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Berlin The new chairman of the Drug Commission of the German Medical Association (Akd), Bernd Mhlbauer, wants to focus his work on the issue of drug costs. We are faced with major tasks: When it comes to the annual drug costs of statutory health insurance, we are now close to the 60 billion euro mark, said Mhlbauer after his election as Akd chairman last Friday at the commission’s general meeting in Berlin.

And what is dispensed for medicine is missing elsewhere in the system. Among other things, I see it as the Akd’s task to create clarity about the fact that the resources are finite and that we can only spend the money on medicines that have a real additional benefit for the patients. We must not waste resources on what is unnecessary.

Mhlbauer also emphasized how important the independence of the Akd is to him. As a young doctor, it wasn’t clear to me until the 1990s what the ACD did. “Your work had no bearing on my medical work,” he reported.

This changed under the chairmanship initially of Bruno Müller-Oerlinghausen and later of Wolf-Dieter Ludwig: During this time, the Akd became an important body whose recommendations and publications actually had an influence on medical practice. I would like to continue this tradition together with the new board and all members of the Akd. We will fight vigorously to ensure that the work of the Akd remains independent and is also perceived as independent by the medical profession.

Many opinions on new medicines

The outgoing chairman of the Akd, Wolf-Dieter Ludwig, previously reported at the general meeting about the diverse activities that the volunteer members of the commission carried out with the office in the past year. In addition to working on guidelines, conducting independent training events or working in the area of ​​drug therapy safety, this also includes writing statements as part of the AMNOG process.

In the current year, the members of the Akd wrote 23 statements as part of the early benefit assessment of new medicines. Since the AMNOG process began in 2011, there have been 263 statements.

Ludwig pointed out that in the early benefit assessment there was a high level of agreement between the Akd’s assessment and the subsequent assessment of the Federal Joint Committee (G-BA). This shows how important the Akd’s participation in the AMNOG process is in order to strengthen the G-BA’s assessments. Because there are still many new drugs coming onto the market for which no additional benefit has been proven.

As of April 1, 2024, the proportion of medications for which the Institute for Quality and Efficiency in Healthcare (IQWiG) found no proven additional benefit is 61%, said the head of the institute, Thomas Kaiser, at the end of last week took stock of 13 years of AMNOG at a scientific symposium.

In a further 8%, the additional benefit was not quantifiable, and in a further 2% it was low. The event was organized by the Federal Medical Association in honor of the outgoing kd chairman Ludwig. The German medical journal reported.

More evidence generation required

Kaiser identified a lack of study data on important healthcare-related questions as a major problem. Ultimately, these are not the same as the questions that are relevant for approval, such as the effect of the drug and the side effects.

What we see here is that there is a strong and continuous and unchanging focus on the requirements of approval, said Kaiser. For example, when asked why there had been no direct comparisons with available active ingredients, manufacturers explained that the study designs had been accepted by regulatory authorities.

If you are now talking about an AMNOG 2.0, it is crucial that you have more influence on the generation of evidence, emphasized Kaiser. It’s not about the absolutely perfect study, but about studies that can be carried out well and quickly. You have to take care of the issue. We can’t leave it to others.

The central achievement for AMNOG is transparency, emphasized Kaiser. Manufacturers must submit all results, all study reports, all study protocols. At IQWiG, among others, we have a different database compared to many others.

This would enable further insights to be gained and a critical examination of even high-level published studies would become possible. Despite the information gain, the available evidence from the AMNOG procedure was relatively rarely taken into account in guidelines, Kaiser noted in an investigation. It is actually a tragedy that this wealth of knowledge has not been used systematically.

Skepticism when looking at the prices of oncologic drugs

Claudia Wild, Managing Director of the Austrian Institute for Health Technology Assessment (Vienna), which, among other things, evaluates the effectiveness and safety of (new) cancer drugs, took a critical look at oncological drugs in particular.

In view of the very high expenditure on these medications in Austria and Germany compared to other European countries, she raised the question of whether this represents particularly good care or irresponsible use of resources.

In both countries, demand begins before approval and there is very early access, said Wild. Even though medicine has always had the aura of innovation, not everything that comes onto the market is innovative. In fact, there is initially a lot of ignorance at the time of approval.

You also have to realize that the great resources that you put into high-priced oncological drugs may be missing elsewhere, for other patients. Wild also calls for the share of public funding in the development of new oncological drugs to be made more transparent.

Regarding the situation in Austria, Wild reported that so far, depending on the federal state, there have been very individual approaches to cancer therapy that are only partially evidence-based – and that patient tourism has therefore developed. We have now reached a turning point: since September there has been a national medicines commission that could lead to a new culture.

In view of high drug costs, other countries also felt compelled to act, described the lawyer and doctor Kerstin Nolle Vokinger (University of Zurich and Harvard Medical School). In Switzerland there is a round table on the topic of cost containment. The aim is to take measures to save around 300 million francs per year from 2026.

And in the USA, where there has been a great lack of transparency in drug prices for decades, Vokinger believes there is at least a step in the right direction: price negotiations for ten important drugs, which initially only affect patients insured through the Medicare program.

In view of the re-election of the Republican Donald Trump as US President, it is unclear whether there will be a step backwards in this regard, said the scientist.

Criticism of secret discounts

With a view to the Medical Research Act passed in this country in the summer and the debate about the introduction of confidential reimbursement prices, Vokinger said that, in her view, Germany had done very well given the massive pressure from industry. There were still improvements to the original version, and the process is initially limited until summer 2028.

Vokiner spoke out in favor of not further anchoring secret discounts, which have existed in Switzerland for a long time, in this country. They are a big problem and there is a risk of losing control over costs. As an important reference country for price setting, Germany also bears responsibility for numerous other countries.

Secret discounts also violate the right to transparency, said Vokinger. Another problem also arises for doctors and their obligation to adhere to the principle of cost-effectiveness: without knowledge of the prices, the choice between medications to be prescribed may be impossible or difficult to make.

Vokinger presented the idea of ​​a price reduction in the event of a gap in evidence as a possible solution to the problem of high costs and often uncertain benefits. If there is proof of benefit, the price could be subsequently revised upwards, also as an incentive to carry out corresponding studies. Another conceivable approach is a stronger link between benefit and price, but this is a difficult ethical discussion, for example when it comes to questions such as the value of a year of life, said the scientist.

Medicines for Eastern Europe

The outgoing kd chairman Ludwig also reported on the Novel Medicines Platform, an initiative of the World Health Organization (WHO), which aims, among other things, to make medicines important for the supply of medicines accessible in Eastern European countries. Today, many new drugs, especially for the treatment of cancer, are not available in Eastern European countries, while they have long been on the market in rich countries like Germany. This is also very unfair from an ethical point of view, emphasized Ludwig.

The WHO wants to eliminate this obvious injustice and ensure that all patients in Europe have access to new medicines with proven benefits and at fair prices. Concrete measures are currently being formulated as part of this initiative to achieve these goals. © fos/ggr/aerzteblatt.de