tafamidis


( Last Updated : June 17, 2022)
Generic Name:
tafamidis
Project Status:
Active
Therapeutic Area:
Transthyretin-mediated amyloidosis
Manufacturer:
Pfizer Canada ULC
Brand Name:
Vyndaqel
Project Line:
Reimbursement Review
Project Number:
SF0722-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Treatment of transthyretin amyloid cardiomyopathy in adult patient.
Submission Type:
Request For Advice
Indications:
Vyndaqel is indicated for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Date NOC Issued:
  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 open22-Dec-21
Request for Advice received14-Dec-21
Manufacturer informed of request for advice17-Dec-21
Manufacturer information or comments due10-Jan-22
Request for Advice initiated11-Jan-22
Call for patient/clinician input closed18-Feb-22
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Draft CADTH review report(s) sent to sponsor15-Mar-22
Deadline for sponsors comments24-Mar-22
CADTH review report(s) and responses to comments provided to sponsor14-Apr-22
Expert committee meeting (initial)27-Apr-22
Draft recommendation issued to sponsor09-May-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Final recommendation issued to sponsor and drug plans17-Jun-22
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Jul-22
CADTH review report(s) posted