Berlin The draft law expected for this week to strengthen statutory health insurance has alarmed German drug manufacturers. This became clear in many discussions and presentations at this year’s Handelsblatt Pharma Conference.
According to the coalition agreement, the new federal government has planned cuts in drug prices, among other things. As a result of such a policy, Germany could fall behind as a pharmaceutical location in global competition, manufacturers fear. “Health policy is always location policy,” said pharmaceutical manager Marco Penske from Boehringer Ingelheim.
The debate comes at a time when the country has caught up internationally thanks to the success of the mRNA vaccine development by the Mainz-based company Biontech. “As a co-technology leader in mRNA, Germany has been able to take the lead in the tough global competition,” said Han Steutel, President of the Association of Research-Based Drug Manufacturers (VFA).
The industry has proven its innovative strength in a very short time with the breakthrough in the Covid-19 vaccine. In Germany, an entire production network has developed around the manufacture of Covid-19 vaccines. Corona drugs are also produced here.
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In this country, however, it is now also a question of dealing with the health costs, which have risen sharply as a result of the pandemic. Last week, preliminary figures from the Federal Ministry of Health showed that the statutory health insurance companies (GKV) had a record deficit of 5.8 billion euros in 2021.
Health Minister Karl Lauterbach (SPD) sees the health insurance companies facing major financial challenges, but wants to keep the health insurance contributions for the insured as stable as possible this year and next. Although hospitals account for the largest share of statutory health insurance expenditure, at EUR 85 billion, pharmaceutical expenditure rose by 7.8 percent to EUR 46.7 billion, much more than hospital treatment, for example, which increased by 4.4 percent.
Health insurance companies should be given more opportunities to save money
In the coalition agreement, the SPD, FDP and Greens have stated that they will continue to develop the law for the reorganization of the pharmaceutical market (Amnog), which was introduced a decade ago. The health insurance companies should be given more opportunities to limit drug prices. Specifically, the reduced drug prices negotiated between manufacturers and health insurance companies should not only apply one year after the market launch of the new product, but from the seventh month.
According to the Amnog law, which has been in force since 2011, pharmaceutical manufacturers can freely set the price for their newly launched products on the German market for the first year. During this time, the product is subjected to a benefit assessment, at the end of which a reimbursement price is negotiated with the health insurance companies.
According to industry information, this reimbursement price for all new products introduced since 2011 is on average around 20 percent lower than the price set by the manufacturer. According to the Central Association of Statutory Health Insurance Funds, it was around 23 percent last year. Over the years, the Amnog Act has brought average savings of 1.9 billion euros per year, and for 2021 the GKV has calculated savings of around 4.8 billion euros.
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Numbers that, in the opinion of VFA President Steutel, speak in favor of not changing the law, as he told the Handelsblatt: “From our point of view, the Amnog does what politicians expected of it: it saves billions and ensures security of supply.” Therefore, there is no objective reason to “deteriorate the reimbursement conditions for medicines in Germany now of all times”.
Interim prices for advanced therapies
Poorer framework conditions for the industry could lead to international companies investing less in Germany in the future, as previous legal cuts have shown, argues Steutel. However, the pharmaceutical world does not only revolve around Germany. In contrast to the USA and China, the German pharmaceutical market is comparatively small: In the USA, the world’s largest pharmaceutical market, turnover was the equivalent of around 350 billion euros in 2021, in China it was 165 billion euros.
Germany is currently the country in Europe where new, innovative medicines are made available to patients the fastest. A service that the statutory health insurance companies also see as positive, as Antje Haas, department head at the National Association of Statutory Health Insurance Funds, said.
According to the coalition agreement, the new federal government has planned cuts in drug prices, among other things.
(Photo: Handelsblatt)
However, a problem for the health insurers is that very few new therapies, such as certain cancer treatments or innovative gene and cell therapies, cause very high costs. These innovative therapies, which can easily cost one to two million euros per patient, receive just one percent of patients. However, they account for 22 percent of statutory health insurance expenditures.
In the case of innovative therapies in particular, the accelerated approval practice of the European Medicines Agency (EMA) would mean that the proof of how effective they are would move after approval. This happens as part of a so-called application-accompanying data collection, according to Haas. This survey is then, so to speak, at the expense of the statutory health insurance, which already reimburses the funds.
Haas therefore advocates a modification of the Amnog law on the benefit assessment of drugs. In the future, manufacturers and health insurance companies should be able to negotiate an interim price for a drug based on criteria that are independent of the evidence, i.e. scientific evidence. Once the scientific benefit assessment of the therapy has been carried out, an evidence-based reimbursement price should apply.
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