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risankizumab

Last Updated: June 24, 2019
Result type: Reports
Project Number: SR0583-000
Product Line: Common Drug Review

Generic Name: risankizumab

Brand Name: Skyrizi

Manufacturer: AbbVie Corporation

Indications: Psoriasis, moderate to severe plaque

Manufacturer Requested Reimbursement Criteria1: Reimburse in a manner similar to other biologics for the treatment of moderate-to-severe plaque psoriasis. Treatment should be discontinued if a response (PASI75) to treatment with risankizumab has not been demonstrated after 16 weeks.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: May 28, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 postedSeptember 19, 2018
Patient group input closedNovember 08, 2018
Clarification:

- Patient input submission received from Arthritis Consumer Experts, Canadian Psoriasis Network (CPN), Canadian Skin Patient Alliance (CSPA) and the Canadian Association of Psoriasis Patients (CAPP)

Patient input summary sent for review to patient input groupsNovember 15, 2018
Patient group comments on input summary closedNovember 22, 2018
Clarification:

- Patient input summary feedback received

Submission receivedOctober 22, 2018
Submission accepted for reviewNovember 05, 2018
Review initiatedNovember 06, 2018
Draft CADTH review report(s) sent to applicantJanuary 25, 2019
Comments from applicant on draft CADTH review report(s) receivedFebruary 05, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedFebruary 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantMarch 08, 2019
Canadian Drug Expert Committee (CDEC) meetingMarch 20, 2019
Clarification:

CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansMay 02, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMay 16, 2019
CDEC Final Recommendation issued to applicant and drug plansMay 24, 2019
CDEC Final Recommendation postedMay 28, 2019
Final CADTH review report(s) postedJune 24, 2019