title: The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries.
abstract: New 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.
  
  
  
  The 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.
  
  
  
  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. 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.
  
  
  
  The 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.
  
  
  
  CELLTRION Healthcare Co., Ltd. sponsored the development and analysis of the budget impact analysis model.
authors.affiliation: Corvinus University of Budapest and HTA Consulting Budapest, Budapest, Hungary. laszlo.gulacsi@uni-corvinus.hu.
authors.forename: László
authors.initials: L
authors.lastname: Gulácsi
authors.affiliation: Corvinus University of Budapest and HTA Consulting Budapest, Budapest, Hungary.
authors.forename: Valentin
authors.initials: V
authors.lastname: Brodszky
authors.affiliation: Corvinus University of Budapest and HTA Consulting Budapest, Budapest, Hungary.
authors.forename: Petra
authors.initials: P
authors.lastname: Baji
authors.affiliation: Corvinus University of Budapest and HTA Consulting Budapest, Budapest, Hungary.
authors.forename: Fanni
authors.initials: F
authors.lastname: Rencz
authors.affiliation: Corvinus University of Budapest and HTA Consulting Budapest, Budapest, Hungary.|Flór Ferenc County Hospital, Kistarcsa, Hungary.
authors.forename: Márta
authors.initials: M
authors.lastname: Péntek
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000191:economics; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000627:therapeutic use*; D017046:Cost Savings; D005060:Europe; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000191:economics; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000191:economics; D008297:Male; D008875:Middle Aged; D000069283:Rituximab / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D000069283:Rituximab
keywords: Biosimilar; Budget impact analysis; CT-P10; Chronic lymphocytic leukemia; Non-Hodgkin’s lymphoma; Rheumatoid arthritis; Rheumatology; Rituximab