Neues aus der Epilepsiebehandlung – Nicht alle neuen auf dem Markt zugelassenen Präparate bestehen die Feuerprobe in ihrer Anwendung

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Das neu zugelassene Epilepsiepräparat Retigabin wurde vom Markt genommen.

Informationen hierzu finden sie im nachfolgenden Artikel.

„Zitat“

Gemeinsame Stellungnahme der Deutschen Gesellschaft für Epileptologie e. V. (DGfE) und der Deutschen Gesellschaft für Neurologie (DGN)Epilepsie: Neues Medikament mit innovativem Wirkmechanismus (Retigabin) ohne „Zusatznutzen“ eingestuft

Firma GSK nimmt Retigabin vorläufig in Deutschland vom Markt

4. Juni 2012 – Vor einem Jahr wurde das neue Antiepileptikum Retigabin in den Markt eingeführt. Ca. 1400 Epilepsie-Patienten in Deutschland nehmen das neue Medikament ein. Bei einem Teil dieser Patienten verhindert dies Anfälle oder reduziert deren Häufigkeit deutlich. Jetzt kam der Gemeinsame Bundesausschuss (G-BA) jedoch zu der Einschätzung, dass sich durch Retigabin kein Zusatznutzen gegenüber den Vergleichssubstanzen Lamotrigin und Topiramat darstelle [1]. Dies bedeutet, dass das neue Medikament zum – unverhältnismäßig niedrigen – Preis der generischen Vergleichssubstanzen angeboten werden muss. In einer Presseinformation kündigte die Firma GSK daraufhin am 31. Mai an, die Preisverhandlungen nicht aufzunehmen und das Medikament zunächst in Deutschland vom Markt zu nehmen, bis eine erneute Nutzenbewertung (mit unklarem Ausgang) erfolgt ist [2]. Das bedeutet nun, dass Retigabin ab dem 1. Juli 2012 nur noch über die internationale Apotheke erhältlich ist und dafür ein Antrag bei der KK gestellt werden muss.

Pressemitteilung zum Download

Die Deutsche Gesellschaft für Neurologie (DGN) und die Deutsche Gesellschaft für Epileptologie (DGfE) sehen die Notwendigkeit, die Behandlungskosten bei neu eingeführten Medikamenten in einem wirtschaftlichen Rahmen zu halten und befürworten dies uneingeschränkt. Das Ergebnis der Nutzenbewertung von Retigabin zeigt jedoch, dass viele besondere Aspekte der individuellen Behandlung von Epilepsiepatienten nicht ausreichend berücksichtigt wurden und daraus eine für die DGN und DGfE unverständliche Einschätzung resultierte. (Siehe auch die Stellungnahme der DGfE vom 7.3.2012 [3].) „Wir möchten gerne im Interesse der von Retigabin profitierenden Patienten einen gemeinsamen Lösungsansatz finden, da aus unserer Sicht ein gut belegbarer Zusatznutzen gegeben ist und dieser anerkannt werden sollte“, betont Professor Dr. Holger Lerche aus Tübingen, erster Vorsitzender der DGfE. „Unser Gesundheitssystem muss es sich leisten können, diesen Patienten mit einer schweren Erkrankung sinnvolle innovative Therapiealternativen anzubieten“, so die Meinung von Prof. Dr. Wolfgang H. Oertel, 1. Vorsitzender der DGN.

Dialog des G-BA mit den Fachverbänden sinnvoll

Die DGfE und die DGN möchten mit dem G-BA gerne in einen Dialog treten, um die Besonderheiten der Behandlung von Epilepsiepatienten – generell und aktuell im Hinblick auf Retigabin – zu erörtern und um eine gemeinsame Lösung zu erarbeiten. „Wir wollen vermeiden, dass Retigabin aufgrund einer international noch nie in ähnlicher Form da gewesenen Preisbildung in Deutschland dauerhaft vom Markt genommen wird und Patienten, die von Retigabin derzeit oder künftig profitieren können, diese innovative Substanz vorenthalten wird“, betont Dr. Thomas Mayer, erster Geschäftsführer der DGfE. Dies gilt in gleichem Maße für zukünftig zu erwartende Markteinführungen innovativer Medikamente. „Es besteht die Gefahr, die für den Standort wichtige Vorreiterrolle von Deutschland bei klinischen Studien und bei der Einführung von Medikamenten durch solche Maßnahmen aufs Spiel zu setzen“, so Prof. Dr. Wolfgang H. Oertel, 1. Vorsitzender der DGN.

Nachgewiesene Anfallsfreiheit

In den klinischen Studien zur Zulassung von Retigabin wurde ein Zusatznutzen durch die Anfallsfreiheit bei bis zu 8 Prozent der Patienten oder eine mindestens 50-prozentige Reduktion der Anfallsfrequenz bei etwa 30 Prozent der Patienten nachhaltig belegt [4]. Ein zusätzlicher Nutzen entsteht, indem erhebliche indirekte Kosten durch eine therapierefraktäre Epilepsie sowie die Verbesserung der Lebensqualität und der sozioökonomischen Situation der Patienten vermieden werden.
Der Anteil der Patienten mit pharmakoresistenter Epilepsie beträgt ca. 25 Prozent aller Epilepsiepatienten, also etwa 150.000 Menschen in Deutschland. Insbesondere die Subgruppe von Patienten mit fokalen Epilepsien ist betroffen. Für diese therapierefraktären Patienten besteht die Hoffnung, durch Zugabe neuer Wirkstoffe schließlich doch einen Therapierfolg zu erzielen. Tatsächlich wird durch den systematischen Einsatz mehrerer neuer Antiepileptika bei ca. 15 Prozent der resistenten Epilepsiepatienten eine Anfallsfreiheit erreicht [5].
Retigabin ist ein Antiepileptikum mit einem neuartigen Wirkungsmechanismus, was die Hoffnung auf eine erfolgreiche Behandlung bisher resistenter Patienten erhöht. Seine antikonvulsive Wirkung beruht auf einer Stabilisierung eines Kaliumkanals im geöffneten Zustand, wodurch die zelluläre Erregbarkeit herabgesetzt wird. Retigabin ist zugelassen als Zusatztherapie für fokale epileptische Anfälle mit oder ohne sekundäre Generalisierung bei Erwachsenen mit Epilepsie.

Gewählte Vergleichstherapie fragwürdig

Die Nutzenbewertung von Retigabin erfolgte gegenüber Lamotrigin bzw. Topiramat. Beide Präparate sind sowohl zur Mono- als auch zur Zusatztherapie bei fokalen und generalisierten Epilepsien bei Erwachsenen und Kindern (altersabhängig) zugelassen und verfügen somit über ein wesentlich größeres Zulassungsgebiet [6]. Lamotrigin ist ein Mittel der ersten Wahl als Monotherapie und wird für eine völlig andere Patientenklientel eingesetzt als Retigabin. Retigabin wurde erst vor kurzem zugelassen und wird auch von der DGfE und der DGN nicht als First-Line-Zusatztherapie gesehen, sondern nur dann, wenn initiale Monotherapien nicht erfolgreich waren und etablierte Zusatztherapien ebenfalls gescheitert sind, zu denen Topiramat zu zählen ist. Lamotrigin und Topiramat entsprechen deshalb nicht den Anforderungen einer zweckmäßigen Vergleichstherapie. Zudem waren die Zulassungsbedingungen für beide Substanzen 1993 bzw. 1998 völlig andere und die durchgeführten Studien sind deshalb nicht gut vergleichbar. Sinnvoll wäre der Vergleich mit einem Arzneimittel, das wie Retigabin erst kürzlich als Zusatztherapie bei fokalen Epilepsien bei Erwachsenen zugelassen wurde.

Literatur

  1. Beschluss des Gemeinsamen Bundesausschusses über eine Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII- Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Retigabin vom 3. Mai 2012
  2. Pressemeldung unter www.glaxosmithkline.de
  3. Stellungnahme zu Retigabin/Trobalt von der Deutsche Gesellschaft für Epileptologie e.V. und der Deutschen Gesellschaft für Neurologie am 7. März 2012. Siehe: http://www.dgfe.info/cweb2/cgi-bin-noauth/cache/VAL_BLOB/4450/4450/1174/Stellungnahme%20zu%20Retigabin-03-2012-DGfE-DGN.pdf
  4. Schiller Y, Najjar Y. Quantifying the response to antiepileptic drugs: effect of past treatment history. Neurology 2008: 70(1): 54-65
  5. Callaghan BC, Anand K, Hesdorffer D, Heuser WA, French JA. Likelihood of seizure remission in an adult population with refractory epilepsy. Ann Neurol. 2007; 62(4): 382-389
  6. S2K-Leitlinie der Deutschen Gesellschaft für Neurologie

Deutsche Gesellschaft für Epileptologie e.V.
Informationszentrum Epilepsie
Reinhardtstr. 14, 10117 Berlin
Webseite: www.izepilepsie.de
Webseite Fachgesellschaft: www.dgfe.info
Tel. 0700/13 14 13 00, Fax: 0700/13 14 13 99
E-Mail: ize@dgfe.info Diese E-Mail-Adresse ist gegen Spambots geschützt! JavaScript muss aktiviert werden, damit sie angezeigt werden kann.

Pressestelle der Deutschen Gesellschaft für Neurologie e.V.
Tel.: +49 (0)89 461486 22
Fax: +49 (0)89 461486 25
E-Mail: presse@dgn.org Diese E-Mail-Adresse ist gegen Spambots geschützt! JavaScript muss aktiviert werden, damit sie angezeigt werden kann.

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