Under Careful Construction: Combining Findings, Arguments, and Values Into Robust Health Care Coverage Decisions

Background: Health care coverage decisions deal with health care technology provision or reimbursement on a national level. The coverage decision outcome, i.e., the publicly available document with reasons for the decision, may contain various elements: quantitative calculations like cost and clinical effectiveness analyses and formalised and non-formalised qualitative considerations. We know little about the process of combining these heterogeneous elements into robust decision outcomes.Methods: In this study, we describe a model for combining different elements into coverage decision outcomes. We build on two qualitative cases of coverage appraisals at the Dutch National Health Care Institute, for which we analysed observations at committee meetings (n=2, with field notes taken) and analysis of audio files (n=3), interviews with appraisal committee members (n=10 in seven interviews) and with Institute employees (n=5 in three interviews).Results: We conceptualise decision outcomes as combinations of elements, specifically (quantitative) findings and (qualitative) arguments and values. Our model contains three steps: 1) identifying elements; 2) designing the combinations of elements, which entails articulating links, broadening the scope of designed combinations, and black-boxing links; and 3) testing these combinations and choosing one as the final decision outcome. Conclusions: The proposed model highlights decision makers’ expertise in composing both elements and combinations. It also provides additional rationales for facilitating appeals and engaging patients and the public. Future research efforts could further explore the relationship between robustness and decision combination strength.

OP230 How Legitimate Is The Process Of Updating the Benefits Package In Israel? A 20 Year Overview

IntroductionThe National Health Insurance Law enacted in 1995 stipulates a minimum list of health services (benefits package) that the four health plans in Israel have to provide to their members. The recommendations on which new technologies or new indications for existing ones should be added every year to the benefits package, subject to a predetermined budget, are made by a public committee that evaluates and prioritizes candidate technologies according to their clinical merit, economic (mainly budget impact), social, ethical and other aspects. We assessed the legitimacy of this coverage decision process over the past 20 years.MethodsThe legitimacy of the process was assessed by adherence to the conditions outlined in the accountability for reasonableness (A4R) framework. A4R defines four conditions for legitimate and fair healthcare coverage decision processes: relevance, publicity, appeals/reversibility, and enforcement. We reviewed the changes made in the coverage decision process over the past 20 years and examined whether these changes have changed its legitimacy.ResultsOur analysis suggests that despite several changes made over the years in the process for updating the benefits package, for example, increase in transparency, introducing a structured appeal process, it only partially fulfills the four A4R conditions. In order to accomplish these goals more fully, several widely used considerations such as cost-effectiveness analysis and incorporating views from patients should be included. Additionally, this decision-making process should become even more transparent than it currently is.ConclusionsThe annual process of updating the benefits package in Israel where hundreds of technologies are “competing” with each other for coverage under a pre-defined budget is unique and not without merit. This process has been operating in the same pattern with only minor changes made since 1999. The main barriers for fulfilling all A4R conditions may relate in part to the large number of technologies assessed each year within a short time frame. Several changes in the process including the assessment of societal values, involvement of diverse stakeholders including patient advocate groups should be made to improve its legitimacy.

Moving Towards Accountability for Reasonableness – A Systematic Exploration of the Features of Legitimate Healthcare Coverage Decision-Making Processes Using Rare Diseases and Regenerative Therapies as a Case Study

Background: The accountability for reasonableness (A4R) framework defines 4 conditions for legitimate healthcare coverage decision processes: Relevance, Publicity, Appeals, and Enforcement. The aim of this study was to reflect on how the diverse features of decision-making processes can be aligned with A4R conditions to guide decision-making towards legitimacy. Rare disease and regenerative therapies (RDRTs) pose special decision-making challenges and offer therefore a useful case study. Methods: Features operationalizing each A4R condition as well as three different approaches to address these features (cost-per-QALY-focused and multicriteria-based) were defined and organized into a matrix. Seven experts explored these features during a panel run under the Chatham House Rule and provided general and RDRT-specific recommendations. Responses were analyzed to identify converging and diverging recommendations. Results: Regarding Relevance, recommendations included supporting deliberation, stakeholder participation and grounding coverage decision criteria in normative and societal objectives. Thirteen of 17 proposed decision criteria were recommended by a majority of panelists. The usefulness of universal cost-effectiveness thresholds to inform allocative efficiency was challenged, particularly in the RDRT context. RDRTs raise specific issues that need to be considered; however, rarity should be viewed in relation to other aspects, such as disease severity and budget impact. Regarding Publicity, panelists recommended transparency about the values underlying a decision and value judgements used in selecting evidence. For Appeals, recommendations included a life-cycle approach with clear provisions for re-evaluations. For Enforcement, external quality reviews of decisions were recommended. Conclusion: Moving coverage decision-making processes towards enhanced legitimacy in general and in the RDRT context involves designing and refining approaches to support participation and deliberation, enhancing transparency, and allowing explicit consideration of multiple decision criteria that reflect normative and societal objectives.