Last Updated : December 16, 2024
Details
FilesGeneric Name:
lecanemab
Project Status:
Suspended
Therapeutic Area:
Alzheimer’s disease
Manufacturer:
Eisai Canada
Call for patient/clinician input open:
Brand Name:
Leqembi
Project Line:
Reimbursement Review
Project Number:
SR0822-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Lecanemab is a
disease-modifying treatment for adult patients with Alzheimer’s disease.
Treatment with lecanemab should be initiated in patients with mild cognitive
impairment or mild dementia stage of disease. Patients must have documented
presence of amyloid beta pathology. Lecanemab should be prescribed by
clinicians with expertise in diagnosing, managing and treating patients with mild cognitive
impairment or mild dementia stage of disease (early AD).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Lecanemab is indicated as a disease-modifying
treatment in adult patients with Alzheimer’s disease. Treatment with lecanemab
should be initiated in patients with mild cognitive impairment or mild dementia
stage of disease.
- 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 | April 25, 2024 |
|---|---|
| Call for patient/clinician input closed | June 17, 2024 |
| Submission received | June 14, 2024 |
| Submission accepted | June 28, 2024 |
| Review initiated | July 02, 2024 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted - Submission temporarily suspended | |
| Draft CADTH review report(s) provided to sponsor for comment | - |
| Deadline for sponsors comments | - |
| 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