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Regulatorische Handhabung der selektiven Erstattung von Arzneimitteln in den ausgewählten Ländern England, Niederlande, Frankreich und Schweden

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  • Wasem, Jürgen
  • Weegen, Lennart
  • Bauer, Cosima
  • Walendzik, Anke
  • Grande, Frederic
  • May, Uwe

Abstract

[Einleitung] Im Rahmen des AMNOG wurde die Preisbildung für patentgeschützte Arzneimittel und damit die Erstattung durch die GKV neu geregelt. Seit 2011 wird in einer Verhandlung festgelegt, wie viel die Krankenkassen ab dem 13. Monat nach Marktzugang für neue Arzneimittel bezahlen, während die Preisbildung in den ersten 12 Monaten nach wie vor frei ist (§ 130b SGB V). Die zentrale Entscheidungsgrundlage für die Verhandlung ist eine zuvor durchgeführte Nutzenbewertung (§ 35a SGB V). Insbesondere das vom G-BA im Rahmen der Nutzenbewertung festgestellte Ausmaß des Nutzens bzw. Zusatznutzens stellt ein wichtiges Kriterium für die Höhe des festzusetzenden Preises dar. Der Nutzen bzw. Zusatznutzen eines Arzneimittels kann dabei für Teile der von der arzneimittelrechtlichen Zulassung abgedeckten Populationen deutlich unterschiedlich ausfallen. Der auf dieser Basis festgesetzte Erstattungsbetrag bzw. Preis ist unterdessen für das zugelassene Arzneimittel einheitlich, wird somit ggf. den unterschiedlichen Nutzenniveaus mehr oder weniger gerecht. Vor diesem Hintergrund wird auch von einem „Mischpreis“ gesprochen. Bei Mischpreisen kann es zu Konstellationen kommen, bei denen ein Präparat unter Gegebenheiten verordnet wird, bei dem sein Preis im Einzelfall gemessen am individuellen Nutzen des betreffenden Patienten zu hoch im Sinne der sozialgesetzlich geforderten Wirtschaftlichkeit ist. Sofern die Erstattungsfähigkeit von Arzneimitteln mit unterschiedlichen Nutzenniveaus nicht auf bestimmte Teilpopulationen mit entsprechenden Nutzenniveaus eingeschränkt wird, kommt es in der Praxis zwangsläufig zu Verordnungen, bei denen der Preis nicht „nutzengerecht“ ist. Die sich hieraus ergebende Situation gibt Anlass zur Untersuchung der Frage, ob und wie eine Einschränkung der Erstattungsfähigkeit, d. h. eine selektive Erstattung, zu einer besseren Handhabung der skizzierten Problematik beitragen könnte.

Suggested Citation

  • Wasem, Jürgen & Weegen, Lennart & Bauer, Cosima & Walendzik, Anke & Grande, Frederic & May, Uwe, 2015. "Regulatorische Handhabung der selektiven Erstattung von Arzneimitteln in den ausgewählten Ländern England, Niederlande, Frankreich und Schweden," IBES Diskussionsbeiträge 211, University of Duisburg-Essen, Institute of Business and Economic Studie (IBES).
    • Handle: RePEc:zbw:udewwd:211
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    References listed on IDEAS

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