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Anatomisch-Therapeutisch-Chemische Klassifikation Mit Tagesdosen Für Den Deutschen Arzneimittelmarkt Gemäß § 73 Abs

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Anatomisch-Therapeutisch-Chemische Klassifikation Mit Tagesdosen Für Den Deutschen Arzneimittelmarkt Gemäß § 73 Abs Wissenschaftliches Institut der AOK GKV-Arzneimittelindex Anatomisch-therapeutisch-chemische Klassifikation mit Tagesdosen für den deutschen Arzneimittelmarkt gemäß § 73 Abs. 8 Satz 5 SGB V. 14. Sitzung der Arbeitsgruppe ATC/DDD des Kuratoriums für Fragen der Klassifikation im Gesundheitswesen am 27. November 2015, BMG in Berlin © WIdO 2015 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 2 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 3 GKV-Arzneimittelindex Das Anatomisch-therapeutisch-chemische Klassifikationssystem A Alimentäres System und Stoffwechsel B Blut und blutbildende Organe C Kardiovaskuläres System D Dermatika G Urogenitalsystem und Sexualhormone H Systemische Hormonpräparate, exkl. Sexualhormone u. Insuline J Antiinfektiva zur systemischen Anwendung L Antineoplastische und immunmodulierende Mittel M Muskel- und Skelettsystem N Nervensystem P Antiparasitäre Mittel, Insektizide und Repellenzien R Respirationstrakt S Sinnesorgane V Varia © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 4 GKV-Arzneimittelindex Das Anatomisch-therapeutisch-chemische Klassifikationssystem Ebene Alimentäres System und Stoffwechsel 1 A (anatomische Hauptgruppe) Antidiabetika 2 A10 (therapeutische Untergruppe) Antidiabetika, exkl. Insuline 3 A10B (therapeutische/pharmakologische Untergruppe) Sulfonylharnstoffe 4 A10B B (chemische/therapeutische/ pharmakologische Untergruppe) Glibenclamid 5 A10B B01 (Untergruppe für die chemische Substanz) Quelle: Wissenschaftliches Institut der AOK (WIdO) 2004: Einführung in die Arzneimittelverbrauchsforschung Nach: World Health Organization. Introduction to Drug Utilization Research. Oslo 2003. © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 5 GKV-Arzneimittelindex Deutsches ATC/DDD-System 2015: 6509 ATC-Codes 1831 ATC-Codes des WIdO 4678 ATC-Codes der WHO © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 6 GKV-Arzneimittelindex GKV-Fertigarzneimittelmarkt 2014 – 1699 internationale ATC-Codes und 741 nationale Ergänzungen 651 Mio. Verordnungen 33,6 Mrd. € Umsatz WIdO WIdO 11 % 8 % WHO WHO 89 % 92 % © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 7 GKV-Arzneimittelindex Das Verordnungsjahr 2014: Arzneimittelklassifikationen im WIdO ATC-Klassifikation 2.440 verordnete Wirkstoffe (ATC-Codes) Pharmazentralnummern 67.786 verordnete Pharmazentralnummern © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 8 GKV-Arzneimittelindex Grundregeln der ATC-Klassifikation • Arzneimittel werden gemäß der wesentlichen therapeutischen Anwendung ihres Hauptwirkstoffs klassifiziert • Ein Wirkstoff kann mehr als einen ATC-Code erhalten, wenn er in zwei oder mehr Dosierungsstärken oder Zubereitungen mit eindeutig unterschiedlicher therapeutischer Anwendung verfügbar ist • Unterschiedliche Zubereitungen für topische und systemische Anwendungen erhalten ebenfalls getrennte ATC-Codes • Jede pharmazeutische Zubereitung erhält in der Regel einen ATC-Code © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 9 GKV-Arzneimittelindex Beispiele von Wirkstoffen mit unterschiedlicher therapeutischer Anwendung und Dosisstärke • Duloxetin: – G04BX18 (Andere Urologika) – N06AX21 (Andere Antidepressiva) • Sildenafil: – C02KX04 (Antihypertensiva zur Behandlung der pulmonalen arteriellen Hypertonie) – G04BE03 (Mittel bei erektiler Dysfunktion) Im deutschen ATC-Index (Stand April 2015) besitzen 692 Wirkstoffe mehr als einen ATC-Code © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 10 GKV-Arzneimittelindex Deutsche Erweiterungen: Klassifikation von Phytopharmaka, Homöopathika und Anthroposophika • Pflanzliche Zubereitungen erhalten soweit möglich eigene ATC-Codes, die auf der 4. Ebene mit dem Buchstaben P gekennzeichnet sind – G04B Urologika – G04BP Pflanzliche Urologika Dies betrifft im ATC-Index (Stand April 2015) 251 ATC-Codes • Homöopathische und anthroposophische Zubereitungen erhalten eigene ATC-Codes, die auf der 4. Ebene mit dem Buchstaben H gekennzeichnet sind – A01A Stomatologika – A01AH Homöopathische und anthroposophische Stomatologika Dies betrifft im ATC-Index (Stand April 2015) 142 ATC-Codes © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 11 GKV-Arzneimittelindex Defined Daily Dose (DDD) — Definierte Tagesdosis Die DDD ist die angenommene mittlere tägliche Erhaltungsdosis für die Hauptindikation eines Arzneimittels bei Erwachsenen. © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 12 GKV-Arzneimittelindex Vorgehensweise bei der DDD-Festlegung – deutsche Systematik • WHO-Empfehlung aus Index und Guidelines • Individuelle Dosierungsempfehlung gemäß der Fachinformation • Literaturangaben • Durchschnittliche Hersteller DDD • Zubereitungen, die ausschließlich zur Anwen- dung bei Kindern bestimmt sind, erhalten eine Kinder DDD © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 13 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 14 GKV-Arzneimittelindex Historische Entwicklung des ATC/DDD-Systems mit nationalen Adaptionen des GKV-Arzneimittelindex (GKV-AI) 1976 1980 1981 1982 1995 Nordic Council Forschungsprojekt Europabüro der WHO Collaborating GKV-AI publiziert on Medicines GKV-AI: WHO empfiehlt in Centre for Drug jährlich eine ATC- setzt das ATC/ Anpassung des internationalen Statistics Klassifikation mit DDD-System ATC/DDD-Systems Untersuchungen Methodology(Oslo) den notwendigen erstmals für an Belange des zum Arzneimittel- koordiniert die Anpassungen und Arzneimittelver- deutschen Marktes verbrauch das Anwendung und Erweiterungen für brauchsstudien und Verwendung ATC/DDD-System Fortschreibung der den deutschen in Skandinavien als wesentliche anzuwenden. ATC-Systematik im Arzneimittelmarkt. ein. methodische Auftrag der WHO. Grundlage. 2001 2002 2004 2005 Seit 2006 GKV-AI publiziert GKV-AI Der internationale Nach Empfehlung Die Weiter- erstmalig die zu kombiniert ATC- ATC-Code wird der Arbeitsgruppe entwicklung des Grunde liegende Code-Verzeichnis erstmalig amtlicher ATC/DDD amtlichen Methodik zur Ver- und die zugrunde deutscher ATC. des KKG deutschen ATC gabe von ATC- liegende Metho- enthält der verläuft nach Codes und defini- dik; diese wird amtliche einem regel- erten Tagesdosen einmal im Jahr als deutsche gebundenen für den deutschen CD-ROM-Version ATC erst- transparenten Arzneimittelmarkt. veröffentlicht. mals natio- Verfahren. nale Anpassungen. © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 15 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 16 GKV-Arzneimittelindex Weiterentwicklung des amtlichen ATC-Index mit Tagesdosen: Workflow ATC/DDD 2016 ATC 2016: Workflow der AG ATC/DDD des KKG Stellungnahme der WHO-ATC WIdO-ATC Pharmaverbände Übersicht aller WHOCC WIdO AG ATC/DDD DIMDI Jan. 2015 bis 30.04.15 bis 29.05.15 Stellungnahmen bis 12.06.15 WEB AG ATC/DDD Herausgabe amtlicher ATC 01.01.2016 KKG AG ATC/DDD WIdO DIMDI Information Empfehlungen des WIdO Beschluss- Amtlicher ATC nächste KKG-Sitzung bis 20.11.15 vorlage bis 16.12.15 Stellungnahmen der bis 25.09.15 Beratung und Pharmaverbände Festlegung Beschlussfassung zur Beschlussvorlage WIdO BMG AG ATC/DDD AG ATC/DDD bis 04.12.15 27.11.15; Ort: BMG bis 23.10.15 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 17 GKV-Arzneimittelindex Agenda • Das anatomisch-therapeutisch-chemische Klassifikationssystem • Entwicklung der ATC/DDD Klassifikation • Workflow ATC/DDD 2016 • Beschlussvorlage • Stellungnahmen zu der Beschlussvorlage • Workflow ATC/DDD 2017 © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 18 GKV-Arzneimittelindex 6.509 ATC-Codes und 3.524 DDD (Stand April 2015) stehen zur Diskussion • Insgesamt sind 9 einzelne Stellungnahmen zum ATC- Index des WIdO eingegangen (29. Mai 2015) • Inhaltliche Zusammenfassung für die Arbeitsgruppe ATC/DDD des KKG durch das WIdO in 7 Empfehlungen in der Beschlussvorlage (25. September 2015) • Empfehlungen zum ATC-Code und zur DDD-Festlegung von 22 neuen Wirkstoffen (25. September 2015) • Eingang von 3 Stellungnahmen nach der Beschlussvorlage (23. Oktober 2015) © WIdO 2015 14. Sitzung der Arbeitsgruppe ATC/DDD des KKG 19 GKV-Arzneimittelindex Verfahren der amtlichen ATC-Klassifikation mit Tagesdosen im Überblick 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Seitenzahl der 235 53 116 82 34 41 42 51 21 20 4 14 Unterlagen + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. + Anl. Stellung- 137 51 56 50 14 17 12 29 11 6 3 9 nahmen Empfehlungen 91 42 44 34 14 17 11 20 11 6 3 7 Änderungen 30 23 32 13 3 9 1 3 4 3 2 4 keine 61 19 12 13 5 7 9 15 5 3 1 3 Änderungen Verweise auf vorherige − − − 8 6 1 1 2 2 − - - Verfahren
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