There are no automatic links between the functional advantages and pressures associated with delegation to independent agencies for Health Technology Assessment (HTA) and their emergence in national regulatory spaces. We argue that the rise of these organizations is mediated by contextual factors, which must be explained. Accordingly, we analyze the German 'regulatory space' for health policy decision-making, identifying contextual factors relevant to the adoption of the Efficiency Frontier approach. Based on qualitative interviews with key stakeholders, we argue that the development of the Efficiency Frontier can be associated with cultural reluctance to frame healthcare prioritization decisions around cost based valuations of human health and related doubts about the validity of metrics for human health gain. Based on this finding, we conclude that the delegation of authority to independent HTA agencies follows a broadly evolutionary pattern, in which contextual factors allow for significant variation in institutional and methodological responses to the functional pressures and advantages leading to their establishment.

译文

与授权给独立的卫生技术评估机构 (HTA) 相关的功能优势和压力与它们在国家监管空间中的出现之间没有自动联系。我们认为,这些组织的兴起是由上下文因素介导的,必须对此进行解释。因此,我们分析了德国卫生政策决策的 “监管空间”,确定了与采用效率前沿方法有关的背景因素。基于对主要利益相关者的定性访谈,我们认为效率边界的发展可能与文化上不愿围绕基于成本的人类健康评估制定医疗保健优先决策以及对人类健康收益指标有效性的相关怀疑有关。基于这一发现,我们得出结论,将权力下放给独立的HTA机构遵循一种广泛的进化模式,在这种模式下,背景因素允许机构和方法对导致其建立的功能压力和优势的反应发生重大变化。

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