Centre for Health Economics, University of York, UK.
Health Econ. 2011 Feb;20(2):212-24. doi: 10.1002/hec.1586.
Institutions with the responsibility for making adoption (reimbursement) decisions in health care often lack the remit to demand or commission further research: adoption decisions are their only policy instrument. The decision to adopt a technology also influences the prospects of acquiring further evidence because the incentives to conduct research are reduced and the ethical basis of further clinical trials maybe undermined. In these circumstances the decision maker must consider whether the benefits of immediate access to a technology exceeds the value of the evidence which maybe forgone for future patients. We outline how these expected opportunity losses can be established from the perspective of a societal decision maker with and without the remit to commission research, and demonstrate how these considerations change the appropriate decision rules in cost-effectiveness analysis. Importantly, we identify those circumstances in which the approval of a technology that is expected to be cost-effective should be withheld, i.e. when an 'only in research' recommendation should be made. We demonstrate that a sufficient condition for immediate adoption of a technology can provide incentives for manufacturers to reduce the price or provide additional supporting evidence. However, decisions based solely on expected net benefit provide no such incentives, may undermine the evidence base for future clinical practice and reduce expected net health benefits for the patient population.
负责做出医疗保健（报销）决策的机构往往没有权限要求或委托进行进一步的研究：采用某项技术的决定是他们唯一的政策手段。采用一项技术的决定还会影响获取进一步证据的前景，因为这会减少进行研究的动力，并且可能破坏进一步临床试验的伦理基础。在这种情况下，决策者必须考虑是否立即获得技术的收益超过了未来患者可能失去的证据的价值。我们从有和没有委托研究权限的社会决策者的角度概述了如何从这些预期的机会损失中确定这些内容，并展示了这些考虑因素如何改变成本效益分析中的适当决策规则。重要的是，我们确定了在哪些情况下应该拒绝批准预计具有成本效益的技术，即应该做出“仅在研究中”的建议。我们证明，采用技术的充分条件可以为制造商提供激励，以降低价格或提供额外的支持证据。但是，仅仅基于预期净收益的决策不会提供这种激励，可能会破坏未来临床实践的证据基础，并降低患者群体的预期净健康收益。
