Last Updated : November 10, 2023
Details
Generic Name:
vutrisiran
Project Status:
Active
Therapeutic Area:
Hereditary transthyretin mediated amyloidosis (hATTR amyloidosis)
Manufacturer:
Alnylam Netherlands B.V.
Call for patient/clinician input open:
Brand Name:
Amvuttra
Project Line:
Reimbursement Review
Project Number:
SR0801-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
AMVUTTRA (vutrisiran injection) is indicated for
the treatment of stage 1 or stage 2 polyneuropathy in adult patients with
hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
AMVUTTRA (vutrisiran injection) is indicated for
the treatment of stage 1 or stage 2 polyneuropathy in adult patients with
hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
- 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 | 23-May-23 |
|---|---|
| Call for patient/clinician input closed | 14-Jul-23 |
| Clarification: - Patient input submission received from TTR Amyloidosis Canada | |
| Submission received | 04-Jul-23 |
| Submission accepted | 18-Jul-23 |
| Review initiated | 19-Jul-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 04-Oct-23 |
| Deadline for sponsors comments | 16-Oct-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 09-Nov-23 |
| Expert committee meeting (initial) | 22-Nov-23 |
| Draft recommendation issued to sponsor | December 04, 2023 To December 06, 2023 |
| Draft recommendation posted for stakeholder feedback | 14-Dec-23 |
| End of feedback period | 05-Jan-24 |
Last Updated : November 10, 2023