Hungary, with a population of 9.9 million, is a Central-Eastern European country with 7 regions. The Hungarian health care system is financed via a mixed system -- both through taxes and the social insurance funds of the National Health Insurance Fund (NHIF) – and can be described as a mandatory public health insurance system. The number of health insurance contributors is slightly below 4 million (3.9 million, 2013) , while the availability of health service is granted to almost the entire population (e.g., pensioners, mothers on maternity leave, full time students, infants etc.). Non-mandatory private health insurance is marginal. In 2011, the number of hospitals in Hungary was 173  with a majority of these being state owned and generally financed through a diagnostic related group (DRG) system. Out of pocket health care expenditure was about 2.5-3% of GDP, and a majority was for pharmaceutical co-payment .
Compared to other high income OECD countries, Hungary has relatively low public health care spending at 5-6% of GDP (5.03% of GDP in 2011) . The share of total health care expenditure between 2001 and 2011 of the Hungarian GDP was around 7.5-8.5% (Figure 1) (7.76% in 2011). Differences are due to health policy decision making and changes in denominator (e.g., GDP). In 2011, public pharmaceutical expenditure, taking into account the mandatory payback from manufacturers, was 1.1% of the GDP while the share of the total pharmaceutical expenditures was 2.3% of the GDP . However, comparing the value of pharmaceutical expenditure with other countries should be handled with care due to methodological difficulties and differences.
Figure 1. Public and total health care expenditure as % of GDP
The State Secretary of Health (SSH), formally known as the Ministry of Health, is responsible for operating the centralised Hungarian Health Care System, including strategic planning, and developing health policy. The SSH regulates the National Health Insurance Fund (NHIF), which is responsible for the allocation of the health insurance budget, and the National Institute for Quality and Organisational Development in Health Care and Medicines, responsible for the national marketing authorization approval of new medicines and the health technology assessment (HTA). Health services are financed primarily through the NHIF and are run by the Fund's administration system. The annual budget of the NHIF is prepared by the Ministry for National Economy, in consultation with the SSH and the NHIF, and is approved by Parliament.
DECISION MAKERS INTERRELATION DIAGRAM
DECISION MAKERS AND INFLUENCERS
Ministry for National Economy
State Secretary of Health (SSH)
National Health Insurance Fund (NHIF)
Health Technology Assessment Committee (HTAC)
National Institute for Quality and Organizational Development in Healthcare and Medicines
Health Technology Assessment Office (HTA Office)
National Pharmaceutical Therapeutic Committee The National Pharmaceutical Therapeutic Committee is responsible for the development and management of the list of essential hospital medicines, purchasing and usage of these medicines. National Pharmaceutical Therapeutic Committee produces background analyses in order to support appropriate therapeutic practice.
Professional Council There are 60 independent professional councils established to support the decision making of the SSH. Professional councils are involved in the development of therapeutic and methodological guidelines. They also participate in the committees and bodies involved in the pharmaceutical reimbursement process.
Parliament The major nationwide legislative body is Parliament, which evaluates and approves any health care legislation.
The National Institute for Quality and Organisational Development in Health Care and Medicines is responsible for the approval of new medicines in the national marketing authorization procedure.
During the process of marketing authorization, the quality, safety, and efficacy of a new medicinal product are assessed by either the National Institute for Quality and Organizational Development in Health Care and Medicines or the European Medicines Agency - Committee for Medicinal Products for Human Use (EMEA-CHMP).
Pricing and reimbursement decisions for new drugs are initiated by the marketing authorization holder of the product. The final reimbursement decision is made by the Director-General of the NHIF taking into consideration the recommendation of the HTAC. The recommendation of the HTAC is not obligatory; the final reimbursement decision could be contrary to the recommendation of the HTAC. However, in certain cases legislation changes are needed or a new indication point needs to be created that involves the SSH and the Ministry for National Economy in the decision-making process.
Indication labels for reimbursement are announced in a ministerial decree. New therapies aiming for reimbursement requires legislation modification as a new therapeutic indication, as well as the approval of the two authorities, SSH and the Ministry for National Economy. Decisions are substantiated by relative effectiveness and pharmacoeconomic data as well as budget impact calculations. The primary source of this information is the manufacturer's submission (Single HTA process). This information is evaluated by the HTA Office from both a medical and economic perspective . Also required in the decision-making process is the expert opinion of the corresponding professional councils; this includes a recommendation for the indication and estimations for the potential number of eligible patients.
There are several criteria which are taken into consideration in the pharmaceutical reimbursement decision.
The applicant is informed about the decision on reimbursement. For products which have a new active substance that apply for reimbursement in the preferential reimbursement categories, a reimbursement volume agreement must be contracted.
The time-frame for decision making for the normal procedure is 90 days, but an additional 90 days are available for decree-modification if needed. The suspension of the process can be initiated either by the NHIF or the manufacturer. If this occurs, decision making may take much more time . With the simplified procedure, the NHIF decides within 60 days.
In 2013, a special HTA committee, the HTA Committee for products reimbursed with itemised reimbursed technique was established in order to evaluate pharmaceuticals applying for itemised/case-by-case reimbursement (special reimbursement technique). These high-price innovative products are generally for inpatient use, requiring additional budget and legislative adjustments. Consequently the SSH and Ministry for National Economy dominate these negotiations.» TO TOP
REIMBURSEMENT AND PRICING APPROVAL PROCESS
The law in Hungary differentiates between simplified and normal reimbursement procedures. The simplified procedure is applicable for new generics and combinations as well as already reimbursed pharmaceutical products with new packaging. Aside from the previously mentioned cases, the normal procedure is applicable requiring a health technology assessment (see figure 3). The normal reimbursement procedure is applicable for all new agents (both in- and out-patient), when applying for a price increase, for reimbursement of an agent for a new indication, or a new route of administration. In case the application for reimbursement is classified in the normal procedure, manufacturers are obligated to submit clinical and economic evidence to the Department of Reimbursement of the NHIF. The Department of Reimbursement forwards the submitted documents to the HTA Office. The submissions should normally include an assessment of both clinical and economic evidence and relevant studies regarding the health technology being assessed. The decision is influenced by the factors described in the “Data Requirements” section (i.e., budget impact, clinical evidence, cost effectiveness etc.). Following the critical evaluation of the HTA Office, the preliminary opinion of the NHIF, and the expert opinion of the Professional Councils, the HTAC recommends whether a technology should or should not be reimbursed. After consideration of the recommendation of the HTAC, the final decision can be made by the NHIF.
The above-mentioned classification is based on the pharmaceuticals' anatomical, therapeutic and chemical (ATC) code: the level of reimbursement is officially determined on ATC level 4, regulated in the relevant decree. In the ATC classification system, the drugs are divided into different groups according to the organ or system on which they act, as well as their chemical, pharmacological, and therapeutic properties. Drugs are classified into five different levels . The 2nd, 3rd, and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups .
In indication-linked reimbursement, the indications are defined in indication points. In the case of innovative therapies, there is a possibility to ask for defining a new indication point for the therapy.
Pharmaceuticals in inpatient care have 100% reimbursement.
Financial protocols could be applied mainly in cases of high cost therapies. The financial protocols are initiated by the NHIF in order to ensure the proper financial planning of expenditures in the specific therapeutic area. The relevant professional council, the HTA Office, the SSH, and the National Pharmaceutical Therapeutic Committee are involved in the development of a financial protocols process.
ATC: anatomical, therapeutic and chemical
Inotai A, Pékli M, Jóna G, Nagy O, Remák E, Kaló Z. Attempt to Increase the Transparency of Fourth Hurdle Implementation in Central-Eastern European Middle Income Countries: Publication of the Critical Appraisal Methodology. BMC Health Serv Res 2012; 12: 332 DOI: 10.1186/1472-6963-12-332
Kaló Z, Bodrogi J, Boncz I, Dózsa CS, Jóna G, Kövi R, Pásztélyi ZS, Sinkovits B. Capacity Building for HTA Implementation in Middle-Income Countries: The Case of Hungary. Value in Health Regional Issues 2013; 2(2) 264-266
Overview of the Hungarian pharmaceutical reimbursement systems
Hungarian Health Economics Association/ISPOR Hungary Chapter website
National Institute for Quality and Organisational Development in Health Care and Medicines
AUTHORS & CONTRIBUTORS
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