Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
PLoS Med. 2019 Jul 30;16(7):e1002872. doi: 10.1371/journal.pmed.1002872. eCollection 2019 Jul.
Some experts have proposed combating rising drug prices by promoting brand-brand competition, a situation that is supposed to arise when multiple US Food and Drug Administration (FDA)-approved brand-name products in the same class are indicated for the same condition. However, numerous reports exist of price increases following the introduction of brand-name competition, suggesting that it may not be effective. We performed a systematic literature review of the peer-reviewed health policy and economics literature to better understand the interplay between new drug entry and intraclass drug prices.
We searched PubMed and EconLit for original studies on brand-brand competition in the US market published in English between January 1990 and April 2019. We performed a qualitative synthesis of each study's data, recording its primary objective, methodology, and results. We found 10 empirical investigations, with 1 study each on antihypertensives, anti-infectives, central nervous system stimulants for attention deficit/hyperactivity disorder, disease-modifying therapies for multiple sclerosis, histamine-2 (H2) blockers, and tumor necrosis factor (TNF) inhibitors; 2 studies on cancer medications; and 2 studies on all marketed or new drugs. None of the studies reported that brand-brand competition lowers list prices of existing drugs within a class. The findings of 2 studies suggest that such competition may help restrain how new drug prices are set. Other studies found evidence that brand-brand competition was mediated by the relative quality of competing drugs and the extent to which they are marketed, with safer or more effective new drugs and greater marketing associated with higher intraclass list prices. Our investigation was limited by the studies' use of list rather than net prices and the age of some of the data.
Our findings suggest that policies to promote brand-brand competition in the US pharmaceutical market, such as accelerating approval of non-first-in-class drugs, will likely not result in lower drug list prices absent additional structural reforms.
一些专家提议通过促进品牌竞争来对抗不断上涨的药品价格，当同一类别中有多个获得美国食品和药物管理局 (FDA) 批准的品牌药物被用于同一病症时，就会出现这种情况。然而，有许多报告表明，在引入品牌竞争后，价格会上涨，这表明这种方法可能并不有效。我们对同行评议的卫生政策和经济学文献进行了系统的文献回顾，以更好地了解新药进入市场与同类药物价格之间的相互作用。
我们在 PubMed 和 EconLit 中搜索了 1990 年 1 月至 2019 年 4 月期间以英文发表的关于美国市场品牌竞争的原始研究。我们对每项研究的数据进行了定性综合，记录了其主要目标、方法和结果。我们发现了 10 项实证研究，其中 1 项研究涉及抗高血压药物、抗感染药物、用于注意力缺陷/多动障碍的中枢神经系统兴奋剂、多发性硬化症的疾病修正疗法、组胺 2 (H2) 阻滞剂和肿瘤坏死因子 (TNF) 抑制剂；2 项研究涉及癌症药物；还有 2 项研究涉及所有已上市或新药。没有一项研究报告表明品牌竞争会降低同类现有药物的标价。有两项研究的结果表明，这种竞争可能有助于控制新药价格的制定。其他研究发现，品牌竞争受到竞争药物的相对质量以及它们的营销程度的影响，安全性更高或更有效的新药和更大的营销与更高的同类标价有关。我们的调查受到了研究中使用标价而非净价以及部分数据陈旧的限制。
我们的研究结果表明，在美国制药市场促进品牌竞争的政策，如加速非首仿药的审批，在没有其他结构性改革的情况下，不太可能导致药品标价降低。
