OVERVIEW OF DECISION MAKING PROCESS AND APPRAISAL OF NEW MEDICAL DEVICE COVERAGE IN HUNGARY

Author(s)

Csaba Laszlo Dozsa, PhD1, Borbala Cseh, PhD1, Melanie Toth, MSc2, Dora Varga, Bsc2, Kornelia Lovas, PhD3.
1University of Miskolc, Miskolc, Hungary, 2Med-Econ Ltd., Budapest, Hungary, 3Medtronic Hungary Ltd., Budapest, Hungary.
OBJECTIVES: Modern medical devices and procedures play a key role in contemporary healthcare systems; however, their inclusion in the basic insurance package is a slow and difficult process that, in many respects, lacks transparency within the Hungarian Health Insurance System (HHIS). The aim of this research is to review the procedural rules approved in 2010 and regulated at the government and ministerial levels, and to identify procedural and organizational problems and areas for improvement.
METHODS: We conducted structured in-depth interviews with several government officials and health-economic professionals who are directly involved in the HTA and reimbursement systems in Hungary. We reviewed 15 years of reimbursement practices of the Health Insurance Fund (HIF), analyzed and organized related documents, and conducted a focused review of the international literature. We represented the identified problems using a problem tree.
RESULTS: Based on a review of the international literature, many countries (e.g., Australia, France, the United Kingdom) have accelerated or temporary access mechanisms designed to facilitate early access to innovative treatments. Based on expert interviews, the main barriers are the length of the process, dependence on budgetary resources, the complexity of the documentation, and the outdated scoring system. The problem tree clearly illustrates that the complexity of the technology adoption system cannot be attributed to a single cause, but rather to several multi-level mutually reinforcing factors.
CONCLUSIONS: Overall, the HHIS is based on a regulated framework; however, decision-making is slow, non-transparent and often ineffective. Modernizing the regulatory framework is essential to increase the number of applications and align with international practices. A more flexible and digitized mechanism—with an adequate, predictable budgetary framework and strengthened organizational and human resources—would facilitate faster innovation while maintaining budgetary stability and professional oversight.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

HPR31

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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