Germany frontrunner for metastatic breast cancer drug approvals, with some hiccups

In terms of breast cancer mortality, Croatia ranks 15th in the EU. [siam.pukkato/shutterstock]

This article is part of our special report Metastatic Breast Cancer: Still a lot to be done.

While the German healthcare system is at Europe’s forefront in terms of making drugs available for the treatment of metastatic breast cancer, problems still arise as some important drugs have been withdrawn from the market.

According to estimates by the Center for Cancer Registry Data (ZfKD) at the Robert Koch Institute, there are about 18,000 new cases of metastatic breast cancer in Germany each year.

Although there is no cure for metastatic breast cancer, modern forms of therapy can significantly improve patients’ quality of life and extend their lifespan, making quick treatment of the disease absolutely essential.

Germany leads the way in Europe with regard to making new forms of therapy available.

“In general, I would say that Germany is one of the best-supplying countries,” Diana Lüftner, executive director of the German Foundation for Young Adults with Cancer, told EURACTIV.

This is because, from the day the European Medicines Agency (EMA) approves an active ingredient, all patients with public health insurance are entitled to the new drug in Germany, with costs covered by the insurance.

“This gives us a unique selling point, as this is not the case in other countries, where there are much more restrictions or delays in approval,” Lüftner emphasised.

Medical care

While in other countries there are lengthy price negotiations between health insurance companies and pharmaceuticals before a drug is placed on the market, in Germany the process is the other way around.

After the EMA approves a drug, it goes directly onto the German market and is available to patients there. In the first year, the manufacturer is then free to set the price of the drug while health insurers cover the cost of treatment.

“All patients with public health insurance are entitled to the innovations that are approved, and in that respect, I think, Germany is already almost unique,” Eva Schumacher-Wulf, editor-in-chief of breast cancer magazine Mamma Mia, told EURACTIV.

Price negotiations between manufacturers and the Federal Joint Committee – the highest decision-making body of health insurers, doctors and hospitals – will then begin after one year, in the so-called AMNOG process.

However, this is precisely the point that receives most criticism, as in the past there had been cases where the manufacturer withdrew treatment medication for metastasizing breast cancer from the market once the negotiations failed.

Schumacher-Wulf emphasised that price negotiations often “don’t always end up in patients’ favour.”

German patients are then dependent on individual imports from other countries, as the active ingredients are still approved in the EU. This is associated with a high bureaucratic effort while at the same time increasing costs due to the import.

Withdrawing drugs from the market

There have been reported cases where companies withdrew a drug from the market after negotiations with the Federal Joint Committee failed.

In the meantime, these drugs are being imported from other countries, where they are not only approved but are also the cheapest on offer.

In some cases, the Federal Joint Committee has halted the negotiations saying there is lack of additional benefit.

However, their methodology of assessing the added benefit of drugs has been criticised by the German Society for Hematology and Medical Oncology which, for its part, says that these drugs have an added benefit for some patients with metastatic breast cancer.

“We have to address this systematic error politically,” Lüftner told EURACTIV. While the AMNOG process is fundamentally positive, she added, it has “hit substances that we could use very well in individual cases and there is already a very high risk of misuse,” she stressed further.

There are several reasons for a manufacturer to take such a drastic step and remove an entire drug from the lucrative German market.

On the one hand, companies are speculating that an improvement of the database will give them a stronger position in price negotiations, and are therefore withholding their drugs from the German market short-term.

More crucially, however, more than 30 countries around the globe are using the outcome of the German AMNOG process as a guide for their own price negotiations.

When manufacturers cannot get their prices accepted in Germany “they’d rather not launch in Germany and have a reasonable price in more than 30 countries in return,” Lüftner said.

Early detection

Another controversial issue is early detection, which is especially essential in the pre-metastatic stage, during which breast cancer is still curable.

“Overall, it is important that the disease is detected as early as possible,” Schumacher-Wulf emphasised.

Between 2004 and 2009, Germany already introduced a breast cancer screening program for early detection across the country, which invites women aged between 50 and 69 to a screening examination every two years.

In addition, an extension of the age limit to all women between 45 and 74 years is currently being discussed by the Federal Joint Committee, as the European breast cancer guideline contains recommendations to extend screening to these age groups.

However, experts disagree about whether such an age extension is plausible.

Schumacher-Wulf, for example, emphasised that there should be more offers, especially for younger women. “I say 50 is just too late,” she warned.

Lüftner, on the other hand, said extending the age limit downward would not be very effective, as breast cancer occurs primarily in women over fifty.

Screening younger patients would only lead to unnecessary biopsies and other examinations and “that is not the purpose of screening,” she said.

[Edited by Zoran Radosavljevic]

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