Last Updated : September 3, 2024
Details
FilesGeneric Name:
infliximab
Project Status:
Complete
Therapeutic Area:
Ulcerative Colitis
Manufacturer:
Celltrion Healthcare Co., Ltd.
Call for patient/clinician input open:
Brand Name:
Remsima
Project Line:
Reimbursement Review
Project Number:
SR0816-001
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
- maintenance treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or were intolerant to conventional therapy. Remsima SC should only be used as maintenance therapy after the completion of an induction period with intravenous infliximab. - maintenance treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or were intolerant to conventional therapy. Remsima SC should only be used as maintenance therapy after the completion of an induction period with intravenous infliximab
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
- maintenance treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or were intolerant to conventional therapy. Remsima SC should only be used as maintenance therapy after the completion of an induction period with intravenous infliximab. - maintenance treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or were intolerant to conventional therapy. Remsima SC should only be used as maintenance therapy after the completion of an induction period with intravenous infliximab
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 22-Aug-23 |
|---|---|
| Call for patient/clinician input closed | 17-Oct-23 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Submission received | 04-Oct-23 |
| Submission accepted | 19-Oct-23 |
| Review initiated | 20-Oct-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 11-Jan-24 |
| Deadline for sponsors comments | 22-Jan-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 15-Feb-24 |
| Expert committee meeting (initial) | 28-Feb-24 |
| Draft recommendation issued to sponsor | 11-Mar-24 |
| Draft recommendation posted for stakeholder feedback | 21-Mar-24 |
| End of feedback period | 08-Apr-24 |
| Final recommendation issued to sponsor and drug plans | 22-Apr-24 |
| Final recommendation posted | 09-May-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 07-May-24 |
| CADTH review report(s) posted | 28-Aug-24 |
Files
Last Updated : September 3, 2024