Canada’s Drug Agency | Drugs, Health Technologies and Systems.

tofersen

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Generic Name:
tofersen
Project Status:
Active
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:
Schedule E
Indications:
The treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
  1. 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 Milestones2
Call for patient/clinician input open15-Jan-25
Call for patient/clinician input closed10-Mar-25
Submission received27-Feb-25
Submission accepted13-Mar-25
Review initiated17-Mar-25
Draft review report(s) provided to sponsor for comment02-Jun-25
Deadline for sponsors comments11-Jun-25
review report(s) and responses to comments provided to sponsor11-Jul-25
Expert committee meeting (initial)23-Jul-25
Draft recommendation issued to sponsorAugust 05, 2025
To
August 07, 2025
Draft recommendation posted for stakeholder feedback14-Aug-25
End of feedback period28-Aug-25

Files

Patient and Clinician Group Input View PDF
Last Updated : April 1, 2025