by Hélène Mauduit
COLOGNE, Nov 8 (APM) - The pressure on pharmaceutical companies to demonstrate the value of their drugs for national healthcare systems is increasing, a conference heard.
This increased pressure is not a problem in itself, said Joerg Moeller, head of development at Bayer's pharmaceutical division. "If we are able to demonstrate value, we are in a good position. The problem is that the public discussion focuses on costs rather than on the [real] value of drugs," he said at the Bio-Europe conference in Cologne on Monday.
Moeller mentioned the most recent hepatitis drugs, which avoid costs linked to transplantation and the long-term care of seriously ill people.
A discussion on value would provide information about what innovative drugs bring to the healthcare system. Moeller mentioned an OECD study showing that life expectancy has increased by almost two years over the past decade and data suggest that three quarters of this increase is attributed to innovative medicines.
But such benefit is barely mentioned in public discussions, he said.
The focus is instead on drug costs, which account for around 15% of overall health costs, while hospital costs - which are much higher - are less closely scrutinised.
"Pharma and biotech companies must engage in a dialogue with other stakeholders to talk about the value we provide". If the value in the research and development process is demonstrated, public discussion will move to a new level, he said.
Talking about Germany, Moeller said he regretted that some health technology assessment (HTA) procedures run the risk of depriving patients of innovative medicines.
He cited Bayer's cancer drug Stivarga (regorafenib), whose added benefit assessment was found to be negative in colorectal cancer because its clinical benefits were "not of a sufficient size" for German HTA bodies. This led Bayer to withdraw the drug because the health insurance was asking for a significant price reduction (APMMA 47463).
Moeller added that it now seems impossible for Stivarga to make a comeback on the German market in the indication of unresectable hepatocellular carcinoma, although it has shown "a proven survival benefit for the first time ever" in second-line treatment in this indication.
The role of innovation in the healthcare system is under scrutiny, said the head of Germany's lower HTA body IQWiG, Juergen Windeler.
A debate on the number of medicines available has begun in the last five years, he said. "What is said is 'we do not need everything that is labelled innovation'. This is not a financial problem but a question about the role of innovation," Windeler said.
When the eighth statin was launched on the German market, patient representatives asked whether it was necessary, Windeler said. Drugs should not be developed and launched for competition only, but if they "add clinical benefit to patient treatments", and companies should provide convincing data.
Financial issues for many national healthcare systems are also playing a role, as well as "a couple of isolated examples when companies tried to get an extraordinary price for a product"
European countries, which mainly have single payer systems, are much more open to discussions on the long-term value of drugs than the U.S., said Kate Bingham, managing partner at UK's venture capital firm SV Life sciences.
In the U.S., people frequently switch insurance carriers, and long-term financial benefits are not valued.
The launch of Novartis' heart failure drug Entresto (sacubitril+valsartan) was much more sucessful in Europe than in the U.S. because there is evidence that this drug enables savings in the system as a whole, an argument which is stronger in a single payer system, Bingham said.
"It is going to be especially difficult for highly-priced orphan drugs because a health care payer will not want to pay half a million or a million dollars for a single curative treatment, if that patient is going to switch carriers three years later," she said.
Pharma companies face the absence of a common definition of what constitutes value, said Moeller.
HTA agencies have different definitions of what is meant by this word, depending on each healthcare system, and this will not change in the next few years, Moeller said.
Despite the effort for harmonisation at the EU level, "I don't expect to see it in my professional lifetime", he concluded.
/hm/clg
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