Healthy Skepticism Library item: 10707

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Publication type: news

Batty D.
Q&A: How Nice works
SocietyGuardian.co.uk 2007 Jun 25
http://society.guardian.co.uk/health/story/0,,395476,00.html

Full text:

How Nice fulfils its aim to ensure the best health treatments are available to NHS patients

What is Nice?
The National Institute for Clinical Excellence was set up in 1999 to decide which drugs and treatments should be available on the NHS in England and Wales. It also provides guidelines on the care and treatment of patients with a wide range of medical conditions, from diabetes to schizophrenia.

In April 2005 it merged with the Health Development Agency to form the National Institute for Health and Clinical Excellence, but is known by the acronym Nice. Since then it has taken on the added responsibility of promoting good health and preventing ill health. The equivalent Scottish body is the Health Technology Board for Scotland.

Why was Nice set up?
To remove clinically ineffective, non-cost effective, or unsafe treatments from the NHS, while making sure the best treatments are made available widely and fairly. This should end the “postcode lottery” in care, where access to treatment depends on where you live.

Why is it in the news?
Nice is facing the first legal challenge over its guidance. A judicial review has been brought by the drug companies making and marketing Aricept, a drug which Nice says does not work well enough to justify the cost to the NHS of giving it to people with mild Alzheimer’s. It ruled the drug should not be used until the disease progresses.

Is Nice just a “penny-pinching” body set up to guard NHS budgets?
Its critics often argue this and it does have to take “cost-effectiveness” into account when it reviews a new treatment. Department of Health figures obtained by healthcare thinktank the King’s Fund estimate that Nice decisions added a net cost of £1,022m to the NHS budget between 2003-04 and 2006-07. The department estimates Nice guidance will cost the NHS another £150m in the current financial year. These figures exclude the impact of Nice guidance on GP services, so the total cost to the NHS could be significantly more.

Meeting the cost of Nice decisions, such as new breast cancer and coronary heart disease drugs, is one of the reasons often used by local NHS trusts to justify overspending their budgets or cutting services. Several local health trusts justified slashing mental health budgets on the grounds that they needed the money to pay for the extra cost of providing the breast cancer drug Herceptin to more women after Nice approved it to treat the early stages of the disease. The medical journal Annals of Oncology calculated that the annual bill for providing Herceptin to the 5,000 women diagnosed each year with early-stage breast cancer would come to £109m.

Is Nice just a way of rationing healthcare?
Its critics say it is rationing care by preventing drugs such as beta interferon (for multiple sclerosis) being made available on the NHS. The government argues that Nice formalises the process of deciding what should and should not be made available on the NHS, which in the past has been uncoordinated and random.

Can Nice rule against a treatment that is proven to be clinically effective?
Yes, on the basis that the cost to the NHS is disproportionate to its long-term clinical benefits. Many expensive new pharmaceuticals do not offer a “cure”, but simply relieve some of the symptoms of chronic diseases such as Alzheimer’s disease and multiple sclerosis (MS). The most controversial Nice decisions have involved attempts to balance clinical effectiveness and cost effectiveness.

Can doctors overrule Nice guidance?
Technically yes, if they are sure that a case warrants ignoring the guidance. But if they persistently overrule guidance their work will be monitored. The Medical Defence Union, which insures doctors against medical negligence lawsuits, recommends that doctors keep a contemporaneous note explaining why they diverged from Nice guidance in case they are sued.

What criteria does Nice base its decisions on?
Nice weighs up the benefits of any treatment against the benefits of none; any undesirable side-effects; the effects of removing NHS availability; the impact of the treatment on length and quality of life; the net cost to the NHS; and the impact of the treatment on NHS resources.

Who decides which treatments Nice should examine?
In England the Department of Health and in Wales the National Assembly refer drugs and treatments for appraisal. Referrals are based on several criteria including whether they are likely to have a significant impact on NHS resources and whether their introduction might result in significant health benefits.

Is it free from ministerial influence?
In theory, yes. However, the health secretary, Patricia Hewitt, was last year accused of pressuring Nice to approve the breast cancer drug Herceptin for treating the early stages of an aggressive form of breast cancer. She pledged that the drug will be made available to any woman who can benefit from it, even though Nice is not expected to begin assessing whether the treatment is cost-effective until August.

Is Nice popular?
Nice introduced itself by saying it intended to “earn and retain the confidence and respect of the community as a whole”, but its highest profile decisions inevitably disappoint some. Its popularity waxes and wanes. Its recommendation in February 2002 that the NHS strictly limit the availability of beta interferon, the MS drug, was widely condemned by patient groups and the media. Following criticism from MPs that it was taking too long to make decisions about new drugs, Nice last year introduced a new fast-track process to speed up publication of its guidance.

How has the pharmaceutical industry reacted to it?
Pharmaceutical companies are understandably keen to get their new drugs approved for use on the NHS and spend considerable time and money lobbying Nice and MPs to achieve this goal. More recently major firms have supported patients campaigning for new drugs to be made available on the NHS, provided funding to relevant charities and co-ordinated media campaigns to raise the profile of their drugs. Pharmaceutical giant Janssen-Cilag struck a deal with Nice to get its bone cancer drug Velcade provided by the NHS. The landmark deal means that the company will refund the cost of the drug in cases where it does not improve a patient’s health. The thinktank Demos said it showed how far drug companies were prepared to go to undermine Nice’s authority.

Who makes Nice decisions?
The chairman of Nice is professor Sir Michael Rawlins, a highly respected clinical pharmacologist and its chief executive is Andrew Dillon, a career NHS manager and former trust chief executive. Each decision follows an appraisal lasting up to 12 months. Each drug or treatment is appraised by a committee of about 20 experts, including senior clinicians, academics, managers, and patient representatives.

What happens after Nice makes its recommendations?
The health secretary generally approves the decision. If this is to allow NHS use of the new treatment, health bodies in England and Wales are obliged to make it freely available, notwithstanding any clinical restrictions placed on its use by Nice. If the decision is to ban NHS use, then any patients receiving the treatment on the NHS usually will continue to do so, but it will be barred to new patients. Patients can still pay privately for the treatment.