Stimufend — Medica

Initial criteria

• For cancer in a patient receiving myelosuppressive chemotherapy, approve if ALL of the following criteria are met:
• A) Patient meets ONE of the following:
• i. Patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (≥ 20% based on the chemotherapy regimen); OR
• ii. Patient is receiving myelosuppressive anti-cancer medications associated with < 20% risk of febrile neutropenia AND has at least one risk factor for febrile neutropenia (e.g., age > 65 years receiving full-dose chemotherapy, prior chemotherapy or radiation, persistent neutropenia, bone marrow involvement by tumor, recent surgery/open wounds, liver dysfunction [bilirubin > 2.0 mg/dL], renal dysfunction [creatinine clearance < 50 mL/min], poor performance status, or HIV infection with low CD4 counts); OR
• iii. Patient had a neutropenic complication from a prior chemotherapy cycle without colony stimulating factor prophylaxis AND a reduced chemotherapy dose/frequency may compromise treatment outcome.
• B) The medication is prescribed by or in consultation with an oncologist or hematologist.
• For Radiation Syndrome (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]), approve if the agent is prescribed by or in consultation with a physician with expertise in treating acute radiation syndrome.
• For Peripheral Blood Progenitor Cell (PBPC) collection and therapy, approve if prescribed by or in consultation with an oncologist, hematologist, or physician specializing in transplantation.

Approval duration

6 months for cancer in patients receiving myelosuppressive chemotherapy; 1 month for radiation syndrome; one dose for PBPC collection and therapy