Can NICE do its job?

The National Institute for Health and Clinical Excellence (NICE) is now in its seventh year. Its main purpose is to ensure equity of access to new treatments and encourage best practice in England and Wales. Yet output on Technology Appraisals and Clinical Guidelines has built up remorselessly so that people responsible for implementing ‘NICE things’ in the NHS struggle to keep up with the volume of work. At the time of writing, 110 Technology Appraisals and 46 sets of Clinical Guidelines have been issued. The sheer volume has also caused problems for NICE itself in deciding priorities, and with capacity and timeliness of its programme; there are complaints that some important new drugs have been licensed and have been available in the NHS for too long prior to guidance being issued on their use. As a result, Primary Care Organisations and Trusts still have to individually assess these drugs, and variations in practice remain commonplace; the very thing that NICE was set up to erradicate. A knock-on effect of this strenuous programme is failure to update guidance in a timely manner. Very few appraisals have been updated within the time stated on the NICE website, and some even argue that the content is outdated at the time of issue because the appraisals’ scope is inflexible and does not incorporate new licence indications. A prime example of this problem is the Technology Appraisal on glitazones in type 2 diabetes (TA63); there are now monotherapy and triple therapy licence indications but an absence of guidance for these uses. A major criticism levelled at NICE is a concern that it is too close to politics and commercial interests. A recent Lancet editorial suggested that the role of NICE in cost-effectiveness decisions is incompatible with the current commitment from Government to respond to patient choice. Incidentally, NICE and the Government still refuse to use the word rationing, rather sticking rigidly to ‘cost-effectiveness’. There are also several examples in which decision-making in NICE has apparently become ‘snarled up’ due to strong representations from patient groups and other interests. The original Technology Appraisal for Osteoporosis, for example, came out in draft format in 2003, and covered primary and secondary prevention. The primary prevention component was withdrawn following very strong lobbying and, three years later, has only just re-emerged, in draft format, for further consultation. How can the NHS be expected to commission and plan bonescanning services in the absence of this detail? Another example of this ‘NICE blight’ concerns drugs for Alzheimer’s disease. The consultation document that suggested the restriction of their use first came out 18 months ago and has only just been formally ratified in November. Again how can the NHS plan these services in the absence of proper guidance? The stalemate caused by restrictive guidance may be an inherent product of the NICE system. NICE itself selects the so-called stakeholders who provide feedback on the scope and content of its guidance from a list of organisations who have volunteered. If a patient support group or drug company volunteers, therefore, they can put considerable time and resources into having their voice heard. Conversely, those who work in the NHS still have their day (and night) job to do, which, paradoxically limits and reduces their involvement. Furthermore, it is important to recognise that the drug industry is a key source of funding for both patient support groups and for the research of some rather vocal clinicians, and that it has the power to harness the media and lobby politicians. As clinicians across the country scratch their heads in the face of these snarl-ups, stalemates and geographical disparities in practice, the Government confuses the issue further by interjecting and turning the guidance on its head. Such was the situation last year when the Secretary of State for Health pre-empted both NICE and the drug licensing process by stating, in essence, that Herceptin® should be provided on the NHS for early breast cancer, begging the question: can NICE do its job? E D I T O R I A L