CDA | Evidence Driven
CDA | Evidence Driven

lecanemab

Details

Files
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
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
Draft review report(s) provided to sponsor for comment15-Oct-24
Deadline for sponsors comments24-Oct-24
Review report(s) and responses to comments provided to sponsor06-Dec-24
Expert committee meeting (initial)18-Dec-24
Draft recommendation issued to sponsorJanuary 07, 2025
To
January 09, 2025
Draft recommendation posted for stakeholder feedback16-Jan-25
End of feedback period31-Jan-25

Files

Patient and Clinician Group input View PDF
Last Updated : August 21, 2024