luspatercept


( Last Updated : August 10, 2021)
Generic Name:
luspatercept
Project Status:
Complete
Therapeutic Area:
beta-thalassemia associated anemia
Manufacturer:
Celgene Inc. / Bristol-Myers Squibb Canada Co.
Brand Name:
Reblozyl
Project Line:
Reimbursement Review
Project Number:
SR0669-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with -thalassemia associated anemia who require red blood cell (RBC) transfusions.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia
Date NOC Issued:
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 openOctober 29, 2020
Call for patient/clinician input closedDecember 17, 2020
Clarification:

- Patient input submission received from the Thalassemia Foundation of Canada and Canadian Organization for Rare Disorders (CORD)

Submission receivedNovember 26, 2020
Submission acceptedDecember 10, 2020
Review initiatedDecember 11, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentMarch 09, 2021
Deadline for sponsors commentsMarch 18, 2021
CADTH responses on draft review report(s) provided to sponsorApril 09, 2021
Expert committee meeting (initial)April 21, 2021
Draft recommendation issued to sponsorMay 03, 2021
Draft recommendation posted for stakeholder feedbackMay 13, 2021
End of feedback periodMay 28, 2021
Final recommendation issued to sponsor and drug plansJune 08, 2021
Final recommendation postedJune 24, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)June 22, 2021
CADTH review report(s) postedAugust 10, 2021