Last Updated : March 17, 2025
Details
Generic Name:
tofersen
Project Status:
Received
Therapeutic Area:
Amyotrophic lateral sclerosis (ALS)
Manufacturer:
Biogen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Qalsody
Project Line:
Reimbursement Review
Project Number:
SR0883-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
QALSODY is to be used for the treatment of adults with ALS associated with a mutation in the SOD1 gene who: Are 18 years of age or older Have weakness attributable to ALS and documented mutation in the SOD1 gene Are treated by a specialist/health care professional treating ALS Can be taken with/without riluzole and/or edaravone
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
The treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
- 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.
| Call for patient/clinician input open | January 15, 2025 |
|---|---|
| Call for patient/clinician input closed | March 10, 2025 |
| Submission received | February 27, 2025 |
| Submission accepted | March 13, 2025 |
| Review initiated | March 17, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | June 02, 2025 |
| Deadline for sponsors comments | June 11, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | July 11, 2025 |
| Expert committee meeting (initial) | July 23, 2025 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | August 14, 2025 |
| End of feedback period | August 28, 2025 |
Last Updated : March 17, 2025