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luspatercept

Last Updated: March 18, 2021
Result type: Reports
Project Number: SR0670-000
Product Line: Reimbursement Review

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.

Key Milestones2

Call for patient/clinician input open December 23, 2020
Call for patient/clinician input closed February 22, 2021
Clarification:

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

Submission received January 28, 2021
Submission accepted March 12, 2021
Clarification:

- Submission was not accepted for review on 11 Feb 2021

Review initiated March 19, 2021
Draft CADTH review report(s) provided to sponsor for comment June 03, 2021
Deadline for sponsors comments June 14, 2021
CADTH responses on draft review report(s) provided to sponsor July 09, 2021
Expert committee meeting (initial) July 21, 2021
Draft recommendation issued to sponsor August 03, 2021
To
August 05, 2021
Draft recommendation posted for stakeholder feedback -