Assessment and approval of drugs to be reviewed in the UK

Abstract

The UK has abandoned proposed changes to the way it approves new treatments for the National Health Service (NHS) in favour of a far wider review of how drugs are developed, assessed, and adopted. The National Institute for Health and Care Excellence (NICE) currently uses a measure called the qualityadjusted life year to quantify whether a new drug will benefi t patients and is good value for money. However, in July, 2013, the Department of Health asked NICE to develop additional mechanisms to assess both the burden of illness and the wider eff ect a drug might have on society—eg, through enabling people to return to work. It also proposed the removal of NICE’s end-of-life criteria, currently applied if a drug is expensive yet off ers the only hope of extending life. NICE released its proposals for consul tation in March, 2014, but after receiving more than 900 comments from individuals and organi sations, they have been shelved. Cancer patient groups were concerned that the proposals might have discriminated against older patients and reduced the availability of new drugs for people with terminal illness. Meanwhile, pharmaceutical com panies said they would have done little to address the changing nature of drug pipelines and the need for new methods of assessment. “The industry is generating more and more targeted medicines aimed at smaller numbers of patients, and with that the evidence base for assessing them is changing”, says Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry (London, UK). Instead, NICE has proposed a far wider review of the NHS’ arrangements for supporting innovation within the drugs industry and the assessment of new treatments. “It’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments”, says NICE chief executive Andrew Dillon. “We also need to look at the model of pharmaceutical research and devel opment, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and at the arrangements for commissioning expensive new treatments.” The decision has been welcomed by patient groups and the pharmaceutical industry alike. “We urgently need a system that values drugs—particularly for those reaching end of life—and that doesn’t bias against treatments for older people”, says Sarah Mee, policy and evidence manager for Prostate Cancer UK.