[The budget control function of the Drug Reimbursement System]. / De budgetbeheersende functie van het Geneesmiddelenvergoedingssysteem.

We now have 10 years of experience with the Dutch Price Reference System (Dutch acronym GVS), which was instituted in order to reduce the growth of extramural pharmaceutical costs to 4.1% annually, assuming no loss of medical quality. The system focussed mainly on budget control rather than on increasing cost-effectiveness by substitution. The budget-control aims were not achieved. As epidemiological and demographic developments would account for about 3% annual budget growth given an unchanged individual consumption of pharmaceuticals, the 4.1% criterion left only 1% room for autonomous growth (price, volume). The current 8% average annual growth rate indicates 5% autonomous growth. This rate is low, however, compared to other European countries, where a number of autonomous growth factors are not systematically counterbalanced at the product level by substitution incentives and control over prices and indication by health-care authorities and health-insurance companies. The GVS and related administrative measures have therefore most likely exerted a significant budget-controlling influence. The current policy of the Dutch Ministry of Health, Welfare and Sports in terms of goals, actors' roles and incentives fits well with the GVS, which should therefore be continued.

Introduction to the pharmacoeconomics of herbal medicines.

This article explores the need to perform pharmacoeconomic evaluations of herbal medicines and assesses the extent to which this approach has been applied so far to these products. There seems to be no compelling need for pharmacoeconomic analyses of herbal over-the-counter medicines, but such analyses are certainly warranted for herbal prescription medicines that have a high level of reimbursement. Such preparations are used in Germany, in particular, where physicians prescribed ginkgo, hawthorn, St John's wort, horse-chestnut and saw palmetto to a value of more than DM50 million each in 1996. In our survey, only a single pharmacoeconomic study, of uncertain quality, was found on these 5 herbs, whereas several pharmacoeconomic reports on synthetic competitors were retrieved. The time has come to submit highly reimbursed herbal prescription medicines to the same rigorous pharmacoeconomic evaluations as their synthetic competitors. At present, such studies are particularly important for Germany, but in the future they may also become relevant for other countries, inside as well as outside Europe.

Reporting format for economic evaluation. Part II: Focus on modelling studies.

This article presents the first version of a reporting format for modelling studies which is based on a general reporting format by our taskforce, which was published in the previous issue of this journal. The use of decision-analytical models for economic evaluations is increasing because, in practice, it is not always possible to derive information from prospective studies. However, the acceptance of modelling studies is generally lower than prospective studies not only because of the use of secondary data, but also because the reports of modelling studies do not always have sufficient transparency. Hence, a standardised reporting format may improve the transparency and, consequently, the acceptance of modelling studies. This article presents an example of a reporting format for economic evaluation based on modelling studies, which may facilitate the development of future guidelines for modelling studies. The format consists of a number of headings, which are followed by a brief recommendation on the content. This format does not deal with methodology and data management, but especially addresses validation and quality assurance, which may increase the transparency of the report.

Reporting format for economic evaluation. Part I: Application to the Dutch healthcare system.

This article presents the first version of the reporting format for economic valuation that was created in 1995 by a multidisciplinary taskforce. The members of this taskforce come from a broad spectrum of backgrounds within the healthcare field and participated in the exercise voluntarily. The format presented should be understood as the preferred Dutch structure for the reporting of any study on economic evaluation. In view of the many areas of contention that exist within the field, this format only gives normative directions in those areas in which consensus exists, as evidenced by the current published international guidelines. A regular review and adaptation of this format will be needed to reflect advances in the field.

[Evaluation of drugs: efficacy, applicability, effectiveness and efficiency]. / Waardebepaling van geneesmiddelen: werkzaamheid, toepasbaarheid, doeltreffendheid en doelmatigheid.

In view of rising costs of drugs and the limited budget, government, institutes, researchers, prescribers, pharmacists and pharmaceutical industries should have a standardized assessment system at their disposal on which to base their pharmacotherapeutic policy. Evaluation can be achieved in four successive steps, taking into account both therapeutical and financial aspects. The first two steps, determining efficacy and applicability, represent the current system of evaluating drugs before allowance to the market. Steps 3 and 4 describe the ways in which effectiveness and efficiency can be involved in the evaluation by means of (cost) effectiveness analysis. Achieving optimal results from this stepwise approach requires speedy acceptance of the currently available guidelines for effective and efficient research.