The Swedish Institute of Health Economics (IHE), Box 2127, 220 02, Lund, Sweden.
Eur J Health Econ. 2010 Apr;11(2):195-203. doi: 10.1007/s10198-009-0166-1. Epub 2009 Jul 29.
Value-based pricing (VBP) is a method of setting prices for products based on perceived benefits to the consumer. When information is symmetric and freely available and agency is perfect, VBP is efficient and desirable. Because of substantial information asymmetries, medical insurance distortions, and the prescribing monopoly of physicians, VBP is rare for prescription drugs, though a number of countries have recently moved in this direction. Because the potential benefits can be sizable, it is high time for a review of actual VBP-based decision-making in practice. Sweden, with its pharmaceutical benefits board (TLV), was an early adopter of VBP decision-making. We illustrate actual decision-making, thus, using the case of Acomplia for the treatment of obesity in Sweden, with and without the presence of co-morbid conditions. This example has a number of features that will be useful in illustrating the strengths and weaknesses of VBP in actual practice, including multiple indications, a need for not just one but two economic simulation models, considerable sub-group analysis, and requirements for additional evidence development. TLV concluded, in 2006, that Acomplia was cost-effective for patients with a body mass index (BMI) exceeding 35 kg/m2 and patients with a BMI exceeding 28 kg/m2 and either dyslipidemia or type 2 diabetes. Because of uncertainty in some of the underlying assumptions, reimbursement was granted only until 31 December 2008, at which time the manufacturer would be required to submit additional documentation of the long-term effects and cost-effectiveness in order to obtain continued reimbursement. Deciding on reimbursement coverage for pharmaceutical products is difficult. Ex ante VBP assessment is a form of risk sharing, which has been used by TLV to speed up reimbursement and dispersion of effective new drugs despite uncertainty in their true cost-effectiveness. Manufacturers are often asked in return to generate additional health economic evidence that will establish cost-effectiveness as part of ex post review. The alternative is to delay the reimbursement approval until satisfactory evidence is available.
基于价值的定价（VBP）是一种根据消费者感知到的收益来为产品定价的方法。当信息对称且自由可得，以及代理机构完美无缺时，VBP 是有效且理想的。由于存在大量的信息不对称、医疗保险扭曲以及医生的处方垄断，VBP 在处方药领域很少见，尽管最近一些国家已经朝着这个方向发展。由于潜在的收益可能相当大，现在是时候对实际实践中的基于 VBP 的决策进行审查了。瑞典的药品福利委员会（TLV）是早期采用 VBP 决策的国家之一。因此，我们使用瑞典 Acomplia 治疗肥胖症的案例，说明了实际决策，包括存在和不存在合并症的情况。这个例子具有许多特点，对于说明 VBP 在实际实践中的优势和劣势将非常有用，包括多个适应症、不仅需要一个而且需要两个经济模拟模型、大量的亚组分析以及对额外证据开发的要求。TLV 于 2006 年得出结论，Acomplia 对 BMI 超过 35kg/m2 的患者和 BMI 超过 28kg/m2 且伴有血脂异常或 2 型糖尿病的患者是具有成本效益的。由于一些基础假设存在不确定性，仅批准到 2008 年 12 月 31 日，届时制造商将需要提交额外的长期效果和成本效益证明文件，以获得持续的报销。决定药品的报销范围是困难的。事前 VBP 评估是一种风险分担形式，TLV 已使用这种形式来加快报销和分散有效的新药，尽管其真实成本效益存在不确定性。反过来，制造商经常被要求生成额外的健康经济学证据，以建立成本效益，作为事后审查的一部分。另一种选择是在获得满意的证据之前延迟报销批准。
