POLICY BRIEF

There is a health crisis in Poland, manifested by the lack of prolongation of the life span observed in previous decades, and in recent years even shortening of the life span of women and men, which has been progressing since 2015 [1]. This unfavorable trend was further aggravated by the COVID-19 pandemic, which resulted in a further increase in health debt understood as a continuous and deepening failure to meet the health needs of the society caused by difficult access to effective health care, which arose as a consequence of the obstruction of the public health system [2].

The main causes of death in Poland are cardiovascular diseases (CVD) and cancer - they account for nearly 70% of all deaths. In 2020, an increase in the number of deaths due to cardiological causes was recorded in Poland compared to the last few years. Over 174.5 thousand people died due to cardiovascular diseases. people, which accounted for 42.6% of all deaths, i.e. for every 100,000 of the country's population, 455 people died as a result of cardiovascular diseases [3]. On the other hand, Poland is one of the fastest aging populations in Europe, which means that in 2060 there will be over 70 people aged 65+ per 100 people of working age (20-64). Among the OECD countries, it will be worse only in Korea, Spain, France, Italy and Japan [1].

The number of cancer cases is constantly growing, which is mainly related to the aging of the population (it is estimated that in 2050 the number of people aged 65+ will amount to over 11 million - 1/3 of the Polish population). Another important factor responsible for the higher number of cases is the increase in morbidity rates. On the other hand, owing to the introduced screening programs, improved detection and innovative medical technologies, survival rates are increasing, which, however, translate directly into a growing number of sick people requiring health services at the same time, and this in turn results in a greater financial burden on the health care system.

One of the important elements of rebuilding the public health system and leveling the health debt is the widest possible and quick access to innovative health technologies, both drug and non-drug, which in Poland and other countries of Central and Eastern Europe (CEE) of the European Union (EU) is clearly limited in relation to five countries (France, Spain, Germany, Great Britain, Italy) of the so-called "old" EU (EU5). The report published in 2021 shows that patients from the ES-W EU countries are twice as likely to receive innovative pharmacotherapy, only 34% of medicines authorized by the European Medicines Agency (EMA) are available in the ES-W EU countries, and the waiting period for an innovative therapy takes as much as 304 days longer than in the case of EU5 countries [4]. Access to modern hardware therapies (non-drug technologies) is similarly limited, mainly due to financial and systemic factors. This clear limitation of access to innovative therapies is one of the reasons for the poorer health condition of the societies of the ES-W EU countries: life expectancy is four years shorter, and mortality from cardiovascular causes is three times higher than in the EU5 countries [5].

We believe that the remedy for the permanently bad situation in Poland, related to the too slow introduction of innovative therapies, which has been going on for many years, should consist in defining the problem and proposing rational solutions, which are given in Table 1.

Innovation is defined as the result of all activities of a scientific, technical, organizational, financial and commercial nature that actually led or were intended to lead to the implementation of changes in the field of products, processes, organization or marketing [6].

Organization for Economic Cooperation and Development (OECD) defines innovation as the implementation of a completely new or significantly improved product (good or service). Innovation can also relate to marketing, process, organization in terms of business practices, organization of the workplace, form of work and even relations with the environment. Innovations appear in every sector of the economy [6]. In turn, the World Health Organization (WHO) indicates that the goal of innovation in the field of health is to develop and provide new or improved health policies, systems, products, technologies, services and methods of their provision that will improve people's health [7].

Table 1. Innovative medical technologies and the possibilities of their introduction in Poland

Source: own study

According to the data of the European Patent Office (EPO), medical technologies are the leading field among patent applications from Poland. Pharmaceutical products (+11.4%) and transport (including the automotive industry) were ranked next, with 81% more patent applications than in the previous year. The two main areas related to healthcare - pharmaceutical products and medical technologies - together represent 19.3% of all Polish patent applications filed with the EPO, compared to 15.3% in 2020. The above data are reflected in the exports of medical equipment and devices from Poland, which in 2019 amounted to EUR 2.4 billion and were 10% higher than in the previous year, when Polish manufacturers exported equipment worth EUR 2.2 billion [8 ]. The importance of start-ups in introducing new technologies to the market is also growing year by year. The latest report of the Startup Poland Foundation shows that the medtech industry - i.e. services in the field of medicine and health - is one of the most popular areas of their activity. About 13% of Polish innovative companies develop in this industry [9].

According to the report "Top Disruptors in Healthcare 2021", which is a review of innovative medical start-ups in Poland, more than half of the surveyed companies operate in the field of telemedicine, 45% indicate AI/machine learning, and medical devices are in third place of the podium ex aequo with the area of medical data (37% each). Compared to the previous version of the study, there is an increase in interest in artificial intelligence in health. In the surveyed group of start-ups, 70% create innovations in cooperation with hospitals. In the case of start-ups whose solutions are developed based on artificial intelligence, the most frequently chosen sectors were oncology (22 startups, 32% of respondents), cardiology (21 startups, 31% of respondents) and radiology (19 startups, 28% of respondents) [ 10].

Investments in innovative technologies in the health care system are closely related to the state of health of the society. It is innovative drugs and vaccines that have made it possible to significantly extend the survival of patients with cancer (e.g. lung cancer, even in the disseminated stage), eradicate or significantly reduce the morbidity of infectious diseases, more effective treatment of chronic diseases (e.g. autoimmune diseases) or therapy of patients with rare and ultra-rare genetic diseases (e.g. spinal muscular atrophy, Fabry disease).

A special source of innovation is the pharmaceutical and medical devices industry, which drives the progress of medicine, leading to the development of new drugs, medical devices, diagnostic methods, but also many discoveries in the field of basic sciences, such as pathophysiology of diseases, biology of cancer and many others. This progress also affects the development of innovation, because the discovery of new therapeutic targets in the form of various proteins leads to the search for the so-called molecularly targeted therapies, which in a targeted and often personalized way, will be an effective way to treat cancer patients. The Polish clinical trials market is worth about PLN 2 billion, with 98% of it being commercial, financed by the pharmaceutical industry. The non-commercial ones - initiated by scientists and not for profit - account for only 2%, while the European average is about 30%, which proves the high dysfunction of public mechanisms in this area and indicates the need for change. It can be expected that the establishment of the Medical Research Agency (ABM) will change this situation [11].

It should be emphasized that the pharmaceutical industry is one of the most innovative branches of the economy. Expenditures on research and development among pharmaceutical and biotechnology companies exceed 15% of the companies' net income. For comparison: in the second most innovative area of services, which is IT, this indicator is less than 12%. The average for 38 branches of the economy, calculated on the basis of data collected from companies registered around the world, is 4.3%. Investment in R&D in Europe in 2020 amounted to €39 billion.

It is also worth noting the extremely important role of academic centers in the process of creating innovation in our country. Applications from universities or research institutes account for over 40% of all applications from Poland submitted to the EPO. This situation is quite unique compared to other countries where industry clearly dominates in this respect. This means a huge potential of Polish universities, which should be included in the innovation development plans in our country.

Innovation in medicine is the result of progress in science, technology and research methods. It leads to many positive consequences:

•        reduction of mortality,

•        extending life (in Europe people live up to 30 years longer than a hundred years ago),

•        control of chronic diseases,

•        "transformation" of some incurable cancers into chronic diseases,

•        improving the quality of life,

•        personalization of therapy, i.e. adjusting treatment to the needs of a specific patient,

•        more accurate and faster diagnosis of many diseases,

•        control of diseases for which there has been no effective treatment so far.

Beneficial medical consequences and reducing the effects of diseases have an impact on the economy. Analyzes show that a 1% increase in the life expectancy of the population can translate into an increase in GDP by up to 6% and GDP per capita by 5% [12].

In terms of treatment, innovation in medicine has led to the development of new therapeutic areas:

•        genomic medicine - based on the result of examining the entire human genome or at least part of it, which makes it possible to determine the individual risk of disease and select the appropriate therapy,

•        personalized medicine - focused on a specific patient, but focusing not only on treatment, but above all on the mechanisms of maintaining health and preventing diseases,

•        translational medicine - involving research in the search for the origin and mechanisms of the disease process and the identification of specific biological processes, biomarkers or pathways leading to the disease, i.e. being the process of transferring discoveries at the molecular level from the laboratory to clinical practice.

Registration offices also notice a special role of innovation. The U.S. Food and Drug Administration (FDA) gives some drugs the status of first-in-class or breakthrough therapy. In 2008-2017, the FDA registered 321 new drug technologies, of which 46 in 2017 [13]. The European Medicines Agency issues an average of 87 positive opinions per year regarding the placing of medicinal products on the market, and also approves an average of 35 new active ingredients in various therapeutic areas. In 2015-2018, the most positive opinions were issued in 2015 (93), while the largest number of new active ingredient were approved in 2018 (42). Most new drugs have been approved in the field of oncology, neurology, infectious diseases and haemato-oncology [14]. The contribution of Polish innovative thought is not visible in this respect, which in view of the high dynamics of patent applications may raise doubts about the mechanisms for implementing innovations in our country.

In Poland, the first ever list of drug technologies with a high level of innovation - in accordance with the provisions of the Act of October 7, 2020 on the Medical Fund (Journal of Laws of 2020, item 1875), the Act of August 27, 2004 on health care services financed from public funds (Journal of Laws of 2020, item 1398, as amended) and the Act of 12 May 2011 on the reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws of 2020, item 357 of as amended) - published in the "Biuletyn Informacji Publicznej" of February 26, 2021. It covered 11 drug technologies. The criteria followed by the Agency for Health Technology Assessment and Tariff System (AOTMiT) in determining the innovativeness of drug technologies include:

•        power of therapeutic intervention,

•        quality of available scientific data,

•        unmet health needs,

•        size of the target population,

•        state health priorities.

Currently, there are almost 7,000 innovative drugs in the development phase in the world, and in the coming years there will be, among others, new therapeutic possibilities for cancer patients (chimeric antigen receptors T cells, CAR-T therapy, which modifies cells of the immune system to make them target certain types of cancers of the blood-forming system), diabetes (cell-based therapy where insulin-secreting islet cells from a healthy donor are inserted into the patient's body), haemophilia (gene therapy where genetic material to replace malfunctioning genes), infectious diseases (monoclonal antibodies targeting bacteria) or Alzheimer's disease (drugs targeting β-amyloid). The main obstacles to the rapid and wide availability of innovative therapies in Poland include backlogs in the implementation of new drugs, inaccurate process of estimating the health effect, long reimbursement process, and, above all, underfunding of the system [15].

The answer to this question should be as follows: innovative therapies (drug and non-drug) enable the treatment of patients in whom the use of existing technologies did not bring the desired/expected prolongation of survival, including healthy survival, and did not help to reduce the frequency of adverse events, e.g. vascular (myocardial infarction, stroke, unscheduled hospitalizations) and improving the quality of life, or there have been no such therapies so far. Using only recent examples in the field of cardiology, we can refer to the introduction of transcatheter aortic valve implantation procedures (transcatheter aortic valve implantation, TAVI) in elderly patients with degenerative, tight and symptomatic aortic stenosis [16-17] and the introduction of new drugs for patients with heart failure with both reduced and preserved left ventricular ejection fraction [18-19]. Both new treatments have proven to be extremely effective and have also been found to be safe.

Highly effective therapies introduced in recent years can also be found in oncology. molecularly targeted treatment directed against a specific mutation in the tumor or modern immunotherapy (checkpoint inhibitors).

Due to the rapid development of medicine, especially oncology and cardiology, and thus the rapid emergence of new technologies, it is inevitable and urgent to find mechanisms to improve access to them while maintaining reasonable costs and measuring the real impact on improving survival rates. Therefore, it is extremely important that the society receives access to innovative technologies in medicine as soon as possible (especially those where predictive factors are known, i.e. selecting patient populations that benefit most from treatment) financed from public funds. This should be achieved by the possibility of their rapid admission to common use, real price reduction, risk-sharing scheme or participation in clinical trials. All of these mechanisms will undoubtedly contribute directly to increasing the availability of innovations in medicine.

According to the PriceWaterhouseCooper (PWC) report, the E SW countries spend less on health care in proportion to GDP compared to the EU5 countries [4]. On average, in the years 2000-2017, EUR 26,000 less was spent on health care per one citizen of the E SW country than per person living in the EU5. If ES-W countries were to spend the same percentage of GDP on health care as EU5 countries, per capita spending in ES-W would increase by 65%, which means an additional EUR 644 per capita in 2017. More recent data from Poland from 2019 is still do not show a significant increase in spending on health care (6.5% of GDP) and remain significantly lower compared to the average value in OECD countries (8.8% of GDP) [11].

In addition, it should be noted that a large part of the health care budget in Poland in 2020-2021 was consumed by expenses related to the COVID-19 pandemic. A similar assessment of the situation in the countries of ES-W, including Poland, is provided by the above-mentioned PWC study from 2021 [4]. It also emphasizes that despite the GDP growth in the years 2010-2017 in the ES-W countries by an average of 1.4% (higher than in the EU5 countries), spending on health care increased disproportionately less - by 0.5%.

Diagram 1.      Public health expenditure as a percentage of gross national income (GDP) in EU5 and ES-W countries

Source:           PWC. Healthcare outcomes and expenditure in Central and Eastern Europe - a review. June 2021.

On the other hand, according to Polish data, in 2020 about PLN 11 billion was allocated for oncological treatment financed from public funds. For comparison, in 2009 it was less than PLN 5 billion. Most of this surplus was allocated to innovative therapies with significantly increased effectiveness, which resulted in several times longer survival rates, including overall survival, and long-term remissions of the disease. In some clinical situations, innovative oncological therapies have completely supplanted classical chemotherapy [20].

The second important element is the indirect costs of illness related to sickness absence, resulting in a reduction of employees' income or lost social security contributions. Permanent incapacity for work of people of working age is associated with lower GDP or the need to pay disability benefits. Reduced productivity at work (presenteeism) as a result of illness also leads to a decrease in GDP.

It should therefore be assumed that increased and rational spending on health care will have a clearly positive impact on all important health measures in Poland, which in turn will translate into improved economic indicators and tax revenues, and will generate savings in the health care system in the long run. This principle of a gradual, but quite fast, increase in expenditure as a percentage of GDP on health care in Poland should in particular translate into faster and more extensive introduction of innovative therapies.

As we wrote earlier, it is extremely important for the society to receive access to innovative technologies in medicine as soon as possible (especially those in which predictive factors are known, i.e. selecting patient populations that benefit most from treatment) financed under public funds health care.

Fast access path (fast track, FS) to new medical technologies is a process aimed at facilitating and accelerating the evaluation and analysis of drugs for practical use in the treatment of diseases directly affecting survival rates and meeting the medical needs of societies. The aim of the FS is to facilitate patients' access to therapies that are more effective than the current standard treatment as soon as possible.

Diseases that directly affect the reduction of survival rates include: diseases of the cardiovascular system or cancer, but also Alzheimer's disease, depression or diabetes are also considered important civilization diseases that threaten the "existence" and development of societies.

Obviously, any newly developed therapy must prove its effectiveness and target an unmet medical need. Features of new therapies should include:

•        better effectiveness, with smaller or acceptable side effects,

•        impact on improving the survival rates of a specific disease,

•        the ability to meet emerging or anticipated public health needs.

Qualification of a specific drug for accelerated approval for reimbursement may be submitted after meeting specific and transparent criteria. A pharmaceutical company submits an application for fast-track drug referral at any stage of its clinical trials. The application should be considered within 60 days based on the HTA analysis and whether the drug meets the criteria of "breakthrough therapies" and can enter the path of conditional financing with the necessary in this case tracking the effectiveness and safety of the new technology in the appropriate register supervised by the National Health Fund or ABM. The Medical Fund at the President of the Republic of Poland may also be involved in the rapid introduction of new, breakthrough drug therapies.

The Food and Drug Administration (FDA) [21] has developed the qualification of drugs into four different groups:

•        access priority analysis,

•        breakthrough therapy,

•        accelerated acceptance,

•        fast track.

Designation as access priority requires the FDA to act on an application submitted by a pharmaceutical company within 6 months.

Breakthrough therapy is the process of reviewing drugs that can show a significant improvement in effectiveness compared to existing and available therapy.

The aim of accelerated acceptance is to authorize the drug for use on the basis of the so-called a surrogate endpoint provided that its indication includes an unmet medical need.

Fast Path (FS) is a process to accelerate the evaluation of drugs (within 60 days) for the treatment of significant diseases that reduce survival rates and quality of life. Their goal is to satisfy hitherto unmet medical needs in the shortest possible time.

It seems that a similar qualification system should also apply to innovative non-drug (hardware) technologies. However, in the case of these technologies, the process of reporting to AOTMiT is different from that applicable to medicines and it probably needs to be changed and standardized. One should also not forget, as in the case of drug technologies, about the possibilities of using the Medical Fund.

Based on the presented data, it is necessary to create a similar system adapted to Polish conditions, which must be transparent, objective and unambiguous in order to evaluate therapies whose indications cover unmet medical needs. Therefore, we believe that it is necessary to strengthen the role of AOTMiT. This means not only the stability of good financing for its activities, but also maximum independence from political factors.

The marketing authorization and reimbursement of each drug is usually limited and specific to the treatment of patients with known cancer or cardiovascular disease, e.g. as in the case of PCSK9 inhibitors in the treatment of familial hypercholesterolaemia or in patients with a history of myocardial infarction (program of the Ministry of Health B.101) [22]. This results in a certain limitation of access to new, innovative therapies. In addition, there are significant differences in the possibilities of applying innovations in the countries - members of the European Union. This is one of the reasons why there are significant differences in survival rates across the European Union. They obviously result from the financial outlays allocated to health care in individual countries, but also from the different prices of drugs.

Therefore, an important element in increasing, and perhaps even in equalizing the chances of the societies of EU countries would be, for example, the central purchase of oncological drugs or drugs used in the so-called orphan diseases at the level of the European Commission. Undoubtedly, the negotiating argument with pharmaceutical concerns with such a large purchase of drugs for many countries would be huge. This would make it possible to lower the prices of medicines, and thus increase their availability in less affluent countries. Such a purchase has already been successful in the case of SARS-CoV 2 vaccines.

Another mechanism enabling access to innovations in medicine is increasing the participation of cancer patients in clinical trials, which varies in different European countries (in Poland it is still a small group of patients). Currently, the main source of clinical trials are the so-called commercial studies, much less often non-commercial academic studies or studies initiated by investigators (investigator initiated study), mainly by scientific institutions.

Another mechanism helpful in increasing access to innovative technologies in medicine is the so-called risk-sharing scheme, which are based on transferring part of the risk and costs to the applicant applying for their financing from public funds [23]. Their use should be clinically practical and based on mutual benefit. These include:

•        determination of the amount of income from the obtained, but at the same time confirmed health effects,

•        relationship between the official selling price and the provision of supplies at a reduced price agreed in negotiations,

•        relationship between the level of the official selling price and the volume of turnover,

•        dependence of the official selling price on the return of part of the refund obtained to the entity obliged to finance services from public funds after exceeding the predetermined turnover volume,

•        establishing specific reimbursement criteria affecting the increase in access to guaranteed services.

Therefore, it becomes necessary to verify the application of the practical sharing risk in relation to innovative technologies in medicine at the negotiating, pre-reimbursement level, based on efficiency data.

It is also necessary to personalize therapy based on the predictive factor (increasing the availability of cancer molecular tests - molecular finger print), an analysis of potential adverse effects of therapy in relation to comorbidities, adjustment to the location and dynamics of lesions, the general condition of patients or the expected survival time. This allows for directing innovative therapies mainly to the patient population that can actually benefit from the innovative technologies used.

Figure 1 shows the scheme we propose for introducing innovative medical technologies (drug and non-drug) in Poland, which we believe will streamline the verification process and accelerate and increase access to these innovative therapies for patients in our country. The scheme is compliant with the rules currently in force in Poland for reporting innovative therapies.

The role of hospitals with the status of National Research Institutes as well as university (academic) hospitals and other units that are regional centers of excellence is crucial here. These hospitals should keep strictly controlled registers of new medical technologies, commissioned by the Ministry of Health and/or the Medical Research Agency, the results of which would allow for a decision on possible financing in the country. At the same time, regional centers of excellence, which should be established on the basis of strictly defined criteria by the Minister of Health in consultation with AOTMiT and the National Health Fund, should be treated on an equal footing (at least with the same reference level) with academic units, and their role should not be limited to service and clinical activities (as the third reference level), but should also cover research and scientific activities, taking into account close cooperation with academic units on a partnership basis. As centers of excellence, they should provide postgraduate education in the full sense of the word.

Figure 1. Proposed scheme for introducing innovative medical technologies in Poland Source: own study

explanation of abbreviations

ABM - Medical Research Agency

AOTMiT - Agency for Health Technology Assessment and Tariffs

HTA- health technology assessment

MH - Ministry of Health

additional markings

1.         There is a health crisis in Poland, manifested by the lack of prolongation of the life span observed in previous decades, and rather shortening of the life span of women and men, which has been progressing since 2015. This unfavorable trend was further aggravated by the COVID-19 pandemic, which resulted in further accumulation of health debt.

2.         The main causes of death in Poland are cardiovascular diseases and cancer - they account for nearly 70% of all deaths.

3.         One of the important elements of rebuilding the public health system and leveling the health debt is the widest possible and quick access to innovative health technologies, both drug and non-drug, which in Poland (and other countries of Central and Eastern Europe) is clearly limited.

4.         Innovative therapies (drug and non-drug) make it possible to treat patients in whom the use of existing technologies did not bring the desired/expected prolongation of survival, including healthy survival, and did not help to reduce the frequency of events and improve the quality of life, or such therapies have not been used so far.

5.         In order to ensure greater and faster access for Polish patients to innovative medical technologies, it is necessary to increase spending on health care in Poland for drugs, vaccines and advanced therapy medical products.

6.         Efforts should be made to strengthen public institutions operating in the health care sector, such as the Ministry of Health, the National Health Fund, AOTMiT, and the involvement of leading medical centers in the country (centers of excellence) in order to use data from real practice (real world evidence), including the creation and maintenance of strictly controlled registers of new technologies and decision-making based on the analysis of these registers.

7.         Taking into account the medical, legal and financial specificity in Poland, concepts such as breakthrough therapy, accelerated acceptance and fast track introduction/access to new medical technology should be defined.

8.         All this should result, on the one hand, in integrating the system of introducing innovations with the public health system in Poland, and on the other - faster and easier access to innovative medical technologies for patients.

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