New drugs rarely with better benefits

Innovation Report 2014: Therapeutic benefits of many newly approved drugs doubtful

04/03/2014

Although stricter transparency rules apply to the introduction of new medicines, and the medicines are subjected to a benefit assessment in accordance with the AMNOG, in which they have to prove their added benefit over already approved medicines, therapeutic progress through the supposed innovations is often not apparent.

The scientists come to this conclusion to the health expert Professor. Gerd Glaeske from the University of Bremen in the, with the support of the Techniker Krankenkasse (TK) created, Innovation Report 2014, which was presented to the public on Wednesday in Berlin. The benefit assessment by the AMNOG is often not considered in practice and also rich „a single evaluation of new medicines basically not enough“, explained the TK CEO, Dr. med. Jens Baas and added: „What we need are further late assessments with experiences from everyday medical care - in medicine one would say: follow-up examinations - in order to better assess the actual benefit of new drugs.“

Therapeutic progress on 20 drugs checked
Twenty active substances in the year of „2011 - ie in the first year after the entry into force of the AMNOG - came on the German market“, 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 labels for eight drugs - including so-called Rote-Hand-Briefe“, reports the TC further. In order to be able to make a statement on the therapeutic progress of the new medicines, according to the health insurance company, three dimensions were considered: „First, if there are already available therapies for the treatment of each disease. Second, whether the active substance can actually provide a relevant added benefit. And third, whether the costs are higher or lower compared to existing therapies.“

Only three active ingredients cut off positively
The result of the evaluations for the year 2011 falls according to statement of Professor Glaeske „overall rather modest.“ Of the active substances tested, only three can be considered as therapeutic progress in the overall picture. In addition, the researchers found that „the results of the AMNOG reviews today do not arrive one-to-one in the care.“ For example „the first evaluated AMNOG drug ticagrelor is still used incorrectly in every third patient“, reports the TC. Although no added benefit for the disease to be treated could be demonstrated, the drug will continue to be prescribed. That would have „already the evaluations for the year 2011 showed, and also in the following year nothing changed in the prescription practice“, stressed TK CEO Baas.

AMNOG so far without the hoped-for effect
Since 2011, the AMNOG provides for a benefit assessment by the Joint Federal Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) prior to the introduction of new drugs. The results of this assessment form the basis of the decision on how much the statutory health insurance reimburses for a new drug with a new active ingredient. The pharmaceutical companies are obliged to submit a dossier for the benefit of the product already for the market launch of a new product or for the approval of existing drugs for a new area of ​​application. But despite these requirements by the AMNOG lie „At the time of market introduction, there is often insufficient evidence about the therapeutic advances of new drugs in the real daily routine of care“, reported the Techniker Krankenkasse, citing the Innovation Report 2014.

Patients should ask for new medicines
The Independent Patient Counseling Germany (UPD) explained to the news agency in view of the results of the innovation report „dpa“, that patients should generally ask some important questions when prescribing new medicines. Why a new drug? What is the advantage over existing medicines? What effects can be expected? What should be achieved? These „W questions“ According to UPD expert Stefan Palmowski, it makes sense in every case. To the well-known side effects also worthwhile a more intense demand, since „these have been noticed in the admission studies“ must continue, Palmowski continues. In addition, according to the expert, patients should inquire about possible drug-drug interactions. (Fp)