Successful role of PPRS defended.
UK MPs have been told that the National Institute for Health and Clinical Excellence (NICE) should have the same powers as the UK licensing authority, because their respective decisions are of equal importance. MPs also heard evidence from the Office of Health Economics about the Pharmaceutical Price Regulation Scheme's success in containing product pricing.
According to a 12 October report by The PharmaTimes, the fact that NICE cannot demand to see all the evidence relating to a medicine, in the same way that the regulator can, "represents a source of frustration." Karl Claxton, Professor of economics at York University and a member of NICE's appraisal committee, told the House of Commons Health Select Committee's continuing inquiry into NICE that while NICE can ask manufacturers to conduct data analyses on their products, NICE cannot then have these checked independently.
A further source of frustration, discussed by Prof Claxton, is that NICE is only able to issue guidance relating to a product's licensed indications, even when the medicine is routinely used throughout the National Health Service for unlicensed indications. It cannot make statements about unlicensed use as to do so would undermine the licensing authority. Therefore, there is a danger of NICE guidance being irrelevant for much of NHS practice, he warned.
Criticising the quality and relevance of clinical trial data, as currently submitted by manufacturers to NICE in support of their products, Claxton proposed a move away from the Pharmaceutical Price Regulation Scheme's profit and price controls towards a value-based pricing (VBP) system, as suggested in the Office of Fair Trading's report on the PPRS, thereby providing incentives for companies to make the necessary improvements.
Price regulation vs value for money
Giving evidence to MPs, Adrian Towse, director of the UK industry-backed Office of Health Economics, saw the main challenge identified by the OFT report – assuring value for money for the NHS – as the function of NICE, not the PPRS. Price does not necessarily reflect a product's value. The aim of the PPRS, which he asserted had been very successful, is to keep the UK medicines bill under control for the government so that aggregate prices, and company profits, are not too high. Towse saw a NICE assessment as "incredibly important" for the worldwide success of a drug.
The UK accounts for about 4% of global demand for pharmaceuticals, while other countries, representing a further 25% of world sales, set their own prices with reference to the UK. Nothing in the OFT report would help speed the uptake of new medicines. The industry was uneasy with the idea of their products' prices being set by the government. That would be an area of uncertainty never before seen in the UK, Towse warned.
About NICE
NICE is considered as among the foremost bodies for cost effectiveness assessment in major pharmaceutical markets. As NICE has had an increasing impact on the availability of new drugs in England and Wales, it has also generated considerable attention globally. NICE plays a key role in the UK healthcare system although it does not currently assess all new drug approvals. The impact of NICE is felt outside the UK as organisations and individual physicians in other countries also monitor its conclusions. Cancer drugs have accounted for the largest number of NICE's completed assessments.
Keywords : National Institute for Health and Clinical Excellence (NICE), Health Economics, Pharmaceuticl Price Regulation Scheme (PPRS), Cost effectiveness, Availability of new medicines
