CDA | Evidence Driven
CDA | Evidence Driven

donanemab

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Generic Name:
donanemab
Project Status:
Active
Therapeutic Area:
Alzheimer's disease
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0857-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Donanemab is indicated for the treatment of Alzheimer's disease. Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. In controlled clinical trials, donanemab was found to slow the decline in cognition and function in a clinically meaningful manner and demonstrated significant amyloid plaque removal.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​Donanemab is indicated for the treatment of Alzheimer's disease. Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. In controlled clinical trials, donanemab was found to slow the decline in cognition and function in a clinically meaningful manner and demonstrated significant amyloid plaque removal.
  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 open19-Jun-24
Call for patient/clinician input closed12-Aug-24
Submission received28-Aug-24
Submission accepted12-Sep-24
Review initiated13-Sep-24
Draft CADTH review report(s) provided to sponsor for comment29-Nov-24
Deadline for sponsors comments10-Dec-24
CADTH review report(s) and responses to comments provided to sponsor10-Jan-25
Expert committee meeting (initial)22-Jan-25
Draft recommendation issued to sponsorFebruary 04, 2025
To
February 06, 2025
Draft recommendation posted for stakeholder feedback13-Feb-25
End of feedback period28-Feb-25

Files

Patient and Clinician Group input View PDF
Last Updated : October 18, 2024