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The aim of this paper is to propose and discuss procedures to …

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- The value of health care – a matter of discussion in Germany

Scientific suggestions for assessment of the value of health-care services

A position report of the Betriebskrankenkassen, BKK (Company-affiliated social health insurances) [31] established that the effectiveness according to the Arzneimittelgesetz (German Drug Law) corresponds with the socio-legal term "expediency", i.e., with the therapeutic value of a drug. The service obligation is to be decided based on cost-benefit considerations. The criteria for the list of recommended drugs states that the therapeutic value can be measured by the extent to which the desired therapeutic effect is attained. This observation is important from a scientific point of view, but the application of different evaluation criteria for chemically defined and other drugs (e.g., from the fields of phytotherapy, homeopathy, anthroposophy) is problematic. According to this definition, the therapeutic value of chemically-defined drugs must be investigated according to evidence-based criteria while "other" drugs only have to comply with internal evaluation systems founded on scientific theory.

A position paper [32] of the Verband der Forschenden Arzneimittelhersteller, VFA (German Association of Research-Based Pharmaceutical Companies) presented a detailed suggestion for different criteria which should be observed in the assessment of the value of drugs. It stated that the assessment of value should exceed the boundaries of individual sectors, i.e., should include the prevention or reduction of hospitalisations, early retirement, nursing care or visits to physicians. An appropriate point in time should be chosen for the assessment of value, i.e., the indication and other circumstances determine how great the time interval between registration and possible evaluation of value should be because statements concerning the value of a new therapy immediately following its registration are, by definition, not possible. Registration usually results from proof of efficacy, rarely of effectiveness, and almost never of value. The value of a drug or a health-care service certainly cannot be sufficiently described by its efficacy or effectiveness. Therefore, we point out the necessity of a scientific differentiation between efficacy, effectiveness and value.

It is also correct that the methodic approach to assessing value should not be too narrow. The use of only randomised studies – as suggested by German authorities – to describe the value can hardly be justified scientifically because these studies have both advantages and disadvantages, just like any other scientific method. Since the appropriate definition of evaluation criteria represents one of the greatest problems in assessing value, one must pay particular attention to maintaining scientific criteria. Arbitrary rules including minimum times or minimum dimensions cannot be upheld from a scientific standpoint. Most complex decisions require a structured dialogue, which we confirm to be an essential part of value assessment.

In its final report on short-acting insulin analogues, the Institute for Quality and Efficiency in Health Care demands observation of long-term effects to evaluate benefit and harm [33]. This requirement makes sense if it can be fulfilled under the prevailing conditions [34]. Since the required data have not yet been collected and cannot be handed in within a short time, other ways to assess value must be discussed.

The report also mentions additional benefit relevant to the patients [33], but provides no indication of what is meant by the term additional benefit and with which data this should be proven. Thus, the statements made by the Institute for Quality and Efficiency in Health Care do not make the anticipated contribution to the evaluation of health-care services.

This impression has been confirmed in a critical statement [35] concerning the commission and the activities of the Institute. It has also been accused of a lack of independence and unscientific arguments. This reproach is not unjustified, since the practicability of generally accepted assessment rules has been questioned without mentioning the available literature on the term value.

The Deutsche Pharmazeutische Gesellschaft, DPhG (German Pharmaceutical Association) contributes to the definition and differentiation of different forms of innovation in its position paper [35]. When referring to innovation, "(additional) value" is pointed out along with the "(real) innovativeness", whereby the former usually can only be evaluated some time after an innovation has been introduced. In this case, it would be reasonable to name the criteria and the expected time for the confirmation of value as soon as an innovation is recognised as such.

A comprehensive description of value assessment containing a summary of the discussed aspects was established by the Bundesverband der Arzneimittelhersteller BAH e.V. (Federal Association of Drug Manufacturers) [37]. Therein from an economic viewpoint value is understood as an abstract measurement for the satisfaction of needs which a consumer can get from consuming a good. Value is equated with health-related quality of life and is, therefore, subjective and related to time and place.

This concept is, however, problematic in practical application because:

• value must be measurable (objective, interpersonally comparable and it should be possible to aggregate it as social benefits),

• value must reflect different perspectives and

• the conflict between individual and social value has to be solved.

It is shown that socio-legal aspects (expediency, efficiency, not surpassing the required limits) are necessary, but not sufficient, criteria for value assessment. Criteria of welfare economics and regulatory policies can hardly be applied for value assessment because the physician's decisions have to be tailored to the individual patient. Even if it hardly seems possible to take these three aspects into consideration in a common strategy for value assessment, an approximate solution which is supported by a sufficiently large majority remains a worthwhile goal in the absence of other reasonable alternatives.

The Bundesverband der Pharmazeutischen Industrie, BPI (German Pharmaceutical Industry Association) [38] illustrated the value assessment of drugs under methodic aspects with ten examples. These examples describe the complexity of value assessment by demonstrating the measurement of effectiveness, quality of life, compliance, side effects and costs on different models. The introduction to the topic contains a general and technically well-founded criticism of methods relating to value assessment in medicine. This presentation of the components of value assessment is a prerequisite for the following necessary step of finding a consensus in which these components are summarised into a value judgment for an indication and a treatment method.

The drug manufacturer, Pfizer Germany, [39] recruited scientists from different disciplines and institutions for a pertinent discussion of the value of drugs. The didactically valuable, comprehensible contributions reflect the different understanding of the various methods which are applied to describe value in the different disciplines. The contributions appear to coincide in the opinion that a differentiated judgment of the benefit for the individual patients in everyday medical care is not possible. We are not yet satisfied with this result because, when there is no consensus on the value assessment, there is a risk that arbitrarily chosen criteria will be legitimated either to publicly finance health services which are of little patient benefit or not to publicly finance beneficial services and, thereby, restrict their availability to part of society. For that reason we are strongly in favour of gaining a consensus concerning the value assessment of health-care services. Even if this consensus initially has severe limitations, it makes more sense to begin the process of consensus building now than later.

Perleth [40] and Busse [41] called attention to the growing importance of Health Technology Assessment (HTA) Reports in the evaluation and reimbursement of health-care services. Although the importance of these summary reports is generally accepted, one must keep in mind that there exist qualitative differences among these reports. If the quality of scientific papers which are summarized in HTA reports reveals errors and these are not mentioned in the HTA report [42], a major pillar of our decision-making processes could become instable. The compilation of complex data with scientific methods does not necessarily increase the reliability of their statements. In our own interest we should consider whether quality-ensuring measures should be introduced for these important components.

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