next Review Date

Key ActionRequest initial authorization for 6 months and reauthorization for 12 months with documentation of benefit; ensure genetic testing confirms at least one F508del or a responsive CFTR mutation and that a pulmonologist prescribes or is consulted.

SourceLink

POLICY UPDATE CHANGES

Reviewed dates updated through 05/2025; no material clinical or coverage changes.

1Covered Indication (CF with qualifying mutation)

>=2Minimum age (years)

3/dayTablet quantity limit

2/dayPacket (granule) quantity limit

Coverage Summary & Indications

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Policy applies to Medicaid members and covers Trikafta (elexacaftor/tezacaftor/ivacaftor). Trikafta is FDA‑approved for 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 in vitro data. This policy references the Trikafta package insert (Vertex Pharmaceuticals Inc; January 2025) as the primary product reference.

Indications (Covered)

Trikafta is covered for the treatment of cystic fibrosis when all approval criteria are met:

ALL of the following

Patient has cystic fibrosis (CF)
Patient is age 2 years or older>= 2 years
Patient has at least one F508del mutation in the CFTR gene OR a CFTR mutation responsive based on in vitro data
Genotype testing documentation required
If genotype unknown, an FDA-cleared CF mutation test is used to confirm presence of at least one F508del mutation or a mutation responsive based on in vitro data
Medication is prescribed by or in consultation with a pulmonologist
Trikafta will not be used in combination with other ivacaftor-containing medications

Genotype testing documentation required

Initial Therapy Criteria

Initial Approval

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Genetic testing: Documentation that genetic testing was conducted to detect a mutation in the CFTR gene
Listed mutations
- Example listed mutations
  - A46D
  - A120T
  - A234D
  - A349V
  - A455E
Prescribed by or consultation with a pulmonologist
Member is at least 2 years of age>= 2 years
Avoid concomitant ivacaftor: Trikafta will not be used in combination with other ivacaftor-containing medications

Prior Authorization

Authorization required

Initial authorization may be granted for 6 months.

Documentation Required

Genetic testing documentation

Providers must document genetic testing confirming at least one F508del mutation or a CFTR mutation responsive based on in vitro data; if genotype is unknown an FDA-cleared CF mutation test should be used to confirm the mutation.

Documentation Required

Specialist involvement

Medication must be prescribed by or in consultation with a pulmonologist; include documentation of pulmonologist prescription or consultation.

Continuation Therapy (Reauthorization)

Continuation of Therapy (Reauthorization)

Authorization of 12 months may be granted for continued treatment when benefit demonstrated:

ALL of the following

Member requests reauthorization for an indication listed in Section I
Evidence of benefit: Member is experiencing benefit as evidenced by disease stability or disease improvement (example: improvement in FEV1 from baseline)

Prior Authorization

Reauthorization requirements

Reauthorization may be granted for 12 months contingent on documentation of benefit such as disease stability or improvement (example: improvement in FEV1 from baseline).

Provider Actions & Billing Rules

Billing Rule

Avoid concomitant ivacaftor products

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

Billing Rule

Quantity limits

Quantity limits apply:

Trikafta tablets: limit 3 tablets per day
Trikafta packets (granules): limit 2 packets per day

Scope: Medicaid coverage criteria govern initial and continuation authorization, age and genetic mutation requirements, quantity limits, and prescribing/consultation requirements for Trikafta. Minimum age requirement is >= 2 years. Initial authorization may be granted for 6 months when criteria including genetic testing documentation, presence of a qualifying mutation, and pulmonologist prescription/consultation are met; continuation (reauthorization) may be granted for 12 months when clinical benefit (disease stability or improvement such as FEV1 improvement) is documented. Quantity limits apply (tablets and packets).

Definitions & Background

Definitions: F508del — a specific mutation (phenylalanine deletion at position 508) in the CFTR gene. Additional context: coverage requires confirmation of at least one F508del mutation or a CFTR mutation responsive based on in vitro data; if genotype is unknown, an FDA‑cleared CF mutation test should be used. Prescribing or consultation with a pulmonologist is required and Trikafta must not be used with other ivacaftor‑containing products.

Key thresholds

Minimum age>= 2 years

Tablet quantity limit3 tablets/day

Packet quantity limit2 packets/day

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrikafta (elexacaftor/tezacaftor/ivacaftor)

Policy CodePolicy N/A

Change TypeReviewed (dates updated)

Effective DateApr 1, 2020

Next Review Date

SourceLink

On This Page

OpenPayer

Trikafta (elexacaftor/tezacaftor/ivacaftor)

Coverage Summary & Indications

Initial Therapy Criteria

Continuation Therapy (Reauthorization)

Provider Actions & Billing Rules

Applicable Codes

Clinical Evidence & References

Definitions & Background

Revision History