infliximab

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Generic 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
  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 openAugust 22, 2023
Call for patient/clinician input closedOctober 17, 2023
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission receivedOctober 04, 2023
Submission acceptedOctober 19, 2023
Review initiatedOctober 20, 2023
Draft CADTH review report(s) provided to sponsor for commentJanuary 11, 2024
Deadline for sponsors commentsJanuary 22, 2024
CADTH review report(s) and responses to comments provided to sponsorFebruary 15, 2024
Expert committee meeting (initial)February 28, 2024
Draft recommendation issued to sponsorMarch 11, 2024
Draft recommendation posted for stakeholder feedbackMarch 21, 2024
End of feedback periodApril 08, 2024
Final recommendation issued to sponsor and drug plansApril 19, 2024
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 06, 2024
CADTH review report(s) posted-