Vladimír Rogalewicz

Cost-Effectiveness Studies on Medical Devices: Application in Cardiology

Current discussions about cost-effectiveness in the field of medical devices for cardiology are reviewed. In order to identify the trends, we performed a review of studies published in medical journals. After having reviewed 1143 originally identified papers, we finally selected 61 papers to be studied in detail. The selected papers are classified into two categories: diagnostic and therapeutic medical devices, while technology for telemedicine is briefly mentioned. In each category, cost-effectiveness results of chosen modalities are presented. The main trend seems to be avoiding invasive technology during the treatment. This trend is obvious both in the field of diagnostic and therapeutic devices. In CAD diagnostics, some authors try to prove that CT, PET or SPECT are more cost-effective than ICA. As compared with the classical (open chest) surgery in the past, the treatment of cardio-vascular illnesses is moving to less invasive interventions (TAVI versus SAVR is just one example).

Science versus design; comparable, contrastive or conducive?

Science and design are two completely separated areas of expertise with their own specialists. Science analyses the existing world to create new knowledge, design uses existing knowledge to create a new world. This tunnel-vision mentality and narrow-minded approach is dangerous for problem solving, where a broad view on potential solutions is required to realise a high-quality answer on the defined problem. We state that design benefits from scientific methods, resulting in a more effective design process and in better products, while science benefits from a design approach, resulting in more efficient and effective results. Our philosophy is illustrated using examples from the field of biomedical engineering. Both methods can benefit tremendously from each other. By applying scientific methods, superior choices will be made in the design process. With design, more accurate, effective and efficient science will be performed.

HTA in the Czech Republic: Still Behind

The paper analyses the current state of HTA implementation and organisational initiatives in the Czech Republic. Although there have been some substantial elements of HTA applied in the decision process of pharmaceutical reimbursement since 2008, HTA methods are rather disregarded in other technologies. Since there is practically no demand for HTA studies from payers and state representatives, HTA has been cultivated above all by interested individuals and small academic research groups around them. These groups have succeeded in keeping pace with the global development both in theoretical and practical issues (among others in HTA methods for medical devices), however, the practical production of country specific HTA studies is rather rare. The main problem is non-existence of a national commonly accepted methodology and a legal framework. At least two attempts to establish a regular HTA process initiated by the Ministry of Health were destined to fail due to frequent personal changes in the Ministry. We discuss topical issues to be solved on the way to a national HTA system, and present our vision of a possible solution.

Health technology assessment as a tool for medical devices management in hospitals

HTA has been used much less in case of medical devices than drugs or therapeutic interventions. It was shown that the problem - difficulties in evaluation of (patient-reported) quality of life - appears above all when appraising diagnostic devices, while the therapeutic ones can be assessed as a part of the entire intervention. The idea of multiple-criteria analytic methods utilization brought in some progress. In the last years, HTA methods are more and more used also on a hospital level. This approach, called hospital-based HTA, has different objectives and employs different methods than the traditional HTA. In hospitals, HTA methods are usually applied to strategic decisions, device procurement and management, and general organizational issues. Recently, medical devices became the main field, where hospital-based HTA proved beneficial. The paper summarizes different attitudes to HTA implementation on a hospital level. Typical applications in device selection and procurement, intra-hospital organization, and/or strategic decisions are shown.

HTA for Medical Devices: Multiple-Criteria Decision Making as an Outcome Evaluation Tool

Health Technology Assessment (HTA), although having been routinely applied in drugs and surgery for a long time, is still quite challenging in medical devices. The reason is that the main objective of HTA studies for devices is not optimization of the cost-effectiveness ratio, but rather decisions about procurement and/or incorporation of the apparatus. The clinical benefit is not expressed in terms of quality of life, but in the rate of diagnostic yield, comfort of the clinician, or the extent to which the technology makes the therapy shorter and/or more patient-friendly. Utilization of multiple-criteria decision-making methods for evaluation of the aggregated clinical, technical and user’s effect (outcome) is recommended as the input to cost-effectiveness analyses. Different methods are derived for strategic and/or operational assessment of new technology.

Multidisciplinary teamwork training for progress in developing and using medical technology

A characteristic feature of biomedical engineering is multidisciplinarity. Engineers from different branches have to work together with life sciences experts. Their working culture is different: they speak different languages, think different ways, and if they say the same, usually they have something entirely different in mind. Moreover, the world is shrinking and people experience working in a multicultural environment. However, working in a multicultural team brings problems and conflicts. There are barriers to communication. The problem is that students are generally not aware of all these differences. This ignorance often frustrates cooperation and makes it difficult, limiting the possible benefits. Considering this a serious problem, European Society of Engineering and Medicine organizes a summer school “Biomedical Engineering Teamwork” to give students an opportunity to work in multidisciplinary multicultural teams, and teach them to exchange ideas and benefit from different approaches.

Cost-Effectiveness Analysis of Intrabeam System Introduction to the Czech Healthcare System Environment

Backround: Intrabeam system is a technology used in oncology for intraoperative radiotherapy (IORT), a technique of partial delivery of radiation therapy to the tumour bed during surgery. The aim of this study is to evaluate cost effectiveness of the Intrabeam system compared to the standard treatment with external beam radiotherapy (EBRT) in early stage breast cancer treatment in order to reach a decision on a possible introduction of the technology to the Czech healthcare system. Methods: In order to determine the clinical effects, a worldwide literature review was conducted. The cost of the Intrabeam system was estimated based on available information about acquisitions of the system worldwide in the last 5 years. The cost of treatment was calculated from the perspective of a healthcare payer, and all the information gathered was summarized in a Markov model to finalize the cost-effectiveness calculation. A sensitivity analysis was performed. Results: The input of the model was based on the TARGIT-A pragmatic randomized controlled trial—the largest and most comprehensive study among 26 selected studies from the literature review. The estimated purchase cost of the system for the Czech Republic was determined in the range of CZK 16–20 million without VAT. Based on the findings, three versions (baseline, optimistic, pessimistic) of the calculation for IORT interventions using Intrabeam were determined. In the baseline scenario, the cost of the Intrabeam system intervention was CZK 38 559, the ICER value was CZK 53 483 saved per 1 QALY lost. The results of the sensitivity analysis are consistent with the results of the baseline scenario. The ICER value is not above the cost-effectiveness threshold (currently a little above CZK 1.2 million), which is required to consider the technology cost effective. Conclusion: According to the results of the cost-effectiveness analysis, we do not currently recommend the Intrabeam system to be introduced into the Czech healthcare system.

The cost of acute myocardial infarction treatment in the Czech Republic — The case of General University Hospital in Prague

The paper deals with costs of the treatment of acute myocardial infarction treated with percutaneous coronary intervention in the General University Hospital in Prague, Czech Republic in 2012. The average amount of the cost of treatment in patients with ST segment elevation myocardial infarction (STEMI) was CZK119 600 when figured out by the bottom-up method in the hospital. According to the general Health Insurance Company, the cost of treatment of a patient during one year after his release from the medical facility amounted to CZK 84 617. Hence, the total cost of treatment in patients with STEMI, calculated for one-year period, is CZK 204 217. A detailed specification of these figures is provided and discussed thoroughly.

CEMACUBE: The first European Master's course in biomedical engineering

For a single university it is difficult to have sufficient expertise of all sub-specialisations in biomedical engineering in order to provide 4th level education at an adequate level. Therefore a consortium of six universities has combined their knowledge and specific expertise into a 2-year European Masters in biomedical engineering: the Universities of Groningen (The Netherlands), Aachen (Germany), Dublin (Ireland), Ghent and Brussels (Belgium), Prague (Czech Republic). The Erasmus Mundus Masters course Common European MAsters Course in Biomedical Engineering (CEMACUBE) will prepare students from Europe and outside Europe for professions in biomedical engineering by giving them a Europan view and a broad solid foundation of the main topics of the field of biomedical engineering.

BME master studies as project-oriented learning at CTU Prague

Project-oriented learning presents a reasonable and flexible alternative to traditional curricula in engineering. Faculty of Biomedical Engineering at CTU in Prague offers project-oriented studies in BME master degree. The projects are offered by faculty members, external professors, and by industry; they are individual, open-ended, and non-trivial. Experience from the first two-year group of students is discussed.