Pharmaceutical manufacturers can help the National Institute for Clinical Excellence (NICE) speed up its appraisal of new medicines by providing it with the right information at the right time, NICE’s chairman, Professor Sir Michael Rawlins, told a meeting organised in London by PharmaTimes this week.

The Institute is setting up a scientific advisory service, along the lines of those provided by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA), to help companies provide the appropriate data packages in support of their products, he said. Following a “very successful” pilot study conducted with Swiss-based drugmaker Novartis, the service will now be rolled out industry-wide. Sir Michael stressed that NICE will charge companies for this service – “we’re not in cahoots with the industry,” he said – and if a “problem of perception” does develop, the Institute will have to deal with it. Nevertheless, he said, the service will be beneficial to everyone.

Dr David Brickwood, vice president for international government affairs, Europe, at Johnson & Johnson, agreed that this was “a step in the right direction,” but warned that NICE should not expect all the evidence for a product to be available at its launch.

The meeting was held to discuss the government’s response to the report of the latest parliamentary inquiry into NICE, published by the House of Commons Health Select Committee on January 10. The Institute’s influence extends far beyond the UK - it is still “the tallest kid in the playground” - and we now need to be improving its processes, but the government has been “rather complacent” in not endorsing some of the Members of Parliament’s (MPs) recommendations,, said Jim Furniss, a former head of the Department of Health’s Pharmaceutical Industry Branch (PIB).

Mr Furniss, who is now director of pricing and reimbursement at consultancy Bridgehead International, also criticised the government for failing to address the issue of how NICE guidances will be financed in the future. The National Health Service (NHS) has seen high levels of spending growth over the last 10 years but for the next few years this will no longer be the case, and there will be much less money to spend on upcoming technological advances, he said.

He did welcome the government’s acceptance of the MPs’ call for the assessment of the costs and benefits of individual treatments to be widened to include the cost of caring and of unemployment caused by illness. The industry would support any move to take account of wider societal costs, said Dr Brickwood, but NICE’s chairman, Professor Sir Michael Rawlins, warned of the risk of possible unintended consequences, in that an emphasis on employment could potentially disadvantage those people who are not, or no longer, economically active.

Dr Andrew Walker, economics reviewer at the Scottish Medicines Consortium (SMC), was also concerned at the implications of this proposal. He asked: once you start redrawing the boundaries, where do you stop?

The Select Committee’s chairman, Kevin Barron MP, said that the culture within the NHS is changing because of NICE, albeit slowly. He added that, once NICE has decided that a treatment should be provided on the NHS, it was “fundamentally” wrong for Primary Care Trusts (PCTs) to then make their own decisions on its availability. This leads to post-code prescribing, he warned.

PCTs are already applying different, and lower, cost-per-Quality-Adjusted Life Year (QALY) thresholds to those applied by NICE, Mr Furniss agreed, and Sir Michael said he is looking forward to patients taking a PCT to court for failing to implement NICE guidance; so far, Trusts have always backed down before such threats have reached the courts.

The robustness of NICE’s decisions and the potential for challenge are crucial issues, the meeting heard. Sir Michael said he was very unhappy with the Select Committee’s recommendation that NICE should conduct fast, “rough and ready” appraisals of all new medicines at launch, and at a lower cost-per-QALY than it applies to its full appraisals now, The Institute’s reputation rests on its robust appraisals, and adopting this path would leave it wide open to judiciary review, he warned.

Mr Barron also warned of the potential for legal challenge with government/company risk-sharing schemes, which the Committee report has recommend said should be used only with caution. While such schemes may sound wonderful, “it is more likely to be a barrister, rather than a doctor or patient, who tells you whether the drug works or not,” he said.

The Select Committee’s recommendation that the QALY threshold should be set by an outside, independent body rather than NICE was “fine,” said Sir Michael, but he added that this entity must have responsibility throughout the NHS and not just cover NICE appraisals. It must also have the flexibility to be able to spend more when necessary.

The cost-per-QALY threshold has no empirical basis - it is a political decision, said Dr Walker, and, if some people believe that the current average of around £20,000 per year is too low, while others think it is too high, then perhaps it’s about right.

He acknowledged however, that QALY measurement may not be sufficiently sensitive, for example in assessing contraceptives or treatments for short-term acute pain, but the SMC likes the QALY because it provides consistency across very different decisions, he said. The Consortium’s advice to companies is that: “we want QALYS, unless you think they’re inappropriate,” he said.

The industry regards the QALY as “a tool, not a rule,” said Dr Brickwood and, while the view in the UK is that it is “the only game in town,” other countries make no use of the measure at all. So, he asked, is it right to use the QALY for everything?

Further coverage of the meeting will appear in the next issue of PharmaTimes magazine.