ReviewA systematic review of coverage decision-making on health technologies—Evidence from the real world
Introduction
Coverage decision-making that determines the inclusion in or exclusion from a basket of health services is perceived as a promising instrument to regulate the allocation of health services in publicly funded healthcare systems [1], [2], [3]. So-called fourth hurdle decisions are highly complex and made heterogeneously across countries as they depend on healthcare system needs and the value judgements of decision-makers. Facing an increase in formal requirements, stakeholders are interested in the determinants of coverage decisions [4]. Manufacturers strive for knowledge to achieve fast market entry. Patients seek access to promising health technologies. Third-party payers are interested in cost containment, whereas governments may be driven by political opportunism.
Existing evidence reviews have dealt with description of decision processes and the role of health economic evaluation. Stafinski et al. provide a collection of decision processes based on official documentation [5]. They elicit similarities and differences between components of processes in industrialized countries and identify common criteria, namely clinical need, health impact and affordability. Erntoft examines the use of health economic evaluation in priority setting and coverage decision-making [6]. She identifies criteria at all levels of healthcare systems and elicits institutional–political, cultural and methodological barriers.
Analysis of actual decisions is promising as these reflect the revealed preferences of third-party payers which may deviate from pre-defined processes. New technologies challenge existing appraisal procedures, or decisions are influenced by political commitment. Examination of real-world decision-making allows the making of inferences from true instead of hypothetical decisions. Vuorenkoski et al. conducted a review of studies that analyze real-world coverage decision-making. Six publications were identified that each examines one decision maker [7]. The study concludes that according to the available evidence, decision-makers define explicit criteria, but economic considerations play a minor role. Applied research methods are based on qualitative approaches. Yet, the review does not structure the aspects of decision-making that have been considered in the studies. As coverage may be analyzed from a multitude of perspectives and documentation of single decisions is rapidly growing, structured methods are needed for empirical research that capture components of coverage decision-making and information about past decisions.
As more decision-making bodies have been enforced, it can be assumed that a critical mass of studies is available beyond Vuorenkoski's review that analyze the work of decision-makers. Furthermore, the number of coverage decisions completed is sufficiently large for selected institutions to apply quantitative methods for analysis. A review of quantitative studies provides the opportunity to structure approaches of empirical research. Accounting for the current evidence, the objective of this study is to review research methods on coverage decision-making based on quantitative analysis of real-world decisions.
Section snippets
Components of coverage decision-making
To structure the variables used in empirical research of coverage decision-making, decision processes were segmented by their components. The objective was to assign each variable used for analysis to one component uniquely and identify common approaches of empirical research. The components ‘methods and evidence’, ‘criteria and standards’, ‘decision outcome’ and ‘processes’ were defined based on two frameworks that suggest structuring of processes and ground on real-world decisions and expert
Results
In total, 32 studies were included of which thirteen references were identified outside the systematic search. Fig. 1 provides a flowchart of the study selection. Articles that have been reviewed in full text but excluded were categorized by the reasons for exclusion. Most studies did not analyze real-world decision-making (41 studies), case studies were reported narratively (12), a qualitative approach was used (11) or research methods were not described (11). The two publications by Anis et
Discussion
The review of studies on coverage decision-making demonstrated a great heterogeneity of how empirical research has addressed this topic. Thus, no general approach of analysis could be identified. Regarding the scope of the studies, research focused on the factors that influence decision outcomes and appraisal criteria and concentrated on coverage of pharmaceuticals and decision-makers with longer traditions in the use of cost considerations. Accordingly, future research could address other
Conclusion
Coverage decision-making is a policy tool which is increasingly considered to regulate technology diffusion. This literature review synthesizes approaches of quantitative research based on real-world decisions by four components. Seventy-two variables that have been used for analysis were identified which indicates that coverage decision-making is addressed very heterogeneously by empirical research. Only a few variables were identified that were used by several studies. As sound evidence is
Funding
This research was carried out on behalf of Helmholtz Zentrum München – German Research Center for Environmental Health (HMGU). The HMGU is an independent organization funded by the German and Bavarian governments.
Conflict of interest
None.
Acknowledgements
I would like to thank Reiner Leidl for comments on earlier drafts of this article and for support in the identification and selection of articles for this literature review. Also, I am deeply grateful to Wolf Rogowski for comments on the study design and Rudolf Blankart, Florian Koerber and Jürgen John who provided valuable comments on previous versions of this manuscript. Finally, I would like to thank the two anonymous reviewers who provided valuable comments to this manuscript.
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