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Evidenz Und Versorgungsrealität Von Kurzwirksamen Insulinanaloga in Der Behandlung Des Typ-2-Diabetes Mellitus

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Evidenz Und Versorgungsrealität Von Kurzwirksamen Insulinanaloga in Der Behandlung Des Typ-2-Diabetes Mellitus Evidenz und Versorgungsrealität von kurzwirksamen Insulinanaloga in der Behandlung des Typ-2-Diabetes mellitus – Eine Versorgungsanalyse auf der Basis von Sekundärdaten – Dissertation zur Erlangung des Doktorgrades der Naturwissenschaften vorgelegt beim Fachbereich 14 - Biochemie, Chemie und Pharmazie der Johann Wolfgang Goethe-Universität in Frankfurt am Main von Matthias S. Pfannkuche aus Brühl Frankfurt am Main, im Jahr 2009 vom Fachbereich 14 - Biochemie, Chemie und Pharmazie der Johann Wolfgang Goethe-Universität als Dissertation angenommen. Dekan: Prof. Dr. rer. nat. Dieter Steinhilber Gutachter: Prof. Dr. rer. nat. Theo Dingermann Prof. Dr. rer. nat. Gerd Glaeske (Universität Bremen) Datum der Disputation: 15. Februar 2010 Bildnachweis Titelseite: Insulin Hexamer: http://commons.wikimedia.org/wiki/File:Human-insulin-hexamer-3D-ribbons.png (letzter Zugriff: 11.06.2009) Non semper ea sunt, quae videntur. (Phädrus, fabulae 4, 2, 5) Danksagung Diese Dissertation sowie die hiermit in Verbindung stehenden Publikationen wären ohne die Anregungen und Unterstützung durch viele Kollegen, Freunde und Organisationen nicht möglich gewesen. Ihnen möchte ich an dieser Stelle danken. Mein besonderer Dank gilt Prof. Dr. rer. nat Gerd Glaeske und Prof. Dr. rer. nat. Theo Dingermann, die diese Arbeit in vielerlei Hinsicht erst ermöglichten. Überaus dankbar bin ich Prof. Dr. rer. nat. Gerd Glaeske für die freundliche Aufnahme in seine Arbeitsgruppe, die es mir ermöglichte weitere Einblicke in die Gesundheitsökonomie, Gesundheitspolitik und Versorgungsforschung zu nehmen. Für das Korrekturlesen der kompletten Arbeit, die zahlreichen Hinweise und konstruktiven Diskussionen sowie die zahlreichen Mittagspausen danke ich im besonderen Dr. P.H. Falk Hoffmann. Herzlicher Dank gilt auch dem gesamten Arbeitskreis in Bremen sowie den Projektbeteiligten Krankenkassen, allen voran der GEK, die mir durch den Zugriff auf ihre Daten erst viele Analysen ermöglichten. Ein ganz herzlicher Dank gilt auch meinen Eltern, meiner Schwester und Ihrem Mann sowie meinen Freunden, die alle auf Ihre Weise zum Gelingen dieser Arbeit beigetragen haben. Inhaltsverzeichnis Inhaltsverzeichnis Abstract ................................................................................................................................................... 1 Zusammenfassung ................................................................................................................................ 2 1 Einleitung ................................................................................................................................................ 4 2 Diabetes mellitus ................................................................................................................................... 9 2.1 DEFINITION UND KLASSIFIKATION ........................................................................................................ 9 2.2 PATHOPHYSIOLOGIE ............................................................................................................................. 10 2.3 BEGLEIT- UND FOLGEERKRANKUNGEN ............................................................................................... 11 2.4 EPIDEMIOLOGIE ..................................................................................................................................... 12 2.5 THERAPIE DES TYP-2 DIABETES MELLITUS IN DEUTSCHLAND .......................................................... 15 2.6 KOSTEN DES TYP-2 DIABETES MELLITUS ............................................................................................. 17 2.7 VERSORGUNGSSITUATION VON PATIENTEN MIT DIABETES MELLITUS ............................................. 20 2.7.1 Versorgungssituation von Typ-2-Diabetikern in Deutschland ....................................... 21 2.7.2 Versorgungssituation von Typ-2-Diabetikern mit Antidiabetika .................................. 25 3 Insulin und kurzwirksame Insulinanaloga ...................................................................................... 28 3.1 INSULIN .................................................................................................................................................. 29 3.1.1 Entdeckung des Insulins .................................................................................................... 29 3.1.2 Molekularer Aufbau von Insulin ...................................................................................... 30 3.1.3 Biosynthese des Insulins .................................................................................................... 31 3.1.4 Signalübertragung auf Effektorzellen .............................................................................. 32 3.1.5 Wirkung von Insulin .......................................................................................................... 33 3.1.6 Regulation des Blutglukosespiegels .................................................................................. 34 3.1.7 Entwicklung von tierischem Insulin über Humaninsulin hin zu Analoginsulinen . 35 3.2 KURZWIRKSAME INSULINANALOGA .................................................................................................... 40 3.2.1 Insulin lispro ........................................................................................................................ 44 3.2.2 Insulin aspart ....................................................................................................................... 45 3.2.3 Insulin glulisin ..................................................................................................................... 46 3.3 MARKTANALYSE .................................................................................................................................... 47 3.3.1 Vergleich GKV vs. PKV ..................................................................................................... 50 3.3.2 Produkt-Lebenszyklus und Marktdurchdringung ........................................................ 53 3.3.3 Finanzielle Aufwendungen ................................................................................................ 58 3.3.4 Nutzenbewertungen und deren Konsequenzen ............................................................. 60 3.3.4.1 Nutzenbewertung durch das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen ............................................................................................................. 62 Evidenz und Versorgungsrealität von kurzwirksamen Insulinanaloga in der Behandlung des T2DM Inhaltsverzeichnis 3.3.4.2 Änderung der Arzneimittel-Richtlinie durch den Gemeinsamen Bundesausschuss ............................................................................................................... 64 3.3.4.3 Auswirkungen des G-BA Beschlusses ............................................................................ 65 4 Nutzenbewertung von kurzwirksamen Insulinanaloga anhand von publizierter Literatur ... 69 4.1 EVIDENCE BASED MEDICINE / EVIDENCE BASED HEALTHCARE IM KONTEXT DER GKV ............... 70 4.1.1 Externe Validität und Einzel- vs. Gruppennutzen ........................................................ 73 4.1.2 Die Nutzendefinition .......................................................................................................... 76 4.1.3 Patientenrelevante Endpunkte .......................................................................................... 79 4.2 ANFORDERUNGEN AN ASSESSMENT UND APPRAISAL ........................................................................ 91 4.2.1 Evidenzrecherche ................................................................................................................ 91 4.2.2 Evidenzbewertung ............................................................................................................... 93 4.2.3 „Best available evidence“ .................................................................................................... 94 4.2.3.1 Evidenzstufen ..................................................................................................................... 94 4.2.3.2 Studientypen ...................................................................................................................... 98 4.2.3.3 Übersichtsarbeiten (Reviews) .......................................................................................... 99 4.2.3.4 Randomised controlled trial (RCT) ............................................................................. 103 4.2.3.5 „Best available evidence“ ................................................................................................ 107 4.3 NUTZENBEWERTUNG VON KURZWIRKSAMEN INSULINEN AUF BASIS DER PUBLIZIERTEN LITERATUR ........................................................................................................................................... 110 4.3.1 Forschungsfrage ................................................................................................................ 110 4.3.2 Methodik ............................................................................................................................ 110 4.3.3 Evidenzrecherche .............................................................................................................. 112 4.3.4 Selektion und Bewertung der aufgefundenen Evidenz ............................................... 116 4.3.4.1 Davey et al., 1997 ............................................................................................................
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