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Auswirkungen der frühen Nutzenbewertung auf Patienten mit Epilepsie in Deutschland

Aktuelle Versorgungsrealität und therapeutischer Bedarf

Impact of early benefit assessment on patients with epilepsy in Germany

Current healthcare provision and therapeutic needs

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Zusammenfassung

Die Epilepsie gehört zu den häufigsten chronischen neurologischen Erkrankungen und stellt für die Betroffenen, Angehörigen und die Gesellschaft eine erhebliche Belastung dar. Bei mehr als drei Viertel der Patienten erfolgt die antikonvulsive Therapie mit Valproat, Carbamazepin, Lamotrigin oder Levetiracetam. Bei therapierefraktären Patienten ist meist eine Polytherapie notwendig und die Erkrankung führt zu negativen Auswirkungen auf die Lebensqualität, Berufstätigkeit und damit verbundenen hohen indirekten Kosten. Für eine umfassende Behandlung insbesondere dieser Patientengruppe ist der Zugang zu neuartigen Antikonvulsiva notwendig. Bislang scheitern allerdings alle Verfahren in Rahmen des Arzneimittelmarktneuordnungsgesetzes (AMNOG), einen Zusatznutzen von neuen Antikonvulsiva zu belegen, an systemimmanenten Vorgaben, insbesondere der Definition einer „zweckmäßigen Vergleichstherapie“. Es ist äußerst fraglich, ob es in Zukunft in der Epileptologie Studien geben wird, die der jetzigen Form des AMNOG genügen werden. Stattdessen könnte der individuelle Zusatznutzen derzeit am besten durch eine Nachbeobachtung der Substanz nach der Zulassung und Einführung des Präparats überprüft werden.

Abstract

Epilepsy is one of the most common chronic neurological diseases and represents a significant burden for patients, their families and society. In more than 75 % of patients anticonvulsant therapy consists of valproate, carbamazepine, lamotrigine or levetiracetam. There is a need for polytherapy in drug-refractory patients and they suffer from negative effects on quality of life and employment that is associated with high indirect costs. To allow a comprehensive treatment in this patient group, access to new anticonvulsants with novel modes of action is needed; however, all applications for new antiepileptic drugs failed to prove added benefits during the Pharmaceutical Market Restructuring Act (AMNOG) in Germany. One of the main reasons is the mandatory definition of a standard comparative therapy. It remains unclear whether there will be studies in the future which will fulfill the requirements of the current version of AMNOG. Observational studies after approval and marketing of new antiepileptic drugs could be better alternatives to prove added benefits for individual patients in the current German healthcare system.

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Authors and Affiliations

  1. Epilepsiezentrum Frankfurt Rhein-Main, Klinik für Neurologie, J.W. Goethe Universität, Schleusenweg 2–16, Haus 95, 60528, Frankfurt am Main, Deutschland

    A. Strzelczyk

  2. Epilepsiezentrum Hessen, Klinik für Neurologie, Philipps-Universität Marburg, Marburg, Deutschland

    A. Strzelczyk

  3. Epilepsiezentrum Erlangen, Klinik für Neurologie, Friedrich-Alexander Universität, Erlangen, Deutschland

    H. M. Hamer

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A. Strzelczyk erhielt Beratungs-, Referentenhonorare und/oder Unterstützung für Forschungsvorhaben von Bayer HealthCare, Boehringer Ingelheim, Desitin Arzneimittel, Eisai, Pfizer, Sage Therapeutics und UCB Pharma. H.M. Hamer erhielt Beratungs-, Referentenhonorare und/oder Unterstützung für Forschungsvorhaben von Cerbomed, Desitin, Eisai, GSK, Janssen-Cilag, IQWiG, Nihon Kohden, Novartis, Pfizer, Thieme und UCB Pharma.

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Strzelczyk, A., Hamer, H.M. Auswirkungen der frühen Nutzenbewertung auf Patienten mit Epilepsie in Deutschland. Nervenarzt 87, 386–393 (2016). https://doi.org/10.1007/s00115-016-0087-z

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