Last Updated : November 2, 2020
Details
FilesGeneric 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:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Indicated 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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Request for Resubmission: Eligible (Decision Date: August 20, 2021)
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 |
Files
Last Updated : November 2, 2020