Last Updated : April 21, 2022
Details
Generic Name:
natalizumab
Project Status:
Withdrawn
Therapeutic Area:
Multiple Sclerosis, relapsing-remitting
Manufacturer:
Biogen Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Tysabri
Project Line:
Reimbursement Review
Project Number:
SR0687-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Tysabri SC to be funded in similar manner as Tysabri IV.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
Tysabri (intravenous, IV; and subcutaneous, SC) is indicated as monotherapy for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability. Tysabri is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, other therapies for multiple sclerosis.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones | |
|---|---|
| Call for patient/clinician input open | 23-Mar-21 |
| Call for patient/clinician input closed | 14-May-21 |
| Clarification: - Patient input submission received from Multiple Sclerosis Society of Canada | |
| Submission received | 21-Apr-21 |
| Submission accepted | 05-May-21 |
| Review initiated | 06-May-21 |
| Clarification: - Submission temporarily suspended - Voluntarily withdrawn by the sponsor on 21-Apr-2022 | |
Last Updated : April 21, 2022