Trikafta (elexacaftor-tezacaftor-ivacaftor) — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. ONE of the following: A. ALL of the following: 1. The patient has a diagnosis of cystic fibrosis AND 2. The patient has a CFTR gene mutation(s), confirmed by genetic testing, according to the FDA label for the requested agent (medical records required) AND 3. If the requested agent is Kalydeco, the patient does NOT have F508del mutation on BOTH alleles of CFTR gene (NOT homozygous) OR B. The patient has another FDA labeled indication for the requested agent and route of administration AND
• 2. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication AND
• 3. The patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication AND
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent
• Additional approval pathway: 1. The member resides in Ohio AND 2. The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO articles from major peer-reviewed journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective (case studies not acceptable)

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. ONE of the following: A. The patient has a diagnosis of cystic fibrosis AND has had improvements or stabilization with the requested agent (e.g., improvement or stabilization of FEV1, weight/BMI, CFQ-R Respiratory Domain score, respiratory symptoms such as cough, sputum production, difficulty breathing, number of pulmonary exacerbations) OR B. The patient has a diagnosis other than cystic fibrosis AND has had clinical benefit with the requested agent AND
• 3. The patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication AND
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Initial: 6-12 months; Renewal: 12 months