The Pharmaceutical Journal
Vol 269 No 7228 p861
14 December 2002

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National Institute for Clinical Excellence summary

Appraising drugs immediately after launch

The National Institute for Clinical Excellence is increasingly likely to appraise new drugs at the time of their launch, although lack of data could hamper this move.

Professor Alasdair Breckenridge, chairman of the Committee on Safety of Medicines and recently appointed chairman-designate of the new Medicines and Healthcare Products Regulatory Agency (PJ, 7 December, p801) highlighted the lack of information on effectiveness and cost effectiveness available on new drugs at the time of their launch.

Speaking to delegates attending a seminar at the NICE conference, Professor Breckenridge said NICE would expect to see data comparing the new drug with an established therapy, rather than a placebo. In addition, exposure should be in the general population and the duration of the study would be expected to be longer than that of a clinical trial.

As an example, he said: "While one would accept tumour shrinkage in licensing, changes in life expectancy would be desirable for effectiveness." Professor Breckenridge added that there were a number of options that could address this.

One of these would be for NICE to delay appraisal until appropriate data had accrued, which would satisfy the pharmaceutical manufacturers, but would almost certainly not satisfy ministers. A second option would be to make such data a requirement of the licensing procedure, where companies would need to give a commitment to undertake randomised control trials specifically looking at effectiveness. Mathematically modelling phase III trial data to estimate effectiveness and cost effectiveness could also be investigated and this is something that NICE is interested in.

Lastly, Professor Breckenridge mentioned observational databases, such as the prescription event monitoring scheme based at Southampton. "Up until now, they have been used to look at problems of safety, but could we use them for efficacy as well? It is something worth looking at," he said.