Pharmacy Prior Authorization Criteria

Trikafta (elexacaftor/tezacaftor/ivacaftor)

Indications for Prior Authorization

Trikafta (elexacaftor/tezacaftor/ivacaftor)

• For diagnosis of Cystic Fibrosis
  Indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene 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 the presence of at least one F508del mutation or a mutation that is responsive based on clinical and/or in vitro data.

Criteria

Trikafta

*Please consult Background section for table of CFTR gene mutations responsive to Trikafta. For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of cystic fibrosis (CF)
AND
• One of the following:
• For granule packets, patient is at least 2 to less than 6 years of age
• For tablets, patient is 6 years of age or older
AND
• Patient has at least one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as detected by a FDA-cleared cystic fibrosis mutation test or a test performed at a Clinical Laboratory Improvement Amendments (CLIA)-approved facility:*
• F508del mutation
• A mutation in the CFTR gene that is responsive based on clinical and/or in vitro data
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Specialist affiliated with a CF care center

P & T Revisions

2025-05-01, 2025-04-30, 2025-03-25, 2025-02-19, 2024-11-04, 2023-10-27, 2023-05-16, 2022-10-31, 2021-11-03, 2021-08-16, 2021-02-04, 2020-10-27, 2019-10-30

References

1. Trikafta Prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. December 2024.
2. Keating D, Marigowda G, Burr L, et al. VX-445–tezacaftor–ivacaftor in patients with cystic fibrosis and one or two Phe508del alleles. N Engl J Med. 2018;379:1612-20.

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Revision History

• 2025-05-01: Approval length updated to "Approved- no reauthorization required"
• 2025-04-30: Removing reauthorization requirement as part of extended reauthorization program.
• 2025-03-25: Removing reauthorization requirement as part of extended reauthorization program.
• 2025-02-19: Updated guideline with revised indication and gene mutation criteria. Updated background table of CFTR gene mutations. Updated references.
• 2024-11-04: Annual review: No criteria changes.
• 2023-10-27: Annual review: Updated reauthorization criteria verbiage to "Patient demonstrates positive clinical response to therapy." Updated references.
• 2023-05-16: Added in new granule formulation and added age criteria to guideline
• 2022-10-31: Annual review: No criteria changes.
• 2021-11-03: 2021 Annual Review, no changes to criteria.
• 2021-08-16: Updated guideline with new lower strength dose pack (50-25-37.5 mg, 75mg) and expanded indication to patients 6 years of age.
• 2021-02-04: Updated criteria and included background table due to expanded indication approved for additional mutations. Removed reference to drug name from reauth criteria.
• 2020-10-27: 2020 Annual Review, no changes to criteria.
• 2019-10-30: New drug guideline

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