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Modul 2(Pdf 551,29 Dokumentvorlage, Version vom 20.01.2011 Dossier zur Nutzenbewertung gemäß § 35a SGB V Pixantron (Pixuvri®) CTI Life Sciences Ltd. Modul 2 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Stand: 20.11.2012 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Inhaltsverzeichnis Seite Tabellenverzeichnis .................................................................................................................. 2 Abbildungsverzeichnis ............................................................................................................. 3 Abkürzungsverzeichnis ............................................................................................................ 4 2 Modul 2 – allgemeine Informationen ............................................................................ 7 2.1 Allgemeine Angaben zum Arzneimittel ....................................................................... 7 2.1.1 Administrative Angaben zum Arzneimittel ............................................................ 7 2.1.2 Angaben zum Wirkmechanismus des Arzneimittels ............................................... 8 2.2 Zugelassene Anwendungsgebiete ............................................................................... 34 2.2.1 Anwendungsgebiete, auf die sich das Dossier bezieht .......................................... 34 2.2.2 Weitere in Deutschland zugelassene Anwendungsgebiete ................................... 34 2.2.3 Zulassungsstatus international ............................................................................... 35 2.3 Beschreibung der Informationsbeschaffung für Modul 2 ........................................... 36 2.4 Referenzliste für Modul 2 ........................................................................................... 37 Pixantron (Pixuvri®) Seite 1 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Tabellenverzeichnis Seite Tabelle 2-1: Allgemeine Angaben zum zu bewertenden Arzneimittel ...................................... 7 Tabelle 2-2: Pharmazentralnummern und Zulassungsnummern für das zu bewertende Arzneimittel ................................................................................................................................ 8 Tabelle 2-3: Wirkmechanismus von Arzneistoffen aus derselben pharmakotherapeutischen Gruppe wie Pixantron .................................................................... 12 Tabelle 2-4: Wirkmechanismus und Zulassungsstatus von Monotherapien zur Behandlung von NHL ................................................................................................................................... 19 Tabelle 2-5: Wirkmechanismus und Zulassungsstatus von Kombinationstherapeutika zur Behandlung von NHL .............................................................................................................. 27 Tabelle 2-6: Zugelassene Anwendungsgebiete, auf die sich das Dossier bezieht ................... 34 Tabelle 2-7: Weitere in Deutschland zugelassene Anwendungsgebiete des zu bewertenden Arzneimittels ............................................................................................................................ 35 Tabelle 2-8: Zulassungsstatus international ............................................................................. 35 Pixantron (Pixuvri®) Seite 2 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Abbildungsverzeichnis Seite Abbildung 2-1 Zielmoleküle antineoplastischer Substanzen ................................................... 10 Abbildung 2-2 Doxorubicin, Mitoxantron und Pixantron Molekülstrukturen ......................... 17 Pixantron (Pixuvri®) Seite 3 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Abkürzungsverzeichnis Abkürzung Bedeutung 90Y Yttrium-90 ADCC Antikörper-abhängige zelluläre Zytotoxizität AG Aktiengesellschaft AMP Adenosinmonophosphat AM-RL Arzneimittel-Richtlinien Ara-CTP Arabinosylcytosintriphosphat ATC-Code Anatomisch-Therapeutisch-Chemischer Code ATPase Adenosintriphosphatasen B-Zell-NHL Non-Hodgkin B-Zell-Lymphom bzgl. bezüglich bzw. beziehungsweise ca. zirka Ca2+ Kalzium CD Unterscheidungsgruppen (Cluster of Differentiation) CDC Komplement-abhängige Zytotoxizität CHOP Cyclophosphamid, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristin), Prednison CIBO-P Vincristin, Lomustin, Ifosfamid, Bleomycin, Cisplatin CLL chronisch-lymphatische B-Zell-Leukämie (chronic lymphatic leukemia) COP Cyclophosphamid, Oncovin (Vincristin), Prednison/Prednisolon CpA synonym für TpG, Thymin-phosphatidyl-Guanosin-Dinukleotid CpG Cytosin-phosphatidyl-Guanosin-Dinukleotid DHFR Dihydrofolat-Reduktase DLBCL Diffuses großzelliges Non-Hodgkin B-Zell-Lymphom (Diffuse large B-cell lymphoma) DNS/DNA Desoxyribonukleinsäure (Desoxyribonucleic acid) DS Dosierungsschema EPAR European Public Assessment Report FDA Food and Drug Administration Fe Eisen (Ferrum) Pixantron (Pixuvri®) Seite 4 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete FL Follikuläres Lymphom G1-Phase Präsynthesephase G2-Phase Postsynthesephase G-BA Gemeinsamer Bundesausschuss GmbH Gesellschaft mit beschränkter Haftung H Wasserstoff Hb Hämoglobin i.v. intravenös IgG Immunglobulin G IVAMdex Ifosfamid, Etoposid, Cytarabin, Methotrexat und Dexamethason KOF Körperoberfläche l Liter m2 Quadratmeter max. maximal mg Milligramm mm Millimeter mm3 Kubikmillimeter mol Mol M-Phase Mitosephase MTD maximal tolerierte Dosis NHL Non-Hodgkin Lymphom NK-Zellen Natürliche Killerzellen nM Nanometer NNR Nebennierenrinde ProMACE- CytaBOM Prednison, Doxorubicin, Cyclophosphamid, Etoposid, Cytarabin, Bleomycin, Vincristin, Methotrexat, Folinsäure PZN Pharmazentralnummer R-CHOP Rituximab+Cyclophosphamid, Hydroxydaunorubicin (Doxorubicin), Onkovin (Vincristin) und Prednison R-FCM Rituximab+Fludarabin, Cyclophosphamid, Mitoxantron RNS Ribonukleinsäure (Ribonucleic acid) s. siehe S-Phase Synthesephase Pixantron (Pixuvri®) Seite 5 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete u.a. unter anderem z.B. zum Beispiel ZNS Zentralnervensystem Pixantron (Pixuvri®) Seite 6 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete 2 Modul 2 – allgemeine Informationen Modul 2 enthält folgende Informationen: – Allgemeine Angaben über das zu bewertende Arzneimittel (Abschnitt 2.1) – Beschreibung der Anwendungsgebiete, für die das zu bewertende Arzneimittel zugelassen wurde (Abschnitt 2.2); dabei wird zwischen den Anwendungsgebieten, auf die sich das Dossier bezieht, und weiteren in Deutschland zugelassenen Anwendungsgebieten unterschieden. Darüber hinaus wird der internationale Zulassungsstatus für das zu bewertende Arzneimittel dargestellt. Alle in den Abschnitten 2.1 und 2.2 getroffenen Aussagen sind zu begründen. Die Quellen (z. B. Publikationen), die für die Aussagen herangezogen werden, sind in Abschnitt 2.4 (Referenzliste) eindeutig zu benennen. Das Vorgehen zur Identifikation der Quellen ist im Abschnitt 2.3 (Beschreibung der Informationsbeschaffung) darzustellen. Im Dokument verwendete Abkürzungen sind in das Abkürzungsverzeichnis aufzunehmen. Sofern Sie für Ihre Ausführungen Tabellen oder Abbildungen verwenden, sind diese im Tabellen- bzw. Abbildungsverzeichnis aufzuführen. 2.1 Allgemeine Angaben zum Arzneimittel 2.1.1 Administrative Angaben zum Arzneimittel Geben Sie in Tabelle 2-1 den Namen des Wirkstoffs, den Markennamen und den ATC-Code für das zu bewertende Arzneimittel an. Tabelle 2-1: Allgemeine Angaben zum zu bewertenden Arzneimittel Wirkstoff: Pixantron Markenname: Pixuvri® ATC-Code: L01DB11 Geben Sie in der nachfolgenden Tabelle 2-2 an, welche Pharmazentralnummern (PZN) und welche Zulassungsnummern dem zu bewertenden Arzneimittel zuzuordnen sind, und benennen Sie dabei die zugehörige Wirkstärke und Packungsgröße. Fügen Sie für jede Pharmazentralnummer eine neue Zeile ein. Pixantron (Pixuvri®) Seite 7 von 40 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Tabelle 2-2: Pharmazentralnummern und Zulassungsnummern für das zu bewertende Arzneimittel Pharmazentralnummer Zulassungsnummer Wirkstärke Packungsgröße (PZN) 0927010 EU/1/12/764/001 29mg Pixantron 1 Durchstechflasche (entspricht 50mg Pixantron dimaleat) 2.1.2 Angaben zum Wirkmechanismus des Arzneimittels Beschreiben Sie den Wirkmechanismus des zu bewertenden Arzneimittels. Begründen Sie Ihre Angaben unter Nennung der verwendeten Quellen. Der wirksame Bestandteil von Pixuvri® ist Pixantronbase, ein zytotoxisches Aza- Anthracendion. Als chemotherapeutische Substanz greift Pixantron in den Wachstumszyklus von Zellen ein, die sich in einer aktiven Replikationsphase befinden und dadurch empfindlich für die Therapie sind. Ruhende Zellen dagegen sind unempfindlich gegenüber Chemotherapien. Die Interaktionen von Pixantron mit DNS, bei der Pixantron über Formaldehyd extrinsisch aktiviert werden kann, um stabile DNS-Addukte zu bilden, wurde 2007 von Evison und Kollegen beschrieben [1]. Das so aktivierte Pixantron alkyliert DNS vorwiegend an CpG und CpA Nukleotiden [2]. Die CpG Inseln sind
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