The Pharmaceutical Journal
Vol 268 No 7203 p881
22 June 2002

This article
Reprint
Photocopy

PDF* 35K

Drug and Therapeutics Bulletin seminar

Is UK prescribing too conservative?

United Kingdom prescribers are relatively slow in their uptake of new medicines compared with prescribers in other countries, said ADRIAN TOWSE, director of the Office of Health Economics.

A study by the Pharmaceutical Industry Competitiveness Task Force showed that UK uptake of 46 major new NHS-reimbursed medicines launched in the UK since 1995 is low compared with the other countries investigated. During the first year of the five-year study, UK consumption of these new medicines in volume terms was about one quarter of the average consumption in all the countries included in the study. By year five, UK usage had increased but was still only about half of the average for the comparator countries. The study also found that the UK spends less on pharmaceuticals as a share of gross domestic product than most of the comparator nations — only Switzerland and the Netherlands were lower — and its growth in share over the five-year period was among the slowest.

Moreover, guidance from the National Institute for Clinical Excellence (NICE) appeared to have had a limited impact on prescribing so far, he said. For example, if taxanes were prescribed as NICE recommended, costs would increase by £3m to £3.5m per month, yet statistics showed that there had not been much change in prescribing so far. This also applied to the prescribing of proton pump inhibitors where, if NICE recommendations were followed, costs would fall by £20m a month; this had not happened either.

The NICE position

Encouraging innovation was one of the criteria that NICE used in deciding which products to appraise, according to Professor Sir MICHAEL RAWLINS, chairman of NICE. Failure to appraise innovative products would lead either to denying patients the benefits of effective new treatments or wasting resources on treatments of unproven value. It could also lead to post-code prescribing.

Of the 33 pharmaceuticals that NICE had appraised so far, 18 had been established products and 15 innovative products. Of the 15 innovative pharmaceuticals, however, only four had been recommended for routine use and 11 for restricted use whereas, of the 18 established products, nine had been recommended for routine use, seven for restricted use, one for research use and one not at all.

The reasons for restricting the use of innovative products lay mainly in the relative scarcity of good, robust evidence for their clinical and cost effectiveness, he explained. Studies were often short term with limited numbers of subjects who did not necessarily reflect the population in which the product would be used. Other problems included unhelpful comparators (eg, placebo rather than standard care), clinically inappropriate endpoints (eg, surrogate markers) and the paucity of relevant economic data. Company-sponsored studies were often considered to be a problem, but there was more fraud in clinical trials conducted by doctors than in those involving companies. The idea that treatments should not be recommended because there were no independent trials was morally indefensible, he said.

What is a genuine therapeutic innovation?

ANDREA TARR, of the International Society of Drug Bulletins (ISDB) said that there was a great deal of confusion about what constituted a genuine therapeutic advance. The experience of those working on independent drug bulletins was that only a small percentage of newly approved drugs each year offered worthwhile advantages to patients over previously available options.

When judging whether a new intervention was a therapeutic advance, it was crucial to consider efficacy, safety and convenience. However, drug efficacy was generally tested by clinical trials whose design often left a lot to be desired. In addition, approval of a new drug by the regulatory bodies was not dependent on demonstrating superiority of the new product over existing treatments. Moreover, the safety profile of a new drug at the time of licensing was provisional and rare adverse effects could only be recognised when a large population had been exposed to the drug. The balance between safety and efficacy could, therefore, change with time and drugs needed to be continually re-evaluated. A genuine therapeutic innovation could not be measured at the time of a new drug launch, and it was important to realise that not every new drug was necessarily a genuine therapeutic advance for patients.

Hazards of early evidence

Dr MIKE CLARKE, of the UK Cochrane Centre, Oxford, emphasised that care needed to be taken not to act too rapidly on the basis of new research findings. A Cochrane methodology review bringing together cohorts of randomised trials had shown that trials with statistically significant positive results tended to be published a couple of years earlier than those with null or negative results. Thus, early results frequently gave an overly optimistic impression of the potential benefit from a particular treatment. For example, an early trial of liver infusion in patients with colorectal cancer had indicated an absolute benefit of 39 per cent, but this figure was reduced to 3 per cent in later studies.

The hazards of early evidence could be minimised by conducting well-designed, large scale, randomised controlled trials, systematic reviews and meta-analyses in areas that patients and health professionals wanted and needed. Moreover, there was a need to tell patients that the information in a newspaper article could well represent early findings that might be overstated.

Professor Joe Collier (editor, Drug and Therapeutics Bulletin) concluded the seminar by saying that the UK was slow in its uptake of new drugs compared with other countries, but that might be a good thing. However, there was a need to recognise that when there was a genuine therapeutic advance it needed to be implemented.