Last Updated : August 10, 2021
Details
FilesGeneric Name:
luspatercept
Project Status:
Complete
Therapeutic Area:
beta-thalassemia associated anemia
Manufacturer:
Celgene Inc. / Bristol-Myers Squibb Canada Co.
Brand Name:
Reblozyl
Project Line:
Reimbursement Review
Project Number:
SR0669-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with -thalassemia associated anemia who require red blood cell (RBC) transfusions.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with
red blood cell (RBC) transfusion-dependent anemia associated with
beta(β)-thalassemia
Date NOC Issued:
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | October 29, 2020 |
| Call for patient/clinician input closed | December 17, 2020 |
| Clarification: - Patient input submission received from the Thalassemia Foundation of Canada and Canadian Organization for Rare Disorders (CORD) | |
| Submission received | November 26, 2020 |
| Submission accepted | December 10, 2020 |
| Review initiated | December 11, 2020 |
| Clarification: - Selected for CADTH/INESSS Joint Clinician Engagement | |
| Draft CADTH review report(s) provided to sponsor for comment | March 09, 2021 |
| Deadline for sponsors comments | March 18, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | April 09, 2021 |
| Expert committee meeting (initial) | April 21, 2021 |
| Draft recommendation issued to sponsor | May 03, 2021 |
| Draft recommendation posted for stakeholder feedback | May 13, 2021 |
| End of feedback period | May 28, 2021 |
| Final recommendation issued to sponsor and drug plans | June 08, 2021 |
| Final recommendation posted | June 24, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | June 22, 2021 |
| CADTH review report(s) posted | August 10, 2021 |
Files
Last Updated : August 10, 2021