Last Updated : December 16, 2024
Details
FilesGeneric Name:
donanemab
Project Status:
Suspended
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.
- 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 | June 19, 2024 |
|---|---|
| Call for patient/clinician input closed | August 12, 2024 |
| Submission received | August 28, 2024 |
| Submission accepted | September 12, 2024 |
| Review initiated | September 13, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | November 29, 2024 |
| Deadline for sponsors comments | December 10, 2024 |
| Clarification: - Submission temporarily suspended | |
| 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 | - |
Files
Last Updated : December 16, 2024