Final programme EBHC Symposium 2013 (1 MB)
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The Symposium took place in Warsaw on October 7th and 8th, 2013 in Hyatt Regency Warsaw Hotel.

Even the most developed and richest countries pay particular attention to rational utilization of resources in health care as, due to development of new health technologies, any amount of money may be spent on health care.
Appropriate functioning of tools that allow for rational expenditure in health care should become a priority of health care policy.
For more than 10 years we have repeated this text like a mantra in numerous articles, presentations, analyses, reports, and publications of CEESTAHC. And, despite passing years, despite the government’s announcements of introduction of the ultimate and only right solution, despite electoral promises of revolutionizing the existing mechanisms, despite support from every corner of the political scene, despite voices from upper and lower levels of administration of the health care system itself, the Polish benefit package is neither a basic, nor efficient, nor even transparent tool for rationalization of expenses in public health care.

The scientific program of the Symposium was presented over two days in seven main thematic sessions:

1. The role of the HTA agency in a health care system - fee free session
2. Public Health
3. Health insurances and benefit packages
4. Patient involvement in HTA - how to communicate?
5. The valuation of services in the benefit package
6. Reforms in health care systems
7. The role of non-experimental studies in medical decision proces

1. The role of the HTA agency in a health care system
Fee free session
The primary activity of the Health Technology Assessment Agency is to be a guard that means elimination of health benefits with unproved effectiveness or that which are not economically efficient and were financed from the public sources. The important role of the HTA agency in the system is due to the fact that it is an administrative, relatively independent tool of assessment that gives the information about clinical effectiveness and economical efficiency of tests and diagnostic equipment, medical items and methods or other medical technologies (including health programs). Its primary role, therefore, is to provide broadly understood access for the patient to the reliable and objective information about potentially refunded products or services. The Health Technology Assessment Agency should use, what makes its undisputable advantage, objective scientific approach. Through that its expert opinions have value of scientific research in a sense that is defined by science (repeatability, reliability of evaluation using statistical tools). High reliability of opinions prepared by the HTA agency is one of the crucial argument for the establishment of that body. The major force of the agency is an independence from influences of current political issues or pharmaceutical lobbing.
In comparison to many western countries Poland still works on clear and transparent system of “critical appraisal” as a part of the EBHC (the Evidence Based Health Care). At the same time, in terms of transparency and reliability in decision making process about refunds and prices, Poland is certainly the leader in Central and Eastern Europe. It is important to watch the development of Polish solutions in perspective of 10-12 years and by the fact of the discretion transition (without justification, analysis, the HTA, without fulfilling the provisions of Transparency Directive). Current recommendations of the HTA (usually in compliance with the opinion of the Transparency Council) are most often taken under consideration in case of negotiations by the Economy Committee. Studying the system in Poland not only is it important to know what is the HTA, but also what issues were the base of social discussions, according to the shape of the HTA agency in Poland and way of taking decisions about refunds or prices – what patterns from the world were taken under consideration, and what were rejected deliberately.
The aim of the session is to show management models for the HTA agencies in the world and comparison of the achievements of our region to changes which have been taking place in Western Europe (Germany, the UK, Australia). During the session there will be presented results of the comparison of the Agency activities – its duties, types of recommendation and eventually what is its impact on the shape of health benefits basket, which means the direct formation of guaranteed services basket. There will be presented solutions (models) of the HTA agency present in different countries with an indication of the advantages and drawbacks of this model.

2. Public Health
According to the changes in refund of health benefits there is a discussion about broadly understood (dominant role in public health) restorative medicine (acute) and long term treatment. Despite national programs (screenings, calendar of vaccines) since the 70s have been introduced more and more educational or promotion programs about population health or medical exams for prevention of vascular diseases or other chronic diseases. Within these programs, although described in details methodology, more and more often are considered possibilities of evaluation effectiveness of its introducing – via the influence on mortality, morbidity, assessment of risk factors etc.
The domain of public health is focus on the “intervention” towards health improvement, not on the health improvement of one man or clinical approach. And here it is necessary to pay attention to the terminology and definitions from the HTA. There is a fundamental difference between effects in one person and population effects in public health. There are few causes:

1. First of all – the assessment of programs is more difficult than the one technology (medicine, diagnostic medicine etc.) because usually it concerns comprehensive and applies to multi interventional activities that are involved in numerous institutions (doctors, schools, taxpayers, the media and the society).
2. Secondly, evaluation of the primary endpoint is usually not possible or would require a very long and costly methods of data collection. It is necessary to evaluate also a large population which makes large organizational problems.
3. Thirdly, public health programs usually touch environmental, economy, social and other (which usually are combined with political decision and resistances from groups of interest e.g. control over the advertisement of tobacco products) issues.
4. Fourthly, many introduced programs are not evaluated, since they are considered to be effective and from logic perspective obvious to use.
5. Fifthly, public health and evaluation of its effectiveness is not so attractive and appealing as evaluation of one medicine, new diagnostic equipment or introducing public health care programs, which are far more rarely described in the newspapers.

Because of that, development of research in public health care, introducing evaluation of the programs according to health improvement (not improvement of health care system work) without creation of strategy and political decisions, which will trigger financial support is highly unlikely.

3. Health insurances and benefit packages
The condition of health care system in Poland is seen by patients and media from the perspective of hospital care. This health market sector is (apart from few special areas) in more and more difficult situations. Increased spending of the National Health Fund (NHF) for the inpatient care has not kept pace with dynamically increased costs of hospitals. This increase is linked with various issues: intensive salary pressure (especially from the doctors), unsuitable infrastructure for local health needs, and additionally often ineffective management. Profits, almost only from the contracts with the NHF, are low, and cost assessments of procedures usually inaccurate. Finally, in hospitals there are cumulated also negative effects of this poor health system organization – ill-treated patients sooner or later will go to the hospital. Unsurprisingly, therefore we have: increased in media conflicts around contracts over-realizations, restructuring of the procedures that are well priced (not necessarily needed).
Diagnostics and hospital treatment are the highest ranked position in public payer budget in Poland. The NHF spending for that purpose is 50% of its total financing structure. Hospital treatment paid privately is a financial margin of this sector, focused on the procedures with significant commercial demand. Publicly funded sector with great difficulties subject to restructuring and efficiency improvement. In addition, this raise of effectiveness concerns short-sighted sense of economic efficiency, without rated long-term impact on the population health and costs to be incurred in the future.
So far, very politicized in social discourse, attempts to reform hospital treatment were unsuccessful, half-hearted and inconsistent. We believe that the idea of the omnipotent State which plans, organizes, finances and treats (even by private entities) in Poland does not work. Operation of the system, apparently effective (as compared with the EU countries "we buy relatively a lot of health" in relation to the money spent), is becoming more and more distant from the needs and expectations of patients. In the current design of the system it is not feasible to balance the needs and possibilities. At the same time no radical activity is possible or would be effective.
It seems that we need a well-planned evolution of the system in the following ways:

• withdraw of the State to the regulating position, the introduction of a strong and competent supervision (also enforces quality), forming a framework for public and private payers;
• "admitting" to the system money currently spent by patients in the form of direct payments - we have to do that on a large scale by health insurance;
• allow private entities (not just health insurance) to manage the purchase of medical services, not only to provide these services;
• design of competences based on the EBM and the HTA in the long-term management of health.

This type of reform done in the Netherlands (however, in different system conditions) lasted over 20 years. Further management of the NHF budget in the next 1-2 years will trigger many social and political crises related with health, increased differences in the access to treatment and in consequences deterioration of society health.

4. Patient involvement in HTA – how to communicate?
As HTA is a multidisciplinary process that seeks to inform policy it would seem obvious that patients should be involved in the HTA process. They can provide unique insights to add to those of other professional disciplines in HTA and for political legitimacy surely policy influencers should consult with the general public to ensure their voice is heard.
Despite the seemingly obvious call for patients to be involved in HTA. They are often excluded from the process because their voice is considered anecdotal or tainted by industry influence. However, patients have important perspectives to offer about living with a disease and the effects that treatments have. Their views on the outcomes that are most important often differ to the views of clinicians and regulators. Furthermore they can help quantify what the size of an effect really means to them as a patient and what is of real value.
The 2010 INAHTA survey of consumer involvement in HTA highlighted that from the 33 HTA Agencies that responded only 52% involved consumers (patients or citizens). However, 81% intended to involve patients in the future. So what are the mechanisms for patient involvement in HTA? There are two different forms of approach.
Firstly patients can be involved in the process of HTA – helping define the scope of the topic, consulting on draft reports, developing patient summaries etc. Secondly evidence about patients’ perspectives of the disease and its existing and new treatments can be gathered. Patients’ perspectives can be determined through formal social science research or via evidence submissions from patient organisations or using individual patients to share their experience with an HTA committee.
Processes for these approaches are maturing, but there is still much to be done to ensure that patient input is optimized so that their perspectives can add most value to HTA.

5. The valuation of services in the benefit package
Valuation of health services, procedures, Diagnosis Related Groups (DRGs; also Health Related Groups, HRGs) or any other elements which are paid by the insurer is of essential significance for functioning of the health care system from the patient's perspective. However, from the payer's perspective valuation may be of essential significance in case of real competition or a little significance in case of a monopsony.
In Poland there is no and never have been any competition with regard to payers. Today there is a national monopsonist - the National Health Fund and in the past there were regional monopsonists - Sickness Funds. A monopsonist has virtually no incentive (apart from political) and motivations to care for quality (including cost-effectiveness), availability of services, wholesomeness of the society or the insured nor shape of service providers. It only has to take care of budget discipline and expenditure within the financial plan. The National Health Fund behaves coherently in this specific way of thinking by introducing quotas and limiting contracts with service providers according to voluntary and vague rules. Additionally, new health technologies are introduced to the market constantly and the guaranteed benefits package increases disproportionally fast in relation to the increase of funds from the basic contribution. It leads to the following results:

• it is not a matter of financing services (apart from drugs in reimbursement lists) but rather of financing service providers, it is conducted on similar terms as a division of funds based on historic budgets, like in the socialistic era.
• there is no competition of service providers for patients and money connected to them, but rather competition for the contract's amount and quota which is set on the vague terms between the service provider and the monopsonist - the National Health Fund.
• some services are valued too low and other too high, with all the negative consequences thereof, both for patients and service providers.
• the scale of wastefulness and abuse is enormous, with minimal possibilities of control and little interest in eliminating of the pathology.

Generally, the system does not meet its primary role and is increasingly inefficient. It may be indicated by increasing limitations in access to health care services and increasing pool of funds outside the public system. In case of a monopsony, valuation plays a secondary role, and the payer does not take the opportunity to actively create the supply for benefits that are guaranteed in the basket, which can be described as basic, highly effective and very cost effective. In case of imposed quotas and rigid contracting, the payer is not afraid to breach the fiscal discipline because of new technologies included in the package. Effects of such actions are passed to service providers who have to get into debt and, what is even worse, to patients who are experiencing restrictions on access to health services more and more painfully and who have to pay more for medical care from their own pockets. The role of valuation of health care services from the package increases in significance in case of:

• introduction of real competition between payers;
• liquidation of quotas;
• introduction of fee-for-service financing of services partially guaranteed with a significant co-payment.

In these cases valuation becomes an essential issue and a regulating mechanism of the whole system, which touches upon all dimensions or areas of health insurances. First two points do not require any comment. Some implications are caused by dividing services into three categories:

1. guaranteed - services guaranteed in real, fully financed in 100% from the the basic health contribution's funds, to which access is not limited, regardless the fact that there is a single payer or multiple payers and regardless of the financing scheme (all schemes are allowed);
2. partially-guaranteed - important factors are: co-payment amount (a fee above the minimum level which really prevents abuse and wastefulness; it must not be symbolic) and co-payment level, in theory between 1-99% of the cost (possible to be covered with a complementary insurance);
3. outside the guaranteed benefits package - services which are not obtainable under the basic health insurance (they might be included in complementary insurance competing on services not included in the package).

In case of introducing a division of services based on the three, above-mentioned categories, the valuation will start to play the most important, essential role in the regulation of the whole health care system. Services guaranteed 'in reality' have to be valued above the realization cost to ensure a high enough supply of services in the system. These should be the basic, highly effective services, which have the best cost to effect ratio among the alternative procedures. The greater the shortage of staff, premises, equipment or other, standing in the way of ensuring the health needs of Polish society in the guaranteed services, the higher the contractual surplus over the costs of their performance should be (excess valuation, overvaluation). The situation should be dynamic and the tariffs agency should adjust the excessive valuation according to the adaptation and reaction of the market to health needs, maintaining it on various levels, as long as the service remains guaranteed.
In case of the partially guaranteed services, the role of the tariffs agency will be as important. It will be necessary to set the amount of co-payment in case of the price limit and to set the prices of services, procedures and groups, meaning the amounts which the third party payer will be obliged to pay regardless the payment scheme. It seems that the tariffs agency should have the same role as the pricing agency (the Economic Commission) in case of drugs included in the outpatient reimbursement lists and therapeutic programmes, which means that it should negotiate the prices of non-drug technologies and some of the drug-based procedures both with service providers and occupational groups, as well as the manufacturers, when necessary.
Apart from the allocation of services in different categories, or parts of the package (de facto speaking of various packages) it is crucial to conduct an active valuation as the supply of services and thus ensuring appropriate level of realization of insured' health needs will be dependant on it. Taking reimbursement (regarding the introduction of a service into a given part of the package) and pricing (negotiations, statutory price setting and co-payment level if necessary) decisions are the most important mechanisms regulating the health care system.

6. Reforms in health care systems
Europe is facing considerable resource pressures on their health care costs driven by well known factors including ageing populations, the continued launch of new premium priced technologies and rising patient expectations.
This is exacerbated by the ongoing economic situation in a number of European countries. This is leading to multiple reforms in Europe. These include reforms concerning established drugs to lower the price of generics as well as potentially reference pricing in a class.
There are also ongoing reforms to proactively review reimbursement and funding for new drugs. This will become increasingly important given the substantial number of new biological drugs in development and their anticipated prices. Consequently, the session will focus on 2 streams:

• Stream A - ongoing measures regarding established drugs, their impact and future direction.
• Stream B - ongoing developments regarding new drugs. This includes greater patient follow-up in registries.

We hope this will be an exciting and stimulating session.

7. The role of non-experimental studies in medical decision proces
Non-experimental studies, that means studies without randomization or pseudo-randomization methods, are mainly observational studies conducted after registration and medicine authorization on the market. Such studies often enable assessment of the effectiveness and safety of treatment with the participation of a large group of patients, significantly enriching the knowledge accumulated during the time before the drug registration. However, due to the lack of randomization and possible selection bias, the analysis of data collected during this study demand including the nature of their planning and implementation.
The session will discuss the role and importance of non-experimental studies in current clinical practice and reimbursement decisions. There will be presented currently used statistical methods in the analysis of non-randomized data and the basic problems of drawing conclusions about a cause-and-effect relationship based on non-experimental data. There will be discussed, based more on the intuition rather than on the technical details, methods and risks associated with attempts of such conclusions, also based on a case study – a sample analysis of observational data.
Chronic obstructive pulmonary disease (COPD) and asthma are chronic diseases of civilization, and the decision to include the treatment is taken for years. Clinical practice shows that the role of phase IV studies (post-marketing) is essential in making therapeutic decisions, determines the patient's co-operation with the doctor, and also has a role in monitoring the safety of the therapy. The presentation will show the phase IV study, conducted in patients with asthma and COPD.

CEESTAHC Society prints:

• Final programme EBHC Symposium 2013 (1 MB)