Abstract

IntroductionNew biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. We analyzed the budgetary impact of the introduction of CT-P10 into the European Union (EU) for use in patients with rheumatoid arthritis and cancer diagnoses, using a budget impact analysis model.MethodsThe model used a base case scenario in which the 1-year uptake of CT-P10 was estimated at 30%, and the cost of CT-P10 was assumed to be 70% of the cost of RTX. A second 1-year scenario was also modeled, in which the market share of CT-P10 was assumed to be 50% (scenario 2). Finally, 3-year time horizon outcomes were calculated, in which the market share of CT-P10 was assumed to be 30%, 40%, and 50% in the first, second, and third years, respectively.ResultsIn the base case scenario, the introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment. This was equivalent to a 6.4% increase in the number of rituximab-treated patients. In scenario 2, budget savings were €150.10 million, with a total of 12,551 additional patients able to access rituximab, equivalent to a 10.7% increase. Over a 3-year time horizon, projected budget savings were approximately €570 million, equating to 47,695 additional patients able to access rituximab.ConclusionsThe model predicted that the introduction of CT-P10 in the EU will be associated with significant budget savings, the reallocation of which will enable many more patients to access rituximab treatment. This is likely to have a significant impact on health gains at patient and societal levels. Funding: CELLTRION Healthcare Co., Ltd. sponsored the development and analysis of the budget impact analysis model.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-017-0522-y) contains supplementary material, which is available to authorized users.

Highlights

  • New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment

  • The model predicted that the introduction of CT-P10 in the European Union (EU) will be associated with significant budget savings, the reallocation of which will enable many more patients to access rituximab treatment

  • In this study of the budget impact of the introduction of CT-P10 into the European Union (EU), we focus primarily on rheumatoid arthritis (RA), non-Hodgkin’s lymphoma (NHL), and chronic lymphocytic leukemia (CLL)

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Summary

Introduction

New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. Results: In the base case scenario, the introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment. This was equivalent to a 6.4% increase in the number of rituximab-treated patients. Rituximab was the first monoclonal antibody to be approved for the treatment of cancer and is approved in the treatment of rheumatoid arthritis (RA) (as MabTheraÒ [Roche] in Europe and RituxanÒ [Biogen/Genentech] in the USA) [1, 2] As this anti-CD20 monoclonal antibody has reached patent expiration, biosimilar versions are in development. Biosimilars of more complex, second-generation biologicals such as monoclonal antibodies (‘‘second-generation biosimilars’’) [5], have been approved in RA and other immune-related inflammatory diseases (e.g., the infliximab biosimilars CT-P13 [RemsimaÒ, Celltrion], FlixabiÒ [Samsung Bioepis], and InflectraÒ [Hospira], and the etanercept biosimilar BenepaliÒ [Samsung Bioepis]) [6]

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