infliximab

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Generic Name:
infliximab
Project Status:
Complete
Therapeutic Area:
Rheumatoid arthritis
Manufacturer:
Celltrion Healthcare Co., Ltd
Call for patient/clinician input open:
Brand Name:
Remsima
Project Line:
Reimbursement Review
Project Number:
SR0659-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
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
Fee Schedule:
Schedule C
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open August 26, 2020
Call for patient input closed October 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 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 August 10, 2021