Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School.
Milbank Q. 2021 Dec;99(4):1162-1197. doi: 10.1111/1468-0009.12533. Epub 2021 Aug 10.
Policy Points In the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug-pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage. As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards. Prescription drug-pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation.
Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs.
We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews.
Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021.
Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.
政策要点在联邦政府对不断上涨的处方药成本采取行动之前,我们审查了五个已制定处方药定价委员会的州的详细信息,这些州试图根据产品的价值来降低药品价格。在这些州中,目前有六个这样的委员会获得授权;它们具有相似之处,但在结构、权限、范围和影响力方面有所不同。截至 2021 年 6 月,我们样本中的只有一个委员会进行了定价审查;其他州的立法者可以从现有委员会的成功和挑战中吸取经验教训。处方药定价委员会代表了一种新颖且有前途的方式,可以控制州支出并为处方药的价值付费,但在实施过程中面临法律和政治障碍。
不断上涨的处方药成本正在消耗越来越大的州和私人预算份额。作为回应,立法者尝试了各种政策来控制支出并实现处方药的价值。作为这一系列改革的一部分,最近一些州立法机构授权处方药定价委员会来解决品牌处方药的高价格问题,并评估这些药物的价值。
我们在美国确定了州处方药定价委员会,将其定义为任何经州立法机构授权审查特定药物并追求基于价值的药物价格的机构。为了描述委员会的特点,我们获取了授权立法的公共记录、指导文件和委员会会议记录。我们比较了委员会的权力和责任,并分析了已完成的定价审查。
五个州的六个州药品定价委员会符合我们的定义;它们的设计有很大的不同。其中两个委员会(纽约医疗补助计划和马萨诸塞州)有权审查州医疗补助计划支付的药品回扣,一个委员会(纽约药品问责委员会)有权审查州监管的商业保险,另外三个委员会(缅因州、马里兰州和新罕布什尔州)负责监督非医疗补助、州资助的保险。三个委员会被授权要求制造商提交与审查药物的定价和临床效果相关的机密信息,以告知价值确定。截至 2021 年 6 月 3 日,只有一个委员会(纽约医疗补助计划)完成了定价审查。
委员会的结构、范围和法定杠杆作用,以迫使制造商协商降低净成本,是影响委员会能否以及在多大程度上为各州节省成本的关键因素。尽管法律限制可能会限制处方药定价委员会的有效范围,但这些机构可以使各州能够部分通过其存在来解决处方药成本不断上升的问题。为了克服实际限制,寻求实施类似政策的州可以借鉴现有委员会的经验和设计。