Around the Tables – Contextual Factors in Healthcare Coverage Decisions Across Western Europe

Abstract

Background: Across Western Europe, procedures and formalised criteria for taking decisions on the coverage (inclusion in the benefits basket or equivalent) of healthcare technologies vary substantially. In the decision documents, which display the justification of, the rationale for, these decisions, national healthcare institutes may employ ‘contextual factors,’ defined here as situation-specific considerations. Little is known about how the use of such contextual factors compares across countries. We describe and compare contextual factors as used in coverage decisions generally and 4 decision documents specifically in Belgium, England, Germany, and the Netherlands. Methods: Four group interviews with 3 experts from the national healthcare institute of each country, document and web site analysis, and a workshop with 1 to 2 of these experts per country were followed by the examination of the documents of 4 specific decisions taken in each of the 4 countries, sampled to vary widely in type of technology and decision outcome. Results: From the available decision documents, we conclude that in every country studied, contextual factors are established ‘around the table,’ ie, in deliberation. All documents examined feature contextual factors, with similar contextual factor patterns leading to similar decisions in different countries. The Dutch decisions employ the widest variety of factors, with the exception of the societal functioning of the patient, which is relatively common in Belgium, England, and Germany. Half of the final decisions were taken in another setting, with the consequence that no documentation was retrievable for 2 decisions. Conclusion: First, we conclude that in these countries, contextual factors are actively integrated in the decision document, and that this is achieved in deliberation. Conceptualising contextual factors as both situation-specific and actively-integrated affords insight into practices of contextualisation and provides an encouragement for exchange between decision-makers on more qualitative aspects of decisions. Second, the decisions that lacked a publicly accessible justification of the final decision document raised questions on the decisions’ legitimacy. Further research could address patterning of contextual factors, elucidate why some factors may remain implicit, and how decisions without a publicly available decision document may enable or restrain decision-making practice.

Necessity under construction – societal weighing rationality in the appraisal of health care technologies

“…First, these argumentations are employed not only by professional decision-makers but also by other parties, such as patients and other societal stakeholders, who may also be present at the appraisal meeting (further information below). Second, necessity argumentations are variable in usage as their perceived validity and allotted weight differs per decision, making their patterns especially vivacious (Kleinhout-Vliek et al ., 2017 ; Kleinhout-Vliek et al ., 2020 ).…”

“…Therefore, many coverage decisions feature a second part, sometimes (but not always) a distinct step in time and space: the appraisal. An appraisal entails the formulation of a (recommended) coverage decision based on contextualisation of the given evidence (Oliver et al ., 2004 ; Walley, 2007 ; Patera and Wild, 2014 ; Jansen et al ., 2017 ; Kleinhout-Vliek et al ., 2020 ). Previously, contextualisation has broadly been defined as taking into account a variety of values and considerations (Patera and Wild, 2014 ).…”

“…‘Necessity’ is, as a consequence of being a formalised criterion, present in the documents providing input for the appraisal as they outline the available information per criterion. It has, however, also been considered to be established especially in appraisal (Mastenbroek et al ., 2006 ; Couwenbergh et al ., 2013 ; Kleinhout-Vliek et al ., 2017 ; Zorginstituut Nederland, 2017 ; Kleinhout-Vliek et al ., 2020 ). Therefore, this paper will explore how the appraisal committee constructs necessity , as this may aid in uncovering elements that are specific to the achievement of societal weighing rationality (Poley et al ., 2002 ; Stolk et al ., 2002 ; Hoedemaekers and Oortwijn, 2003 ).…”

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

“…There are also contextual factors specific to a decision about use of a health technology that is established during the deliberation about the technology itself (see Box 5).

Understanding the Role of Contextual Factors Specific to a Health Technology Kleinhout-Vliek et al (32) studied the use of contextual factors in health coverage decision making for four health technologies (nivolumab, benzodiazepines, smoking cessation, and walking aid with wheels) in Belgium, England, Germany, and the Netherlands. Contextual factors were operationalized as arguments about necessity (e.g., disease severity, unmet medical need, dignity, and human rights) because their perceived validity varies per health technology and because they are elements not easily quantified in clinical and/or economic assessment.

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Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

“…Kleinhout-Vliek et al 32 studied the use of contextual factors in health coverage decision making for four health technologies (nivolumab, benzodiazepines, smoking cessation, and walking aid with wheels) in Belgium, England, Germany, and The Netherlands. Contextual factors were operationalized as arguments about necessity (eg, disease severity, unmet medical need, dignity, and human rights) because their perceived validity varies per health technology and because they are elements not easily quantified in clinical and/or economic assessment.…”