Joenja (leniolisib) — Point32Health

Initial criteria

• Documented diagnosis of activated phosphoinositide 3-kinase delta syndrome (APDS)
• Documented APDS-associated PIK3CD/PIK3RI mutation
• Patient age ≥ 12 years
• Prescribed by or in consultation with a pediatrician, immunologist, hematologist, oncologist, or allergist

Reauthorization criteria

• Documented diagnosis of activated phosphoinositide 3-kinase delta syndrome (APDS)
• Documented APDS-associated PIK3CD/PIK3RI mutation
• Patient age ≥ 12 years
• Prescribed by or in consultation with a pediatrician, immunologist, hematologist, oncologist, or allergist
• Documentation patient is responding positively to therapy based on provider attestation (e.g., lymph node size, percentage of naïve B cells)

Approval duration

initial 6 months, reauth 12 months