ustekinumab


( Last Updated : September 16, 2020)
Generic Name:
ustekinumab
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Stelara/Stelara I.V
Project Line:
Reimbursement Review
Project Number:
SR0627-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Ulcerative colitis
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 posted July 12, 2019
Patient group input closed September 03, 2019
Clarification:

- Patient input submission received from Crohn's and Colitis Foundation of Canada and Gastrointestinal (GI) Society

Patient input summary sent for review to patient input groups September 06, 2019
Patient group comments on input summary closed September 13, 2019
Clarification:

- Patient input summary feedback received

Submission received August 12, 2019
Submission accepted August 26, 2019
Review initiated August 27, 2019
Draft CADTH review report(s) sent to sponsor November 18, 2019
Comments from sponsor on draft CADTH review report(s) received November 27, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor January 03, 2020
Canadian Drug Expert Committee (CDEC) meeting January 15, 2020
CDEC recommendation sent to sponsor and drug plans January 29, 2020
Embargo period ended March 12, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agenda June 17, 2020
CDEC recommendation sent to sponsor and drug plans June 24, 2020
Embargo period ended July 09, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans July 16, 2020
CDEC Final Recommendation posted July 20, 2020
Redaction requests from sponsor on draft CADTH review report(s) received July 30, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans August 12, 2020
Validation of redacted CADTH review report(s) received August 19, 2020
Final CADTH review report(s) posted September 14, 2020