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Last Updated: February 21, 2020
Result type: Reports
Project Number: SR0625-000
Product Line: Common Drug Review

Generic Name: tafamidis

Brand Name: Vyndaqel

Manufacturer: Pfizer Canada

Indications: transthyretin-mediated amyloidosis

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

Submission Type: New

Project Status: Active

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 posted June 05, 2019
Patient group input closed July 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 groups July 29, 2019
Patient group comments on input summary closed August 06, 2019

- Patient input summary feedback received

Submission received July 04, 2019
Submission accepted July 18, 2019
Review initiated July 19, 2019

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) sent to sponsor October 07, 2019
Comments from sponsor on draft CADTH review report(s) received October 17, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 08, 2019
Canadian Drug Expert Committee (CDEC) meeting November 20, 2019
CDEC recommendation sent to sponsor and drug plans January 28, 2020
Embargo period ended February 11, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans February 19, 2020
CDEC Final Recommendation posted February 21, 2020
Redaction requests from sponsor on draft CADTH review report(s) received March 04, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans -
Validation of redacted CADTH review report(s) received -
Final CADTH review report(s) posted -