@rki.krtk.hu
Transdanubian Research Department
Institute for Regional Studies
Economist (2009) - University of Pécs, Hungary
Finance, Geography, Planning and Development, Economics, Econometrics and Finance
Scopus Publications
Scholar Citations
Scholar h-index
Scholar i10-index
Ágota Mészáros, Sándor Kovács, Tibor Héja, Zsolt Bagyura, and Antal Zemplényi
Springer Science and Business Media LLC
Abstract Background Data harmonisation is essential in real-world data (RWD) research projects based on hospital information systems databases, as coding systems differ between countries. The Hungarian hospital information systems and the national claims database use internationally known diagnosis codes, but data on medical procedures are recorded using national codes. There is no simple or standard solution for mapping the national codes to a standard coding system. Our aim was to map the Hungarian procedure codes (OENO) to SNOMED CT as part of the European Health Data Evidence Network (EHDEN) project. Methods We recruited 25 professionals from different specialties to manually map the procedure codes used between 2011 and 2021. A mapping protocol and training material were developed, results were regularly revised, and the challenges of mapping were recorded. Approximately 7% of the codes were mapped by more people in different specialties for validation purposes. Results We mapped 4661 OENO codes to standard vocabularies, mostly SNOMED CT. We categorized the challenges into three main areas: semantic, matching, and methodological. Semantic refers to the occasionally unclear meaning of the OENO codes, matching to the different granularity and purpose of the OENO and SNOMED CT vocabularies. Lastly, methodological challenges were used to describe issues related to the design of the above-mentioned two vocabularies. Conclusions The challenges and solutions presented here may help other researchers to design their process to map their national codes to standard vocabularies in order to achieve greater consistency in mapping results. Moreover, we believe that our work will allow for better use of RWD collected in Hungary in international research collaborations.
Róbert György Vida, Eszter Sághy, Richárd Bella, Sándor Kovács, Dalma Erdősi, Judit Józwiak-Hagymásy, Antal Zemplényi, Tamás Tényi, Péter Osváth, and Viktor Voros
Springer Science and Business Media LLC
Abstract Background Several meta-analyses demonstrated the efficacy of unilateral High-Frequency Left-sided (HFL) repetitive Transcranial Magnetic Stimulation (rTMS) for individuals with Major Depressive Disorder (MDD); however, results are contradictory due to heterogeneity of the included studies. Methods A systematic literature review (SLR) of English language articles published since 2000 was performed in March 2022 on PubMed and Scopus databases. Empirical evidence on the relative efficacy of rTMS treatment compared with standard pharmacotherapy in Treatment-Resistant Depression (TRD) were extracted. Random effects models were used to assess the effects of rTMS on response and remission rates. Results 19 randomized double-blinded sham-controlled studies were included for quantitative analysis for response (n = 854 patients) and 9 studies for remission (n = 551 patients). The risk ratio (RR) for response and remission are 2.25 and 2.78, respectively for patients after two treatment failures using rTMS as add-on treatment compared to standard pharmacotherapy. Cochrane’s Q test showed no significant heterogeneity. No publication bias was detected. Conclusions rTMS is significantly more effective than sham rTMS in TRD in response and remission outcomes and may be beneficial as an adjunctive treatment in patients with MDD after two treatment failures. This finding is consistent with previous meta-analyses; however, the effect size was smaller than in the formerly published literature.
Antal Zemplényi, Judit Józwiak-Hagymásy, Sándor Kovács, Dalma Erdősi, Imre Boncz, Tamás Tényi, Péter Osváth, and Viktor Voros
Springer Science and Business Media LLC
Abstract Background The cost-effectiveness of treatment strategies for patients with Major Depressive Disorder (MDD) who have not responded to two adequate treatments with antidepressants (TRD) are still unclear. The aim of this analysis was to evaluate the cost-effectiveness of add-on repetitive Transcranial Magnetic Stimulation (rTMS) compared with standard treatment. Methods A Markov-model simulated clinical events over one year from the perspective of healthcare payer. Third- and fourth-line treatment pathways (augmentation, antidepressant switch or combination, and Electro-Convulsive Therapy (ECT)) were defined based on medical practice guidelines. Transition probabilities were derived from a recent meta-analysis and scientific publications. Resource utilization and cost estimates were based on the patient-level database of a large university hospital. Results Incremental Quality-Adjusted Life Years (QALYs) and costs were 0.053 and 785 €, respectively, corresponding to an Incremental Cost-Effectiveness Ratio (ICER) of 14,670 € per QALY. The difference in cost between standard treatment and rTMS is explained by the rTMS sessions used in acute (€660) and maintenance (€57/month) treatments, partly offset by lower hospital costs due to higher remission rates in the rTMS arm. Key parameters driving the ICER were incremental utility of remission, unit cost of rTMS treatment and remission rate. At a threshold of €22,243 add-on rTMS is a cost-effective alternative to pharmacotherapy. Evidence on long-term effectiveness is not yet available, so results are estimated for a one-year period. Conclusion Not only does rTMS treatment have beneficial clinical effects compared with drug therapy in TRD, but it also appears to offer good value-for-money, especially in centres with larger numbers of patients where unit costs can be kept low.
Sandor Kovács, Zoltán Kaló, Rita Daubner‐Bendes, Katarzyna Kolasa, Rok Hren, Tomas Tesar, Vivian Reckers‐Droog, Werner Brouwer, Carlo Federici, Mike Drummond,et al.
Wiley
AbstractExperiences with coverage with evidence development (CED) schemes are fairly limited in Central and Eastern European (CEE) countries, which are usually late adopters of new health technologies. Our aim was to put forward recommendations on how CEE health technology assessment bodies and payer organizations can apply CED to reduce decision uncertainty on reimbursement of medical devices, with a particular focus on transferring the structure and data from CED schemes in early technology adopter countries in Western Europe. Structured interviews on the practices and feasibility of transferring CED schemes were conducted and subsequently, a draft tool for the systematic classification of decision alternatives and recommendations was developed. The decision tool was reviewed in a focus group discussion and validated within a wider group of CEE experts in a virtual workshop. Transferability assessment is needed in case of (1) joint implementation of a CED scheme; (2) transferring the structure of an existing CED scheme to a CEE country; (3) reimbursement decisions that are linked to outcomes of an ongoing CED scheme in another country and (4) real‐world evidence transferred from completed CED schemes. Efficient use of available resources may be improved by adequately transferring evidence and policy tools from early technology adopter countries.
Michael Drummond, Carlo Federici, Vivian Reckers‐Droog, Aleksandra Torbica, Carl Rudolf Blankart, Oriana Ciani, Zoltán Kaló, Sándor Kovács, and Werner Brouwer
Wiley
AbstractHealth economists have written extensively on the design and implementation of coverage with evidence development (CED) schemes and have proposed theoretical frameworks based on cost‐effectiveness modeling and value of information analysis. CED may aid decision‐makers when there is uncertainty about the (cost‐)effectiveness of a new health technology at the time of reimbursement. Medical devices are potential candidates for CED schemes, as regulatory regimes do not usually require the same level of efficacy and safety data normally needed for pharmaceuticals. The purpose of this research is to assess whether the actual practice of CED for medical devices in Europe meets the theoretical principles proposed by health economists and whether theory and practice can be more closely aligned. Based on decision‐makers' perceptions of the challenges associated with CED schemes, plus examples from the schemes themselves, we discuss a series of proposals for assessing the desirability of schemes, their design, implementation, and evaluation. These proposals, while reflecting the practical challenges with developing CED programs, embody many of the principles suggested by economists and should support decision‐makers in dealing with uncertainty about the real‐world performance of devices.
Sándor Kovács, Bertalan Németh, Dalma Erdősi, Valentin Brodszky, Imre Boncz, Zoltán Kaló, and Antal Zemplényi
Springer Science and Business Media LLC
Péter Vajda, Katalin Richter, Zsolt Bodrogi, Robert G Vida, Lajos Botz, Sándor Kovács, Antal Zemplényi, Richárd Bella, and Andras Fittler
BMJ
Objectives, setting and participantsIn July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies.DesignA 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period.ResultsOur representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as €2173, on average (SD: €3366) and the median was €1506 (range: €0–€20 723). The total IT investment cost per institution was valued at €1410 (SD: €335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size.ConclusionsNotably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.
András Inotai, Tamás Ágh, Ramona Maris, Dalma Erdősi, Sándor Kovács, Zoltán Kaló, and Elżbieta Senkus
Elsevier BV
Carlo Federici, Vivian Reckers-Droog, Oriana Ciani, Florian Dams, Bogdan Grigore, Zoltán Kaló, Sándor Kovács, Kosta Shatrov, Werner Brouwer, and Michael Drummond
Springer Science and Business Media LLC
Abstract Objectives Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization. Methods We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years. Results We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion. Conclusions CED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.
Rita Daubner-Bendes, Sándor Kovács, Maciej Niewada, Mirjana Huic, Michael Drummond, Oriana Ciani, Carl Rudolf Blankart, Olena Mandrik, Aleksandra Torbica, John Yfantopoulos,et al.
Frontiers Media SA
Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.
Benedetta Pongiglione, Aleksandra Torbica, Hedwig Blommestein, Saskia de Groot, Oriana Ciani, Sarah Walker, Florian Dams, Rudolf Blankart, Meilin Mollenkamp, Sándor Kovács,et al.
Cambridge University Press (CUP)
Abstract Aim Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? Methods We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. Results We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. Conclusions RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.
Sándor Kovács, Márton Tóth, József Janszky, Tamás Dóczi, Dániel Fabó, Imre Boncz, Lajos Botz, and Antal Zemplényi
Elsevier BV
Marton Toth, Kata Szilvia Papp, Noemi Gede, Kornelia Farkas, Sandor Kovacs, Jean Isnard, Koichi Hagiwara, Csilla Gyimesi, Diana Kuperczko, Tamas Doczi,et al.
Elsevier BV
Sándor Zsolt Kovács
Hungarian Central Statistical Office