García-Goñi Manuel, Río-Álvarez Isabel, Carcedo David, Villacampa Alba
Department of Applied & Structural Economics and History, Faculty of Economics and Business, Complutense University of Madrid, Campus de Somosaguas, Pozuelo de Alarcón, 28223 Madrid, Spain.
Spanish Biosimilar Medicines Association, BioSim, 28027 Madrid, Spain.
Pharmaceuticals (Basel). 2021 Apr 9;14(4):348. doi: 10.3390/ph14040348.
Since the first biosimilar medicine, Omnitrope (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions.
自首款生物类似药Omnitrope（活性物质生长激素）于2006年获批以来，西班牙已批准了53种生物类似药。我们从国家卫生系统（NHS）的角度估算了2009年至2019年期间生物类似药在西班牙的预算影响。考虑公共采购程序（医院招标）中的商业折扣后的药品采购成本，以及原研药和生物类似药的使用数据（作为NHS实际消耗的单位）是所考虑的两个变量。比较了两种情景：一种是没有生物类似药可用的情景，另一种是生物类似药有效销售的情景。在此期间所有面临生物类似药竞争的分子都纳入了分析。通过进行多次敏感性分析来测试模型的稳健性。从支付方的角度估计，采用生物类似药所产生的节省在11年内将达到2.306亿欧元，这相当于所有生物类似药的累计节省。三种分子（英夫利昔单抗、生长激素和促红细胞生成素）占节省金额的60%。本研究首次估算了生物类似药在西班牙的财务影响，同时考虑了制造商给医院的折扣效果以及生物类似药不断增长的市场份额。我们估计在我们数据的最后一年即2019年，使用生物类似药相对于西班牙药品总支出所产生的节省为3.92%。尽管还需要更多研究，但我们的证据支持这样一种情况，即生物类似药通过合理用药支出为NHS的可持续性提供了一个巨大机遇，而且生物类似药节省的全部潜力尚未实现，因为各自治区生物类似药的使用存在很大差异。
