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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: Remsima

Manufacturer: Celltrion Healthcare Co., Ltd

Therapeutic Area: Rheumatoid arthritis

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.

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.

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Active

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
Deadline for sponsors commentsJanuary 11, 2021
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

CADTH responses on draft review report(s) provided to sponsorMarch 05, 2021
Expert committee meeting (initial)March 17, 2021
Draft recommendation issued to sponsorMarch 31, 2021
End of embargo periodApril 15, 2021
Final recommendation issued to sponsor and drug plansApril 22, 2021
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)-
CADTH review report(s) posted-