Manufacturer Requested Reimbursement Criteria
1
:
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.
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.
Key Milestones
2
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Call for patient/clinician input open
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23-Dec-20
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Call for patient/clinician input closed
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22-Feb-21
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Clarification:
- Patient input submission received from the Aplastic Anemia and Myelodysplasia Association of Canada and the Leukemia & Lymphoma Society of Canada
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Submission received
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28-Jan-21
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Submission accepted
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12-Mar-21
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Clarification:
- Submission was not accepted for review on 11 Feb 2021
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Review initiated
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19-Mar-21
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Draft CADTH review report(s) provided to sponsor for comment
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09-Jun-21
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Deadline for sponsors comments
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18-Jun-21
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CADTH responses on draft review report(s) provided to sponsor
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09-Jul-21
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Expert committee meeting (initial)
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21-Jul-21
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Draft recommendation issued to sponsor
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04-Aug-21
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Draft recommendation posted for stakeholder feedback
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12-Aug-21
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End of feedback period
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26-Aug-21
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Clarification:
- Reconsideration: major revisions requested by sponsor
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Expert committee meeting
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24-Nov-21
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Final recommendation issued to sponsor and drug plans
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07-Dec-21
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Final recommendation posted
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23-Dec-21
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Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
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21-Dec-21
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CADTH review report(s) posted
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11-Feb-22
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