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Government accused of letting pharmaceutical industry dictate drug prices and NICE approvals



The NHS is spending too much on drugs because the Government is allowing the pharmaceuticals industry to hide behind regulatory processes and undermine NICE appraisal processes, health economists have claimed.

The experts – from the renowned University of York health sciences team – argue UK drug prices are higher than in many other countries because of ‘successive governments’ desire to support the pharmaceutical science base and exports’.

Writing in the Royal Society of Medicine’s flagship journal, Professor Alan Maynard and Professor Karen Bloor say drugs companies are effectively being subsidised and forcing NICE to approve drugs at too high a price.

They said this is potentially stifling research into other, more innovative and beneficial products for the health service.

The authors call for greater transparency on negotiations on drugs pricing and other regulatory processes including patent protection.

In the editorial Professors Maynard and Bloor say NICE has been forced to keep the cost-effectiveness threshold for approving drugs on the NHS artificially high, at £30,000 per quality-adjusted life-year (QALY), despite Department of Health-commissioned research suggesting it should be set much lower.

They say: ‘There is now further pressure to ease the NICE cut-off and make it easier for products to obtain NHS reimbursement. This has been encouraged not only by industry but also my media, patient charities and politicians, although these groups may often be influenced, directly or indirectly, by industry funding.’

The experts say industry is using licensing and patenting issues to prevent the NHS getting the most cost-effective medicines – highlighting the controversy over CCGs being prevented from promoting use of the unlicensed bevacizumab (Avastin) for wet AMD instead of the approved drug ranizumab (Lucentis), despite clinical evidence the former is just as effective.

They write that ‘switching patients in England to bevacizumab could in principle save the NHS over £100 million each year’ but that the drug licence holders ‘challenge legally commissioners who seek greater efficiency in the use of their constrained budgets in this way’, while the Government ‘is powerless, or quietly condones excessive pricing’.

Speaking to Pulse, Professor Maynard said the PPRS and patenting processes offer the industry an ‘enormous hidden subsidy’ without offering clear returns.

Professor Maynard said: ‘If you’re going to subsidise them, whether directly or indirectly, there needs to be some accountability…what are we getting in exchange for that protection, and that subsidy to the industry?’

He added that he believed the Government should be more robust in handling the ongoing dispute over a ‘second medical use’ patent on pregabalin for neuropathic pain – and that he sympathised with GPs concerned this affected their prescribing principles.

Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee, said: ‘Although the problems raised in this article are not new they are well articulated and deserve attention. GPs every day see the problems patients have caused by scarcity of resources in the NHS, and there is a concern that these are worsened by the actions of very sophisticated companies whose public-service publicity does little to hide their overriding desire to maximise profit.

‘This is a shame, because when politics, business, and patients come together the patients are unlikely to come out as winners.’

Alison Clough, executive commercial director of the Association of the British Pharmaceutical Industry, said that the Pharmaceutical Price Regulation Scheme – a five-year voluntary scheme – has helped keep NHS expenditure on branded medicines flat for two years and within agreed controlled growth levels for a further three years.

She added: ‘What is needed is urgent transformation of NICE which will ensure that the right patients get the right medicines at the right time whatever their condition.’