EVERSANA, Burlington, Canada.
Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.
J Med Econ. 2024 Jan-Dec;27(1):952-962. doi: 10.1080/13696998.2024.2379212. Epub 2024 Jul 23.
Biosimilars improve patient access by providing cost-effective treatment options. This study assessed the potential for savings and expanded patient access with increased use of two biosimilar disease modifying anti-rheumatic drugs (DMARDs): (a) approved adalimumab biosimilars and (b) the first tocilizumab biosimilar, representing an established biosimilar field and a recent biosimilar entrant in France, Germany, Italy, Spain, and the United Kingdom (UK).
Separate ex-ante analyses were conducted for each country, parameterized using country-specific list prices, unit volumes annually, and market shares for each therapy. Discounting scenarios of 10%, 20%, and 30% were tested for tocilizumab. Outputs included direct cost-savings associated with drug acquisition or the incremental number of patients that could be treated if savings were redirected. Two biosimilar conversion scenarios were tested.
Savings associated with a 100% conversion to adalimumab biosimilar ranged from €10.5 to €187 million (UK and Germany, respectively), or an additional 1,096 to 19,454 patients that could be treated using the cost-savings. Introduction of a tocilizumab biosimilar provided savings up to €29.3 million in the most conservative scenario. Exclusive use of tocilizumab biosimilars (at a 30% discount) could increase savings to €28.8 to €113 million or expand access to an additional 43% of existing tocilizumab users across countries.
This study demonstrates the benefits that can be realized through increased biosimilar adoption, not only in an untapped tocilizumab market, but also through incremental increases in well-established markets such as adalimumab. As healthcare budgets continue to face downwards pressure globally, strategies to increase biosimilar market share could prove useful to help manage financial constraints.
生物类似药通过提供具有成本效益的治疗选择，提高了患者的可及性。本研究评估了在法国、德国、意大利、西班牙和英国（英国）增加使用两种生物类似物疾病修饰抗风湿药物（DMARDs）的潜在节省和扩大患者可及性的机会：（a）已批准的阿达木单抗生物类似物和（b）首个托珠单抗生物类似物，代表了已建立的生物类似物领域和最近进入市场的生物类似物。
针对每个国家进行了单独的事前分析，使用特定国家的标价、每年的单位数量和每种治疗方法的市场份额进行参数化。针对托珠单抗测试了 10%、20%和 30%的折扣方案。结果包括与药物获取相关的直接节省成本，或如果节省成本被重新定向，可以治疗的额外患者数量。测试了两种生物类似物转换方案。
100%转换为阿达木单抗生物类似物的节省金额范围为 1050 万至 1.87 亿欧元（英国和德国分别），或者使用节省成本可治疗的额外 1096 至 19454 名患者。在最保守的情况下，引入托珠单抗生物类似物可节省高达 2930 万欧元的费用。独家使用托珠单抗生物类似物（打 30%的折扣）可将节省金额增加到 2880 万至 1.13 亿欧元，或在各国增加现有托珠单抗使用者的可及性增加 43%。
本研究表明，通过增加生物类似物的使用，可以实现收益，不仅在尚未开发的托珠单抗市场，而且在阿达木单抗等成熟市场也可以实现收益。随着全球医疗保健预算继续面临下行压力，增加生物类似物市场份额的策略可能有助于应对财务限制。
