3 - The role of NICE in the evidence-based health system

Summary

In early October 1999, Sir Richard Sykes, the chairman of Glaxo Wellcome, then Britain's biggest pharmaceutical company, stormed into 10 Downing Street. He was incandescent.

A body that most people had not heard of – the National Institute for Clinical Excellence (NICE) – in its very first decision had just recommended that the National Health Service (NHS) in England should not prescribe what the company had expected to be its next big money-spinner. A treatment for influenza, known as Relenza.

Given by inhaler, if used within 48 hours of symptoms, it reduced the duration of the symptoms from six to five days. But of the 6,000 patients in the clinical trial, just 70 had been elderly and there was no evidence that it reduced complications in those most at risk from flu: the elderly and asthmatics, for example. Furthermore, it cost £24 for a five-day course and NICE had calculated that in an epidemic year – and when the initial symptoms of flu differ little from a bad cold – Relenza could cost the NHS £100 million. At a time when the entire drug budget outside hospitals was under £4 billion. NICE judged that Relenza was not cost-effective and should not be prescribed.

Sir Richard branded the decision ‘ludicrous’. Proof of efficacy in high risk patients would come as the drug was used, he said, otherwise clinical trials to prove that would run on for years. He threatened to withdraw Glaxo Wellcome from the UK, saying that the decision called into question whether the UK was a suitable base for a multinational pharmaceutical company. However Tony Blair, still a relatively new prime minister, and Frank Dobson, his health secretary, stood by their new baby's recommendation. Relenza was not prescribed – other than by one defiant practice in Devon – and the threat of the company withdrawing from the UK evaporated. NICE had been launched. It was there to provide not just recommendations on whether new pharmaceuticals and other technologies are sufficiently cost-effective for the NHS to adopt them, but also guidelines for clinicians on best practice.