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
Performance Metric:
Achieved
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 openJune 14, 2023
Call for patient/clinician input closedAugust 04, 2023
Clarification:

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

Submission receivedJuly 26, 2023
Submission acceptedAugust 10, 2023
Review initiatedAugust 11, 2023
Draft CADTH review report(s) provided to sponsor for commentNovember 02, 2023
Deadline for sponsors commentsNovember 14, 2023
CADTH review report(s) and responses to comments provided to sponsorDecember 08, 2023
Expert committee meeting (initial)December 20, 2023
Draft recommendation issued to sponsorJanuary 10, 2024
Draft recommendation posted for stakeholder feedbackJanuary 18, 2024
End of feedback periodFebruary 02, 2024
Final recommendation postedMarch 05, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 01, 2024
CADTH review report(s) postedMay 01, 2024