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Clinical and economic review report : Celltrion Healthcare Co., Ltd. : indication : rheumatoid arthritis. Infliximab SC (Remsima) / Canadian Agency for Drugs and Technologies in Health.
- Format:
- Book
- Author/Creator:
- Canadian Agency for Drugs and Technologies in Health, author, issuing body.
- Series:
- CADTH common drug review.
- CADTH Common Drug Review
- Language:
- English
- Subjects (All):
- Outcome assessment (Medical care).
- Physical Description:
- 1 online resource.
- Edition:
- Version: Final (with redactions).
- Place of Publication:
- Ottawa (ON) : Canadian Agency for Drugs and Technologies in Health, 2021.
- Summary:
- This tailored review assesses the efficacy, safety, and cost associated with the SC form of biosimilar infliximab (Remsima SC, with a NOC status of completed on January 28, 2021) for the treatment of patients with RA. The new formulation consists of a solution for SC administration (120 mg/mL) in a 1 mL pre-filled syringe. Remsima SC is expected to be the first SC formulation of infliximab, aimed at patients who are initiating infliximab therapy (maintenance after 2 IV doses) or who are currently receiving infliximab IV maintenance therapy and are suitable to be switched to the SC formulation. The potential advantage for patients is a formulation that can be easily self-administered at home - of particular interest in the current COVID-19 pandemic - with better preparation time, patient convenience, and adherence, resulting in optimization of medical resources.
- Contents:
- Abbreviations
- Executive Summary
- Introduction
- Stakeholder Engagement
- Clinical Evidence
- Cost Information
- Conclusions
- Disease Background
- Standards of Therapy
- Drug
- Patient Group Input
- Clinician Input
- Pivotal Study CT-P13 3.5
- Sponsor's Summary of the Results
- Critical Appraisal
- Internal Validity
- External Validity
- Sponsor-Submitted Cost Comparison Table
- Critical Appraisal of Cost Information
- CADTH Re-Analyses
- Price Reduction Analyses
- Issues for Consideration
- Discussion
- Summary of Available Evidence
- Interpretation of Results
- Cost
- Appendix 1. Submitted Budget Impact Analysis and CADTH Appraisal
- References.
- Notes:
- Includes bibliographical references.
- Description based on publisher supplied metadata and other sources.
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