Joenja (leniolisib) — United Healthcare
activated phosphoinositide 3-kinase delta syndrome (APDS)
Initial criteria
- Diagnosis of activated phosphoinositide 3-kinase delta syndrome (APDS)
- Diagnosis has been confirmed by the presence of an APDS-associated genetic variant in either PIK3CD or PIK3R1
- Documentation of other clinical findings and manifestations consistent with APDS (e.g., recurrent respiratory tract infections, recurrent herpesvirus infections, lymphadenopathy, hepatosplenomegaly, autoimmune cytopenias)
- Patient has a history of trial and failure, intolerance or contraindication to current standard of care for APDS (e.g., antimicrobial prophylaxis, immunoglobulin replacement therapy, immunosuppressive therapy)
- Prescribed by one of the following: Hematologist OR Immunologist
- Patient is 12 years of age or older
- Patient weighs greater than or equal to 45 kg
Reauthorization criteria
- Documentation of positive clinical response to Joenja therapy (e.g., reduced lymph node size, increased naïve B-cell percentage, decreased frequency or severity of infections, decreased frequency of hospitalizations)
- Prescribed by one of the following: Hematologist OR Immunologist
- Patient weighs greater than or equal to 45 kg
Approval duration
12 months