Last Updated : May 1, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | June 14, 2023 |
|---|---|
| Call for patient/clinician input closed | August 04, 2023 |
| Clarification: - Patient input submission received from the Leukemia & Lymphoma Society of Canada | |
| Submission received | July 26, 2023 |
| Submission accepted | August 10, 2023 |
| Review initiated | August 11, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | November 02, 2023 |
| Deadline for sponsors comments | November 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | December 08, 2023 |
| Expert committee meeting (initial) | December 20, 2023 |
| Draft recommendation issued to sponsor | January 10, 2024 |
| Draft recommendation posted for stakeholder feedback | January 18, 2024 |
| End of feedback period | February 02, 2024 |
| Final recommendation posted | March 05, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 01, 2024 |
| CADTH review report(s) posted | May 01, 2024 |
Files
Last Updated : May 1, 2024