Generic Name: filgrastim
Brand Name: TBC
Manufacturer: Pfizer Canada Inc.
Indications: Prevention or treatment of neutropenia in various indications
Manufacturer Requested Reimbursement Criteria1: Listed in accordance with the Health Canada approved indications, in a similar manner to other biosimilar filgrastim products in CanadaCancer Patients Receiving Myelosuppressive ChemotherapyTo decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. Nivestym is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. Patients with Acute Myeloid LeukemiaFor the reduction in the duration of neutropenia, fever, antibiotic use and hospitalization, following induction and consolidation treatment for acute myeloid leukemia. Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow TransplantationTo reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in patients undergoing myeloablative therapy followed by bone marrow transplantation. Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and TherapyFor the mobilization of autologous peripheral blood progenitor cells in order to accelerate hematopoietic recovery by infusion of such cells, supported by Nivestym, after myelosuppressive or myeloablative chemotherapy. Patients with Severe Chronic Neutropenia (SCN)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. Patients with HIV InfectionIn patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal ANC (i.e. between 2 x 109 and 10 x 109/L).
Submission Type: New
Project Status: Suspended
Companion Diagnostics: No
Fee Schedule: Schedule D
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
|Call for patient input posted||October 03, 2018|
|Patient group input closed||November 22, 2018|
- No patient input submission received
|Submission received||November 01, 2018|
|Submission accepted for review||November 08, 2018|
|Review initiated||November 09, 2018|
- Submission temporarily suspended pending receipt of information
|Draft CDR review report(s) sent to applicant||-|
|Comments from applicant on draft CDR review report(s) received||-|
|Final CDR review report(s) sent to applicant||-|
|Final CDR review report(s) posted||-|
blood, cancer, pediatrics, hiv/aids