vutrisiran

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Generic Name:
vutrisiran
Project Status:
Active
Therapeutic Area:
Hereditary transthyretin-amyloidosis
Manufacturer:
Alnylam Canada ULC
Call for patient/clinician input open:
Brand Name:
Amvuttra
Project Line:
Reimbursement Review
Project Number:
SR0904-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Documented cardiac disease due to ATTR-CM: Evidence of cardiac involvement by echocardiography with end diastolic interventricular septal wall thickness of greater than 12 mm in males, and greater than 11 mm in females Presence of amyloid deposits in biopsy tissue (fat aspirate, salivary gland, median nerve connection tissue sheath, or cardiac); OR transthyretin (TTR) precursor protein identification by immunohistochemistry, scintigraphy, or mass spectrometry Patients who have all of the following characteristics: Are in New York Heart Association (NYHA) class I to III Have a history of heart failure, defined as at least one prior hospitalization for heart failure or clinical evidence of heart failure that required treatment with a diuretic Have not received a heart or liver transplant Do not have an implanted cardiac mechanical assist device (CMAD) Are not receiving other disease-modifying treatments for transthyretin amyloidosis (ATTR) Discontinuation criteria: Treatment should be discontinued if a patient receiving vutrisiran: Receives a heart or liver transplant Receives an implanted CMAD
Submission Type:
Initial
Submission Complexity:
Standard Review
Fee Schedule:
Schedule A
Indications:
​Amvuttra (vutrisiran) is indicated for the treatment of wild-type or hereditary transthyretin-amyloidosis in adult patients with cardiomyopathy.
  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 open29-May-25
Call for patient/clinician input closed18-Jul-25
Submission received09-Jul-25
Submission accepted23-Jul-25
Review initiated24-Jul-25
Draft CADTH review report(s) provided to sponsor for comment09-Oct-25
Deadline for sponsors comments21-Oct-25
CDA-AMC review report(s) and responses to comments provided to sponsor14-Nov-25
Expert committee meeting (initial)26-Nov-25
Draft recommendation issued to sponsorDecember 08, 2025
To
December 10, 2025
Draft recommendation posted for stakeholder feedback18-Dec-25
End of feedback period-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)26-Nov-25