The bare necessities? A realist review of necessity argumentations used in health care coverage decisions

Health care coverage decisions may employ many different considerations, which are brought together across two phases. The assessment phase examines the available scientific evidence, such as the cost-effectiveness, of the technology. The appraisal then contextualises this evidence to arrive at an (advised) coverage decision, but little is known about how this is done. In the Netherlands, the appraisal is set up to achieve a societal weighing and is the primary place where need- and solidarity-related (‘necessity’) argumentations are used. To elucidate how the Dutch appraisal committee ‘constructs necessity’, we analysed observations and recordings of two appraisal committee meetings at the National Health Care Institute, the corresponding documents (five), and interviews with committee members and policy makers (13 interviewees in 12 interviews), with attention to specific necessity argumentations. The Dutch appraisal committee constructs necessity in four phases: (1) allowing explicit criteria to steer the process; (2) allowing patient (representative) contributions to challenge the process; (3) bringing new argumentations in from outside and weaving them together; and (4) formulating recommendations to societal stakeholders. We argue that in these ways, the appraisal committee achieves societal weighing rationality, as the committee actively uses argumentations from society and embeds the decision outcome in society.

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“…Overview of the 20 argumentation types that fall under the necessity criterion and their respective descriptions(Kleinhout-Vliek et al, 2017) …”

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confidence: 99%

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

Kleinhout-Vliek

Bont

Boer

2020

HEPL

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“…We have operationalised these situation-specific contextual factors using a list of previously-described necessity argumentations that are used across Europe and generally vary per decision. 7 We draw the following conclusions. From part 1 of the study, we conclude that situation-specific contextual factors, operationalised as necessity argumentations, are present in decision-making processes at HCKC/NIHDI in Belgium; NICE in England; G-BA in Germany; and ZIN in the Netherlands.…”

Section: Discussionmentioning

confidence: 72%

“…Necessity argumentations are used to provide a justification of, a rationale for, coverage decisions in several European countries, including France, Germany, Sweden, the United Kingdom, and the Netherlands. 7 These argumentations are largely considered valid not only by decision-makers, but also by the public. In the overall study, the Netherlands was taken as the entry point in terms of country selection and overall study focus, because necessity has been described and used as a criterion for Dutch coverage decisions.…”

Section: Approachmentioning

confidence: 99%

“…Contextual factors will be operationalised here by means of a list of previously-described necessity argumentations. 7 Necessity argumentations have been shown to be used in coverage decisions around the world, but are not considered valid for every healthcare technology by everyone: their perceived validity varies per situation. These argumentations comprise a varied list, and include eg, the presence or absence of alternative treatments, the Rule of Rescue, the societal impact of (lack of) coverage, whether similar treatments are covered, medical necessity, and moral hazard considerations.…”

Section: Introductionmentioning

confidence: 99%

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

Kleinhout-Vliek

Bont

Boysen

et al. 2020

Int J Health Policy Manag

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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.

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“…2.1). The part of the coding tree for the essential element 'ideas' was derived from the Dutch package criteria and the review of Kleinhout-Vliek et al [14,29,30]. The complete coding tree is displayed in Additional le D. Coding was conducted using MAXQDA 2019 [31].…”

Section: Discussionmentioning

confidence: 99%

What Influences the Outcome of Active Disinvestment Processes in Healthcare? A Qualitative Interview Study on five Recent Cases of Active Disinvestment

Rotteveel

Lambooij

Rijt

et al. 2020

Preprint

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Background: Recent attempts of active disinvestment (i.e. withdrawal of reimbursement by means of a policy decision) of reimbursed healthcare interventions in the Netherlands have differed in their outcome: some were successful, with interventions actually being disinvested, while others were terminated at some point, implying continuation of reimbursement. This study aimed to obtain insight into recent active disinvestment processes, and to explore what aspects affect their outcome.Methods: Semi-structured interviews were conducted from January to December 2018 with stakeholders (e.g. patients, policymakers, physicians) who were involved in the policy process of five cases for which the full or partial withdrawal of reimbursement was considered in the Netherlands between 2007 and 2017: benzodiazepines, medication for Fabry disease, quit smoking programme, psychoanalytic therapy and maternity care assistance. These cases covered both interventions that were eventually disinvested and interventions for which reimbursement was maintained after consideration. Interviews were transcribed verbatim, double coded and analyzed using thematic analysis.Results: The 37 interviews showed that support for disinvestment from stakeholders, especially from healthcare providers and policymakers, strongly affected the outcome of the disinvestment process. Furthermore, the institutional role of stakeholders as legitimized by the Dutch health insurance system, their financial interests in maintaining or discontinuing reimbursement, and the possibility to relieve the consequences of disinvestment for current patients affected the outcome of the disinvestment process as well. No evidence was found of a consistent role of the formal Dutch package criteria (i.e. effectiveness, cost-effectiveness, necessity and feasibility) in active disinvestment processes.Conclusions: Contextual factors as well as the possibility to relieve the consequences of disinvestment for current patients are important determinants of the outcome of active disinvestment processes. These results provide insight into active disinvestment processes and their determinants, and provide guidance to policymakers for a potentially more successful approach for future active disinvestment processes.

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The bare necessities? A realist review of necessity argumentations used in health care coverage decisions

Cited by 13 publications

References 118 publications

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

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

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

What Influences the Outcome of Active Disinvestment Processes in Healthcare? A Qualitative Interview Study on five Recent Cases of Active Disinvestment

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