Pharma Agenda: Germany after the federal election
With regard to the pharmaceutical market, the new government is under clear pressure to act: On the one hand, it must guarantee security of supply and ensure that potential innovations continue to reach the market. However, this will only succeed if, on the other hand, there is a sufficient reimbursement volume to cover these costs. Security of supply and cost-effectiveness are two sides of the same coin. However, it is becoming increasingly clear that the available funds cannot cover expenditures. Contribution increases are the result. Therefore, the issue of cost regulation remains high on the agenda of the new government.
Statutory health insurance (SHI) spending on pharmaceuticals (excluding vaccines) rose by 9.7 percent to €53.7 billion in 2024. There had also been significant increases in previous years, which, from the perspective of the health insurance funds, cannot be sustained. In 2022, the Statutory Health Insurance Financial Stabilization Act (GKV-Finanzstabilisierungsgesetz) and the introduction of the so-called "guard rails," combination discounts, and the sales cap for orphan drugs marked an initial attempt to halt the rise in costs and bring about a cap on pharmaceutical spending. Unfortunately, this attempt was unsuccessful, as we now know, it only led to marginal savings.
At the same time, however, there was – at least according to the pharmaceutical industry – the unpleasant side effect that some new, innovative drugs were not brought to market in Germany. Even if the number of these is disputed, the fact remains that the adopted measures are unsuitable for achieving their intended goal.
The traffic light coalition once again attempted to amend the Medical Research Act. Unfortunately, here too, they were unable to reach a major agreement to completely abolish the "guard rails." Instead, they merely provided for privileged treatment if a certain proportion of study participants participated in certain trials in Germany. It is currently unclear whether this will actually help. At the European level, we will also have to consider the EU pharmaceutical strategy and the requirements of the EU Health and Safety Assessment (HTA).
The exciting question in this legislative period will therefore be: How do we continue to facilitate corresponding initiatives for the development and German market launch of new, innovative medications? In my opinion, we will not be successful without further changes to our approval practices in connection with the AMNOG. We should therefore – as enshrined in the coalition agreement – embark on the amendment and further development of the AMNOG.
New medications or precision medicine, due to their novel mode of action (keyword: single-use applications), often fail to meet the required study requirements and, at the same time, drive up costs. Therefore, we must adopt a different reimbursement structure based on "pay-for-performance" and develop more flexible models for early benefit assessment, for example, through data collection during treatment, in order to be able to demonstrate the additional benefit in a patient-friendly manner over the course of therapy.
I have long advocated for a renewed dialogue with the pharmaceutical industry. Together, we could develop methods for determining the added benefit and appropriate comparator therapy, thus achieving a reasonable balance between the speed of market entry and the cost-effectiveness of the reimbursement prices to be negotiated.
In this context, there is another issue we must address: the development of orphan drugs. There appear to be some outliers in the application of the orphan drug privilege. Known diagnoses are being diversified into more complex therapeutic areas, only to then fall under the approval privilege of orphan drugs. We should reexamine the definition of rare diseases and thus also of orphan drugs to ensure that they cannot be used as a loophole for privileged approval and the correspondingly higher reimbursement. These are all immense challenges, and they only affect the market for innovative pharmaceuticals.
Another factor to consider is the far larger number of generic drugs. We are particularly concerned about the BfArM list of currently approximately 500 medications that are essential to healthcare provision but not readily available. This problem arises from international markets, but also plays a role in the question of how major pharmaceutical companies operate in the European market and in the establishment of new production facilities in Europe. This must be supported by a sensible, financially backed incentive policy, but no convincing measures or instruments have yet been developed for this. We must also address this issue during this legislative period.
Beyond quantifying which cost items will continue to grow into the future, I believe we can no longer afford to leave existing products completely untouched. There are medical developments that may necessitate the re-evaluation of one or another drug. To avoid service cuts while drug costs continue to rise, I believe we will have no choice but to review the entire pharmaceutical market for evidence.
Those medications that have come onto the market since the introduction of AMNOG meet these requirements. However, before the introduction of AMNOG, there are still a number of medications for which this was not the case. If an analysis reveals a significant cost relevance, we should take another look at them.
It was foreseeable that all of these topics would not be addressed in depth in the coalition paper, but rather in the form of general programmatic statements. However, it is also clear that an intensive debate must be conducted on all of these points. Otherwise, we will experience a very critical macroeconomic development in light of ever-increasing social security contributions. This can be neither in the interest of economic growth nor in the interest of the insured or employees.
© Tobias Koch
Arzte zeitung
