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
Date Recommendation Issued: April 22, 2021
Recommendation Type: Reimburse with clinical criteria and/or conditions
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 |
|
|---|---|
| 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 |
| Deadline for sponsors comments | January 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 sponsor | March 05, 2021 |
| Expert committee meeting (initial) | March 17, 2021 |
| Draft recommendation issued to sponsor | March 31, 2021 |
| End of embargo period | April 15, 2021 |
| Final recommendation issued to sponsor and drug plans | April 22, 2021 |
| Final recommendation posted | April 26, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 06, 2021 |
| CADTH review report(s) posted | - |