Last Updated : April 24, 2024
Details
FilesGeneric Name:
infliximab
Project Status:
Active
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
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
- 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 | August 22, 2023 |
|---|---|
| Call for patient/clinician input closed | October 17, 2023 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Submission received | October 04, 2023 |
| Submission accepted | October 19, 2023 |
| Review initiated | October 20, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | January 11, 2024 |
| Deadline for sponsors comments | January 22, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | February 15, 2024 |
| Expert committee meeting (initial) | February 28, 2024 |
| Draft recommendation issued to sponsor | March 11, 2024 |
| Draft recommendation posted for stakeholder feedback | March 21, 2024 |
| End of feedback period | April 08, 2024 |
| Final recommendation issued to sponsor and drug plans | April 22, 2024 |
| Final recommendation posted | - |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 07, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : April 24, 2024