Trikafta — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ALL of the following:
• 1. ONE of the following:
• A. ALL of the following:
• 1. Patient has a diagnosis of cystic fibrosis AND
• 2. 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. Patient has another FDA labeled indication for the requested agent and route of administration AND
• 2. If patient has an FDA labeled indication, then ONE of the following:
• A. 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. Patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication AND
• 4. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or has consulted with such a specialist AND
• 5. Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval:
• - BCBSIL and BCBSMT: 12 months
• - ALL other plans: 6 months
• FOR OHIO MEMBERS:
• 1. Member resides in Ohio AND
• 2. Plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
• A. Patient does NOT have any FDA labeled contraindications to the requested agent AND
• B. ONE of the following:
• 1. Patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. Patient has another indication supported in compendia for the requested agent and route of administration OR
• 3. Prescriber has submitted TWO articles from major peer-reviewed medical journals supporting proposed use(s) as generally safe and effective (case studies not acceptable)

Reauthorization criteria

• ALL of the following:
• 1. Patient was previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. ONE of the following:
• A. Patient has a diagnosis of cystic fibrosis AND has had improvement or stabilization with the requested agent (e.g., FEV1, weight/BMI, CFQ-R Respiratory Domain score, respiratory symptoms, or pulmonary exacerbations) OR
• B. Patient has another diagnosis and has had clinical benefit with the requested agent AND
• 3. Patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication AND
• 4. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or has consulted with such a specialist AND
• 5. Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: 12 months

Approval duration

6–12 months