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HUNGARY - REIMBURSEMENT PROCESS
(Updated October 2008) Description of Health Care System Insurance and Payment In Hungary, the National Health Insurance Fund Administration (NHIFA), the organization solitarily responsible for health care financing, was established in 1993. Most of the health care budget comes from contributions. Employees pay a contribution of 6% of their gross income and employers pay 6% without an income ceiling. The major actors, such as general practitioners (GPs), out-patient departments and hospitals are financed through different financial incentives, described as follows. Hungarian GPs have a gatekeeper role towards the secondary and tertiary care provided by specialists. The main source of GPs’ revenues comes from a capitation fee based on patients’ age, with a special point system for different age groups. Outpatient care, an activity based point payment system (called German fee-for-service point system) is used for financing. The medical procedures are listed according to the ICPM (International Classification of Procedures in Medicine) code system of the WHO (World Health Organization) and each procedure has a point value. Acute inpatient care is financed through the implementation of a system similar to the American Diagnosis Related Groups (DRG): Homogén Betegségcsoportok, further referred to as HBCS. The Hungarian HBCS system has its own characteristics. The cost calculation of acute hospital care started in the late 1980s and it is based on representative studies carried out in the hospital sector. The regular application of the HBCS system started in July, 1993. The disease groups reflect the epidemiological characteristics of the Hungarian population. The Hungarian HBCS system covers all the costs occurring during hospital care, including diagnosis and therapy, drugs, wages (doctors, nurses, etc.), accommodation costs (heating, cleaning, meals, etc.) and costs of hospital management except for investment costs. In 2004, in addition to the activity based fee-for-service (in Hungary it is called as German point) payment system in out-patient care and to the DRG like financing technique in acute hospital care, the so-called Performance Volume Limit (PVL) (Teljesítmény Volumen Korlát) was introduced forming an artificial financial cap for the activity based financing of the Hungarian hospitals. Introduction, Institutionalization, Training and Education of HTA In Hungary; 1993-2004 Following the establishment of the Hungarian Coordinating Office for Health Technology Assessment (1993), the Hungarian Society for Health Technology Assessment (1996) was formed and then the Journal of the Hungarian Society for Health Technology Assessment (1997) came into life. Those were motivated health care professionals, practicing physicians, nurses, staff members of the NHIFA and other professionals who set up these organizations and maintained their activities on non-governmental basis sponsored by various national and international organizations. This was a typical ‘low budget – high motivation’ project; nobody helping the cause of the HTA movement in its early phase received remuneration as a reward for their work. The Research Centre of Health Economics and Health Technology Assessment of Corvinus University Budapest (formerly named as research unit) has been the member of INAHTA (International Network of Agencies in Health Technology Assessment) since 2001 under the name HunHTA. At this research center courses on HTA (as well as health economics and health policy and financing) started in 1997 and since 2002 it has been an elective major. The PhD program in health technology assessment (and health economics) started in 2001. In 2002, the Ministry of Health released guidelines for conducting health economic analyses. These guidelines determine the methodological issues of health economic evaluations. The following milestone was passed when the Hungarian Health Economics Association was set up in 2003. HTA in Practice; 2004-2009 On May 1, 2004, Hungary joined the European Union, hence it was necessary to adopt the EU Transparency Directive. Based on the introduction of the Transparency Directive, decisions on pricing and reimbursement of drugs are made in accordance with the regulations and practices of the EU. In 2004, some important steps were taken whereby the government officially recognized the importance of the results from health economics analyses and HTA. The Transparency Secretariat named after the European Transparency Directive and Technology Appraisal Committee (TAC) was formed the same year at the NHIFA by the NHIFA and Ministry of Health to assess the therapeutic value, or clinical benefits of drugs and to compare them with existing therapies to prepare decisions on reimbursement applications. TAC members are delegated by the major stakeholders. Also in 2004, The National Institute for Strategic Health Research of the Ministry of Health (NISHR) (Egészségügyi Stratégiai Kutatóintézet) was established, which assists with decision making in four major areas of health policy and financing: medical informatics and information policy, health economics, health services research and health technology assessment. The latter one, the Office of Health Technology Assessment (OHTA) has the task of providing an organizational framework for technology assessment, which serves as the basis for the medicine subsidy approval policy of the NHIFA, and performing the related medical and economic assessment duties. Results from this governmental HTA evaluation agency are the input for the TAC. TAC puts forward proposals on classifying drugs in reimbursement categories. As a result of this development Hungary has moved towards introducing the ‘Fourth Hurdle’ for pharmaceuticals. Reimbursement and Pricing Approval Process Reimbursement Process The application for reimbursement procedure [Figure 1] can be started by external application, submitted by the holder of the marketing authorization or ex-officio, launched by the NHIFA. In general, the manufacturer submits a reimbursement dossier to the Transparency Secretariat of the NHIFA. The transparency Secretariat makes the registration, administrative check, decision on the type of procedure (normal vs. simplified) and follow-up. Department of Pharmaceuticals of NHIFA makes a pre-appraisal. Afterwards, the Office of Health Technology Assessment (OHTA) at the National Institute for Strategic Health Research makes a critical appraisal based on the submitted dossier (only in the case of a regular procedure). This appraisal is forwarded to the TAC, which proposes a decision to the head of Department of Pharmaceuticals of NHIFA. The Head of Department of Pharmaceuticals of NHIFA decides about reimbursement and will publish the official decision. (Figure 1) Seeking legal remedy against the decision (Department of Pharmaceuticals of NHIFA) is an option of the director general of NHIFA (within 15 days). Remedies must be submitted to the Transparency Superior Secretariat of the NHIFA, which is responsible for the registration, administrative check and follow up of it. The Appeal Committee, consisting of delegates from: Ministry of Health, Ministry of Finance, Ministry of Economy, National Institute of Pharmacy, and Prime Minister’s Office makes a proposal to the director general of NHIFA, who decides about legal remedy within 60 days. Figure 1.
Hungarian Guidelines for Economic Evaluation of Health Care TechnologiesGuideline 1: Description of health care technology (health care service) and patient population to be addressed in the analysis Source: Hungarian Guidelines for economic evaluation of health care technologies, Official Gazette of the Ministry of Health, Hungary (Egészségügyi Közlöny) 2002;11:3-1520. Acronyms
HunHTA: the Research Centre of Health Economics and Health Technology Assessment of Corvinus University Budapest Reimbursement Organizations/HTA Organizations NISHR: The National Institute for Strategic Health Research of the Ministry of HealthOHTA: Office of Health Technology Assessment TAC: Technology Appraisal Committee Suggested Reading
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