Last Updated : December 12, 2022
Details
Generic Name:
masitinib mesylate
Project Status:
Suspended
Therapeutic Area:
Amyotrophic lateral sclerosis (ALS)
Manufacturer:
AB Science SA
Brand Name:
Alsitek
Project Line:
Reimbursement Review
Project Number:
SR0766-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Masitinib mesylate film-coated tablets in combination with riluzole is indicated for treatment of adult patients with amyotrophic lateral sclerosis (ALS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Alsitek (masitinib mesylate) in combination with riluzole is indicated for treatment of adult patients with amyotrophic lateral sclerosis (ALS)
- 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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | September 29, 2022 |
| Call for patient/clinician input closed | November 18, 2022 |
| Clarification: - Patient input submission received from ALS Action Canada and ALS Society of Canada | |
| Submission received | October 28, 2022 |
| Submission accepted | November 15, 2022 |
| Clarification: - Submission was not accepted for review on 11 Nov 2022 | |
| Review initiated | November 16, 2022 |
| Clarification: - Submission temporarily suspended | |
| Draft CADTH review report(s) provided to sponsor for comment | |
| Deadline for sponsors comments | |
| CADTH review report(s) and responses to comments provided to sponsor | |
| Expert committee meeting (initial) | |
| Draft recommendation issued to sponsor | |
| Draft recommendation posted for stakeholder feedback | |
| End of feedback period | |
Last Updated : December 12, 2022