Joenja (leniolisib) — Highmark
Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)
Initial criteria
- age ≥ 12 years
- Patient weighs ≥ 45 kg
- Diagnosis of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) (ICD-10: D81.82)
- Confirmed variant in PIK3CD OR PIK3R1 gene
- Clinical findings of APDS (e.g., lymphoproliferation, lymphadenopathy, splenomegaly, recurrent infections)
Reauthorization criteria
- Prescriber attests the member is tolerating therapy AND has experienced a therapeutic response defined as disease improvement OR delayed disease progression
Approval duration
12 months