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'It seemed like a Nice idea in the beginning'

Some doctors believe the National Institute for Health and Clinical Excellence is preventing many patients from getting drugs they need. Health Editor Barry Nelson weighs up the arguments.

WHEN the then Health Secretary Frank Dobson set up the National Institute for Clinical Excellence (Nice) in 1999, most people seemed to think it was a good thing. Before Nice was established, the availability of newly-licensed drugs around the UK was very patchy.

Patients in one part of country could be prescribed a new drug while patients from the next town or county were turned down.

It was to prevent this so-called postcode lottery that the still relatively new Labour Government set up Nice.

The idea was that new drugs would be assessed centrally by an independent body drawing on the talents of many experts.

Once Nice ruled that a drug was suitable to be prescribed across the NHS, local primary care trusts up and down the country would be obliged to make the drugs available to their local patients.

While that sounded reasonable, in practice many new drugs began falling foul of the formula used by Nice to assess new drugs.

Bearing in mind the cash-limited nature of the NHS, drugs were also assessed on their value-for-money, as well as their effectiveness.

This was supposed to result in common sense decisions that would be widely accepted across the NHS and by the wider public.

But in practice, Nice has consistently upset the medical profession, charities and patient groups by turning down or placing restrictions on a range of new drugs widely available in Western Europe and the US.

Nice defended those decisions through value-for-money arguments, saying that by lavishing scarce NHS funds on only marginally effective new drugs, less money was available for other patients.

But many doctors feel frustrated that new drugs with a good track record in clinical trials are restricted or rejected by Nice on the grounds of cost effectiveness.

A particular irritation is another part of the Nice equation, the so-called secret formula used to assess the impact of drugs on a patient's quality of life.

Another concern is the length of time taken by Nice to assess new drugs, which has seen the return of postcode lotteries as local primary care trusts decide to fund drugs or turn them down ahead of national Nice guidance.

An example of this is when patients in the North-East were recently given access to the kidney cancer drug Sutent, pending a ruling by Nice, while a patient in neighbouring North Yorkshire has been denied access.

Sutent and Nexavar have been in use in Western Europe for some time, yet Nice has only just started the appraisal process.

A decision on Sutent and Nexavar, which experts claim represent the biggest breakthrough in the treatment of advanced kidney cancer in years, is not expected until January 2009.

Growing frustration with the way Nice works has manifested itself in a number of ways.

A House of Commons select committee recently announced it would conduct a review of how Nice operated.

Recently, Nice were taken to the High Court for the first time by drug companies backed by the Alzheimer's Society in an attempt to overturn restrictions on a number of anti-dementia drugs.

That dispute ended in a clear cut victory for Nice, but there are further challenges ahead.

Roche, the maker of the anti-lung cancer drug Tarceva has lodged an appeal with Nice over its decision to turn down the drug for use in the English NHS.

The appeal, backed by The Royal College of Physicians, The British Thoracic Society and the Roy Castle Lung Cancer Foundation, seeks to overturn an effective ban on Tarceva as far as NHS funding is concerned.

The decision by Nice came despite a study by cancer specialists in Newcastle, which showed that Tarceva was a cost-effective treatment for patients with non small cell lung cancer compared to an existing drug called Docetaxel. Nice ruled out Tarceva on the grounds of price even when, at a cost of about £6,800 for the average course of treatment, it works out only fractionally more expensive than Docetaxel.

Nice is increasingly under seige, but with the NHS in a cost-containing frame of mind, it is difficult to see it being swept away entirely.

In the meantime, many patients who assume the latest drug will be funded by the NHS could be in for an unpleasant shock.

10:54am Monday 3rd September 2007

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