PE Guidelines logo

Pharmacoeconomic Guidelines Around The World

Country/Region: Hungary

Published PE Recommendations
Az Emberi Eroforrások Minisztériuma szakmai irányelve az egészségügyi technológia értékelés módszertanáról és ennek keretében költséghatékonysági elemzések készítésérol (The Technical Guideline on the Methodology of Health-Economic Analyses and Conducting Cost-Effectiveness Analyses by the Ministry of Human Resources) Egészségügyi Közlöny 2017/3. 821-842.
Guideline (in Hungarian)
Guidelines (in English)

Published PE Recommendations Source:
Ministry of Human Resources

Additional Information:
Szende A, Mogyorosy Z, Muszbek N, Nagy J, Pallos G, Dozsa C. Methodological guidelines for conducting economic evaluation of healthcare interventions in Hungary: A Hungarian proposal for methodology standards. Eur J Health Econom 2002, 3:196–206.

Last Webpage Update: Friday, January 12, 2018

Published PE Recommendations Key Features:
Key Features:  
Title and year of the documentAz Emberi Eroforrások Minisztériuma szakmai irányelve az egészségügyi technológia értékelés módszertanáról és ennek keretében költséghatékonysági elemzések készítésérol The Technical Guideline on the Methodology of Health-Economic Analyses and Conducting Cost-Effectiveness Analyses by the Ministry of Human Resources) Egészségügyi Közlöny (2017)  
Affiliation of authorsISPOR Hungary Chapter / Hungarian Health Economics Association (META), National Institute of Pharmacy and Nutrition - Department of Health Technology Assessment (OGYÉI-TEI), Experts from the public sector, private sector and academia 
Purpose of the documentTo support the decision-making process with sound cost/effectiveness data and good quality economic studies  
Standard reporting format includedNo complete reporting format is defined in the Guideline, however it includes several tables that can be used to report certain parts (e.g. clinical studies, cost elements) of the analysis in a transparent and clear way.  
DisclosureFinancial disclosure from the analysts is not explicitly mentioned in the Guideline, however it is a requirement for formal reimbursement submissions.  
Target audience of funding/ author’s interestsManufacturers, sponsors, health providers, policy makers, and purchasers of health care services 
PerspectiveThe perspective of the analysis should adhere to the audience to whom the analysis is addressed. Payer's perspective is recommended in most cases, that can be supplemented with an analysis conducted from societal perspective. If analyses were conducted from more than one perspective, those should be reported separately. 
IndicationThe indication used in the analysis should be a licensed one - In other cases (e.g. Off-label use), the indication should be justified  
Target populationThe target populaton should be defined.  
Subgroup analysisIf subgroup analyses are conducted, the subgroups should be pre-defined clearly, based on biological or clinical criteria.  
Choice of comparatorThe comparator should be the current accepted standard therapy that could be replaced by the new health technology. If comparison with multiple health technologies can be justified, supplementary analyses can be conducted. If the standard therapy can be selected from multiple alternatives, the weighted average of the prices (using the market share as weights), or the lowest of the prices can be applied. The selection of the comparator should always be justified. 
Time horizonThe time horizon should be long enough to cover all significant clinical and cost consequences that are directly related to the intervention. If the time horizon is several decades long, results should be presented on shorter time horizons as well, as a form of scenario analyses.  
Assumptions requiredThe assumptions used in the analysis should be clearly defined and justified.  
Preferred analytical techniqueThe preferred method is cost-utility analysis (CUA), which can be supplemented with a cost-effectiveness analysis (CEA). If justified, cost-minimization analysis (CMA), cost-consequences analysis (CCA) or cost-benefit analysis (CBA) can also be chosen.  
Costs to be includedIf the study was conducted from a payer's perspective, only direct costs should be included. In analyses conducted from the societal perspective, indirect costs should also be included.  
Source of costsThe source of costs should be clearly stated in the analysis. If the study is conducted from the perspective of the payer, the publicly available costs of health technologies and services should be used in the analysis.  
ModelingModeling should be used to analyze costs and outcomes.  
Systematic review of evidencesSystematic review of evidences is preferrred.  
Preference for effectiveness over efficacyEffectiveness data (when available) is preferred over efficacy data.  
Preferred outcome measureAs cost-utility analysis (CUA) is the preferred type of analysis in most cases, the final outcomes should be presented in Quality-Adjusted Life Years (QALYs). Other outcomes can be used for different types of analyses, like Life Years Gained (LYG) or other clinically relevant outcome variables. 
Preferred method to derive utilityIt is preferred to use Hungarian health-related quality of life (HRQoL) data gathered by using validated versions of questionnaires. If such data is not available, HRQoL data gathered from other European countries can be used.  
Equity issues statedIt is advised to assess the equity issues related to the health technology in question.  
Discounting costsBase-case: 3.7%; Sensitivity Analysis (SA): 2-5%    
Discounting outcomesBase-case: 3.7%; Sensitivity Analysis (SA): 0-5%   
Sensitivity analysis-parameters and rangeSensitivity analyses should be conducted on all uncertain parameters. The range applied in the case of each parameter should be described properly. Ranges should be selected to be meaningful from a real-life perspective.  
Sensitivity analysis-methodsDeterministic (DSA) and probabilistic (PSA) sensitivity analyses can be used with proper documentation of the methodology. The results of the senstivity analyses should be described properly. The results of the DSA can be presented on a tornado diagram, while the results of the PSA can be presented on a scatter plot and a cost-effectiveness acceptability curve (CEAC).  
Presenting resultsFor clarity, reproducibility, and future use of data, results of total and incremetal costs, total and incremental outcomes should be clearly stated, along with the ICER (if applicable to the type of analysis).  
Incremental analysisAssessing incremental costs and outcomes is preferred.  
Total costs vs effectiveness (cost/effectiveness ratio)As the preferred type of analysis is the cost-utility analysis (CUA) that can be supplemented with a cost-effectiveness analysis (CEA), the preferred outcome is the ICER.  
Portability of results (Generalizability)The generalizability of the results should be assessed.  
Financial impact analysisBudget impact over the next 3- to 5- year period should be estimated.  
Mandatory or recommended or voluntaryIt is strongly recommended to conduct analyses according to the guideline.  

Acknowledgement: Bertalan Németh, MSc, Senior Health Economist, Syreon Research Institute and Laszlo Nagyjanosi, MSc, Head of HTA Department, National Institute of Pharmacy and Nutrition (OGYÉI), Budapest, Hungary, contributed to the key feature form.

Country Selection Page  |  PE Guidelines Index Page