CDA | Evidence Driven
CDA | Evidence Driven

eplontersen

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Generic Name:
eplontersen
Project Status:
Active
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
Performance Metric:
Achieved
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:
  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 open27-Feb-24
Call for patient/clinician input closed22-Apr-24
Clarification:

- Patient input submission received from Transthyretin Amyloidosis Canada (TAC)

Submission received09-Apr-24
Submission accepted23-Apr-24
Review initiated24-Apr-24
Draft CADTH review report(s) provided to sponsor for comment10-Jul-24
Deadline for sponsors comments19-Jul-24
CADTH review report(s) and responses to comments provided to sponsor16-Aug-24
Expert committee meeting (initial)28-Aug-24
Draft recommendation issued to sponsor12-Sep-24
Draft recommendation posted for stakeholder feedback19-Sep-24
End of feedback period04-Oct-24
Final recommendation issued to sponsor and drug plans21-Oct-24
Final recommendation posted06-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Nov-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : November 7, 2024