risankizumab

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Generic Name:

risankizumab

Project Status:

Complete

Therapeutic Area:

Psoriasis, moderate to severe plaque

Manufacturer:

AbbVie Corporation

Call for patient/clinician input open:

September 19, 2018

Brand Name:

Skyrizi

Project Line:

Reimbursement Review

Project Number:

SR0583-000

Call for patient/clinician input closed:

November 8, 2018

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

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:

Initial

Fee Schedule:

Schedule A

Indications:

Psoriasis, moderate to severe plaque

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

May 28, 2019

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.

Key Milestones²
Call for patient input posted	September 19, 2018
Patient group input closed	November 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 groups	November 15, 2018
Patient group comments on input summary closed	November 22, 2018
Clarification: - 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 sponsor	January 25, 2019
Comments from sponsor on draft CADTH review report(s) received	February 05, 2019
Redaction requests from sponsor on draft CADTH review report(s) received	February 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor	March 08, 2019
Canadian Drug Expert Committee (CDEC) meeting	March 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 sponsor 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 sponsor and drug plans	May 24, 2019
CDEC Final Recommendation posted	May 28, 2019
Final CADTH review report(s) posted	June 24, 2019