>> The aim of the law is to stabilize the financial situation of the GKV, whose financing is threatened with a 17 billion euro hole in the coming year. In order to achieve this, the law uses various adjustment screws. On the one hand, statutory health insurance revenue will be increased by the federal government increasing its subsidy to the health fund by two billion euros from the current 14.5 billion euros to 16.5 billion euros for 2023. The federal government is also offering the GKV an interest-free loan of 1 billion euros. But in order to limit the expenditure side, the cost dynamics in the pharmaceutical sector should be slowed down. For this purpose, on the one hand, the drug manufacturer's discount for 2023 and in particular for patent-protected drugs will be increased by 5 percentage points; The price moratorium on medicines has also been extended until the end of 2026. Despite a wide range of criticism from many actors - including the AWMF, which suggested retaining the previous methodology of early benefit assessment with four positively rated categories as the basis for price negotiations - the AMNOG is also to be further developed, for example by making structural changes to the pricing of new medicines which have received no or only minor additional benefit from the G-BA.
“We hoped that the lessons from the pandemic would be translated into real politics,” said Dierk Neugebauer, Vice President Market Access at Bristol-Myers Squibb, at the online press conference “Oncology: Rethinking the fight against cancer”. The coalition agreement would also have given rise to hope, but then the Statutory Health Insurance Financial Stabilization Act came along. “The law will put an additional burden on the German pharmaceutical industry of around 3.7 billion euros,” calculated Neugebauer. The pharmaceutical industry has already been asked to pay around 21 billion euros annually, be it through the price moratorium, fixed amounts, manufacturer discounts or other discount agreements with health insurance companies linked to the AMNOG. His general criticism: “The law assumes that pharmaceutical expenditure contributes significantly to keeping the financing of the statutory health insurance system unstable and has constantly increased.” But, Neugebauer continued: “That’s not true.” The share of pharmaceuticals in the total expenditure of the statutory health insurance has been stable for decades and the share of innovative drugs only accounts for 6%. Conversely, 94% of the GKV expenditure would be used for everything except non-patent medicines, Neugebauer did the counter calculation.
However, the biggest problem associated with the new law is not the price burden, but rather the changes decided in AMNOG, with which a structural reform was passed. Neugebauer: “The fact that small and unquantifiable additional benefits will have to be treated equally in the future is, in our view, anti-innovation.” This would discriminate against incremental innovations in terms of price, which is the wrong approach because they “stand for continuous improvement and diversity in the supply of pharmaceuticals. The planned discounts on combination therapies would also particularly affect cancer medicine. <<

The interview was conducted by MVF editor-in-chief Peter Stegmaier.

From “Vision Zero” to a health council
In order to clarify the approach of “Vision Zero”, a broad initiative from science and research, medical societies and associations, foundations, media and industry, Prof. Dr. Christof von Kalle (Berlin Institute of Health, Charité Universitätsmedizin Berlin) presented a well-known analogy at the BMS press conference: occupational and traffic safety. In these areas, says von Kalle, society has made the decision to avoid unavoidable deaths through a series of micro-innovations. The idea of reducing the number of avoidable deaths to zero: every traffic fatality that could have been prevented is one too many. From Kalle: “This is easy to understand and everyone knows what everyone has to do in their area.” This idea and vision has not previously existed in the health sector because illness is often understood as fate, even when it could have been prevented were.
According to von Kalle, it is important that the great success in occupational and traffic safety was only possible after the “Vision Zero” goal was decided, which “does not specify the measures, but the goal”, i.e. systems to perfect things that accommodate people's imperfect behavior. The task of “Vision Zero – Together Against Cancer” is to act as a think tank to transport these considerations into medicine and to think about how preventable cancers can be prevented. For this purpose, so-called First Principals have been formulated, which describe what it would mean if German society tried to get closer and closer to zero preventable cancer deaths. From Kalle's call: “We need vision zero concepts that work in medicine, because then no one has an excuse not to act in their area of responsibility.” It is also important that such a vision describes a goal rather than continuing to be a discussion about it measures and financing or sector separation. When asked by “Monitor Healthcare Research” whether there was the political will to set up a health council along the lines of the Road Safety Council, von Kalle replied: “We all have to develop the necessary political will from the system.” 1969 was which was presented by the then Federal Transport Minister Dr. H. c. Georg Leber, with an overall programmatic concept and supported by its own studies on the causes of traffic accidents, was founded as an association in which road users, vehicle manufacturers and the insurance industry took part in the form of a “consensus from the field”. And about the eponymous idea of a health council, he said: “I will take with me the suggestion as to whether one could consider setting up a somewhat more formalized council in the medium term.”