Last Updated : June 9, 2022
Details
Generic Name:
aducanumab
Project Status:
Withdrawn
Therapeutic Area:
Alzheimer’s disease
Manufacturer:
Biogen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Aduhelm
Project Line:
Reimbursement Review
Project Number:
SR0705-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Biogen Canada Inc. (Biogen) respectfully requests that CADTH recommends the reimbursement of Aduhelm (aducanumab) to slow the clinical decline associated with Alzheimer's disease (AD) progression in patients with early AD (mild cognitive impairment [MCI] due to AD, and mild AD), with the following criteria: MCI due to AD and mild AD dementia can be defined as: Mini Mental State Exam (MMSE) ≥21, OR Montreal Cognitive Assessment (MoCA) ≥17, OR Clinical Dementia Rating (CDR)-Global Score =0.5, OR Using an assessment tool of clinician choice most appropriate to the diagnosis of MCI due to AD and mild AD Documented presence of Aβ pathology Treatment can be initiated in patients who are treatment naïve or on concomitant symptomatic AD treatment Treatment should be initiated by clinicians experienced in the diagnosis and treatment of AD
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Draft indication submitted to Health Canada: Aduhelm is a disease modifying treatment which has slowed the clinical decline associated with Alzheimer's disease progression and is indicated for the treatment of Alzheimer's disease in adults.
- 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 open | 28-Oct-21 |
| Call for patient/clinician input closed | 16-Dec-21 |
| Clarification: - Patient input submission received from Alzheimer Society of Canada | |
| Submission received | 26-Nov-21 |
| Submission accepted | 10-Dec-21 |
| Review initiated | 13-Dec-21 |
| Clarification: - Submission temporarily suspended Voluntarily withdrawn by the sponsor on 9 Jun 2022 | |
Last Updated : June 9, 2022