Strategic Entry Deterrence: The Case of Pharmaceutical Product Hopping and Its Consequences for the Affordability and Accessibility of Prescription Drugs

项目总结/摘要 处方药定价长期以来一直是公众关注的问题， 患者、公共保险计划和私人支付者。此外，高昂的自付费用可能会导致 不坚持服药，恶化健康问题，最终增加医疗服务支出。 处方药支出的很大一部分是由于品牌药物的高价， 由于市场独占性，几年来面临有限的竞争。仿制药通常比 由于价格竞争，他们的品牌同行，以及通用处方的份额 在仿制药进入市场后迅速增加。这导致品牌公司制定战略， 垄断，在某些情况下，通过阻止引入通用版本。如果有效，这将迫使患者 以及支付者支付超出监管机构预期时间的垄断价格。一种这样的策略是 这被称为产品跳跃，旨在将患者从一种面临仿制药进入的药物转换为一种类似的药物， 后到期的市场独占权，有时停止原药品。 本研究项目的最终目的是调查这种营销策略对 处方药对患者的可负担性和可获得性以及第三方支付者的支出。几 关于这一战略的使用和效果的研究已经存在，留下了一些尚未回答的关键问题，本项目旨在 具体调查，产品跳跃是否：（1）阻止和/或延迟仿制药公司进入市场;（2） 降低仿制药的市场渗透率;（3）影响药物类别替代和/或市场 扩张;和（4）影响处方药的使用，平均和最低价格，自付费用，和整体 付款.已为该项目收集了一个大型数据集，其中包含详细的法规 关于药品批准、产品、市场独占和营销的信息，沿着公司和 诉讼构建的样品由165种首次批准的新型活性药物成分组成 在2000年至2018年期间，有93家公司和273家公司赞助了323种最初批准的药品， 随后批准了来自同一公司的类似药品。产品停药发生在3 一种含有93种活性成分的新产品上市后数年。使用这些药物水平数据，回归模型将 估计，以检查产品跳跃对第一个通用条目的危害和 原产品的仿制药进入者，使用同一药物类别内的非产品啤酒花药物作为对照。 我将把这些数据与个人水平的数据合并，以估计仿制药对市场渗透的影响， 药品类别替代和市场扩张，以及患者和付款人的使用和支出。的结果 该研究项目将提供关键证据，为处方药政策提供信息， 关于是否以及如何监管药品公司的产品跳跃和其他战略行为。

PROJECT SUMMARY/ABSTRACT Prescription drug pricing has long been an issue of public concern due to worries about excessive spending by patients, public insurance programs, and private payers. Furthermore, high out-of-pocket costs can cause medication nonadherence and worsen health problems, ultimately increasing spending on healthcare services. A large proportion of prescription drug expenditures is due to high prices for brand name drugs, which often face limited competition for several years due to market exclusivities. Generics are typically much cheaper than their branded counterparts due to price competition, and the share of generic prescriptions dispensed increases quickly after generics enter the market. This has led brand firms to develop strategies to extend their monopolies, in some cases by deterring the introduction of generic versions. If effective, this forces patients and payers to pay monopoly prices beyond the time period anticipated by regulators. One such strategy is called product hopping, which aims to switch patients from one drug facing generic entry to a similar drug with later-expiring market exclusivity, sometimes discontinuing the original drug product. The ultimate objective of this research project is to investigate the effects of this marketing strategy on the affordability and accessibility of prescription drugs to patients and on spending by third-party payers. Few studies on the use and effects of this strategy exist, leaving unanswered key questions that this project aims to investigate—specifically, whether product hopping: (1) deters and/or delays market entry by generic firms; (2) diminishes market penetration by generic versions; (3) affects within drug class substitution and/or market expansion; and (4) affects prescription drug use, average and minimum prices, out-of-pocket costs, and overall payments. A large dataset has been assembled for this project that incorporates detailed regulatory information about drug approvals, products, market exclusivities, and marketing, along with data on firms and lawsuits. The constructed sample consists of 165 novel active pharmaceutical ingredients first approved between 2000 and 2018, resulting in 323 originally approved drug products sponsored by 93 firms and 273 subsequently approved similar drug products from the same firms. Product discontinuations occur within 3 years post-launch of a new product for 93 active ingredients. Using this drug-level data, regression models will be estimated to examine the effects of product hopping on the hazard of first generic entry and the number of generic entrants for the original products, using non-product hop drugs within the same drug class as controls. I will merge this data with individual-level data to estimate the effects on market penetration by generics, within drug class substitution and market expansion, and use and spending by patients and payers. The results of this research project will provide key evidence that will inform prescription drug policy, including decisions about whether and how to regulate product hopping and other strategic behavior by pharmaceutical firms.