Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

belumosudil

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Generic Name:
belumosudil
Project Status:
Complete
Therapeutic Area:
Graft-versus-host disease
Manufacturer:
Sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Rezurock
Project Line:
Reimbursement Review
Project Number:
SR0789-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
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/clinician input open14-Jun-23
Call for patient/clinician input closed04-Aug-23
Clarification:

- Patient input submission received from the Leukemia & Lymphoma Society of Canada

Submission received26-Jul-23
Submission accepted10-Aug-23
Review initiated11-Aug-23
Draft CADTH review report(s) provided to sponsor for comment02-Nov-23
Deadline for sponsors comments14-Nov-23
CADTH review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor10-Jan-24
Draft recommendation posted for stakeholder feedback18-Jan-24
End of feedback period02-Feb-24
Final recommendation posted05-Mar-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Mar-24
CADTH review report(s) posted01-May-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : December 13, 2024