Last Updated : August 2, 2022
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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
---|---|
Call for patient input open | January 02, 2020 |
Call for patient input closed | February 21, 2020 |
Clarification:
- Patient input submission received from the Canadian Hemophilia Society |
|
Submission received | April 29, 2020 |
Submission accepted | May 13, 2020 |
Review initiated | May 14, 2020 |
Draft CADTH review report(s) provided to sponsor for comment | July 29, 2020 |
Deadline for sponsors comments | August 10, 2020 |
CADTH responses on draft review report(s) provided to sponsor | September 03, 2020 |
Expert committee meeting (initial) | September 16, 2020 |
Draft recommendation issued to sponsor | September 29, 2020 |
End of embargo period | November 11, 2020 |
Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested |
|
Expert committee meeting | February 17, 2021 |
Draft recommendation issued to sponsor | February 24, 2021 |
End of embargo period | March 10, 2021 |
Final recommendation issued to sponsor and drug plans | March 17, 2021 |
Final recommendation posted | March 22, 2021 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 31, 2021 |
CADTH review report(s) posted | May 11, 2021 |
Files
Last Updated : August 2, 2022