vutrisiran

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Generic 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:
  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 openMay 23, 2023
Call for patient/clinician input closedJuly 14, 2023
Clarification:

- Patient input submission received from TTR Amyloidosis Canada

Submission receivedJuly 04, 2023
Submission acceptedJuly 18, 2023
Review initiatedJuly 19, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 04, 2023
Deadline for sponsors commentsOctober 16, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 09, 2023
Expert committee meeting (initial)November 22, 2023
Draft recommendation issued to sponsorDecember 06, 2023
Draft recommendation posted for stakeholder feedbackDecember 21, 2023
End of feedback periodJanuary 12, 2024
Final recommendation postedFebruary 15, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 12, 2024
CADTH review report(s) postedApril 29, 2024