tafamidis


( Last Updated : March 23, 2021)
Generic Name:
tafamidis
Project Status:
Complete
Therapeutic Area:
transthyretin-mediated amyloidosis
Manufacturer:
Pfizer Canada
Call for patient/clinician input open:
Brand Name:
Vyndaqel
Project Line:
Reimbursement Review
Project Number:
SR0625-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details

Manufacturer Requested Reimbursement Criteria1:
Treatment of transthyretin amyloid cardiomyopathy in adult patients
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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
Clarification:

- 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
Clarification:

- Patient input summary feedback received
Submission received July 04, 2019
Submission accepted July 18, 2019
Review initiated July 19, 2019
Clarification:

- 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 March 16, 2020
Validation of redacted CADTH review report(s) received March 23, 2020
Final CADTH review report(s) posted April 08, 2020

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions