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TK presents Innovation Report 2015

The AMNOG clearly missed its goal in the fourth year. It should achieve savings in drug prescriptions amounting to two billion euros annually. In 2014, just 320 million were reached. “The economic relief for statutory health insurance is at a homeopathic level,” says Dr. Jens Baas, Chairman of the Techniker Krankenkasse (TK). "If the AMNOG as a much-cited 'learning system' is consistently developed further, much greater savings are possible."

The Innovation Report 2015, which Professor Dr. Gerd Glaeske and scientists from the University of Bremen with the support of the TK also shows that the early benefit assessment also falls short of expectations in terms of quality: of the 20 preparations that came onto the market in 2012, only twelve were fully evaluated. Either the expected prescription volume was too low, the preparations cannot be reimbursed by the statutory health insurance or they are medicines for rare diseases. “If the AMNOG is finally to arrive in the doctor’s office and be a real decision-making aid, all new drugs without exception must be evaluated for their patient-relevant additional benefits,” says Glaeske.

Only one out of 20 traffic lights is green

In this year's innovation report, the preparations were again evaluated according to the traffic light scheme. Only one drug received a green light in the overall evaluation. The traffic light shows yellow seven times and red twelve times. When it comes to marketing, however, the pharmaceutical manufacturers have done their homework. After their market launch, the preparations were prescribed almost as frequently as the new medicines in the previous year (41,000 packs versus 49,000 packs at the expense of TK). Only sales were lower due to the lower innovative strength (27.5 million euros compared to 74.0 million euros).

Nevertheless, more than half of the products examined have already been included in the guidelines of medical societies. According to a current DocCheck survey commissioned by TK, 30 percent of the doctors surveyed most often make their decision to prescribe new drugs based on such guideline recommendations. Only 15 percent of those surveyed cited the results of the early benefit assessment as the most common source of information.

Another result of the innovation report: “The innovations focus on the wrong areas. Research is clearly not taking place where it is needed,” says Baas. “Instead of new antibiotics, the focus is primarily on indication areas in which the pharmaceutical industry expects the greatest return.” Of the 20 new preparations in 2012, five are approved for the treatment of rare diseases and nine against cancer. This initially positive trend is offset by extremely high prices for these medications. In addition, the increased approval of drugs against rare diseases does not automatically mean that there are now significantly more treatment options for people who have a rare congenital disease. Rather, it is in the industry's interest to redefine major common diseases in such a way that patient groups are reduced to the level of rare diseases. This ensures that you can go through the AMNOG process relatively quickly and, by law, have additional benefits.

No waiting periods for moon prices

Baas: “From a technical perspective, it makes sense that the negotiated reimbursement amount applies retroactively from the day of market launch and not only from the second year. Either a new active ingredient has an additional benefit for patients or it does not. Waiting periods for 'moon prices' for preparations without additional benefits must therefore be eliminated.” It also makes sense that the reimbursement amount negotiated between the National Association of Statutory Health Insurance Funds and the pharmaceutical company is at least partially secret. Public prices put additional pressure on the entrepreneur due to the special role of the German market (reference price country). Statutory health insurance companies could negotiate higher discounts through secret discounts because the industry would no longer automatically have to accept discounts in many other markets.

In a special chapter, the innovation report deals with drugs against cancer. In addition to the demographic change with the increasing number of patients, the longer duration of treatment and the increased number of cancer drugs, it is above all the high prices that make the therapy a financial challenge for statutory health insurance companies. “It depends on the level of innovation and
“The actual medical benefits are often not in proportion to the price,” says Professor Dr. Wolf-Dieter Ludwig, Chairman of the Drug Commission of the German Medical Association
and co-editor of the innovation report. In addition, the AMNOG also has serious weaknesses here. If the comparison drug achieves a price as high in the early benefit assessment as it does in the
As cancer medicine is common, the new drug does not need any additional benefit to the existing therapy. This means that in the medium term it is not possible to protect the system from counterfeit drugs.

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