Kalydeco — Blue Cross Blue Shield of Kansas

other FDA labeled indication

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

6 months