Last Updated : March 23, 2021
Details
FilesGeneric 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
Biosimilar:
No
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:
- 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
Last Updated : March 23, 2021