Frankfurt The law planned by Federal Minister of Health Karl Lauterbach (SPD) for the financing of statutory health insurance companies continues to cause criticism in the health sector. Among other things, the draft provides for various price reductions for newly introduced drugs. The pharmaceutical industry, but also physicians from various specialist societies, fear a deterioration in the supply of patients with innovative medicines.
The pharmaceutical company Janssen is currently causing a stir in the industry. It recently took its lung cancer drug Rybrevant off the market in Germany and now wants to postpone the introduction of the new drug Tecvayli for malignant bone marrow diseases (multiple myeloma) in Germany.
According to the pharmaceutical division of the US group Johnson & Johnson, they want to critically examine a market entry and its possible timing. The reason for this is “methodological, outdated regulations in the German benefit assessment system, which cannot reflect the added value of the therapy with the data available at the moment”.
Companies and doctors warn that the new law could make such decisions much more frequently. Competitor Abbvie is already considering whether to bring a drug against a rare type of blood cancer to the market after its European approval in Germany. “We see the acute danger that in the future it will no longer be worthwhile bringing every innovative drug onto the market in Germany,” says Han Steutel, President of the Association of Research-Based Pharmaceutical Companies (vfa).
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Overall, the pharmaceutical industry can currently come up with many innovations. After a record year with 46 newly introduced active ingredients in 2021, there could be even more this year: by mid-September, 37 drugs with new active ingredients had already been introduced in Germany – against Covid-19, various forms of cancer, infectious and inflammatory diseases, such as one the exclusive evaluation of the vfa available to the Handelsblatt.
In total, 36 new funds remain if you subtract Rybrevant, which was withdrawn from the market at the end of August. So far, such market exits have been the exception: Since 2017, eight drugs have been withdrawn from the market by pharmaceutical companies after going through the so-called Amnog process, with a total of more than 200 new products being launched during this time.
The further development of this procedure, which Minister Lauterbach wants to implement with the GKV Financial Stabilization Act, is the focus of criticism. Amnog stands for Drug Market Reorganization Act. Since January 2011, the prices for new, patent-protected medicines have been determined on the basis of an additional benefit assessment. The aim is for health insurance companies to only pay as much for the new drug as corresponds to the determined additional benefit of the drug compared to a previously specified comparative therapy.
Obstacles for new launches are becoming significantly higher
In the future, however, there could be significantly more withdrawals of new medicines, the Working Group of Medical Societies also fears. According to Lauterbach’s draft law, only drugs with a “considerable” or “considerable” benefit will soon be able to achieve a higher price compared to the comparative therapy. However, this only applies to a small proportion of the new launches.
“Based on previous experience, that would still be 20 percent of the new drugs instead of the previous 56 percent. This would eliminate a major incentive for the availability of new medicines in Germany,” says Rolf-Detlef Treede, President of the Association of Scientific Medical Societies.
Pharmaceutical companies have been able to set the prices of their newly launched drugs themselves for a year while the process is ongoing. According to the new draft law, it should only be six months in the future.
The Federal Joint Committee, which includes doctors and health insurance companies, is responsible for the assessment. This not only determines against which therapy standard the additional benefit of the new drug must be proven, but also what evidence must be submitted.
There are always cases where the benefit of a drug cannot be proven for formal reasons because the required studies were not submitted. According to the law, the innovative drug must not be more expensive than the comparative therapy – regardless of whether other studies have shown a benefit for patients.
Rybrevant patients are cared for from abroad
That would also have been the case with the cancer drug Rybrevant. The drug can mean a significant extension of life for a small group of patients with a very rare mutation in non-small cell lung cancer, as the German Society for Hematology and Medical Oncology emphasizes.
However, because Janssen was unable to present the required data, instead of the previous 135,000 euros for a year’s therapy, the drug should only have cost a tenth of that, namely 13,000 euros like the patent-free generic comparative therapy.
“Especially in the case of cancer, it is often the combination of two preparations that brings about gradual progress in treatment.” Matthias Wernicke, Managing Director of Merck Healthcare in Germany
Started price negotiations with the statutory health insurance did not lead to an acceptable result for Janssen, which is why the company decided to take it back. Now the patients in Germany are being cared for from abroad, where the drug is still on the market.
The Janssen drug Tecvayli, which recently received conditional approval from the EU on the basis of early clinical studies due to the high medical need, would probably fare similarly. These studies do not currently meet the requirements of the benefit assessment in Germany, so that Janssen also expects the judgment “benefit not proven” here.
Prices for combination therapies are also expected to drop sharply
In this case, the planned GKV Financial Stabilization Act provides for an additional price reduction of ten percent compared to the comparative therapy. Tecvayli will not be marketed by Janssen in Germany for the time being.
And another regulation is causing criticism: According to the draft law, the price for combination therapies should be significantly reduced in the future. This applies above all to innovations in oncology. “Especially in the case of cancer, it is often the combination of two preparations that brings about gradual progress in treatment,” says Matthias Wernicke, Managing Director of Merck Healthcare in Germany. With the discount on the drug combination, the possibilities of such step innovations, which are often the basis for large new developments, are reduced.
The pharmaceutical association vfa is now calling for the new regulations on Amnog to be removed from the draft law and for further detailed consultation with the self-governing healthcare system, experts and industry.
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