Generic Name: von Willebrand Factor [recombinant]
Brand Name: Vonvendi
Manufacturer: Shire Pharma Canada ULC, now part of Takeda
Therapeutic Area: von Willebrand disease, adults, treatment and perioperative management
Indications: Indicated for: Treatment and Control of bleeding episodes in adults (age ≥18) diagnosed with von Willebrand Disease (VWD).Perioperative management of bleeding in adults (age ≥18) diagnosed with VWD
Manufacturer Requested Reimbursement Criteria1: Indicated for: Treatment and Control of bleeding episodes in adults (age 18) diagnosed with von Willebrand Disease (VWD). Perioperative management of bleeding in adults (age 18) diagnosed with VWD
Submission Type: Initial
NOC Status at Filing: Post NOC
Project Status: Active
Companion Diagnostics: No
Date Recommendation Issued: March 17, 2021
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
- 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 | - |