Feiring Eli, Wang Hege
Department of Health Management and Health Economics, University of Oslo, PO Box 1089, Blindern, 0317, Oslo, Norway.
Department of Guidelines and Professional Development, Norwegian Directorate of Health, PO Box 7000, St Olavs plass, 0130, Oslo, Norway.
BMC Health Serv Res. 2018 May 9;18(1):342. doi: 10.1186/s12913-018-3137-3.
Governments are facing tough choices about whether to fund new, promising but highly expensive drugs within the public healthcare system. Decisions that some drugs are not sufficiently beneficial relative to their cost to merit public funding are often contentious. The importance of making decisions that stakeholders can understand and accept as legitimate is increasingly recognized and is commonly understood to be a crucial component for stakeholder support and successful implementation. Yet, little is known about clinicians' perceptions of legitimate limit-setting. This study aimed to examine oncologists' perceptions of the legitimacy of governmental decisions to deny patients access to new cancer drugs because effectiveness and cost-effectiveness of the drugs has not been demonstrated.
Semi-structured in-depth interviews with 12 Norwegian oncologists were carried out. Data were interpreted with the use of theory driven thematic analysis. The analytical framework of Accountability for reasonableness aided data gathering and interpretation.
The participants endorsed the ideal of explicit criteria-based priority setting. Yet, when confronted with actual rationing decisions, they were far more equivocal. They advocated for increased access to drugs and were not always prepared to accept rationing of drugs they felt would benefit their patient. Distrust in the Norwegian centralised drug review process was found and different rationales were identified: i) Lack of engagement with the process, ii) Disagreement with the use of rationing criteria, iii) Lack of transparency and lack of dispute resolution procedures. Concerns about the wider implications of rationing decisions were reported. Most importantly, these related to negative impact on patient-doctor relationship of micro-level rationing and to inequities in drug availability resulting from privatisation of high-cost cancer treatment.
Drawing on the analytical framework, we conclude that perceptions of legitimacy regarding rationing of high-cost drugs include procedural fairness. However, notions of substantive justice also seem to be important for accepting reasons given for decisions. Regulatory legitimacy may further warrant a more sophisticated theoretical account of second-order beliefs about the justifiability of rationing new technologies. These findings indicate a need for a broader concept of legitimacy than is commonly used in the literature on healthcare prioritisation.
政府面临着艰难的抉择，即在公共医疗体系内是否为新的、有前景但成本高昂的药物提供资金。一些药物因其成本效益不足以获得公共资金支持的决策往往存在争议。做出利益相关者能够理解并接受为合理的决策的重要性日益得到认可，并且通常被视为利益相关者支持和成功实施的关键组成部分。然而，对于临床医生对合理设定限制的看法却知之甚少。本研究旨在探讨肿瘤学家对于政府因药物有效性和成本效益未得到证实而拒绝患者使用新癌症药物这一决策合理性的看法。
对12名挪威肿瘤学家进行了半结构化深度访谈。运用理论驱动的主题分析法对数据进行解读。合理性问责分析框架辅助了数据收集与解读。
参与者认可基于明确标准进行优先排序的理念。然而，面对实际的配给决策时，他们的态度却模棱两可得多。他们主张增加药物可及性，并且并不总是愿意接受他们认为会使患者受益的药物配给。研究发现对挪威集中式药物审评过程存在不信任，并确定了不同的理由：（i）未参与该过程；（ii）不同意使用配给标准；（iii）缺乏透明度和争议解决程序。报告了对配给决策更广泛影响的担忧。最重要的是，这些担忧涉及微观层面配给对医患关系的负面影响以及高成本癌症治疗私有化导致的药物可及性不平等。
借助分析框架，我们得出结论，对于高成本药物配给的合理性认知包括程序公平性。然而，实质正义的观念对于接受决策理由似乎也很重要。监管合法性可能进一步需要对关于新技术配给合理性的二阶信念进行更复杂的理论阐释。这些发现表明，需要一个比医疗保健优先排序文献中常用的更广泛的合法性概念。
