Orkambi — Blue Cross Blue Shield of Alabama

Initial criteria

• Patient has a diagnosis of cystic fibrosis AND
• Patient has a CFTR gene mutation(s), confirmed by genetic testing, according to the FDA label for the requested agent (medical records required) AND
• If the requested agent is Kalydeco, patient does NOT have F508del mutation on BOTH alleles of CFTR gene (NOT homozygous) OR patient has another FDA labeled indication for the requested agent and route of administration AND
• If the patient has an FDA labeled indication, then ONE of the following: • Patient’s age is within FDA labeling for the requested indication for the requested agent OR • There is support for using the requested agent for the patient’s age for the requested indication AND
• Patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication AND
• 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
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

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

Approval duration

initial 6 months; renewal 12 months