caplacizumab


( Last Updated : November 30, 2022)
Generic Name:
caplacizumab
Project Status:
Active
Therapeutic Area:
Acquired thrombotic thrombocytopenic purpura (aTTP)
Manufacturer:
sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Cablivi
Project Line:
Reimbursement Review
Project Number:
SR0736-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Cablivi (caplacizumab) is indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Cablivi (caplacizumab) is indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.
  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 openMay 09, 2022
Call for patient/clinician input closedJuly 04, 2022
Clarification:

- Patient input submission received from Answering T.T.P. (Thrombotic Thrombocytopenic Purpura) Foundation

Submission receivedJune 07, 2022
Submission acceptedJune 21, 2022
Review initiatedJune 22, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 07, 2022
Deadline for sponsors commentsSeptember 16, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 14, 2022
Expert committee meeting (initial)October 26, 2022
Draft recommendation issued to sponsorNovember 07, 2022
Draft recommendation posted for stakeholder feedbackNovember 17, 2022
End of feedback periodDecember 01, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor