tofersen

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.
  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 openJanuary 15, 2025
Call for patient/clinician input closedMarch 10, 2025
Submission receivedFebruary 27, 2025
Submission acceptedMarch 13, 2025
Review initiatedMarch 17, 2025
Draft CADTH review report(s) provided to sponsor for commentJune 02, 2025
Deadline for sponsors commentsJune 11, 2025
CADTH review report(s) and responses to comments provided to sponsorJuly 11, 2025
Expert committee meeting (initial)July 23, 2025
Draft recommendation issued to sponsorAugust 05, 2025
To
August 07, 2025
Draft recommendation posted for stakeholder feedbackAugust 14, 2025
End of feedback periodAugust 28, 2025