The Observer view on big pharma and lifesaving drugs

http://www.theguardian.com/commentisfree/2015/jun/07/observer-view-on-big-pharma-cost-of-lifesaving-drugs

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Pascal Soriot, boss of pharmaceutical company AstraZeneca has said that he is “perplexed” that the National Institute for Health and Clinical Excellence (Nice), the NHS’s “budgetary police” has decided that olaparib, a drug that treats ovarian cancer, is too expensive to fund at £4,200 per month.

It is Nice’s unenviable job to decide which drugs the NHS can afford and on what basis – and which it can’t. It has a guideline that no drug should cost more than £30,000 per additional year of a patient’s life. However, that simple rule almost becomes irrelevant given the number of exceptions and the power of the media when a high-profile, heartbreaking case comes to the fore. In affluent countries, the cost of providing high-quality, equitable care is outstripping budgets. Innovations in treatment, ageing populations, increasingly sophisticated patient demand and a taboo around death are all factors, so that an extra few weeks of life is increasingly seen as every citizen’s right.

Another way of looking at the dilemma of how “value” is defined by the NHS is viewing any set of hard-headed calculations from the position of the man or woman with, say, a diagnosis of terminal pancreatic cancer. Humanity suggests, as Nigel Edwards of the thinktank the Nuffield Trust correctly points out, that the NHS footing a bill of more than £20,000 a month, for two months’ extra life, appears a bargain, especially so if the extra time lengthens to several months and longer, as it does in some cases. However, money paid in one direction is resources forfeited in another. That is the NHS’s terrible dilemma.

Last week, in the US, at an annual gathering of oncology researchers and doctors, the accelerating breakthroughs in the treatments of cancer – for instance, in the generation of new drugs that use the body’s immune system to destroy the disease – were reasons to celebrate. The less welcome news was of the huge amounts of profit being made by the pharmaceutical companies. Bristol-Myers Squibb’s Opdivo, for example, costs £98,000 for a full course of treatment. So how is Nice to decide who receives a lifeline, and on what grounds, and who is refused? Certainly, the current system is a mess and a muddle and profoundly unfair.

In 2010, on a political whim, David Cameron set up the Cancer Drugs Fund; £200m was allocated for drugs that had yet to be evaluated by Nice or not recommended “on the basis of cost-effectiveness.” Thus 55,000 people have had access to “last-chance” drugs that would have been denied them before. Nevertheless, the Association of the British Pharmaceutical Industry is right to call the CDF “a sticking plaster covering a seeping wound”. Academics have found the £200m could have generated five times the benefit if returned to the NHS.

A task-force has been established to report by the summer on how to develop a more effective five-year strategy for dealing with cancer. But cancer is not the only disease in which rationing of drugs is an issue. Liberal Democrat MP Greg Mulholland has fought courageously, for instance, for the tiny minority of children suffering from extremely rare diseases who can be helped by life-changing yet costly drugs.

Clear criteria, however ethically difficult to apply, are essential, not least to end the discriminatory rationing that means, as a patient, the care you receive is influenced by geography, class, age and the type of disease. But what is also required is an overhaul of the price of drugs to the NHS. In 2013, 100 leading oncologists called on the pharmaceutical industry to exercise justum pretium – fair value – or risk bankrupting national healthcare systems. In that year, five pharmaceutical companies, including Eli Lilley, had a profit margin of 20% or more. Innovation deserves reward. It can cost up to £1bn to research and develop a new drug but the oncologists argued that drug companies continue to boost the price long after costs have been recovered and a healthy profit already made.

Drug companies can and do behave well. Merck, for example, provided ivermectin free, saving the vision of 30 million people. However, when a course of new treatment costs, say, £65,000 per patient, an analysis of how that price tag is reached is vital. George Osborne’s decision last week to axe £200m from the public health budget that invests in measures to prevent disease makes no sense at all. A great deal has yet to be learned.