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Registers for benefit assessments are possible in principle

“Detailed analyzes of methodological literature as well as intensive discussions with registry operators and external medical biometricians have led us to the opinion that with high-quality patient registries it is possible to set up studies on these registries and to use the collected care-related data for the extended benefit assessment of medicines.” That such words ever passed the lips of Prof. Dr. Jürgen Wascher, the director of the IQWiG institute, no one would have even suspected. diaperer, who has always been an apologist for pure science, explained in the cover interview with “Monitor Healthcare Research” (01/18) at the beginning of 2018 that good registries can be used to answer questions about patient adherence, doctors’ prescribing behavior, check-ups and much more can answer more, but they are not suitable for questions of benefit. Now, with the rapid report presented at the beginning of the year “Concepts for the generation of care-related data and their evaluation for the purpose of assessing the benefits of medicines in accordance with Section 35a SGB V” 1, he changed his previously negative attitude quite drastically and even assumes that “the first “Data from high-quality registries can be incorporated into benefit assessments of medicines.” Even if he restricts registration studies that could be carried out both with and without randomization as a sinequa non condition: “The decisive factor in both cases is the high quality of the data.”

02.04.2020
Targeted oncologics: innovation and sales guarantee

Cytostatics have been the drug of choice in oncological therapy for many years. For a good 20 years, they have been supplemented by biologics and other specific active ingredients, which can be seen as important treatment alternatives for some of the over 200 different types of cancer that have now been identified. The new, so-called targeted therapies are causing sales for pharmaceutical companies in oncology, but also the costs for the community of insured persons in the statutory health insurance, to rise significantly. To what extent does this overview of the market for oncologic drugs and in particular targeted therapies show.

02.04.2020
“We are reaching the limits of the established methods”

“We want to make our contribution to making medicine a little better.” That’s what Prof. Dr. med. Jörg F. Debatin MBA, Chairman of the health innovation hub (hih), in the cover interview with “Monitor Healthcare Research”. Among other things, Debatin and his team, which he has gathered around him in a very multi-professional manner, want to help ensure that the “digitalization that is quite theoretically anchored in the law actually reaches the patient”. That makes hih, as Debatin explains in the interview, “very free in our ideas and not obligated to anyone else.” And since the end of hih's business activities is already certain at the end of 2021, there is no need to worry about follow-up orders, extensions or the like.

02.04.2020
Charité focuses on health services research

“It was and is time to supplement the Charité’s scientific profile with the area of health services research.” With this commitment, Prof. Dr. phil. Adelheid Kuhlmey, Director of the Institute for Medical Sociology and Rehabilitation Science at the Charité, the 1st Charité Healthcare Research Congress, an initiative of the newly founded platform - Charité Healthcare Research, of which she is the spokesperson. This dedication and commitment to health services research is something very special for this university hospital, which is one of the most research-intensive medical institutions in Germany, with its 279 professors and 7,500 students, over 17,000 employees and over 3,000 beds. And it is by no means an ill-advised act, as the idea of establishing an in-house platform for health services research and perpetuating this with its own congress has been carefully considered over the last year and a half.

17.01.2020
More than just obstetricians on the platform – Charité health care research

Das Institut für Medizinische Soziologie und Rehabilitationswissenschaft (IMSR) der Charité – Universitätsmedizin Berlin wurde bereits im März 2002 neu gegründet. Und damit in genau dem Jahr, in dem an der Universität zu Köln der 1. Deutsche Kongress für Versorgungsforschung (DKVF) ausgerichtet wurde. Doch das war noch lange nicht der Beginn des IMSR, denn es steht in einer langen Tradition medizinsoziologischen und sozialmedizinischen Denkens innerhalb der Berliner Universitätsmedizin und gehörte bereits 1970 zur Struktur des damals entstandenen Zentralinstituts für Soziale Medizin an der Freien Universität Berlin. Geleitet wird das Institut von Prof. Dr. phil. Adelheid Kuhlmey, die im „Nebenjob“ seit 2014 die Prodekanin für Studium und Lehre an der Charité ist.

17.01.2020
Three associations merge to form the German Health Alliance

On the occasion of the merger of the three associations German Healthcare Export Group (GHE), German Healthcare Partnership (GHP) and German-Sino Healthcare Group (GSHCG) on January 1, 2020 to form the GHA - German Health Alliance, the members of the new initiative of the Federal Association of Germans Industry e. V. (BDI) met together for the first time. At this meeting at the end of last year in Berlin, the GHA's German Global Health Award 2019 was presented to Professor Dr. Detlev Ganten awarded.

17.01.2020
„Leistungsanspruch“ auf Care- und Casemanagement

Nach den Innovationsfonds-Projekten Cardiolotse (MVF 04/19), Stroke OWL (MVF 05/19) und Mambo (MVF 06/19) wird in dieser Ausgabe das Projekt RubiN vorgestellt, das – nach Aussage des Akronyms – erforschen will, wie die Versorgung von geriatrischen Menschen „Regional ununterbrochen betreut im Netz“ funktionieren kann. Das mit rund acht Millionen Euro aus dem Innovationsfonds geförderte Modellvorhaben hat ganz aktuell einen wichtigen Meilenstein erreicht: Ende letzten Jahres wurden in fünf Modellregionen insgesamt 3.200 geriatrische Patienten in das Projekt aufgenommen, was bedeutet, dass nun ausgebildete Care- und Casemanager pro Region 640 Senioren im Alltag begleiten, die bei Ärztenetzen angesiedelt sind und zentral koordiniert werden.

17.01.2020
Ein tiefer Einblick in die Welt des Innovationsfonds

Wenn Prof. Josef Hecken, der unparteiische Vorsitzende des G-BA und Vorsitzende des Innovationsfonds-Ausschusses, von über 1.900 Kooperationspartnern spricht, die sich in den inzwischen vielen hundert Projekten des Innovationsfonds engagieren, irrt er. Diese, von ihm verbreitete Heilsbotschaft über die Innovationsfreundlichkeit des deutschen Gesundheitssystems ist jedoch keine absichtliche Falschinformation, sondern alleine der Art und Weise geschuldet, wie die Inhalte des Innovationsfonds dargestellt werden: lediglich in Form von einzelnen, nacheinander abrufbaren PDFs, was quantitative wie qualitative Auswertungen erschwert bis nahezu unmöglich macht. Genau dies will die Innovationsfonds-Datenbank des Berliner Wissensmanagement-Unternehmens Ordinary People ändern: Mit Erscheinen dieser Ausgabe von „Monitor Versorgungsforschung“ wird allen MVF-Lesern ein kostenloser Datenbankzugang ermöglicht.

17.01.2020
Patent expirations 2020 – Biosimilars continue to gain ground

Due largely to the patent expiry of the TNF-alpha inhibitor adalimumab, an exceptionally large sales volume was released for the generic market in 2018. In 2019, however, the exclusivity for substances with significantly lower potential ended. The current year is characterized by the patent expiry of a few substances, which, however, represent the majority of the volume released. As in previous years, these are, in particular, genetically engineered drugs, a selection of which will be examined in more detail below.

17.01.2020
Benefit-oriented healthcare in Germany and the USA

In Rahmen der aktuellen Debatte um mögliche Veränderungen des Gesundheitssystems in den USA geht es unter anderem um die künftige Gestaltung der Arzneimittelpreise. In diesem Zusammenhang werden mehrere Vorschläge diskutiert, darunter auch die Einführung eines Referenzpreissystems. Die Einführung eines solchen Systems hätte zur Folge, dass sich die Arzneimittelpreise in den USA künftig am Preisniveau ausgewählter Länder mit einer vergleichbaren Wirtschaftsstärke, namentlich Australien, Canada, Frankreich, Deutschland und Japan, orientieren. Grundlage für Preisverhandlungen wäre der mithilfe dieses „Länder-Korbs“ ermittelte Referenzpreis.

17.01.2020

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