luspatercept

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Generic 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
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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open23-Dec-20
Call for patient/clinician input closed22-Feb-21
Clarification:

- Patient input submission received from the Aplastic Anemia and Myelodysplasia Association of Canada and the Leukemia & Lymphoma Society of Canada

Submission received28-Jan-21
Submission accepted12-Mar-21
Clarification:

- Submission was not accepted for review on 11 Feb 2021

Review initiated19-Mar-21
Draft CADTH review report(s) provided to sponsor for comment09-Jun-21
Deadline for sponsors comments18-Jun-21
CADTH responses on draft review report(s) provided to sponsor09-Jul-21
Expert committee meeting (initial)21-Jul-21
Draft recommendation issued to sponsor04-Aug-21
Draft recommendation posted for stakeholder feedback12-Aug-21
End of feedback period26-Aug-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting24-Nov-21
Final recommendation issued to sponsor and drug plans07-Dec-21
Final recommendation posted23-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)21-Dec-21
CADTH review report(s) posted11-Feb-22