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Last Updated: May 22, 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: Active

Biosimilar: No

Companion Diagnostics: No

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 posted September 19, 2018
Patient group input closed November 08, 2018

- 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 groups November 15, 2018
Patient group comments on input summary closed November 22, 2018

- Patient input summary feedback received

Submission received October 22, 2018
Submission accepted for review November 05, 2018
Review initiated November 06, 2018
Draft CADTH review report(s) sent to applicant January 25, 2019
Comments from applicant on draft CADTH review report(s) received February 05, 2019
Redaction requests from applicant on draft CADTH review report(s) received February 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicant March 08, 2019
Canadian Drug Expert Committee (CDEC) meeting March 20, 2019

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 plans May 02, 2019
Embargo period ended and validation of redacted CADTH review report(s) received May 16, 2019
CDEC Final Recommendation issued to applicant and drug plans May 24, 2019
CDEC Final Recommendation posted -
Final CADTH review report(s) posted -