Last Updated : May 28, 2024
Details
FilesGeneric Name:
von Willebrand Factor [recombinant]
Project Status:
Complete
Therapeutic Area:
von Willebrand disease, adults, treatment and perioperative management
Manufacturer:
Shire Pharma Canada ULC, now part of Takeda
Brand Name:
Vonvendi
Project Line:
Reimbursement Review
Project Number:
ST0639-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Shire Pharma Canada ULC, now part of Takeda, requests reimbursement of VONVENDI for the following patient populations: Adults (age 18) diagnosed with severe VWD Adults (age 18) diagnosed with mild or moderate VWD that do not respond or are intolerant to DDAVP.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
1. Treatment and Control of bleeding episodes in adults (age ≥18) diagnosed with von Willebrand Disease (VWD). 2. Perioperative management of bleeding in adults (age ≥18) diagnosed with VWD.
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.
| Call for patient input open | 02-Jan-20 |
|---|---|
| Call for patient input closed | 21-Feb-20 |
| Clarification: - Patient input submission received from the Canadian Hemophilia Society | |
| Submission received | 29-Apr-20 |
| Submission accepted | 13-May-20 |
| Review initiated | 14-May-20 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Jul-20 |
| Deadline for sponsors comments | 10-Aug-20 |
| CADTH responses on draft review report(s) provided to sponsor | 03-Sep-20 |
| Expert committee meeting (initial) | 16-Sep-20 |
| Draft recommendation issued to sponsor | 29-Sep-20 |
| End of embargo period | 11-Nov-20 |
| Clarification: - Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested | |
| Expert committee meeting | 17-Feb-21 |
| Draft recommendation issued to sponsor | 24-Feb-21 |
| End of embargo period | 10-Mar-21 |
| Final recommendation issued to sponsor and drug plans | 17-Mar-21 |
| Final recommendation posted | 22-Mar-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 31-Mar-21 |
| CADTH review report(s) posted | 11-May-21 |
Files
Last Updated : May 28, 2024