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.

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

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

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