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infliximab

Last Updated: December 23, 2020
Result type: Reports
Project Number: SR0659-000
Product Line: Reimbursement Review

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

  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 input openAugust 26, 2020
Call for patient input closedOctober 16, 2020
Clarification:

- Patient input submission received from Arthritis Consumer Experts, Arthritis Society, Crohn’s and Colitis Canada, Gastrointestinal Society and Institute for Optimizing Health Outcomes

Submission receivedSeptember 24, 2020
Submission acceptedOctober 08, 2020
Review initiatedOctober 09, 2020
Draft CADTH review report(s) provided to sponsor for commentDecember 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-