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Ag-Atc-Beschluss-20151127.Pdf Uwe Fricke · Judith Günther · Anette Zawinell 27. November 2015 Anatomisch-therapeutisch- chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß §73 Abs. 8 Satz 5 SGB V Beschlussfassung der Arbeitsgruppe ATC/DDD des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen WIdO · GKV-Arzneimittelindex Die Publikation ist ein Beitrag des GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO) für die Geschäftsstelle der Arbeitsgruppe ATC/DDD des Kuratori- ums für Fragen der Klassifikation im Gesundheitswesen. Anatomisch-therapeutisch-chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß § 73 Abs. 8 Satz 5 SGB V. Beschlussfassung für die ATC-Arbeitsgruppe des Kuratori- ums für Fragen der Klassifikation im Gesundheitswesen Stand: 27.November 2015 Wissenschaftliches Institut der AOK (WIdO) im AOK-Bundesverband GbR Rosenthaler Str. 31, 10178 Berlin Geschäftsführender Vorstand Martin Litsch (komm.), Frank Michalak (komm.) Norbert Kaufhold (Bevollmächtigter) http://www.aok-bv.de/impressum/index.html Aufsichtsbehörde: Senatsverwaltung für Gesundheit, Umwelt und Verbraucherschutz Brückenstraße 6, 10179 Berlin Pharmazeutisch-technische Assistenz: Manuela Steden Titelfoto: Ulrich Birtel Nachdruck, Wiedergabe, Vervielfältigung und Verbreitung (gleich welcher Art), auch von Teilen des Werkes, bedürfen der ausdrücklichen Genehmigung. E-Mail: [email protected] Internet: http://www.wido.de Inhalt Hinweise ......................................................................................................................... 6 Wichtige Information .................................................................................................... 6 Vorwort ........................................................................................................................... 7 1 Einleitung ........................................................................................................ 11 1.1 Der GKV-Arzneimittelindex .......................................................................................... 11 1.2 Internationales ATC/DDD-System .............................................................................. 12 1.2.1 WHO Collaborating Centre for Drug Statistics Methodology ............................. 12 1.2.2 WHO International Working Group for Drug Statistics Methodology ................................................................................................................... 13 1.3 Herbal ATC Classification ............................................................................................. 14 1.3.1 Struktur ............................................................................................................................. 15 1.3.2 Nomenklatur .................................................................................................................... 16 1.3.3 Allgemeine Prinzipien .................................................................................................... 16 1.3.4 Änderungen der HATC-Klassifikation ........................................................................ 17 1.3.5 Definierte Tagesdosen (DDD) ....................................................................................... 17 1.4 Deutsches ATC/DDD-System ........................................................................................ 18 1.4.1 Amtliche deutsche Fassung ......................................................................................... 19 2 Das anatomisch-therapeutisch-chemische (ATC) Klassifikationssystem ...................................................................................... 21 2.1 Grundsätzliche Bemerkungen ..................................................................................... 21 2.1.1 Struktur ............................................................................................................................. 21 2.1.2 Nomenklatur .................................................................................................................... 22 2.2 Umfang des ATC-Klassifikationssystems .................................................................. 22 2.3 Grundregeln der Klassifikation .................................................................................... 23 2.3.1 Allgemeine Prinzipien .................................................................................................... 23 2.3.2 Klassifikation von Monopräparaten ........................................................................... 26 2.3.3 Klassifikation von Kombinationspräparaten ............................................................ 26 2.3.4 Klassifikation von Phytopharmaka, Homöopathika und Anthroposophika ............................................................................................................ 29 2.4 Änderungen der ATC-Klassifikation ........................................................................... 30 3 DDD .................................................................................................................. 31 3.1 Definition.......................................................................................................................... 31 3.2 Grundregeln für die DDD-Festlegung ........................................................................ 32 3.2.1 Monopräparate ............................................................................................................... 33 3.2.2 Pädiatrische DDD ............................................................................................................ 35 3.2.3 Kombinationspräparate ................................................................................................ 36 3.2.4 Andere Faktoren ............................................................................................................. 38 3.2.4.1 Gruppen mit Standarddosen ........................................................................................ 38 3.2.4.2 Depotzubereitungen ...................................................................................................... 38 3.2.4.3 Intermittierende Dosierung .......................................................................................... 38 3.2.4.4 Behandlungsdauer ......................................................................................................... 39 3.2.5 Verwendete Einheiten ................................................................................................... 39 3.2.6 Priorisierung von Informationsquellen für die Ermittlung der DDD .................. 40 3.2.6.1 WHO-Empfehlung aus Index und Guidelines .......................................................... 41 3.2.6.2 Literaturangaben ............................................................................................................ 41 3.2.6.3 Durchschnittliche Hersteller-DDD .............................................................................. 42 3.2.6.4 Individuelle Dosierungsempfehlung gemäß Zulassung ......................................... 42 3.2.7 Grundregeln bei der DDD-Festlegung gemäß einer individuellen Herstellerempfehlung – Ergänzungen zum Regelwerk der WHO ....................... 43 3.2.7.1 Allgemeine Grundregeln ............................................................................................... 43 3.2.7.2 Angaben zur Anwendungshäufigkeit ........................................................................ 44 3.2.7.3 Angaben zur Dosierungseinheit .................................................................................. 46 3.2.7.4 DDD-Berechnung bei Kombinationspackungen ...................................................... 49 4 Literatur ........................................................................................................... 51 5 Zusammenfassung der Stellungnahmen und Beschlussvorlagen ................ 52 6 Beschlussvorlagen neuer Wirkstoffe des Jahres 2015 ................................. 54 6.1 Empfehlungen zu ATC-Codes neuer Wirkstoffe ...................................................... 54 6.1.1 Nonacog gamma (Rixubis) ........................................................................................... 54 6.1.2 Tedizolid (Sivextro) ......................................................................................................... 55 6.1.3 Insulin degludec und Liraglutid (Xultophy) .............................................................. 56 6.1.4 Safinamid (Xadago)........................................................................................................ 57 6.1.5 Lenvatinib (Lenvima) ..................................................................................................... 59 6.1.6 Nivolumab (Opdivo und Nivolumab BMS) ............................................................... 60 6.1.7 Edoxaban (Lixiana) ......................................................................................................... 61 6.1.8 Pembrolizumab (Keytruda) ........................................................................................... 63 6.1.9 Gaxilose (Lactest) ........................................................................................................... 64 6.1.10 Olodaterol und Tiotropiumbromid (Spiolto Respimat) siehe auch Stellungnahme 7.1.4 ...................................................................................................... 65 6.2 Empfehlungen zu DDD-Berechnungen neuer Wirkstoffe ..................................... 66 7 Beschlussvorlagen
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