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Last Updated: March 6, 2021
Result type: Reports
Project Number: SR0625-000
Product Line: Reimbursement Review

Generic Name: tafamidis

Brand Name: Vyndaqel

Manufacturer: Pfizer Canada

Therapeutic Area: transthyretin-mediated amyloidosis

Indications: Treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Manufacturer Requested Reimbursement Criteria1: Treatment of transthyretin amyloid cardiomyopathy in adult patients

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: February 19, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 input postedJune 05, 2019
Patient group input closedJuly 25, 2019

- Patient input submission received from the Canadian Organization for Rare Disorders with support of Canadian Amyloidosis Support Network

Patient input summary sent for review to patient input groupsJuly 29, 2019
Patient group comments on input summary closedAugust 06, 2019

- Patient input summary feedback received

Submission receivedJuly 04, 2019
Submission acceptedJuly 18, 2019
Review initiatedJuly 19, 2019

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) sent to sponsorOctober 07, 2019
Comments from sponsor on draft CADTH review report(s) receivedOctober 17, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansJanuary 28, 2020
Embargo period endedFebruary 11, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansFebruary 19, 2020
CDEC Final Recommendation postedFebruary 21, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedMarch 04, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansMarch 16, 2020
Validation of redacted CADTH review report(s) receivedMarch 23, 2020
Final CADTH review report(s) postedApril 08, 2020