leniolisib phosphate — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The patient has a diagnosis of activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS)
• The patient has a variant in either PIK3CD or PIK3R1 [chart notes are required]
• 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
• The patient's weight is ≥ 45 kg
• 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
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [patients not previously approved for the requested agent will require initial evaluation]
• The patient has had clinical benefit with the requested agent
• 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
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6–12 months (BCBSIL: 12 months; all other plans: 6 months; renewal 12 months)