New drugs often not better but more expensive

Data analysis: New drugs are not better but more expensive

18/02/2012

Every year new drugs come to the German pharmaceutical market. Above all, drugs are being redesigned for indications for which numerous alternative preparations already exist. According to a recently presented medical study, many new drugs are not even better and do not produce fewer side effects. For the funds 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.

Often alleged material innovations in medical areas with a high number of patients are presented. For the pharmaceutical manufacturers, replacing the competition means more profit and better market positioning. A new study by scientists and medical experts led by Vice-President of the German Medical Association, Prof. Ursula Gundert-Remy, showed that the effectiveness of many drugs is no better than their predecessors. Even improved tolerability could not be proven in many cases. This was the result of a study by leading physicians in the „German Medical Journal“ was presented. The experts evaluated a total of 39 German approval trials for new drugs in the period 2009-2010. Not flowed into the data: „Generic drugs, biosimilars, vaccines, orphan drugs, new dosage forms, drug-same finished medicinal products and new combinations of known drugs“.

No legal regulations for comparisons with predecessor drugs
During an approval procedure, three corner pillars are the deciding factors: „Quality, effectiveness and safety“. In Germany, medicines can be authorized in three different ways. Either a centralized procedure of the European Union with authorization for all EU states takes place, or an admission procedure takes place only on national level, for which then the federal institute for medicines and medical products or the Paul Ehrlich institute are responsible. The third variant is the so-called mutual recognition procedure. This can happen if a national authorization procedure has already been completed in one EU country and the drug should also be extended to other member states. The procedures can not prevent new preparations from being more expensive, even though they do not work better or produce fewer changes or side effects. They are often not compared with similar or equivalent means. The legislature does not provide for a comparison with commercial drugs. Instead, according to the study, in approximately 50 percent of the cases, the drug was compared to a placebo (dummy drug) in the approval procedures, rather than being measured for better efficacy and tolerability over its predecessor.

New drugs are almost always more expensive
According to the study, the new funds were substantially more cost-intensive, than preparations that are already available on the drug market. In 2009 alone, the statutory health insurance companies had to spend about 874 million euros more, according to calculations of researchers for new drugs, than in the same period last year. So that doctors actually prescribe the new drugs, they are promoted with elaborate promotions of the pharmaceutical industry. It only went in „In exceptional cases, it is clear that the authorized finished medicinal product has a higher treatment benefit than previous alternatives“, remind the authors of the drug study. „This may give rise to room for interpretation for the marketing of new pharmaceuticals to industry in terms of pricing“, write that „German Medical Journal“ in an article. The study authors even suspect that the new funds are even inferior to those that are already on the drug market, even in their effectiveness.

„At least better compatibility“
If no better effect is achieved, write the doctors, then should the admission studies „At least make sure that a better tolerance for the patient is proven“. In summary, the authors demand new ones „Regulations and legislation to improve the database available at the time of approval and increase the cost-effectiveness of the pharmaceutical market“. A new hope is the amendment to the law on the reorganization of the pharmaceutical market of health insurance companies, which applies since the beginning of 2011. This law stipulates that the price of the new drug should be based on the added benefit found. This is a first step in the right direction, write the doctors.

The Institute for Quality and Efficiency in Health Care (IQWiG) recently pointed out that the majority of the medicines on offer are "superfluous". There are currently around 50,000 different medicines on the market. "Without quality loss, their number could be reduced to 10,000." Barmer's Pharmaceuticals Report found that around 40 percent of new medicines "provide no added benefit to the patient" and only cause higher expenditure. (Sb)

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Image: Benjamin Klack