Last Updated : December 22, 2021
Details
FilesGeneric Name:
luspatercept
Project Status:
Complete
Therapeutic Area:
Myelodysplastic syndromes-associated anemia
Manufacturer:
Celgene Inc., a Bristol Myers Squibb company
Brand Name:
Reblozyl
Project Line:
Reimbursement Review
Project Number:
SR0670-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Reblozyl (luspatercept for injection) is indicated for: the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta()-thalassemia. the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC units over 8 weeks resulting from very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Reblozyl (luspatercept for injection) is indicated for:  the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia.  the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC units over 8 weeks resulting from very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based 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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 23-Dec-20 |
| Call for patient/clinician input closed | 22-Feb-21 |
| Clarification: - Patient input submission received from the Aplastic Anemia and Myelodysplasia Association of Canada and the Leukemia & Lymphoma Society of Canada | |
| Submission received | 28-Jan-21 |
| Submission accepted | 12-Mar-21 |
| Clarification: - Submission was not accepted for review on 11 Feb 2021 | |
| Review initiated | 19-Mar-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 09-Jun-21 |
| Deadline for sponsors comments | 18-Jun-21 |
| CADTH responses on draft review report(s) provided to sponsor | 09-Jul-21 |
| Expert committee meeting (initial) | 21-Jul-21 |
| Draft recommendation issued to sponsor | 04-Aug-21 |
| Draft recommendation posted for stakeholder feedback | 12-Aug-21 |
| End of feedback period | 26-Aug-21 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 24-Nov-21 |
| Final recommendation issued to sponsor and drug plans | 07-Dec-21 |
| Final recommendation posted | 23-Dec-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 21-Dec-21 |
| CADTH review report(s) posted | 11-Feb-22 |
Files
Last Updated : December 22, 2021