Last Updated : April 29, 2024
Details
FilesGeneric Name:
vutrisiran
Project Status:
Complete
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
Performance Metric:
Achieved
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).
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 | May 23, 2023 |
|---|---|
| Call for patient/clinician input closed | July 14, 2023 |
| Clarification: - Patient input submission received from TTR Amyloidosis Canada | |
| Submission received | July 04, 2023 |
| Submission accepted | July 18, 2023 |
| Review initiated | July 19, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 04, 2023 |
| Deadline for sponsors comments | October 16, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | November 09, 2023 |
| Expert committee meeting (initial) | November 22, 2023 |
| Draft recommendation issued to sponsor | December 06, 2023 |
| Draft recommendation posted for stakeholder feedback | December 21, 2023 |
| End of feedback period | January 12, 2024 |
| Final recommendation posted | February 15, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 12, 2024 |
| CADTH review report(s) posted | April 29, 2024 |
Files
Last Updated : April 29, 2024