Skip to content
The Policy VaultThe Policy Vault

Joenja (leniolisib)CareFirst (Caremark)

Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)

Initial criteria

  • Member’s diagnosis was confirmed by genetic testing demonstrating variant in either the PIK3CD or PIK3R1 gene
  • Member has clinical manifestations of disease (e.g., history of repeated oto-sino-pulmonary infections, lymphoproliferation, autoimmunity [e.g., cytopenia], enteropathy, organ dysfunction [e.g., lung, liver])
  • Member is age ≥ 12 years and weight ≥ 45 kg
  • Medication is prescribed by or in consultation with an immunologist or a physician who specializes in the treatment of APDS

Reauthorization criteria

  • Member is currently receiving the requested medication
  • Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement

Approval duration

Initial: 6 months; Reauthorization: 12 months