An analysis of cost-saving in the German statutory health insurance system due to the introduction of epoetin alfa biosimilars in Germany

Aims: Epoetin alfa, an erythropoiesis-stimulating agent, is the mainstay for treating severe anemia caused by kidney disease or induced by cancer-chemotherapy. This study aims to investigate the potential for reducing drug costs through the utilization of epoetin alfa biosimilars within the German statutory health insurance system (SHI). Methods: For the analysis, price and product data from ABDATA with sales volume data from IQVIA Pharmascope for the period from 2008 to 2023 were pooled. This enabled a comparison of cost savings due to the market introduction of epoetin alfa biosimilars from 2007 onwards. Results: From 2008 to 2023, overall epoetin alfa unit volume has increased by a total of 23%. Compared to the other epoetin derivatives such as, epoetin beta, zeta and theta, an average unit share of 57% (between 2008 and 2023) highlights the importance of epoetin alfa within the segment of erythropoiesis-stimulating agents. Among the various dosing strengths of epoetin alfa, the nephrological strength 4,000 IU formulation has gained notable sales growth (12%) from 2008 to 2023. Economically, the introduction of epoetin alfa biosimilars has led to substantial cost-savings for the SHI, amounting to €505,731,202 between 2008 and 2023 for nephrological strengths. Due to biosimilar competition, the price of epoetin alfa decreased by 47% from 2007 to 2012, further contributing to the diminished price difference between originator epoetin and other epoetin alfa biosimilars. Notably, the 4,000 IU nephrological strength alone accounted for savings of €143,720,363, reflecting its widespread clinical adoption. Conclusion: The introduction of epoetin alfa biosimilars has not only enhanced clinical accessibility, but also yielded significant cost savings for the German healthcare system. This underscores the dual role of biosimilars in improving healthcare affordability and maintaining effective therapeutic outcomes.