“The manufacturer can take fantasy prices”

MIRROR: The pharmaceutical expenditure of the Statutory health insurance 2018 is 41.2 billion euros, again a new high. Will blow up the cost of drugs at some point, the Budget of the health insurance companies?

Schwabe: The new drug prescription report shows that the fast could happen, if you are not careful. For example, with the new therapy with a monoclonal antibody developed for the prevention of migraine. In the new drug regulation report, we looked at the prescribing figures for the first drug of this type, Erenumab,. It is with an average treatment cost of approximately € 12,500 per year, around 200 times more expensive than the previous Prophylaktika. Meanwhile, two other agents of this type have come on the market, Fremanezumab and Galcanezumab.

SPIEGEL: But is it not a blessing, if desperate migraine patients now, finally, be helped can?

Schwabe: Of Course. For 14,000 to 15,000 patients in Germany, the response to any of the five currently available preventive therapies, or cannot tolerate, to use the benefit assessment of the Federal Joint Committee for a significant add-on to a therapy with Erenumab result. In this group the new therapy can reduce the migraine time in the month to an average of 3.2 to 3.7 days compared to a Placebo, the effect of 1.8 days, also quite good. The almost Euro 200 million, the treatment costs in this patient group, and are therefore acceptable.

SPIEGEL: then what’s the Problem?

Schwabe: Erenumab was from the European medicines Agency without restriction for all patients with at least four migraine days per month allowed. All of these 2.43 million people in Germany would be treated with Erenumab, there would be a year of unimaginable high cost of over EUR 30 billion – although for the vast majority of these patients, it is totally unclear whether you can benefit from the drug at all. Even if only five percent of these patients would Erenumab, it would still cost 1.5 billion.

MIRROR: Can nothing be done?

Schwabe: Yes, of course. The Federal Joint Committee may exclude, for example, certain groups of patients from the regulation. That is why the manufacturers have even asked, but of the Federal Joint Committee has refused. It could be agreed a refund amount with the manufacturer, which is based on a mixed price of Erenumab and previous therapies. The only one to two percent of the previous price would be in this case, but then – I can’t imagine that the producers want to get involved. Or the health insurance funds may conclude with the associations of accredited physicians, so-called structure agreements in which an evidence-based, and thus in this case also, saving costs at the end of treatment agreed upon.

MIRROR: Hold one of these possibilities is realistic?

Schwabe: I’m afraid that many health insurance companies afraid of competition, and therefore just try to be fast discount contracts with the manufacturers of the new drugs to complete. But this is a comparatively expensive solution. For me, these rebate contracts are pure Marketing of expensive drugs.

MIRROR: the cancer therapy in the last few years, getting more and more expensive. It has been confirmed this Trend in the new drug regulation report?

Schwabe: Oh, Yes. In the past year, around seven billion euros in spending, more than a sixth of the entire medicines, alone for cancer treatment drugs output. A huge Problem I see in the next few years to come, treatments the combination. Even as a single therapy modern cancer drugs such as monoclonal antibodies or protein kinase inhibitors is extremely expensive. If you start now, to combine these agents in the treatment, as it brings in the classic chemotherapy success – then the costs will rise to Exorbitant.

For cancer therapy, antibodies that are directed against a specific Antigen of a cancer cell, can be produced in the lab – in unlimited quantities. These identical, from a cell derived proteins are called monoclonal antibodies.

The proliferation of cancer cells to interrupt and tumor cells to destroy, also the so-called protein kinase inhibitors can be used: These enzymes inhibit certain signal transmission chains in the Interior of the cancer cells, so that certain growth stimuli no longer be forwarded.

MIRROR: do you Have an example?

Schwabe: even today, this is what happens when Multiple myeloma, a Form of bone marrow cancer: Because there is a triple combination of modern medicines can help, were 2018 alone for the therapy of this type of cancer 687 million euros issued – an increase compared to the previous year by about 16 percent.

SPIEGEL: Should we not rejoice that the cancer treatment is making progress?

Schwabe: of Course, no patient with a proven effective therapy for reasons of cost denied – but that’s exactly why it is so important, the money for the statutory health insurance companies is useful and not just of the pharmaceutical industry in the the throat to throw. I think it’s bad that a lot of good savings opportunities that we have and through the no Patient less well treated, would, as now, not be exploited.

MIRROR: What are the opportunities for savings are there for?

Schwabe: The largest cost drivers are the new drugs still with a patent protection. And not because they are prescribed frequently, but because they are always more expensive. The number of regulations of patent-protected medicines has halved in the last 20 years, their turnover has still tripled. Alone, if we were to Orient the German prices for patent medicines on the European market, where they are usually very much more cost-effective, we could save so every year, 1.5 billion Euro.

SPIEGEL: In Germany medication in the first year after the market launch, before the Federal Joint Committee, the early benefit assessment – no price fixing.

Schwabe: The manufacturer can fantasy prices! If the company would have to pay back the additional revenue from such an overpriced first-year prices to the benefit assessment, we could save each year 200 million Euro. And if the health insurance companies, ancient, controversial medicinal products, which include, for example, homeopathic remedies, would not pay, would be another 500 million euros in savings.

SPIEGEL: In the case of the first expensive biologics, with the help of genetic engineering can be produced, and against cancer and rheumatism used to be, is the patent protection already fallen. Since then, generic drugs, called Biosimilars, are available on the market. Biosimilars offer the greatest potential for savings?

Schwabe: Overall, could we with Biosimilars each year, around 1.2 billion euros. But this potential is not exploited. In the case of off-patent biologics 75 percent of sales are still the first-party preparations, and only 25 percent to the significantly lower-priced Biosimilars.

SPIEGEL: How can that be?

Schwabe: in 2018, for example, the patent protection of the revenues of the strongest drug in the world expired, the antibody Adalimumab. It is used in rheumatoid Arthritis or inflammatory bowel disease, Crohn’s disease. The Biosimilars, as concluded by the producer with numerous health insurance discount contracts. As Adalimumab is cheaper than before, so the Doctors prescribe it more – but probably still 20 to 30 percent more expensive than a Biosimilar. Huge savings potential remains unused, the money is missing to other parts of the health system.

MIRROR: In the year 2000, passed a law that pharmaceutical companies large incentives offered, if you are taking medicines for rare diseases such as congenital enzyme defects developed, the to disability and death. At least these so-called Orphan drugs is a success story?

Schwabe: If you just take the Numbers to look at, Yes. Since the year 2000, approximately 180 such drugs have been approved, of which about 120 are still on the market. Alone in 2018 were among 37 newly introduced medicines, 13 Orphan Drugs.

MIRROR: Where is the Problem?

Schwabe: Only a few of these Orphan drugs are really for people with serious rare diseases such as congenital enzyme defects benefit. Instead, Big Pharma, the Orphan has discovered Drugs as a lucrative business field, and there’s a Trick thought up: With the help of biomarkers actually frequent diseases are diseases, especially cancer, in small sub-groups, that they are to rare diseases. It’s called “Slicing” or “orphan capitalization”. The funds will be approved only for patients with a certain cancer who also have a specific Biomarker.

MIRROR: What are the advantages for the company?

Schwabe: Orphan medicinal products have, in any case, ten years of patent protection. Also, the requirements for registration appear to be low: A study showed that between 2000 and 2010, approved Orphan drugs, only around 60 percent of the cases, high-quality, randomized-controlled studies were submitted. For medicinal products with Orphan-very high prices, these drugs are per daily dose, on average, 26 times as expensive as patent-protected medicines. 2018 the Orphan have reached medication cost of 3.7 billion euros, almost ten percent of the total of the Statutory health insurance funds for medicines expenditure. The Situation of people suffering from a rare congenital genetic defects, has improved as a result of the Orphan drug act, however, is hardly something. This law needs to be changed as a matter of urgency. The way it is utilized is really a scandal.