Office of Health Economics, 7th Floor, Southside, 105 Victoria Street, London, SW1E 6QT, UK.
Pharmacoeconomics. 2013 Jan;31(1):1-10. doi: 10.1007/s40273-012-0001-x.
The UK Government is proposing a novel form of price regulation for branded medicines, which it has dubbed 'value-based pricing' (VBP). The specifics of how VBP will work are unclear. We provide an account of the possible means by which VBP of medicines might be operationalized, and a taxonomy to describe and categorize the various approaches. We begin with a brief discussion of the UK Government's proposal for VBP and proceed to define a taxonomy of approaches to VBP. The taxonomy has five main dimensions: (1) what is identified as being of value, (2) how each element is measured, (3) how it is valued, (4) how the different elements of value are aggregated, and (5) how the result is then used to determine the price of a medicine. We take as our starting point that VBP will include a measure of health gain and that, as proposed by the UK Government, this will be built on the QALY. Our principal interest is in the way criteria other than QALYs are taken into account, including severity of illness, the extent of unmet need, and wider societal considerations such as impacts on carers. We set out to: (1) identify and describe the full range of alternative means by which 'value' might be measured and valued, (2) identify and describe the options available for aggregating the different components of value to establish a maximum price, and (3) note the challenges and relative advantages associated with these approaches. We review the means by which aspects of VBP are currently operationalized in a selection of countries and place these, and proposals for the UK, in the context of our taxonomy. Finally, we give an initial assessment of the challenges, pros and cons of each approach. We conclude that identifying where VBP should lie on each of the five dimensions entails value judgements: there are no simple 'right or wrong' solutions. If a wider definition of value than incremental QALYs gained is adopted, as is desirable, then a pragmatic way to aggregate the different elements of value, including both QALYs and benefits unrelated to QALYs, is to use a multi-criteria decision analysis (MCDA) approach. All approaches to VBP ultimately require the conversion of value, however assessed, into a monetary price. This requires assessment of the marginal values of all types of benefit, not just of QALYs. All stages of the VBP process are subject to uncertainty and margins of error. Consequently, the assessment of overall value can provide bounds to a price negotiation but cannot be expected to identify a precise value-based price.
英国政府正在提议对品牌药品进行一种新颖的价格监管形式，称之为“基于价值的定价”（VBP）。VBP 的具体运作方式尚不清楚。我们提供了一种可能的操作方法，以及一种描述和分类各种方法的分类法。我们首先简要讨论英国政府对 VBP 的提议，然后定义 VBP 的分类法。该分类法有五个主要维度：（1）确定什么是有价值的，（2）如何衡量每个元素，（3）如何对其进行估值，（4）如何聚合不同的价值元素，以及（5）如何利用结果来确定药品的价格。我们的出发点是 VBP 将包括对健康收益的衡量，并且，正如英国政府所提议的，这将建立在 QALY 的基础上。我们主要关注的是除了 QALYs 之外的其他标准被考虑的方式，包括疾病的严重程度、未满足需求的程度以及更广泛的社会考虑因素，如对照顾者的影响。我们的目标是：（1）确定和描述可以用来衡量和评估“价值”的各种替代方法，（2）确定和描述用于聚合不同价值组件以确定最高价格的选项，以及（3）注意这些方法的挑战和相对优势。我们审查了一些国家目前在 VBP 方面的运作方式，并将这些方式以及英国的提议置于我们的分类法中。最后，我们对每种方法的挑战和利弊进行了初步评估。我们的结论是，确定 VBP 在五个维度中的每一个维度上的位置都需要进行价值判断：没有简单的“对或错”的解决方案。如果采用更广泛的定义，即不仅仅是增量 QALYs 获得，而是包括 QALYs 和与 QALYs 无关的收益，那么一种聚合不同价值元素的实用方法，包括 QALYs 和与 QALYs 无关的收益，是使用多准则决策分析（MCDA）方法。所有的 VBP 方法最终都需要将价值（无论如何评估）转换为货币价格。这需要评估所有类型收益的边际价值，而不仅仅是 QALYs。VBP 过程的所有阶段都受到不确定性和误差幅度的影响。因此，对总体价值的评估可以为价格谈判提供一个范围，但不能期望确定一个精确的基于价值的价格。
