Dea Niebuhr

Verfahren und Kriterien zur Konkretisierung des Leistungskatalogs in der gesetzlichen Krankenversicherung

ZusammenfassungDie Konkretisierung des Leistungsanspruchs für die Versicherten der GKV erfolgt durch Gremien der gemeinsamen Selbstverwaltung. Die Legitimität der angewandten Verfahren und Kriterien wird sowohl aus Input- als auch aus Output-Perspektive bewertet. Aus der Input-Perspektive ist die Priorisierung der Beratungsthemen überhaupt nicht und die Veröffentlichung von Beratungsthemen nur für Fachleute transparent. Außerdem sind die zuständigen Gremien nicht ausreichend repräsentativ zusammengesetzt. Aus der Output-Perspektive werden Potenziale für die Optimierung der wirtschaftlichen Mittelverwendung nicht genutzt, weil Kosten-Nutzen-Relationen in der Entscheidungsfindung eine untergeordnete Bedeutung einnehmen. Gleichzeitig werden Rationierungen vermieden. Darüber hinaus sind die angewandten Verfahren nur eingeschränkt konsistent und insgesamt als wenig effektiv zu bewerten. AbstractThe content of the benefits package in German social health insurance is determined by intermediate bodies of healthcare providers and healthcare funds. Legitimacy of procedures and criteria are evaluated by looking at inputs as well as at outputs. From an input perspective, the prioritization of topics totally lacks transparency, while the publication of decisions is transparent only for experts. Moreover, the composition of the intermediate bodies of healthcare providers and healthcare funds is not representative. From an output perspective, opportunities for a more rational allocation of resources are lost, since cost-benefit ratios are not used for decisions. However, rationing does not take place. Procedures are often inconsistent and for the most part relatively ineffective.

Reform of Prescription Drug Reimbursement and Pricing in the German Social Health Insurance Market: A Comparison of Three Scenarios

We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries.Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible.The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US).We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.

Preisregulierung und Kosten-Nutzen-Bewertung von Arzneimitteln im Ländervergleich — Internationale Erfahrungen und Optionen für Deutschland

The 2007 health care reform has introduced maximum prices for prescription drugs in German social health insurance. In contrast to internal reference pricing — which has been introduced in 1989 — maximum prices need to be based on an assessment performed by the IQWiG of the patient relevant costs and benefits of all therapeutic alternatives to the respective drugs. Alternatively, they can be negotiated between the peak organisation of social health insurers and individual manufacturers. Moreover, costs for research and development need to be taken into account. e aim to assess the feasibility of maximum prices in the context of German social health insurance.MethodsWe compare direct price regulation in France and Switzerland and indirect price regulation in England and Wales to German regulation. Moreover, we compare the relationship between the determination of prices to the clinical and economic effectiveness of prescription drugs in these countries.ResultsIn both France and Switzerland the determination of prices of prescription drugs is connected to the listing on national formularies. Thus, manufacturers face strong incentives to acknowledge prices which are limited by price regulation. In both countries, higher incremental clinical effectiveness leads to price mark-ups. Costs for research and development are taken into account in a rather arbitrary fashion. Economic evaluation is hardly relevant for the determination of prices.DiscussionIn contrast to France and Switzerland, manufacturers in Germany face little incentives to acknowledge maximum prices for their products. First, maximum prices may only be determined by the peak organisation of social health insurers if sufficient data on costs and benefits are available. However, in Germany the scientific infrastructure for the application of pharmacoeconomic assessments still needs substantial development in order to provide economic evaluations on a regular basis. If, secondly, the threat of unilateral determination of maximum prices is a weak one and maximum prices are not linked to a national formulary, manufacturers will continue to determine prices themselves. Since Germany is an important reference country for external reference pricing, we conclude that the current maximum price regulation in Germany will have little impact.

Reform der Erstattungs- und Preisregulierung von verschreibungspflichtigen Arzneimitteln auf dem Markt der gesetzlichen Krankenversicherungen in Deutschland

We review regulation of two important parameters for third-party payers and Abstract manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries.Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible.The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US).We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.

Steuerung des Arzneimittelmarktes im internationalen Vergleich

In den letzten Jahren wurden die Ausgaben der Gesetzlichen Krankenversicherung zunehmend durch hohe Arzneimittelkosten belastet. Wodurch wurde diese Entwicklung verursacht? Welche Reformen werden fur den Arzneimittelmarkt diskutiert? Wie wird dieser Markt in anderen Landern gesteuert?In den letzten Jahren wurden die Ausgaben der Gesetzlichen Krankenversicherung zunehmend durch hohe Arzneimittelkosten belastet. Wodurch wurde diese Entwicklung verursacht? Welche Reformen werden für den Arzneimittelmarkt diskutiert? Wie wird dieser Markt in anderen Ländern gesteuert?