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von Willebrand Factor [recombinant]

Last Updated: January 14, 2021
Result type: Reports
Project Number: ST0639-000
Product Line: Reimbursement Review

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

Fee Schedule: Schedule A

  1. 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 openJanuary 02, 2020
Call for patient input closedFebruary 21, 2020
Clarification:

- Patient input submission received from the Canadian Hemophilia Society

Submission receivedApril 29, 2020
Submission acceptedMay 13, 2020
Review initiatedMay 14, 2020
Draft CADTH review report(s) provided to sponsor for commentJuly 29, 2020
Deadline for sponsors commentsAugust 10, 2020
CADTH responses on draft review report(s) provided to sponsorSeptember 03, 2020
Expert committee meeting (initial)September 16, 2020
Draft recommendation issued to sponsorSeptember 29, 2020
End of embargo periodNovember 11, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

- Target CPEC reconsideration meeting date to be determined