Last Updated : August 29, 2022
Details
FilesGeneric Name:
tafamidis
Project Status:
Complete
Therapeutic Area:
Transthyretin-mediated amyloidosis
Manufacturer:
Pfizer Canada ULC
Brand Name:
Vyndaqel
Project Line:
Reimbursement Review
Project Number:
SF0722-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of transthyretin amyloid cardiomyopathy in adult patient.
Submission Type:
Request For Advice
Indications:
Vyndaqel is indicated for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Date NOC Issued:
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 22-Dec-21 |
| Request for Advice received | 14-Dec-21 |
| Manufacturer informed of request for advice | 17-Dec-21 |
| Manufacturer information or comments due | 10-Jan-22 |
| Request for Advice initiated | 11-Jan-22 |
| Call for patient/clinician input closed | 18-Feb-22 |
| Clarification: - Patient input submission received from the Canadian Organization for Rare Disorders | |
| Draft CADTH review report(s) sent to sponsor | 15-Mar-22 |
| Deadline for sponsors comments | 24-Mar-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 14-Apr-22 |
| Expert committee meeting (initial) | 27-Apr-22 |
| Draft recommendation issued to sponsor | 09-May-22 |
| Draft recommendation posted for stakeholder feedback | 19-May-22 |
| End of feedback period | 03-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 17-Jun-22 |
| Final recommendation posted | 06-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 04-Jul-22 |
| CADTH review report(s) posted | 18-Aug-22 |
Files
Last Updated : August 29, 2022