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仅生物类似药使用不足并不能预示生物制品市场的崩溃。

Biosimilar underutilization alone does not foretell a broken biologics market.

作者信息

LaMountain Fariel, Beinfeld Molly T, Wong William, Kim Eunice, Chambers James D

机构信息

Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA 02111, United States.

Genentech, Inc., San Francisco, CA 94080, United States.

出版信息

Health Aff Sch. 2024 Jul 17;2(7):qxae090. doi: 10.1093/haschl/qxae090. eCollection 2024 Jul.

Abstract

Biosimilars offer the potential for cost savings and expanded access to biologic products; however, there are concerns regarding the rate of biosimilar uptake. We assessed the relationship between biosimilar and originator pricing, coverage, and market share by describing four case studies that fall into two categories: (1) sole preferred coverage strategy (ie, aim is to have originator product preferred; biosimilar(s) non-preferred), defined as steep average sales price (ASP) reductions for originator products (decline in net prices by at least 50% following the introduction of biosimilar competition by 2022) and (2) non-sole preferred coverage strategy (ie, aim is to have originator product preferred alongside biosimilar products), defined as moderate ASP reductions for originator products with (net prices did not decline by at least 50% of its pre-biosimilar competition value). We found that originators with sole preferred coverage strategies maintained formulary preference and market share relative to originators with non-sole preferred coverage strategies. Regardless of strategy, the market-weighted ASP for all four product families (originator and biosimilars) declined significantly in the years following the introduction of biosimilars, suggesting that biosimilar uptake alone may not be a complete measure of whether the biosimilar market is facilitating competition and lowering prices.

摘要

生物类似药有可能节省成本并扩大生物制品的可及性;然而,人们对生物类似药的采用率存在担忧。我们通过描述分为两类的四个案例研究,评估了生物类似药与原研药定价、医保覆盖范围和市场份额之间的关系:(1)唯一优先医保覆盖策略(即目标是使原研产品优先;生物类似药不优先),定义为原研产品平均销售价格(ASP)大幅降低(到2022年生物类似药竞争引入后净价下降至少50%),以及(2)非唯一优先医保覆盖策略(即目标是使原研产品与生物类似药产品一同优先),定义为原研产品ASP适度降低(净价下降未达到其生物类似药竞争前价值的至少50%)。我们发现,与采用非唯一优先医保覆盖策略的原研药相比,采用唯一优先医保覆盖策略的原研药保持了医保目录中的优先地位和市场份额。无论采用何种策略,在生物类似药引入后的几年里,所有四个产品系列(原研药和生物类似药)的市场加权ASP均显著下降,这表明仅生物类似药的采用率可能不是衡量生物类似药市场是否促进竞争和降低价格的完整指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fa5/11282456/abb66dcf65b2/qxae090f1.jpg

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