CDA | Evidence Driven
CDA | Evidence Driven

lecanemab

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Generic Name:
lecanemab
Project Status:
Active
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
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
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.
  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 open25-Apr-24
Call for patient/clinician input closed17-Jun-24
Submission received14-Jun-24
Submission accepted28-Jun-24
Review initiated02-Jul-24
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

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

Patient and Clinician Group input View PDF
Last Updated : November 8, 2024