luspatercept

Generic Name: luspatercept

Brand Name: Reblozyl

Manufacturer: Celgene Inc., a Bristol Myers Squibb company

Therapeutic Area: Myelodysplastic syndromes-associated anemia

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.

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

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

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.