Global Health Technology Assessment Road Maps

Hungary - Pharmaceutical


Updated: May 2014
Validated by: Judit BIDLÓ, Reimbursement Department, NHIF
Bertalan NÉMETH, Health Economist, HTA Office, National Institute for Quality and Organizational Development in Healthcare and Medicines

Hungary Map

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BACKGROUND

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) [1], 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 [2] 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 [3].

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) [3]. 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 [4]. 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
Public and total health care expenditure
Source: World Health Organization Regional Office for Europe. HFA-DB [3]

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.

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DECISION MAKERS INTERRELATION DIAGRAM

Decision makers interrelation diagram
Figure 2: Decision makers interrelation diagram
*See Figure 3: Reimbursement and pricing approval process


Model description and Symbols:
The ultimate decision maker is listed at the top of the model

Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision

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DECISION MAKERS AND INFLUENCERS

Ministry for National Economy
Pharmaceuticals, depending on whether they are prescribed for outpatient or inpatient care, are reimbursed with various techniques from different dedicated budgets and are allocated by the Ministry for National Economy.

State Secretary of Health (SSH)
The SSH is responsible for the development and regular revision of the various therapeutic and methodological guidelines (i.e. Guideline for the Development of Health Economic Analyses). Also involved in this process is the relevant professional council which prepares the proposal for the SSH. Together with the Ministry for National Economy, the SSH has a major impact on the system for reimbursement of pharmaceuticals through developing, improving and revising the laws and decrees, in cooperation with the NHIF. The representatives of these governmental organisations are members in several committees which discuss and decide about the reimbursement of pharmaceuticals (i.e., Health Technology Assessment Committee (HTAC), National Pharmaceutical Therapeutic Committee).

National Health Insurance Fund (NHIF)
This is an independent administrative organisation under the supervision of the (SSH). The NHIF directs the administrative functions of the insurance system and controls the calculation and payment of benefits. Additional responsibilities of the NIHF are implementing the interstate agreements regarding health insurance, collecting, processing and analysing the statistical data on the health insurance system, and operating the database of the health insurance system.
The NHIF is led by a Director General, who is responsible for the administration of the central and regional health insurance fund offices. The Director General is appointed by the government.

Department of Reimbursement
Within the NHIF, the Department of Reimbursement is responsible for supporting the decision making regarding pricing and reimbursement.

Health Technology Assessment Committee (HTAC)
Appointed by the Director-General of the NHIF – the HTAC is responsible for evaluating the reimbursement applications after receiving the assessment report prepared by the HTA Office. In the HTAC all major stakeholders involved in the decision making process are represented (e.g., representatives of NHIF, Medical Professional Council, Ministry for National Economy, State Secretary of Health, HTA Office).

National Institute for Quality and Organizational Development in Healthcare and Medicines
The new methodological center was established on May 1, 2011 by the merger of several former health policy institutions, including the National Institute for Strategic Health Research and the National Institute for Pharmacy. The National Institute for Quality and Organizational Development in Healthcare and Medicines' major task is the preparation of the national strategy for health care quality improvement and patient safety.

Health Technology Assessment Office (HTA Office)
The HTA Office was founded in 2004 as a Department of the National Institute of Strategic Health Research. Similarly to other EU member states, the aim of establishing an HTA institute in Hungary was to create an independent institution in order to support decision makers in rational and efficient use of scarce resources, by providing analyses and recommendations. In 2011 the Health Technology Assessment Office was integrated into the National Institute for Quality and Organizational Development in Healthcare and Medicines.
The main tasks of the HTA Office are the health technology assessment of pharmaceuticals and medical devices, participation in EUnetHTA, consultancy with NHIF regarding finance protocols, and consultancy with SSH and providing expert opinion on special issues related to HTA.

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.

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DECISION-MAKING PROCESS

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).
There are four types of procedures to issue a marketing authorization in Hungary – as it is common in the EEA (European Economic Area) as well:

  • Centralized Procedure: the documentation of the new product is assessed by the EMEA-CHMP; the authorization is issued by the European Commission.
  • Decentralized Procedure (DCP): the new product has not been authorized in any European countries at the time the application is submitted; the Directorate of National Institute for Quality and Organizational Development in Healthcare and Medicines is entitled to assess the documentation and to issue the marketing authorization.
  • Mutual Recognition Procedure (MRP): the new product has been authorized in at least one European country at the time of application submission. The National Institute for Quality and Organizational Development in Healthcare and Medicines is entitled to assess the documentation and to issue the marketing authorization.
  • National Procedure: assessment is carried out by the National Institute for Quality and Organizational Development in Healthcare and Medicines; the marketing authorization is valid only in Hungary [5].

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 [6]. 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.

  • Product-specific criteria:
    • medical and therapeutic value
    • safety
    • lack of alternative therapies
    • prescription status
  • Economic criteria:
    • cost-effectiveness
    • reference price
    • budget impact
  • Patient and disease-specific criteria (e.g., age, sex, chronic or terminal illness, severity of illness, special medical needs, etc.)

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 [7]. 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.

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REIMBURSEMENT AND PRICING APPROVAL PROCESS

 Reimbursement and pricing approval process
Figure 3: 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.

Pricing:
A drug with a new chemical substance can get reimbursement only at the minimum European price level. In this comparison, all EU member states as well as Norway, Switzerland, Iceland, and Lichtenstein are considered. Additionally, an important mandatory condition for reimbursement is the price volume agreement. There are four different types of these agreements:

  • Reimbursement Cap, in which after reaching the preliminarily defined volume the manufacturer has to pay back the surplus to the health insurance fund;
  • A Claw Back, which is defined as a certain percentage of the reimbursement;
  • Outcome-Based Agreement, in which the reimbursement is paid by the NHIF only if certain outcome criteria are fulfilled; and
  • Compliance-Based Agreement, in which the criterion for reimbursement is the improvement of compliance – in practice this type of price volume agreement is not common.

Generics pricing:
In the case of generics reimbursement, the NHIF is expecting a minimum price reduction; there is an expected minimum of a 40% price reduction from the first generic product, and an additional 20% reduction from the second generic product (as compared to the first generic product's price level). Further expected reductions are: 10%, 5%, 5%, 5% compared to previous generic products' price levels. For biosimilar products, these rates are 30%, 10%, and 10%.

Reimbursement levels:
The reimbursement levels are established according to the specifications of the therapies; the more chronic and severe the disease, the higher the reimbursement level. There are two major types of reimbursement techniques in outpatient care:

  • Normative reimbursement, with general prescription rights for all physicians in all indications listed in the Summary of Product Characteristic (SMPC), at levels of 25%, 55%, 80%; and
  • Indication-linked reimbursement, which restricts reimbursement to only:
    • certain professionals who can prescribe the drug,
    • granted in a subset of authorized indication,
    • granted if the conditions defined by the payer are met. The level of reimbursement is 50%, 70%, 90%, and 100%.

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 [8]. The 2nd, 3rd, and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups [9].

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.

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DATA REQUIREMENTS

  1. Marketing Authorization, Summary of Product Characteristic (SMPC)
  2. Application form
    • technical characteristics (e.g., strength, package size, ATC, price, foreign prices, applied indication)
    • list of scientific publications
    • summary of relevant pivotal clinical trials
    • health economic evaluation: cost effectiveness report, optionally health economic model
    • budget impact report, optionally budget impact model
    • summary of relevant pharmacoeconomic studies
    • epidemiology (eligible patients in the targeted indication, incidence, prevalence)
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ACRONYMS

ATC: anatomical, therapeutic and chemical
DCP: Decentralized Procedure
DRG: diagnostic related group
EEA: European Economic Area
EMEA-CHMP: European Medicines Agency - Committee for Medicinal Products for Human Use
EU: European Union
GDP: gross domestic product
HTA: health technology assessment
HTAC: Health Technology Assessment Committee
MRP: Mutual Recognition Procedure
NHIF: National Health Insurance Fund
OECD: Organisation for Economic Co-operation and Development
SMPC: Summary of Product Characteristic
SSH: State Secretary of Health

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SUGGESTED READING

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

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USEFUL LINKS

Overview of the Hungarian pharmaceutical reimbursement systems
http://www.i-s.hu/pdf/Overview-Hungarian-Reimbursement-System-EMAUD.pdf

Hungarian Health Economics Association/ISPOR Hungary Chapter website
http://www.metaweb.hu

National Institute for Quality and Organisational Development in Health Care and Medicines
http://www.gyemszi.hu

HTA Office
http://www.eski.hu/new3/technologia_en/technologia_en.php

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REFERENCES

  1. Hungarian Central Statistical Office
    http://www.ksh.hu/employment [Accessed online: 2013.12.2.]
  2. National Health Insurance Fund (2012) [in Hungarian] OEP Gyógyinfók 2012 http://www.gyogyinfok.hu/magyar/archiv/betegforgalmi/2011/korhazi_agyszam2011.pdf
  3. World Health Organization Regional Office for Europe. European health for all databases (HFA-DB). http://www.euro.who.int/hfadb [Accessed online: 2013.09.20.]
  4. [in Hungarian] Kaló Z, Merész G, Mezei D, Tótth Á, Inotai A. A Széll Kálmán Terv gyógyszerágazati fejezetének szakmai megalapozottsága és következményei. IME Az egészságügyi vezetõk szaklapja 2012; 11: 12-16.
  5. National Institute of Pharmacy
    http://www.ogyi.hu/uj_beadvany_en/ [Accessed online: 2013.12.2.]
  6. 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
  7. Kaló Z, Boncz I, Inotai A. Implications of Economic Crisis on Health Care Decision-making in Hungary: An Opportunity to Change? Journal of Health Policy and Outcomes Research 2012; 1: 20-26
  8. The Anatomical Therapeutic Chemical Classification System with Defined Daily Doses (ATC/DDD) http://www.who.int/classifications/atcddd/en/ [Accessed online: 2013.12.2.]
  9. WHO Collaborating Centre for Drug Statistics and Methodology
    http://www.whocc.no/atc/structure_and_principles/ [Accessed online: 2013.12.2.]

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AUTHORS & CONTRIBUTORS

Authors:
András BORSI, MSc
András INOTAI, PharmD, PhD
Jónás KALMÁR, MSc
Krisztián KÁRPÁTI, PharmD
Péter RÓZSA, MSc
Balázs SINKOVITS, MSc, BSc
Gergely Balázs TÓTH, PharmD
All authors represent the ISPOR Hungary Chapter

Contributors:
Unit of Young Professionals Task Force, ISPOR Hungary Chapter, E-mail: meta@metaweb.hu

Revised and approved by:
Board of the ISPOR Hungary Chapter

 


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