von Willebrand Factor [recombinant]

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Generic 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:
  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 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