Last Updated : August 16, 2023
Details
FilesGeneric Name:
risankizumab
Project Status:
Complete
Therapeutic Area:
Crohn's disease
Manufacturer:
AbbVie
Brand Name:
Skyrizi
Project Line:
Reimbursement Review
Project Number:
SR0767-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Risankizumab is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. (i.e., tumour necrosis factor-alpha [TNF-] antagonists, gut-selective anti-inflammatory biologics, interleukin 12/23 inhibitors).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Risankizumab is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. (i.e., tumour necrosis factor-alpha [TNF-α] antagonists, gut-selective anti-inflammatory biologics, interleukin 12/23 inhibitors).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
| Call for patient/clinician input open | September 29, 2022 |
|---|---|
| Call for patient/clinician input closed | November 18, 2022 |
| Clarification: - Patient input submission received from Gastrointestinal Society and Crohn's and Colitis Canada | |
| Submission received | October 28, 2022 |
| Submission accepted | November 11, 2022 |
| Review initiated | November 14, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | February 03, 2023 |
| Deadline for sponsors comments | February 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | March 09, 2023 |
| Expert committee meeting (initial) | March 22, 2023 |
| Draft recommendation issued to sponsor | April 03, 2023 |
| Draft recommendation posted for stakeholder feedback | April 13, 2023 |
| End of feedback period | April 27, 2023 |
| Final recommendation issued to sponsor and drug plans | May 12, 2023 |
| Final recommendation posted | May 31, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 29, 2023 |
| CADTH review report(s) posted | |
Files
Last Updated : August 16, 2023