Chapter 5 Value Based Healthcare (VBHC) as a Tool for Achieving Clinical Effectiveness

In: Economics and Mathematical Modeling in Health-Related Research
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Ewelina Nojszewska
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Agata Sielska
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Abstract

Clinical and cost-effectiveness in healthcare leads to action and solutions to existing problems. Change should enable patients to improve their health while also reducing the costs associated with such improvements. In order to introduce VBHC, the groundwork needs to be completed. First, a set of Key Performance Indicators (KPIs) should be developed to provide a base for making rational decisions. The significance of such a set is high, as it encompasses many factors that help determine the results to be obtained. Knowing the conditions and problems associated with the introduction of VBHC into the healthcare system as a research value, one should consider the conclusions resulting from the review of selected literature related to the concept of VBHC. Since the most important criterion adopted in this chapter is the efficiency aspect of the introduction of VBHC, the presentation of the course of reasoning combining benefits and costs, as well as the practical use of such an approach is a value-added contribution to the development of the discipline. Moreover, the chapter emphasizes the need to design KPIs as an indispensable basis for using VBHC in practice. This is a contribution to the development of the most important mainstream analysis created and used for quantitative tools.

1 Introduction

In recent years, the situation in healthcare has been complicated and difficult in all European countries, for all stakeholders. There are many reasons for this, such as the aging of the population, costs of advances in medical science, and the growing expectations of patients. Additionally, the situation is exacerbated by the Covid-19 pandemic. As a result, the availability and quality of health services are worse than potentially possible. The impact of money shortage as well as waste in healthcare should be emphasized. This involves the waste of human, physical, and financial capital and ignoring unnecessary expenses.

The European Commission has emphasized the importance of cost-effectiveness and the resulting clinical effectiveness based on OECD publications:

Evidence suggests that as much as one-fifth of health spending is wasteful, and could be reduced or eliminated without undermining health system performance. With as much as 9.6% of European GDP directed to health care, reducing such spending is thus important not only for improving access to needed care, but also for ensuring health system resilience.

OECD, 2018, p. 45

According to the EU website, the value of improper treatment and wasted resources was even estimated at 34% of expenses incurred (EXPH, 2019). A problem that has been raised for years should also be mentioned, namely that of the effectiveness of treatment. Many patients do not benefit from the first drug they are offered in treatment. For example, the percentage of the patient population for whom a particular drug in a class is ineffective, on average, is following: SSRI (selective serotonin reuptake inhibitor) anti-depressants – 38%, asthma drugs – 40%, diabetes drugs – 43%, arthritis drugs – 50%, Alzheimer’s drugs – 70%, cancer drugs – 75%. It turns out that one size does not fit all. Studies have linked these differences in response to the differences in genes (Spear et al., 2001). The concept of Value Based Healthcare is a way to help solve the problems of substandard effectiveness of treatment as well as waste and scarcity of all resources. This is possible because VBHC uses personalized medicine, which is based on genome-based treatment. In European countries, including Poland, there is a discussion on the possibility of just such a reform of the healthcare system.

The most important goal for health protection is to ensure the proper effectiveness of treatment and thus the health of patients. However, achieving this goal is possible only with the pursuit of economic and, above all, financial efficiency. Actually all over the world health expenditures continue to rise at an alarming rate. They outpace the growth of GDP (Park et al., 2007). It is now known that focus only on costs and volume is misguided or even leads to a dead end. Because this problem is a challenge for all decision-makers and scientists related to healthcare, a new approach is needed and healthcare systems should be reoriented. The possibility of using VBHC as a way to improve the functioning of the healthcare system becomes an objective.

2 Value Based Healthcare

An approach to VBHC was proposed by Porter (M. Porter & Teisberg, 2006). In his initiatory book, together with Teisberg, he presented quite a new approach to financing, organization and management in healthcare. In many subsequent articles, Porter developed his ideas and refined certain aspects of his VBHC concept, that is, measurement of improvements in health, innovation slowdown, inappropriate cost containment and micromanagement of physicians’ practices. He also stressed that measuring the value of health would allow the reimbursement system to be reformed, the purpose of which is to provide bundled payments covering the full cycle of care (M. E. Porter, 2010). The World Economic Forum and the Boston Consulting Group (BCG) launched a special project devoted to the Value in Healthcare in 2016. Analyses show that four goals should be pursued:

  • To develop a comprehensive understanding of the key components of value-based health systems

  • To draw general lessons about the effective implementation of value-based healthcare by codifying best practice at leading healthcare institutions around the world

  • To identify the potential obstacles preventing health systems from delivering better outcomes that matter to patients, and at lower cost

  • To define priorities for industry stakeholders to accelerate the adoption of value-based models for delivering care (World Economic Forum, 2017, p. 6).

European Commission experts have proposed that VBHC be defined as a comprehensive concept built on 4 pillars: (1) personal value (appropriate care to achieve patients’ personal goals); (2) technical value (achievement of best possible outcomes with available resources); (3) allocative value (equitable resource distribution across all patient groups); (4) social value (contribution of healthcare to social participation and connectedness) (EXPH, 2019).

In seeking to deal with the problem of growing money shortage, waste of resources, the effectiveness of treatment, the possibility of basing healthcare on the VBHC concept is important. This approach to the functioning of the healthcare system focuses on the patient and combines the interests of doctors and economists, medical workers and hospital managers. The following selected sets of issues represent the most important problems that decision-makers must solve. So, they are interested in the main causes of waste of all types of resources in healthcare. The sources of waste can be considered under the following three categories:

  • (1) Reasons why patients do not receive proper treatment: duplication of tests and services; low-value care: ineffective, inappropriate, not cost-effective; avoidable adverse events;

  • (2) Benefits that could be obtained with fewer resources by eliminating: discarded inputs, e.g. purchased drugs; overpriced inputs (e.g. generic vs brand products); high-cost inputs used unnecessarily (HR, hospital care);

  • (3) Resources being unnecessarily taken away from patient care due to administrative waste; fraud, abuse and corruption (OECD, 2017).

Thus, the basis for making decisions must be an appropriate analysis of the costs of health services and the resulting health improvements. Thus, it turns out that the quantity of health services must be the result of the costs and benefits of providing these services as shown in Figure 5.1.

Figure 5.1
Figure 5.1

Relationship between the amount of treatment and the total costs of treatment and health benefits

Source: Authors’ elaboration

The implementation of VBHC is another problem. Experts design the various stages of the healthcare reform towards VBHC. One of the suggestions can be found in an article in which Porter and Lee described the next steps to introduce VBHC (Porter & Lee, 2013). According to their approach, the system should consist of the following components:

  • (1) Coordination units;

  • (2) Measurement of health outcomes and costs;

  • (3) Financing medical services: payments for medical services; value-based pricing; value-based procurement;

  • (4) System coordination;

  • (5) Introduction of an IT and information system.

However, one gets the impression that the quantity and order of these elements seem debatable.

It should be noted that the most important factor determining the amount of expenditures and the state of health of patients is the method of reimbursement of health care providers for costs incurred. This is because the reimbursement method is an incentive for medical staff to make decisions on treatment methods, and thus on costs incurred by the health care provider. Therefore reimbursement incentives should be designed in such a way that it is possible to achieve the best relationship between the costs incurred for treatment and its health outcomes.

Since the main goal is to improve health, the mechanism for achieving value improvement in healthcare can be represented by the following steps that the decision-maker should take:

  1. Collect and share transparent, high-quality outcome data;

  2. Analyze variations;

  3. Identify current best practices;

  4. Change behaviors;

  5. Generate feedback and learning

  6. Enhance value (Soderlund et al, 2012)

The proposed reform of the healthcare system based on VBHC describes a delivery model in which all providers are paid based on patient health outcomes. The benefits of such a system are achieved by the entire society and economy, and in particular by patients, providers, and payers. The benefits for all stakeholders are: (1) providers achieve economic/financial efficiency and clinical effectiveness; (2) payers control costs, reduce risk and align prices with patient outcomes; (3) patients spend less money to achieve better health; (4) the economy achieves faster economic growth and development, which improve the welfare of society; (5) society becomes healthier while reducing overall healthcare spending.

3 Personalized Medicine

Personalized medicine can be defined as follows: It is the use of interdisciplinary knowledge about humans, underlying the prediction of all possible disease courses and treatment prognoses, and thus achieving an improvement in health (Drummond et al., 2005). This means tailored treatment, as patients are stratified into groups based on their susceptibility to disease or their response to particular treatments. Thanks to the identification of risk factors, effective prevention is possible, and thanks to genetic identification and knowledge of the molecular pathology of a disease, it can be treated effectively.

The use of personalized medicine (PM) is a condition that seems necessary for the implementation of VBHC. While there is no universally accepted definition, the European Union Health Ministers defined it as:

A medical model using characterization of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.

European Commission, 2015

The application of PM means that the right drug and right dosage are selected based on the patient’s genome. This makes it possible to avoid taking a drug that is not working or causes adverse side effects. Additionally, PM reveals the molecular predisposition of each patient to a specific disease, and this makes it possible to deliver timely and targeted prevention (European Commission, 2015). To sum up, health outcomes cannot be maximized without patient diagnosis and treatment with the use of PM.

The development of PM depends on interdisciplinary studies, of which two research areas are the most important.

The first group of problems is related to costs and cost-effectiveness questions: (1) How to calculate cost-effectiveness for personalized medicine? (2) How can precision medicine be cost-effective, maybe even more cost-effective than traditional approaches? (3) How to introduce flexibility in conventional payment systems to account for performance (outcome-based payments)?

The second group of questions is connected with innovative financing and payment systems: (1) Cost and pricing: how to calculate the price of a unique life-time dose for an inherently individualized cure? (2) How to develop new payment systems such as those that are widely used in other fields affected by typically low-probability/high impact events (e.g. loans, mortgages, securitization)? (3) How to make these systems affordable and socially acceptable? (4) How to establish the performance of an individualized treatment and how to modulate the price in relation to its outcome or effectiveness and overall value? (5) How to introduce planned flexibility? (6) The cost of “curative” initial treatments may be at the expense of payers who are not those who will see the benefit in the long-term (e.g., Alzheimer’s disease) (Nursimulu et al., 2018).

3.1 Economic Evaluation of Personalized Medicine

The scarcity of resources (medical workers, money, equipment) forces us to constantly research how healthcare resources are used to eliminate any inefficiencies. When focusing on personalized medicine, one should use the tools of economic assessment, which is a comparative analysis of alternative decisions taking into account both costs and benefits. In this case, the alternatives are treatments using genetic testing, that is, treating the patient, and traditional treatment, that is, treating the disease.

Four basic methods are used for economic evaluation. The first is CMA (cost-minimization analysis), which is used when the health outcomes are the same and the cheapest treatment option can be chosen. The second is CEA (cost-effectiveness analysis) used when the results are measured in the same units to select an alternative whose cost per unit of result is lower than the threshold adopted by the HTA agency, the Health Technology Assessment Agency (AOTMiT) in Poland. Third, there is a specific version of the CEA available, CUA (cost-utility analysis), which is used when the results differ and a common measure is needed, which is generally QALY (Quality-Adjusted Life Year). According to the CUA, the alternative is selected for which the cost of obtaining one QALY is lower than the threshold set by the HTA. The fourth one is CBA (cost-benefit analysis), which can be used when the results, due to their differentiation, can only be expressed in money. The alternative is chosen that gives the highest non-negative net present value, that is, the difference between the discounted expected benefits and costs in cash terms.

Beginning with the qualitative analysis, which provides an intellectual framework for further analysis, it is worth starting with listing the potential benefits of using personalized medicine. These include: greater certainty about the diagnosis and the course of disease; better estimation of the risk of subsequent complications and negative outcomes, which allows better management of treatment; better prediction of response to treatment and reduction of negative effects; reducing the waste of healthcare resources by treating drug-resistant patients; improving the quality and cost-effectiveness of a tailored treatment compared to traditional treatment.

It is also worth identifying the potential consequences for each type of stakeholder. For patients, the increase in their costs will be influenced by: higher drug prices and the cost of pharmacogenetic tests. On the other hand, the reduction of costs for them will be possible thanks to: reducing the likelihood of negative consequences; elimination of ineffective treatment; improving health. From the perspective of the service provider/payer, the increase in the cost of personalized treatment will be caused by: higher prices of medicines; the cost of pharmacogenetic testing (including the cost of false positives and negatives); increasing the population of patients treated with particular drugs; enhanced protection for drug and test patents; training, testing and interpretation costs. On the other hand, the reduction of costs will be possible thanks to: reducing the use of resources in healthcare after eliminating waste; skipping treatment for those who are refractory to certain treatments; increasing the share of effective treatment; avoiding treatment with negative consequences and complications; reducing the number of medical malpractice cases. For the industry, the increase in costs will result from: higher R&D costs in the short term; regulatory costs due to a more stringent test approval process; the end of the “cult” drug business model; differentiation between the drug and test industries. On the other hand, the reduction of costs will be caused by: improvement of the decisions made and thus increased medical effectiveness; precise concentration of research programs and thus obtaining better results; early acceptance of new therapies; greater certainty in post-marketing surveillance systems; increasing the patient population for whom the drugs will be effective. From the point of view of all stakeholders and the government budget, the goal to be achieved is not to use, and thus not to pay for, methods that are ineffective.

Benefits obtained thanks to personalized medicine can also be classified as direct net benefits and indirect (social) benefits (Castonguay et al., 2012). Direct net benefits are achieved both by healthcare and by patients and their families, generally informal caregivers. The benefits achieved by healthcare include the costs incurred due to prevention and effective treatment, lower costs of this treatment, and include savings due to less frequent and shorter hospitalizations, fewer consultations with specialists and hospital emergency departments, that is, savings resulting from lower consumption of healthcare resources. On the other hand, the direct net benefits for patients are: reduced direct expenditure, primarily on drugs and medical supplies, and care, less use of long-term care, and lower travel expenses for treatment. Indirect benefits, also referred to as social benefits, are achieved by patients thanks to disease prevention and the possibility of curing them, and they are achieved by reducing morbidity and mortality. This means a reduction in presenteeism and absenteeism, which has an economic dimension as more GDP is produced, and a psychological dimension where patients and their families enjoy a higher quality of work and private life. At the population health level, these benefits mean improved quality of life, increased life expectancy, and reduced premature deaths. Indicators such as QALY and DALY (Disability-Adjusted-Life-Years), which measure the health status of a society, are also improving. From the point of view of economic analysis, two methods are used to determine the monetary value of limited mortality and morbidity, namely the human capital method, which is the most important, and additionally, the friction cost method and the willing-to-pay method can be used. The most commonly used human capital method focuses on the productivity and volume of production that successfully treated people will generate through good health. In the case of traditional treatment that leads to presenteeism of sick people and their informal caregivers, absenteeism of these people, as well as invalidity and premature deaths, the economic and social cost is the value of lost GDP as a result of the disease. Moreover, the value of unpaid taxes and contributions, that is, reduced government budget revenues, should be taken into account, as well as the value of social benefits paid to people unable to work, that is, increased government budget expenses.

3.2 Benefits of Using the Economic Assessment of Personalized Medicine

Thanks to the economic analysis, it is possible to determine the value obtained for the money spent (value-for-money). Calculations and estimates are made in a dynamically changing environment, because, on the one hand, the expectations of patients and their families regarding the effectiveness of treatment are growing, and, on the other, the conditions of treatment are changing due to the progress in medical science and the need to change legal regulations concerning, in particular, valuation, imposed by it. In particular, it is about procedures and methods of reimbursing hospitals for costs incurred for treatment by payers. With this approach, the value of the benefits (preferably in economic or social terms) can be divided by the cost of the procedure or treatment. In order to compare the benefits and costs, as well as value-for-money, thanks to the use of personalized medicine and traditional treatment methods, it is best to plot a decision tree, a tool commonly used in medicine. This way, all possible alternatives, their monetary dimension and the probabilities of the occurrence of individual states are summarized (Blank et al., 2011).

Calculations made with the use of health economics analysis in 2014 (PMC, 2014) show that the use of chemotherapy in women with breast cancer will decrease by 34% each year thanks to the use of genetic tests. The number of strokes will decrease by 17,000 a year after the introduction of genetic testing to diagnostics (McWilliam et al., 2006). Expenditure on colon treatment will decrease by US$ 604 million annually after the introduction of a pre-treatment genetic test (Shankaran, 2009). Such an increase in the benefits of using personalized medicine is accompanied by a reduction in the costs of using scientific and technical progress in medical science, and so the cost of sequencing the human genome in 2001 was US$ 300,000,000, and in 2014 it was only US$ 1,000 (PMC, 2014a).

In economic assessment, the cost-effectiveness study uses calculations showing the costs divided by the life years gained, which means that it is known how much each year of extended life costs. Of course, in severe diseases, in addition to the duration of life, its quality is important and therefore a utility and cost analysis is used, according to which costs should be converted into QALYs – quality-adjusted life years (Nojszewska, 2010).

Therefore, the cost and effectiveness level can be represented as shown in Figure 5.2 (Morris et al., 2011). In practice, improvement in clinical efficacy is most often accompanied by an increase in treatment costs. Therefore, health technology assessment agencies, including AOTMiT in Poland, introduce profitability thresholds. In most countries, including Poland, it is 3% of GDP per capita for one QUALY, because QALY is the best way to assess the effectiveness of spending on medical interventions. American experts estimate the cost-effectiveness of treatment at 50–100 thousand dollars per year for one QALY, that is, for a year of “full-quality” life. This is a brutal approach, but it is due to the fact that all health systems face budgetary constraints. This situation is used by pharmaceutical companies to promote their products.

The confrontation of costs and benefits is aimed at unambiguous determination whether personalized medicine is cost-effective. The pharmacoeconomic literature shows that this is the case for all types of diseases. It is particularly important in the case of oncology, as the cost of cancer treatment is increasing worldwide. Thus, there is a confrontation between the decreasing costs of genetic tests and the increase in the costs of traditional treatment, which is an irrefutable argument when designing health policy and the valuation of medical procedures (PMC, 2014a).

Figure 5.2
Figure 5.2

Economic interpretation of the use of personalized medicine in the cost-effectiveness table

Source: Authors’ elaboration

4 Key Performance Indicators (KPIS)

Seeking to implement VBHC based on personalized medicine, it should be emphasized that this will be possible not only due to progress in medical science, but also thanks to the introduction of appropriate incentives for the purposes of health protection, the most important of which are KPIs.

It can be said that with personalized medicine the outcome of a therapy will be known, which means that health care will cease to be an “experience good”, the quality of which can be known after it has been consumed, and will become a “search good”, the quality of which is known even before the therapy, although in an imperfect way (Nelson, 1970). Healthcare decision-makers seek to understand the economic value of both PM and the optimal pricing of all resources. One of the challenges for PM is patient adherence to treatment. Research shows that non-adherence is an important source of losses. For example, in the US healthcare sector, the losses caused by this in 2014 amounted to about 2.3% of GDP (Egan & Philipson, 2014).

The potentiality of introducing the VBHC idea based on personalized medicine depends on multi-dimensional analysis of the financing, organization and management of the healthcare system taking into account all stakeholders. Should be noted that this is not enough to gain the knowledge of the healthcare sector alone, including patients, payers and insurers. It is necessary to know at least the economic/macroeconomic and social conditions. Properly designed KPIs are the most important tool for acquiring the necessary knowledge. Thus, it can be concluded that it is not only about KPIs related to the medical effectiveness and efficiency of mainly hospitals and all providers. These types of KPIs have long been in place and their values are known and can actually be calculated. The other mentioned types of KPIs showing economic conditions, the public finance framework, social and individual behavior, and the way decisions are made by politicians, bureaucrats, individuals and the whole society are no less important. It turns out that optimization of the quantity and quality of health services is not possible without knowing all these types of measures. VBHC cannot be introduced without KPIs and results of quantitative and qualitative analyses (providing knowledge of the organization, management, financing, investing, and overall functioning of healthcare) (PMC, 2014a). The research conducted so far shows that it is necessary to create a set of the most important key performance indicators (PhRMA, 2015). Building on the knowledge gained from KPIs, it will be possible to make the necessary valuations, control the quality and quantity health services, as well as exercise strategic and operational management of all healthcare providers and the system as a whole. All of this can be done in accordance with the adopted objectives and standards (Arah et al., 2003).

The structure of KPIs necessary for health care focused on the patient and their health status should contain the following components:

  • (1) Performance levels: strategic, tactical, operational;

  • (2) Performance dimensions: safety, effectiveness, efficiency, timelines, equity, patient centeredness;

  • (3) System components: structure, processes, outcomes (Khalifa et al., 2015).

The research on the basis of which the above has been written shows that KPIs for the healthcare system should include three levels of assessment of the functioning of service providers (strategic, tactical and operational) (Eckerson, 2009). The performance dimensions of healthcare functioning necessary for evaluation on the basis of indicators are: patient health safety, clinical effectiveness of treatment, resource efficiency, appropriate time to carry out the treatment process, focus on patient centeredness understood as improving health status and patient satisfaction, as well as equal access for all patients and all types of benefits. In addition, KPIs should assess three components of the treatment process, that is, firstly, a structure representing treatment determinants (e.g., hospital, staff, equipment, financing); secondly, processes that reflect all relationships between healthcare providers and patients during treatment; and thirdly, treatment outcome revealing its impact on the health of the individual and society (Gilbert, 2015).

It has become a goal for decision-makers and researchers alike to develop a group of strategic KPIs to monitor and improve the performance of the healthcare system and all stakeholders, especially hospitals. Such KPIs require an operational definition to be formulated, since they are in essence quantitative measures of quality (Ibrahim, 2001; Thompson & Harris, 2001; Wolfson, 1994). It should be mentioned that many hospitals have been developing KPIs for monitoring, measuring, and managing their performance. Managers strive to ensure the achievement of clinical effectiveness and economic efficiency, and also equality and quality of health services (Khalifa & Khalid, 2015). Examples of KPIs used in hospitals are as follows:

(1) Average Hospital Stay: Evaluate the amount of time your patients are staying; (2) Bed Occupancy Rate: Monitor the availability of hospital beds; (3) Medical Equipment Utilization: Track the utilization of your equipment; (4) Patient Drug Cost Per Stay: Improve cost management of medications; (5) Treatment Costs: Calculate how much a patient costs to your facility; (6) Patient Room Turnover Rate: Balance the turnover with speed and quality; (7) Patient Follow-up Rate: Measure the care for your patients over time; (8) Hospital Readmission Rates: Track how many patients are coming back; (9) Patient Wait Time: Monitor waiting times to increase patient satisfaction; (10) Patient Satisfaction: Analyze patient satisfaction in detail; (11) Staff-to-Patient Ratio: Ensure you have enough staff to care for your patients; (12) Canceled/missed appointments: Keep track of patients’ appointments; (13) Patient Safety: Prevent incidents happening in your facility; (14) ER Wait Time: Identify rush hours in your emergency room; (15) Costs by Payer: Understand the type of health insurance of your patients (DATAPINE, 2021).

Researchers seek to design the most important (economic, social) classes of KPIs and all related individual indicators. To achieve this, they have to answer a number of questions that define the framework for effective functioning of health care and all stakeholders. It is imperative to know and understand all the economic and social determinants of performance frameworks for healthcare, its economic efficiency, and clinical effectiveness (Arah et al., 2003).

To sum up, it is worth emphasizing that there are attempts to implement personalized medicine in the European Union member countries as a condition for the use of VBHC and that means that the creation of KPIs is of particular importance.

5 Discussion and Conclusions

The most important criterion adopted in this chapter is the efficiency of VBHC adoption. That is why the presentation of rationale that combines health benefits and incurred costs, as well as the practical implementation of the VBHC model of the healthcare system is a value-added contribution to the development of this interdisciplinary research. Most importantly, the chapter emphasizes the need to design all desired types of KPIs as an essential basis for the functioning of VBHC in practice. It contributes to the development of the most important kind of analysis creating and using for statistical and generally speaking quantitative tools, of course apart from quality tools such as PROMS (Patient-Reported Outcome Measures), PREMS (Patient-Reported Experience Measures) and other metrics.

Problems with clinical effectiveness and cost effectiveness/economic efficiency in European healthcare systems represent a push to take whatever measures are needed to arrive at appropriate solutions. All improvements should be designed so as to deliver the desired outcomes: they will enable patients to improve their health status and minimize the costs of this improvement. The introduction of VBHC requires many steps, so one needs to prepare the ground for this reform, which requires many time-consuming and interdisciplinary activities. The work should begin with the KPIs that will provide indicators for making rational decisions in all aspects. The significance of such a set of needed KPIs is that it represents many factors (hopefully the most important ones) that determine the results obtained.

The situation in all healthcare systems in Europe (and most likely all over the world) requires immediate changes, of which VBHC seems to be the best solution because it is based on clinical and cost-effectiveness. However, due to the complexity of the determinants of clinical effectiveness, including medical problems and their intricate correlation with economic and social conditions (e.g., public finances, financial capacity, organization and management of the healthcare system, macroeconomic situation, etc.), it reveals research limitations. The largest and the most important of these is the lack of databases, both of medical records (for clinical effectiveness) and databases for the healthcare system as a whole and for individual stakeholders (for economic and social efficiency). There are many limitations, the most important of which is the initial period of work on solutions, and above all KPIs enabling the introduction of VBHC into practice, which also poses a research challenge. Another example of research limitation is the diversity of health care and economic conditions in each country. This is a particular impediment to experience sharing between individual countries. In planning research that will enable the introduction of VBHC in the near future along with ongoing quantitative and qualitative analyses, new research questions and research limitations appear. The biggest problem and limitation facing the research that needs to be done is that only partial and selective qualitative data is available and they are collected differently from country to country. This causes problems with comparisons among countries because of the complexity of the databases and assumptions made in the research conducted in different national settings. Unfortunately, based on the experience gained so far, it can be concluded that controlled implementations of VBHC and access to homogenic cases for cross-country analysis is very rare. Everyone is aware of how important it is to know the experience of countries that have already started implementing the VBHC approach. The literature shows that differentiated value-based approaches are being introduced incrementally and at varying scope and speeds across the healthcare systems in Europe. Introducing this revolutionary reform also represents a tremendous shift in culture for all stakeholders. Healthcare is constructed differently in each country and faces different conditions, and therefore none can mechanically implement recommendations developed in other countries.

Looking at future research, it can be seen that research problems and limitations emerge as further research areas, because one has to deal with them first to be able to put VBHC into practice. However, at the current stage of all types of research, it seems that the most important research challenge is to create the right sets of KPIs that will present a comprehensive picture of both the clinical effectiveness and efficiency of economic functioning of the healthcare system. It is obvious that KPIs should cover all types of conditions affecting the quality and availability of health services.

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