How do pharmaceutical companies rate drugs

Medicines: dubious pricing policy in the industry

Moon price or seriously calculated? The approval of sofosbuvir for the treatment of hepatitis C with costs of 60,000 to 120,000 euros per patient has rekindled the discussion about reasonable drug prices.

Gilead is a place of promise in the Bible. In the here and now, Gilead is a pharmaceutical company that currently lives up to its name in the eyes of thousands of patients infected with hepatitis C. In January, the company launched Sovaldi (Sofosbuvir), a drug that experts believe represents a real therapeutic advance for certain patient groups. In combination with other drugs, Sovaldi promises significantly better cure rates and fewer side effects than the previous standard therapy consisting of interferons and ribavirin, with shorter treatment times. That's the page.

The other side is that Gilead is paying dearly for this progress and is therefore a promise, especially for the company's shareholders. With a price of around 700 euros per tablet, Sovaldi made headlines as the “1,000 dollar pill”. Depending on the therapy regimen, the treatment of a patient costs between 60,000 and 120,000 euros. As a rule, companies justify high prices with enormous research expenditures. This is not the case in this case. Gilead did not develop sofosbuvir itself. The polymerase inhibitor was researched by the small US company Pharmassett (annual sales: almost one million US dollars), which Gilead bought for eleven billion US dollars in 2012 after the first promising tests with sofosbuvir.

The investment was profitable. In the first six months after approval alone, Gilead made sales of around $ 5.8 billion with the drug. The company's profit has quadrupled compared to the first half of 2013 to around six billion dollars.

Admission waiver for commercial reasons

After sofosbuvir, the European Medicines Agency has now approved two further drugs for the treatment of hepatitis C, approval of a fixed combination of new active ingredients is expected this year, and 15 active ingredients are in the advanced stages of clinical trials. Anyone who hopes that prices will drop due to growing competition will likely be disappointed. Because so far, manufacturers have always based their pricing on the therapeutic environment. "Of course, when determining the price, one primarily takes into account the benefits of a drug and also the environment," Johannes Kandlbinder, Gilead's Market Access Director, told Deutsches Ärzteblatt. The therapy costs in the indication hepatitis C have always been high. Treatment with the previous drugs (protease inhibitors, interferons, ribavirin) also incurred costs of almost 70,000 euros per cure, said Kandlbinder, and this does not even take into account follow-up costs due to infection-related complications, which in extreme cases include a liver transplant.

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The prices for innovative drugs are often not justified

In Germany, an estimated 10,000 to 20,000 patients each year are eligible for treatment with the new hepatitis C drugs. Doctors and health insurance companies have also reacted to the associated costs. The National Association of Statutory Health Insurance Physicians (KBV) and the Central Association of Statutory Health Insurance (GKV) put an additional sum of one billion euros in the budget just for the care of hepatitis C patients in their negotiations on the framework for pharmaceuticals for 2015. There are 700 million euros retrospectively for 2014.

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The prices for innovative drugs are not too high

However, the indication hepatitis C is not the only high-price segment in the statutory health insurance pharmaceuticals market, which amounted to a total of 32 billion euros last year. A lot of money can also be made with drugs for multiple sclerosis (MS). For example, the prospect of higher profits prompted the pharmaceutical company Genzyme to voluntarily waive approval for its cancer drug Mabcampath (alemtuzumab) in 2012. The preparation is only suitable for a relatively small number of patients suffering from chronic lymphocytic leukemia (CLL). However, the monoclonal antibody was found to be useful in MS therapy. Higher prices can be achieved there, and the number of patients is higher. Genzyme apparently feared that it would have a negative impact on the price level if alemtuzumab remained on the market for the treatment of CLL. The active ingredient has been available again under the trade name Lemtrada since September 2013. And while Mabcampath once paid 21 euros per milligram, one milligram Lemtrada paid 887 euros.

Pharmaceutical companies exploit loophole in the law

Oncologicals are also a profitable business (graphic). According to the drug regulation report (AVR) 2014, they were the top-selling indication group in the statutory health insurance drug market last year with 4.4 billion euros. Six monoclonal antibodies used in tumor therapy alone caused costs of 1.4 billion euros, write the authors led by the Heidelberg pharmacologist Prof. Dr. med. Ulrich Schwabe. The AVR takes a critical view of the poor cost-benefit ratio of some active ingredients: "With trastuzumab, bevacizumab, cetuximab and panitumumab, the therapy costs are in no plausible relationship to the small increase in overall survival by one to five months."

Apart from the price development in individual indications, the analysis of the most recent prescription data, according to the AVR authors, reveals another trend: New drugs are coming onto the market at ever higher prices. With this strategy, the companies apparently tried to compensate for the steady decline in prescriptions for patented drugs in favor of generics. Since the statutory price moratorium came into force in 2010, simple price increases for the preparations concerned would no longer be an option (see graphic). The AVR figures on this: In 2013, the share of prescriptions for patented drugs in the overall market was nine percent (58 million), while their share of sales was 45 percent (14.2 billion euros). According to the AVR, above-average increases were primarily attributable to therapeutically important innovations: three TNF inhibitors for the treatment of patients with rheumatoid arthritis who are refractory to therapy (net costs 1.3 billion euros) and six products for the treatment of multiple sclerosis (1.2 billion euros).

With the claim to crack the price monopoly of pharmaceutical companies, the then FDP health minister Philipp Rösler took office in 2010. In future, the price of a drug should be geared more closely to its benefits, was the goal. The project resulted in the Medicines Market Reform Act (AMNOG), which came into force in January 2011. Since then, pharmaceutical companies have had to have newly approved drugs subject to an early benefit assessment by the Federal Joint Committee (G-BA). For drugs with additional benefits, the National Association of Statutory Health Insurance Funds and the pharmaceutical company negotiate a reimbursement price based on the amount of additional benefit and the costs of the comparative therapies. Using the example of Sovaldi, however, a discussion has now reignited about whether the AMNOG does not leave pharmaceutical companies too big a loophole when it comes to pricing. Because in the first year after approval - while the early benefit assessment procedure is running - manufacturers can still set their own prices.

Dr. med. Antje Haas, Head of the Pharmaceuticals and Remedies Department at the National Association of Statutory Health Insurance Funds. The health insurers therefore demand that the prices negotiated on the basis of the benefit assessment apply retrospectively in future - "from day one of placing on the market". "The law needs to be improved here," says Haas. “A price based on benefits from day one would certainly also encourage more realistic pricing strategies in the industry.” The industry has long been pursuing a high-price strategy for cancer therapeutics and drugs for the treatment of HIV, as has been the case for drugs against rare diseases. "Now the therapy for multiple sclerosis and hepatitis C is obviously to be added."

Minister Gröhe criticizes the abuse of market power

The KBV also suspects the industry's negotiating strategy behind the high prices for innovations, which can best be tackled with retrospective reimbursement prices. Even more important for KBV board member Dipl.-Med. Regina Feldmann, however, that there is prescription security for the general practitioners who regularly prescribe high-priced drugs. For the new hepatitis C drugs, this has been achieved through the most recent framework for drugs. The preparations are excluded from the benchmark test.

However, Feldmann is interested in a basic regulation: The legislature must make it clear that the negotiated reimbursement amount generally guarantees economic efficiency over the entire area of ​​application. “To stay with the example of hepatitis C: The additional benefit has been proven for certain genotypes, but not yet for others because the manufacturer has not yet submitted any data on this. Doctors must not suffer any disadvantage in the form of recourse when prescribing, ”says Feldmann. "Because we are assuming that the National Association of Statutory Health Insurance Funds will agree on reasonable mixed prices - as was already the case with other drugs." In addition, new drugs would have to be recognized as special practice features more frequently than before in the price negotiations.

27 drugs with new active ingredients came onto the market in 2013. Critics complain that the pharmaceutical industry orients its research too much towards commercially interesting indications.

The Sovaldi case has also sensitized politicians to the issue of drug price policy. "The process must not become a blueprint for other drug manufacturers," the Federal Ministry of Health announced on request. Take developments around the pricing of new hepatitis C drugs “very seriously”. However, the development of expenditure in this case is so far unique, also because many people have been waiting for the new drug. That is why there is apparently no need for action in the ministry. As in the answer to a small question from the left on the price policy of Gilead at the end of September, it is pointed out that the AMNOG procedure with the elements benefit assessment and subsequent price negotiations is designed as a learning system. In the event of any changes, one always has to check what effects this could have on the overall system. “It is currently not possible to foresee whether and which measures may be necessary,” the ministry told the Deutsches Ärzteblatt. Federal Minister of Health Herrmann Gröhe (CDU) had become clearer at the start of the pharmaceutical dialogue with industry in mid-September. "The abuse of market power by individual companies to the detriment of the insured community is unacceptable," wrote Gröhe in an article for the Handelsblatt (September 15) - albeit without targeting a specific company. What is needed is a balance between the interests of companies and the requirements of a solidarity-based health system that can be financed over the long term and focuses on patient benefits.

But how can health systems be prevented from being overwhelmed by excessive price increases? Numerous countries have made independent cost-benefit assessments of new products the basis for their reimbursement decisions.

England: cost-benefit assessment undermined

In England and Wales, the National Institute for Health and Clinical Excellence (NICE) is responsible for such an assessment. It recently classified a drug from the Roche pharmaceutical company for the treatment of advanced breast cancer as not cost-effective and rejected it. * Treatment costs for Kadcyla (trastuzumab emtansine) amount to the equivalent of 115,000 euros. In the opinion of NICE, the product would have been worth a maximum of 13,000 to 31,000 euros based on its benefits. National Health Service (NHS) patients can still be prescribed the drug. Kadcyla is now financed by the Cancer Drugs Fund, into which the NHS pays around 350 million euros annually. Former Health Minister Andrew Lansley set up the foundation in 2011 to provide cancer patients with drugs that are not regularly available in the NHS. The political pressure had become too great.

Heike Korzilius

@What do high-priced therapies mean for prescribing doctors?
5 questions for Dr. med. Axel Baumgarten:
www.aerzteblatt.de/60871

* Hawkes N, "Cancer Drugs Fund receives boost but will no longer fund overpriced drugs",
BMJ 2014; 349 (September 1, 2014).

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