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Drug - Trikafta™ (elexacaftor, tezacaftor and ivacaftor tablets; ivacaftor tablets copackaged) [Vertex Pharmaceuticals Inc..]

April 2020

Therapeutic area - Cystic Fibrosis, Oral

Initial approval criteria

  • Patient is ≥ 12 years of age AND
  • Patient has a diagnosis of cystic fibrosis AND
  • Patient has at least one F508del mutation in the CFTR gene as confirmed by an FDA-cleared CF mutation test AND
  • Confirmation that the patient is not receiving concurrent treatment with any other CFTR-targeted therapy containing one or more of the following: ivacaftor, lumacaftor, tezacaftor, elexacaftor AND
  • Patient will avoid concomitant use with strong CYP3A Inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.) AND
  • Patient has a baseline percent predicted FEV1 (reported measurements may be used on renewal) AND
  • Baseline liver function tests were performed and will be reassessed every 3 months (e.g., ALT, AST, bilirubin) AND
  • Patient does not have severe hepatic impairment (Child-Pugh Class C) AND
  • Baseline ophthalmic examination was performed to monitor lens opacities/cataracts if age 12 years to < 18 years of age (not required in adults) AND
  • Patient must be seen at least twice a year for the first year and once a year thereafter by a provider who is on staff at a Cystic Fibrosis (CF) Care Center accredited by the CF Foundation AND
  • Patient does not have known hypersensitivity to elexacaftor, tezacaftor, or ivacaftor
  • Initial approval is for 6 months

Transition criteria

  • If patient is currently stable on Kalydeco, Symdeko or Orkambi, request to transition to Trikafta may be approved if all of the following conditions are met:
    • the patient meets initial approval criteria AND
    • approved request for Trikafta will not be effective until at least 85% of patient’s current supply of Kayldeco, Symdeko or Orkambi has been depleted (based on pharmacy claims data)
  • Transition approval is for 6 months

Renewal criteria

  • Patient continues to meet the criteria identified above AND
  • Patient demonstrates disease response as indicated by ≥ 1 of the following:
    • Decreased pulmonary exacerbations compared to pretreatment baseline OR
    • Improvement or stabilization of lung function compared to baseline OR
    • Decrease in decline of lung function OR
    • Improvement in quality of life, weight gain, or growth AND
  • Patient has not received a lung transplant AND
  • Prescriber must reassess liver function tests (ALT, AST, bilirubin) every 3 months in the first year, and annually thereafter AND
  • Patient is absent of unacceptable toxicity from the drug (e.g., elevated transaminases [ALT or AST], cataracts or lens opacities)
  • Renewal approval is for 12 months

Quantity limits

  • 84 tablets every 28 days (2 tablets of elexacaftor/tezacaftor/ivacaftor plus 1 tablet of ivacaftor 150 mg per day)


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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