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Unproven additional benefit due to late changes in the appropriate comparator therapy

As part of the early benefit assessment, new, data-protected drugs are evaluated for their added benefit compared to the appropriate comparator therapy. The Federal Joint Committee (G-BA) advises the pharmaceutical company (PJ) on the documentation to be submitted and the appropriate comparator therapy upon request. The G-BA can adjust the appropriate comparator therapy determined during a consultation over time. This can also occur after a benefit assessment has begun. This paper presents examples demonstrating how a change in the appropriate comparator therapy during the ongoing benefit assessment process can lead to a usable randomized controlled trial (RCT) not being considered by the G-BA, which in turn results in an unproven added benefit.

03.12.2024
Relief for medical practices and sustainable care

In Germany, more than 16 million people are over 67 years old. By 2040, this number is expected to exceed 20 million. With the increasing proportion of older people in the population, the number of chronically ill, multimorbid, and care-dependent individuals is also rising. The care situation will become particularly acute in rural and structurally weak regions, as […]

03.12.2024
Aerosols: the ignored problem

Comment within the commentary series „Consequences of Corona“ by Dr. Gerhard Scheuch, physicist specializing in aerosol medicine >> A central topic is being criminally neglected in the analysis of the Corona pandemic: the role of aerosols in the transmission of the virus. Aerosol medicine established even before 1990 that even during quiet breathing, minute aerosol particles are released from the bronchi and lungs […]

03.12.2024
Right to infection protection vs. duty to infection protection

Commentary within the commentary series "Consequences of Corona" by Dr. Andreas F. Rothenberger, entrepreneur & philosopher

03.12.2024
“The goal is to improve nursing care based on evidence”

Series (Part 44): Professorship for Nursing Science at the Department of Health Services Research at the Carl von Ossietzky University of Oldenburg

03.12.2024
German Medical Association calls for effective social co-payments

Position paper „Healthcare 2040” of the Virchowbund

03.12.2024
Hedges: “Laws will sink into quicksand”

Bundeshauptversammlung 2024 des Virchowbundes

03.12.2024
To integrate science and practice even more closely

„Bei der Implementierung müssen die implementierenden Personenauch einen gewissen Sinn in den Dingen sehen, die anders als bisher passieren sollen“ (Köberlein-Neu). „Die Schwarze-Peter-Karte hat die Politik, weil sie innerhalb von Legislaturperioden das Problem lösen muss, trotz zu wenig Geld dafür zu sorgen, dass Patient:innen wieder besser versorgt werden“ (Hoffmann). „Die Praxis hatte schon immer Hemmungen, […]

03.12.2024
How do we manage the entire process of getting supplies?

Es besteht kaum Zweifel daran, dass der Innovationsfonds in den letzten Jahren wesentliche Impulse für die Weiterentwicklung der Gesundheitsversorgung geliefert hat. Ebenso steht außer Frage, dass der Umgang mit den Ergebnissen und gewonnenen Erkenntnissen noch deutliche Potenziale zur Weiterentwicklung hat. Im Rahmen des MSD Gesundheitsforums 2024 am 6. November wurden daher die Barrieren und Erfolgsfaktoren für die Translation von Innovationsfondskonzepten in die Regelversorgung diskutiert. Der vorliegende Beitrag ist ein Kommentar mit fachlich-inhaltlicher Einordnung der Diskussion durch die Autor:innen.

03.12.2024
Are men underserved?

The health care situation – especially for younger men – prior to the onset of typical prostate problems has been little studied. The aim of this study was to assess the status quo of men's health in Germany. It also aimed to identify obstacles and potential for improvement in the implementation of preventive and health-promoting services in order to derive concrete recommendations for action.

03.12.2024

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