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caplacizumab

Last Updated: September 25, 2020
Result type: Reports
Project Number: SR0633-000
Product Line: Common Drug Review

Generic Name: caplacizumab

Brand Name: Cablivi

Manufacturer: Sanofi-Genzyme, a division of sanofi-aventis Canada Inc.

Indications: Acquired thrombotic thrombocytopenic purpura (aTTP)

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: New

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: August 26, 2020

Recommendation Type: Do not reimburse

Fee Schedule: Schedule A

  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 postedAugust 15, 2019
Patient group input closedOctober 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 groupsOctober 17, 2019
Patient group comments on input summary closedOctober 24, 2019
Clarification:

- Patient input summary feedback received

Submission receivedSeptember 13, 2019
Submission acceptedSeptember 27, 2019
Review initiatedSeptember 30, 2019
Draft CADTH review report(s) sent to sponsorDecember 18, 2019
Comments from sponsor on draft CADTH review report(s) receivedJanuary 13, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsorFebruary 06, 2020
Canadian Drug Expert Committee (CDEC) meetingFebruary 19, 2020
CDEC recommendation sent to sponsor and drug plansMarch 06, 2020
Embargo period endedApril 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 agendaAugust 19, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansAugust 26, 2020
CDEC Final Recommendation postedSeptember 01, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedSeptember 10, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansSeptember 24, 2020
Validation of redacted CADTH review report(s) receivedOctober 01, 2020
Final CADTH review report(s) posted-