Despite more rigorous legal requirements, the new medical products introduced on the market by no means always translate into medical improvements for patients. Nor does the procedure of evaluating the value added of medicaments prescribed by a new law with the amazing German title Arzneimittelmarktneuordnungsgesetz (AMNOG) seem to lead to any significant cost reductions for health insurers. These are the conclusions arrived at in the Innovation Report 2014 compiled by health experts Dr. Roland Windt, Daniela Boeschen and Prof. Gerd Glaeske from the Center for Social Policy [Zentrum für Sozialpolitik (ZeS)] at the University of Bremen. The report was prepared with support from the health insurer Techniker Krankenkasse (TK), and was recently made public at a government press conference in Berlin. It offers the medical profession some orientation in the complicated pharmaceutical market and is an important contribution to health care research.
The findings:
In their report the researchers classify only three of the twenty medicaments that came onto the German market in 2011 as representing a therapeutic advance. Seven of the new pharmaceuticals were found not to be innovative at all. On the whole, though, the evaluation results show a slight improvement on the previous report that in 2010 focused on authorized medicines: That report gave only one new product the best evaluation, and 14 out of 21 of the substances scrutinized were found not to be innovative.
“The evidence of value added required by the Arzneimittelmarktneuordnungsgesetz AMNOG since 2011 has evidently not led to any notable increase in innovative substances”, says Professor Gerd Glaeske. Nevertheless, the therapeutic use of newly authorized medicines could be more easily proven in future in so far as the quality of the clinical studies carried out under the AMNOG is further improved upon.
Not only new medicaments should be examined
The report also refers to the medicaments already on the market. According to the authors, it is necessary not only to check new medicines for their benefit and cost, but also those that have been on the market for many years already. Furthermore, the authors shed light on the topic “stratified Medicine”: Especially in the area of cancer treatment the use of new medicines is tied to proving that biomarkers are present in the patient’s body. Such biomarker-based medicine opens opportunities, but there are also risks – for instance, it could happen that patients are refused an innovative therapy because no such markers are present. Biomarkers are also the objective of gene tests available from chemists. Here, too, there is a lack of sufficient evidence that patients can really benefit from such tests. There is clearly an urgent need for further studies in this area.
You can find more information on this topic under www.zes.uni-bremen.de.
Innovation Report for downloading:
If you would like to have further information, please contact:
Universität Bremen
Zentrum für Sozialpolitik (ZeS)
Dr. Roland Windt
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Daniela Boeschen
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Prof.Dr. Gerd Glaeske
email: gglaeskeprotect me ?!zes.uni-bremenprotect me ?!.de
