Eine gesundheitsökonomische Analyse des deutschen Festbetragssystems als Instrument der Arzneimittelregulierung (English shop)

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In view of the development of pharmaceutical expenditure in the statutory health insurance (SHI) system, various regulatory measures have been introduced successively with the aim of cost containment. In the more recent past, deregulation tendencies in other sectors have stood in contrast to an increasing density of regulation in the pharmaceutical sector. In the case of prescription-only medicines, an unjustified enrichment of the pharmaceutical industry is suspected on the supply side, while on the demand side the multiply divided demand poses the problem of insufficient incentives for economic efficiency. The development of a consistent regulatory regime that is able to sustain itself at least for a certain period of time thus becomes a major challenge. Nevertheless, cost control is not the sole objective, since it does not correspond to the preferences of the (compulsorily) insured. Considering trade-offs remains unavoidable in any case.

The present study examines the conceptual and impact-oriented effects of reference price regulation in the German health care system. Reference prices (Festbeträge) constitute the cornerstone of German pharmaceutical reimbursement regulation. Over the past 20 years, they have been supplemented by new, complementary instruments. Reference prices govern the level of reimbursement for those with statutory health insurance in the Federal Republic. In addition to the system of basket-of-goods comparison used in many countries, a reference price can be determined on the basis of an “internal” price comparison. Germany employs a highly complex internal reference price system. As could be demonstrated empirically, and as other authors predominantly confirm, reference prices have a cost-containing effect. However, they require accompanying regulations and are themselves in conflict with other measures. The analysis carried out was able to show, on the one hand, the effect of a strong price adjustment in the Level 1 groups and, on the other hand, that the procedure of the prescription-weighted comparative measure of strength (Wirkstärkenvergleichsgröße) for establishing therapeutic equivalence in non-generic groups must be regarded as capable of further development. Supplements to the procedure in the form of mark-ups for patient-relevant product characteristics would be one approach here. The manner in which the market is modelled by means of a regression, and thus the core element of the reference price rules in Germany, appears adequate and consistent with the objectives. The analysis of order of entry revealed strong price adjustment behaviour of late entrants towards the other members of the group.

Decisive for all (price) regulation efforts is the relationship between health gain and costs. An isolated consideration of benefit makes just as little sense as a purely cost-reducing strategy, which may lead to overcompensation in other sectors. Drug therapies sometimes even replace inpatient stays and can then lead to cost reductions in the system as a whole. This, however, requires a cross-sectoral view of the system, such as payers could take. A discussion of more recent reform proposals shows how a change of strategy can be initiated. A focus on few measures, but ones applied more consistently, is to be recommended. If reference prices remain a core element of expenditure regulation (under the AMNOG the alternative to submitting a dossier for generic followers), all measures in the area of selective contracting should be subjected to close scrutiny in order to limit the increasingly occurring interactions. The thrust of the AMNOG does not point sufficiently in the direction of a slimming down of the “toolbox”.