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
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:
  1. 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.
Key Milestones2
Call for patient input open02-Jan-20
Call for patient input closed21-Feb-20
Clarification:

- Patient input submission received from the Canadian Hemophilia Society

Submission received29-Apr-20
Submission accepted13-May-20
Review initiated14-May-20
Draft CADTH review report(s) provided to sponsor for comment29-Jul-20
Deadline for sponsors comments10-Aug-20
CADTH responses on draft review report(s) provided to sponsor03-Sep-20
Expert committee meeting (initial)16-Sep-20
Draft recommendation issued to sponsor29-Sep-20
End of embargo period11-Nov-20
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Expert committee meeting17-Feb-21
Draft recommendation issued to sponsor24-Feb-21
End of embargo period10-Mar-21
Final recommendation issued to sponsor and drug plans17-Mar-21
Final recommendation posted22-Mar-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)31-Mar-21
CADTH review report(s) posted11-May-21