infliximab

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Generic Name:
infliximab
Project Status:
Active
Therapeutic Area:
Crohn’s disease
Manufacturer:
Celltrion Healthcare Co., Ltd.
Call for patient/clinician input open:
Brand Name:
Remsima
Project Line:
Reimbursement Review
Project Number:
SR0816-000
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
  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/clinician input open22-Aug-23
Call for patient/clinician input closed17-Oct-23
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission received04-Oct-23
Submission accepted19-Oct-23
Review initiated20-Oct-23
Draft CADTH review report(s) provided to sponsor for comment11-Jan-24
Deadline for sponsors comments22-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor11-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24