caplacizumab


( Last Updated : November 2, 2020)
Generic Name:
caplacizumab
Project Status:
Complete
Therapeutic Area:
Acquired thrombotic thrombocytopenic purpura (aTTP)
Manufacturer:
Sanofi-Genzyme, a division of sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Cablivi
Project Line:
Reimbursement Review
Project Number:
SR0633-000
Call for patient/clinician input closed:

Details


Manufacturer Requested Reimbursement Criteria1:
Indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
‚ÄčIndicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.
Recommendation Type:
Do not reimburse
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 input posted August 15, 2019
Patient group input closed October 04, 2019
Clarification:

- Patient input submission received from Answering TTP with the support of the Canadian Organization for Rare Disorders (CORD)

Patient input summary sent for review to patient input groups October 17, 2019
Patient group comments on input summary closed October 24, 2019
Clarification:

- Patient input summary feedback received

Submission received September 13, 2019
Submission accepted September 27, 2019
Review initiated September 30, 2019
Draft CADTH review report(s) sent to sponsor December 18, 2019
Comments from sponsor on draft CADTH review report(s) received January 13, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsor February 06, 2020
Canadian Drug Expert Committee (CDEC) meeting February 19, 2020
CDEC recommendation sent to sponsor and drug plans March 06, 2020
Embargo period ended April 20, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agenda August 19, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans August 26, 2020
Request for Resubmission: Eligible (Decision Date) August 20, 2021
CDEC Final Recommendation posted September 01, 2020
Redaction requests from sponsor on draft CADTH review report(s) received September 10, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans September 24, 2020
Validation of redacted CADTH review report(s) received October 01, 2020
Final CADTH review report(s) posted October 15, 2020