Generic Name: infliximab
Brand Name: TBC
Manufacturer: Celltrion Healthcare Co., Ltd
Therapeutic Area: Rheumatoid arthritis, Crohn’s disease, ulcerative colitis
Indications: Use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate. Subcutaneous infliximab can be used alone or in combination with conventional therapy. Treatment of fistulising Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment. Reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).
Manufacturer Requested Reimbursement Criteria1: Use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate. Infliximab can be used alone or in combination with conventional therapy. Treatment of fistulising Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment. Reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).
Submission Type: Initial
NOC Status at Filing: Pre NOC
Project Status: Suspended
Companion Diagnostics: No
Fee Schedule: Schedule C
- 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 | |
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Call for patient input open | August 26, 2020 |
Call for patient input closed | October 16, 2020 |
Clarification: - Patient input submission received from Arthritis Consumer Experts, Arthritis Society, Crohnâs and Colitis Canada, Gastrointestinal Society and Institute for Optimizing Health Outcomes | |
Submission received | September 24, 2020 |
Submission accepted | October 08, 2020 |
Review initiated | October 09, 2020 |
Draft CADTH review report(s) provided to sponsor for comment | December 23, 2020 |
Clarification: - Submission temporarily suspended pending receipt of information | |
Deadline for sponsors comments | - |
CADTH responses on draft review report(s) provided to sponsor | - |
Expert committee meeting (initial) | - |
Draft recommendation issued to sponsor | - |