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Data evaluation: New drugs are not better, but they are more expensive
New drugs come onto the German pharmaceutical market every year. Above all, medicines are being redesigned for indications for which numerous alternative preparations already exist. According to a recent medical study, many new drugs do not even work better and do not produce fewer side effects. The means are more expensive than before and the health insurance companies have to accept higher financial burdens in favor of the pharmaceutical industry and at the expense of the insured.
Alleged material innovations in medical areas with a large number of patients are often presented. For pharmaceutical manufacturers, replacing the competition means more profit and better market positioning. A new study by scientists and physicians led by the Vice-Chair of the Medicines Commission of the German Medical Association, Prof. Ursula Gundert-Remy, showed that the effectiveness of many medicines is no better than their predecessors. In many cases, even an improved tolerance could not be proven. This was the result of a study by leading doctors, which was presented in the "German Medical Journal". The experts had evaluated a total of 39 German approval studies for new drugs in the period 2009 to 2010. The following did not flow into the data: "Generics, biosimilars, vaccines, orphan drugs, new dosage forms, finished drugs with the same active ingredient and new combinations of known active ingredients".
No legal regulations for comparisons with previous drugs
During an approval process, three corner pillars are decisive for the decision: "Quality, effectiveness and harmlessness". In Germany, drugs can be approved in three different ways. Either there is a central European Union procedure with approval for all EU countries, or an approval procedure only takes place at the national level, for which the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute are responsible. The third variant is the so-called mutual recognition procedure. This can happen if a national approval procedure has already been carried out in one EU country and the drug is to be extended to other member states. The methods cannot prevent new preparations from being more expensive, although they do not work better or produce fewer interactions or side effects. They are often not compared with similar or equivalent agents. The legislature does not provide for a comparison with commercially available drugs. Instead, according to the study, in around 50 percent of the approval processes, the drug was compared with a placebo (dummy drug) instead of measuring it for better effectiveness and tolerability compared to its predecessor.
New drugs are almost always more expensive
According to the study, the new agents were significantly more expensive than preparations that are already available on the drug market. In 2009 alone, according to the researchers' calculations, the statutory health insurance companies had to spend around € 874 million more on new drugs than in the same period of the previous year. So that doctors actually prescribe the new medicines, they are advertised with elaborate advertising campaigns in the pharmaceutical industry. It was only in "exceptional cases that it clearly emerged that the approved finished drug has a higher treatment benefit than previous alternatives," warn the authors of the drug study. "This can leave room for interpretation regarding the pricing of the new pharmaceuticals for industry," writes the "Deutsche Ärzteblatt" in an article. The study authors even suspect that the new drugs are inferior in effectiveness to those that are already on the drug market.
"At least better tolerance"
If no better effect is achieved, the doctors write, then the approval studies should "at least ensure that better tolerability is proven for the patient". In summary, the authors call for new "regulations and legal regulations to improve the database available at the time of approval and to increase the cost effectiveness in the pharmaceutical market". A new hope is the amendment to the law on the reorganization of the pharmaceutical market for health insurance companies, which has been in effect since the beginning of 2011. This law stipulates that the price of the new drug should be based on the identified additional benefit. This is a first step in the right direction, the doctors write.
The Institute for Quality and Efficiency in Health Care (IQWiG) recently pointed out that the majority of the drugs offered are "superfluous". There are currently around 50,000 different medicines on the market. "Without loss of quality, their number could be reduced to 10,000." The pharmaceutical report of the Barmer found that around 40 percent of the new funds "do not offer any additional benefit to the patient" and only cause higher expenses. (sb)
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