vutrisiran

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).
  1. 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.
Key Milestones2
Call for patient/clinician input open23-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from TTR Amyloidosis Canada

Submission received04-Jul-23
Submission accepted18-Jul-23
Review initiated19-Jul-23
Draft CADTH review report(s) provided to sponsor for comment04-Oct-23
Deadline for sponsors comments16-Oct-23
CADTH review report(s) and responses to comments provided to sponsor09-Nov-23
Expert committee meeting (initial)22-Nov-23
Draft recommendation issued to sponsorDecember 04, 2023
To
December 06, 2023
Draft recommendation posted for stakeholder feedback14-Dec-23
End of feedback period05-Jan-24