Last Updated : April 24, 2024
Details
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:
TBC
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:
For treatment of adult
patients with polyneuropathy (PN) associated with hereditary
transthyretin-mediated amyloidosis (hATTR)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Eplontersen injection is indicated for the
treatment of adult patients with polyneuropathy (PN) associated with hereditary
transthyretin-mediated amyloidosis (hATTR).
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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 10, 2024 To September 12, 2024 |
| Draft recommendation posted for stakeholder feedback | September 19, 2024 |
| End of feedback period | October 04, 2024 |
Last Updated : April 24, 2024