tildrakizumab

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Generic Name:

tildrakizumab

Project Status:

Complete

Therapeutic Area:

Psoriasis, moderate to severe plaque

Manufacturer:

Sun Pharma Canada

Brand Name:

Ilumya

Project Line:

Reimbursement Review

Project Number:

SR0624-000

NOC Status at Filing:

Pre NOC

Performance Metric:

N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

Tildrakizumab is expected to be indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Submission Type:

Initial

Companion Diagnostics:

Yes

Fee Schedule:

Schedule A

Indications:

Treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

June 21, 2021

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	June 11, 2019
Patient group input closed	July 31, 2019
Clarification: - Patient input submission received from the Canadian Association of Psoriasis Patients, the Canadian Organization for Rare Disorders, the Canadian Psoriasis Network and the Canadian Skin Patient Alliance
Patient input summary sent for review to patient input groups	September 05, 2019
Patient group comments on input summary closed	September 12, 2019
Clarification: - Patient input summary feedback received
Submission received	July 15, 2019
Submission accepted	August 26, 2019
Clarification: - Submission was not accepted for review on 29 Jul 2019
Review initiated	August 27, 2019
Draft CADTH review report(s) sent to sponsor	November 11, 2019
Comments from sponsor on draft CADTH review report(s) received	November 20, 2019
Clarification: Sponsor waived the opportunity to provide comments Submission temporarily suspended Temporary suspension of the review has been lifted
CADTH review team's comments on draft CADTH review report(s) sent to sponsor	January 03, 2020
Canadian Drug Expert Committee (CDEC) meeting	March 17, 2021
CDEC recommendation sent to sponsor and drug plans	May 31, 2021
Embargo period ended	June 14, 2021
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans	June 21, 2021
CDEC Final Recommendation posted	June 23, 2021
Redaction requests from sponsor on draft CADTH review report(s) received	July 06, 2021
Final CADTH review report(s) posted	August 27, 2021