Last Updated : February 19, 2025
Details
FilesGeneric Name:
eplontersen
Project Status:
Complete
Therapeutic Area:
Polyneuropathy in hereditary transthyretin-mediated amyloidosis
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Wainua
Project Line:
Reimbursement Review
Project Number:
SR0826-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Wainua (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Wainua (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | February 27, 2024 |
|---|---|
| Call for patient/clinician input closed | April 22, 2024 |
| Clarification: - Patient input submission received from Transthyretin Amyloidosis Canada (TAC) | |
| Submission received | April 09, 2024 |
| Submission accepted | April 23, 2024 |
| Review initiated | April 24, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 10, 2024 |
| Deadline for sponsors comments | July 19, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 16, 2024 |
| Expert committee meeting (initial) | August 28, 2024 |
| Draft recommendation issued to sponsor | September 12, 2024 |
| Draft recommendation posted for stakeholder feedback | September 19, 2024 |
| End of feedback period | October 04, 2024 |
| Final recommendation issued to sponsor and drug plans | October 21, 2024 |
| Final recommendation posted | November 06, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 04, 2024 |
| CADTH review report(s) posted | February 18, 2025 |
Files
Last Updated : February 19, 2025