Joenja — Blue Cross Blue Shield of Illinois

activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS)

Initial criteria

1. The patient has a diagnosis of activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS) AND
2. The patient has a variant in either PIK3CD or PIK3R1 [chart notes are required] AND
3. 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 OR B. There is support for using the requested agent for the patient’s age for the requested indication AND
4. The patient's weight is ≥ 45 kg AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent

12 months