Generic Name: filgrastim
Brand Name: TBC
Manufacturer: Sandoz Canada Inc.
Indications: neutropenia, blood cell mobilization (various indications)
Manufacturer Requested Reimbursement Criteria1:
1. Cancer Patients Receiving Myelosuppressive Chemotherapy
Filgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
Filgrastim is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy, and twice per week during filgrastim therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies, filgrastim therapy was discontinued when the ANC was > 10 x 109/L after expected chemotherapy-induced nadir.
2. Patients with Acute Myeloid Leukemia
Filgrastim is indicated for the reduction in the duration of neutropenia, fever, antibiotic use and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.
3. Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation Filgrastim is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g. febrile neutropenia, in patients undergoing myeloablative therapy followed by bone marrow transplantation. A CBC and platelet count should be obtained at a minimum of 3 times per week following marrow infusion to monitor marrow reconstitution.
4. Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy
Filgrastim is indicated for the mobilization of autologous peripheral blood progenitor cells in order to accelerate haematopoietic recovery by infusion of such cells, supported by filgrastim, after myelosuppressive or myeloablative chemotherapy.
5. Patients with Severe Chronic Neutropenia (SCN)
Filgrastim is indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infection in patients with a diagnosis of congenital, cyclic or idiopathic neutropenia.
6. Patients with HIV Infection
Filgrastim is indicated in patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal ANC (e.g. between 2 x 109 and 10 x 109/L). Filgrastim therapy reduces the clinical sequelae associated with neutropenia (e.g., bacterial infections) and increases the ability to deliver myelosuppressive medications used for the treatment of HIV and its associated complications. It is recommended that complete blood counts and platelet counts be monitored at regular intervals (e.g., initially twice weekly for 2 weeks, once weekly for an additional 2 weeks, then once monthly thereafter, or as clinically indicated) during filgrastim therapy
Submission Type: Initial
Project Status: Cancelled
Anticipated Date: December 17, 2018
Fee Schedule: Pending