Health Services Management Training Centre, Faculty of Health and Public Administration, Semmelweis University, Budapest, Hungary.
Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition, Budapest, Hungary.
PLoS One. 2023 Feb 6;18(2):e0281280. doi: 10.1371/journal.pone.0281280. eCollection 2023.
Access to innovative pharmaceuticals is thought to be associated with several exogenous factors related to the local legal or financial framework of pharmaceutical reimbursement. Our aim was to describe the association between the outcome of the reimbursement procedure on innovative pharmaceutical submissions in Hungary and several potential explanatory variables related to the legal or financial framework of reimbursement procedures, such as the submission implying a need for a legal act to conclude on a positive decision; having a risk-sharing agreement (RSA) in place at the time of submission; the aim of the submission and expenditure on individual funding requests.
Publicly available administrative announcements of the Hungarian National Health Insurance Fund Manager were used to construct the analysis dataset including all concluded procedures between 1 January 2018 and 7 June 2021, complemented with information on the overall aim of the submission (new compound or new indication). Logistic regression models were used to estimate odds ratios while adjusting for potential confounding.
Needing a legislative change as a proxy of involving high-level decision makers to reimburse had a lower (OR = 0.05, CI95%:0.02-0.11), whereas having an RSA had a statistically significant higher chance of a positive decision (OR = 3.49, CI95%:1.56-7.82). In contrast, neither the overall purpose of the submission (OR = 1.32, CI95%:0.65-2.69), nor the average biennial expenditure on individual funding requests exceeding 200 million HUFs (OR = 1.04, CI95%:0.92-1.19) had a statistically significant association with the decision.
This study quantitatively demonstrated that the need for legal acts to conclude on a positive decision decreases, whereas having an RSA for the particular product increases the likelihood of a positive reimbursement decision in Hungary. The role of other factors remain unclear. Our findings suggest that the legal requirements and RSAs play key roles in the reimbursement of innovative pharmaceuticals and can be viewed as potential areas of policy interventions in expanding access to these products, although the feasibility of such interventions need strong commitment from decision-makers, as well as implying increased autonomy to the entities involved in reimbursement procedures. Further research is needed to assess the impact of endogenous and exogenous factors in a coherent framework.
人们认为，获得创新药物与当地药品报销的法律或财务框架相关的一些外部因素有关。我们的目的是描述匈牙利创新药物报销程序结果与报销程序法律或财务框架相关的几个潜在解释变量之间的关系，例如需要法律行为才能做出积极决定的提交；提交时存在风险分担协议（RSA）；提交的目的和个别资金请求的支出。
使用匈牙利国家健康保险基金管理局公开的行政公告来构建分析数据集，其中包括 2018 年 1 月 1 日至 2021 年 6 月 7 日期间所有已完成的程序，并补充提交的总体目的（新化合物或新适应症）信息。使用逻辑回归模型估计比值比，同时调整潜在混杂因素。
需要立法变更作为涉及高层决策者报销的代理具有较低的（OR=0.05，95%CI：0.02-0.11），而拥有 RSA 则具有统计学上更高的积极决策机会（OR=3.49，95%CI：1.56-7.82）。相比之下，提交的总体目的（OR=1.32，95%CI：0.65-2.69）或个别资金请求的平均两年支出超过 2 亿匈牙利福林（OR=1.04，95%CI：0.92-1.19）均与决策无统计学显著关联。
本研究定量证明，需要法律行为才能做出积极决定的情况减少，而对于特定产品拥有 RSA 则增加了匈牙利积极报销决定的可能性。其他因素的作用仍不清楚。我们的研究结果表明，法律要求和 RSA 在创新药物的报销中发挥着关键作用，可以被视为扩大这些产品获取途径的潜在政策干预领域，尽管此类干预措施的可行性需要决策者的大力承诺，并意味着参与报销程序的实体自主权增加。需要进一步研究以在一致的框架内评估内源性和外源性因素的影响。
