tildrakizumab


( Last Updated : August 30, 2021)
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

Details

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:
  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 postedJune 11, 2019
Patient group input closedJuly 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 groupsSeptember 05, 2019
Patient group comments on input summary closedSeptember 12, 2019
Clarification:

- Patient input summary feedback received

Submission receivedJuly 15, 2019
Submission acceptedAugust 26, 2019
Clarification:

- Submission was not accepted for review on 29 Jul 2019

Review initiatedAugust 27, 2019
Draft CADTH review report(s) sent to sponsorNovember 11, 2019
Comments from sponsor on draft CADTH review report(s) receivedNovember 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 sponsorJanuary 03, 2020
Canadian Drug Expert Committee (CDEC) meetingMarch 17, 2021
CDEC recommendation sent to sponsor and drug plansMay 31, 2021
Embargo period endedJune 14, 2021
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJune 21, 2021
CDEC Final Recommendation postedJune 23, 2021
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 06, 2021
Final CADTH review report(s) postedAugust 27, 2021

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions