leniolisib phosphate — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS)
• Patient has a variant in either PIK3CD or PIK3R1 [chart notes required]
• If the patient has an FDA labeled indication, then ONE of the following: (A) 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
• Patient weight is ≥ 45 kg
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, immunologist) OR has consulted with such a specialist
• Patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient was previously approved through the plan’s prior authorization process
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, immunologist) OR has consulted with such a specialist
• Patient has no FDA labeled contraindications to the requested agent

Approval duration

6 months (initial, non-BCBSIL); 12 months (BCBSIL); 12 months renewal