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Last Updated: January 23, 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

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 plans-

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.