LAUSR

Introduction 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. Methods 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. Results 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. Conclusions 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.