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When it comes to healthcare, new isn’t necessarily better. An analysis of 216 medicines launched in Germany since 2011, most of which would have been made available throughout Europe, has found that only a quarter brought significant benefits over existing treatments, according to the available evidence. The rest had only minor or no benefits, or the impact of the medicine was unknown.
Medical regulators expect firms to show that their products are both safe and do what they are supposed to. The standard way to do this is through a randomised controlled trial, but pharmaceutical companies are not required to put their new drugs up against the best possible treatment on the market – instead they may test them against placebo pills.
Even when a new therapy is actually tested against an existing one, the old medicine may be given at too low a dose for a fair comparison.
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“That’s a problem, not only for pricing decisions but if a patient has to decide for one or the other,” says Beate Wieseler of the Institute for Quality and Efficiency in Health Care in Germany, one of the authors of the study.
In cases where a new drug is truly better than existing ones, the benefit may be so small as to make little practical difference. This is particularly true for cancer treatments – a study of 72 cancer drugs launched in the US over 12 years, found that, on average, they only extended life by two months.
Richard Torbett of the Association of the British Pharmaceutical Industry disputes Wieseler’s findings. “Often we find that studies making similar claims invariably take a very narrow view of what constitutes ‘value’ that ignores issues that are important to patients,” he says.
It is true that the pharmaceutical industry has sometimes delivered great benefits to our health, including in the past few decades. A mere 15 years after HIV was first identified as the cause of AIDS in the 1980s, the industry had developed triple-drug regimens that give a nearly normal lifespan.
We have recently seen an even more impressive turnaround with a potentially deadly virus that causes hepatitis C. This infection can now be cured with a three-month course of treatment.
So pharmaceutical firms are producing both genuinely life-changing therapies mixed in with a larger number of also-rans. This is a big problem, because all Western countries, whether their healthcare systems are funded by taxes or insurance, are facing rising medical costs, with a significant fraction of that due to drug costs.
This is why in 1999 the UK set up the National Institute for Health and Care Excellence (NICE) to assess whether new drugs are cost-effective, not just medically effective. Its decisions are sometimes unpopular, and politicians have sometimes overruled them, such as when in 2011 the government set up a special fund for paying for new cancer treatments rejected by NICE – which some argue was a waste of money.
But the problem of ever-more expensive new medicines is not going to go away. Drug companies are increasingly painting regulators as barriers to life-saving treatments. Firms lobby for their products to be assessed under “accelerated approval” schemes, where less robust trial evidence is needed.
Politicians need to take a firm line, and work with regulators such as the EMA to make drug companies produce better evidence if they want healthcare systems to pay for them. “Unless we address this, we are afraid the problem will become larger and larger,” says Wieseler.
Journal reference: BMJ, DOI: 10.1136/bmj.l4340
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