leniolisib phosphate — Blue Cross Blue Shield of New Mexico

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 for the requested agent 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 or greater AND
• 5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, immunologist) or 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

Reauthorization criteria

• 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 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

Approval duration

6 months (initial); 12 months (renewal, BCBSIL 12 months for both)