New drugs rarely have better benefits

New drugs rarely have better benefits

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Innovation Report 2014: The therapeutic benefits of many newly approved drugs are doubtful

Although stricter transparency rules apply to the introduction of new medicines and the medicines are subjected to a benefit assessment in accordance with the provisions of the Pharmaceutical Market Reorganization Act (AMNOG), in which they have to demonstrate their added benefit compared to medicines that have already been approved, the therapeutic progress due to the supposed innovations is often not recognizable.

This is the conclusion reached by the scientists around the health expert Professor Dr. Gerd Glaeske from the University of Bremen in the 2014 Innovation Report, which was prepared with the support of the Techniker Krankenkasse (TK) and was presented to the public in Berlin on Wednesday. The benefit assessment by the AMNOG is often not taken into account in practice and, moreover, "a one-off assessment of new medicines is basically not enough," said the TK board chairman, Dr. Jens Baas and added: "What we need are further late assessments with experiences from everyday care - in medicine one would say: follow-up examinations - in order to be able to better assess the actual benefits of new drugs."

Therapeutic progress on 20 active ingredients reviewed Twenty active ingredients that came onto the German market in “2011 - the first year after the AMNOG came into force”, according to the TK communication, the scientists took a closer look at the 2014 innovation report . "Of the 20 active substances that were examined in the report, manufacturers subsequently sent warning notices for eight active substances - including so-called red-hand letters," reports the TK. According to the health insurance company, three dimensions were considered in order to be able to make a statement about the therapeutic progress with the new drugs: “First, whether there are already available therapies for the treatment of the respective disease. Second, whether the active ingredient can actually have a relevant additional benefit. And third, whether the costs are higher or lower compared to existing therapies. "

Only three active ingredients perform positively According to Professor Glaeske, the results of the evaluations for 2011 “are rather modest overall.” Of the active ingredients checked, only three in the overall view can be classified as therapeutic progress. In addition, the researchers found that "the results of the AMNOG evaluations do not arrive one-to-one in care today." For example, "the first evaluated AMNOG active ingredient ticagrelor is still used incorrectly in every third patient," reports the TK. Although no additional benefit for the disease to be treated could be proven, the drug was still prescribed. This had "already been shown by the evaluations for 2011, and nothing changed in the prescription practice in the following year," emphasized Baas, the Chairman of the TK Board.

AMNOG so far without the hoped-for effect Since 2011, the AMNOG has provided for a benefit assessment by the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) before the introduction of new medicines. The results of this assessment form the basis for deciding how much statutory health insurance reimburses for a new drug with a new active ingredient. Pharmaceutical companies are obliged to submit a dossier on the benefits of the preparation when a new product is launched or when existing medicines are approved for a new area of ​​application. However, despite these specifications by the AMNOG, "at the time of the market launch, there is often insufficient knowledge about the therapeutic progress that new drugs represent in everyday care," reports the Techniker Krankenkasse, referring to the 2014 innovation report.

Patients should inquire about new medicines In view of the results of the innovation report to the news agency "dpa", the Independent Patient Advice Service Germany (UPD) explained that patients should generally ask some important questions when prescribing new medicines. Why a new drug? What is the advantage over existing medication? What effects can be expected? What should be achieved? According to the UPD expert Stefan Palmowski, these “W questions” make sense in any case. An increased demand for the known side effects is also worthwhile, since "these must have been noticed in the approval studies", continues Palmowski. In addition, according to the expert, patients should inquire about possible interactions with other drugs. (fp)

Image: Andrea Damm /

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