New drugs are often not better

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In principle, new drugs are rarely better

Every year the number of approved medicines in Germany increases. For new drugs, the Medicines Act requires proof of an additional benefit. Initial evaluations showed that only one in five new products was significantly better.

Rarely additional benefits from new drugs
The pharmaceutical market reorganization law (Amnog) has created pressure for pharmaceutical manufacturers to prove that a newly approved drug is better than those that were previously on the market. This relatively new law, which came into force in 2011, is dealt with by the Federal Joint Committee (G-BA), the highest body in the healthcare sector, which includes representatives of doctors, health insurance companies and clinics. The G-BA has now drawn a first balance and comes to the conclusion that two out of three new drugs for serious diseases (such as cancer, diabetes or high blood pressure) help better than the current ones, but a significant additional benefit is usually not to certify. The German Press Agency (dpa) has the results from an official G-BA examination. The balance sheet is as follows: Only in seven cases out of 37 funds reviewed did the G-BA recognize a significant additional benefit. A small additional benefit was found in 14 others and in three an indefinite one. Most of the other drugs have been certified to have no added value or lack of complete evidence.

New drugs almost always more expensive Health care is still debated about the assessments of these reviews. Far more numerous reviews are still pending. The G-BA chairman Josef Hecken said that it shows that the assessments of his committee are fair. "We are significantly above the evaluation results in other comparative countries," said Hecken. In contrast, representatives of the pharmaceutical industry have repeatedly warned against the evaluation procedures. Birgit Fischer, Managing Director of the Association of Research-Based Pharmaceutical Manufacturers (vfa), said that the evaluations ensured that the supply In reality, only a few people with innovative drugs arrive in reality. She justified this with the fact that the G-BA, like test bodies in other countries, defined an additional benefit for a similar number of drugs, but also said: "Due to its decision-making practice, the G- BA actually added this benefit to a smaller proportion of the patients. " When evaluating a drug, the G-BA differentiates between the additional benefit for different patient groups in which the drug is used. According to Fischer, the number of patients for whom there is an added benefit is kept artificially small. The Institute for Quality and Efficiency in Health Care (IQWiG, Germany) finds that many of the medicines on offer are "superfluous." There are about 50,000 different medicines on the market. "Without loss of quality, the number could be reduced to 10,000." And a pharmaceutical report by Barmer even found that around 40 percent of new drugs "do not offer any additional benefit to the patient" and only cause higher expenses. ("")

The goal is savings worth billions As a result of the new assessments, a pharmaceutical manufacturer and health insurance companies concluded their price negotiations for the first time a year ago. The Amnog stipulates that only what really brings more should also cost more. Currently, the evaluation of drugs that have been on the market for some time is expected. In April the G-BA decided to examine the so-called existing market. Agents for the treatment of common diseases such as diabetes, depression or osteoporosis are first on the checklist. The aim of the valuations is to save billions of dollars, the political goal. The funds with the highest sales, which are under patent protection and have been prescribed millions of times for years, are to be tested. For the first round, medicines were selected that have a combined sales volume of around five billion euros, Hecken said. The G-BA puts them to the test on the basis of scientific expertise and dossiers from the producers. According to Hecken, the first company dossiers must be submitted on October 15. (sb)

Image: Sara Hegewald /

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