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New look NICE

NICE's reach is set to expand, its budget will grow and it is poised to start generating its own income

Cartoon image of Mr Nice from the Mr Men series At this year's NICE Christmas party, it seems unlikely that the senior team will reminisce fondly about the year gone by. In truth, it has been an annus horribilis for the National Institute for Health and Clinical Excellence (NICE).

Only a week into 2008, the Health Select Committee produced its comprehensive report on the work of the institute, highlighting concerns with the evaluation process, the affordability of guidance and its implementation. NICE has also been drawn into debates over co-payments and its internal review of the quality-adjusted life year (QALY) threshold has been preceded by – probably fair – public doubt over the legitimacy of the £30,000 figure.

The storm hit in the summer. In August, NICE ruled that four drugs for kidney cancer were not cost-effective for NHS use. The decision caused a wave of negative publicity and protest; kidney cancer patients and their families stormed the lobby of the agency's Holborn headquarters protesting their "right to life".

Since then, an eminent oncology professor writing in the national press has referred to the "bloodstained portals of the National Institute for Health and Clinical Excellence", a spat between the ABPI and NICE played out very publicly in the newspapers and Her Majesty's Opposition has claimed the institute fritters away £1m a year on 'spin'.

Major changes
In its report, the Health Select Committee noted that: 'In the past, NICE has changed in response to new challenges, and we are sure it can do so again.' With challenges this great, it seems the change may be considerable. Over the next three years, we will see a major expansion of the role, responsibilities and reach of NICE with a remit to provide advice to patients, staff, companies and national governments in new ways. The institute's budget will grow, but so will its ability to generate income through the provision of consultancy services.

Largely eclipsed by the controversy over NICE's decision on kidney cancer drugs, Lord Darzi's Next Stage Review signalled a wholesale reassessment of the institute's role, the implications of which have been generally underestimated by those who noted it.

Darzi's vision
Under Darzi's direction, NICE will expand the reach and number of national standards. In response to frustration from patient groups and clinicians, we will also see a more rapid appraisal process. Darzi outlined his expectation that NICE will issue the majority of its appraisals of new drugs within "a few months of a drug's launch". If this vision is to become a reality, NICE will have to begin its appraisals well before launch. This will require far closer working with pharmaceutical companies during the development process.

Lord Darzi also laid out his plans for a web-based portal – NHS Evidence – containing detailed information for frontline NHS staff on clinical evidence and best practice. The site will be managed and maintained by NICE, which will develop a kitemark system to flag independently verified health information. Importantly, it will also be available to patients.

Some 80 per cent of internet users have searched online for information about a specific disease, medical problem, prescription drug or other health-related topic. Among users who say their search had any kind of impact, 58 per cent say the information they found affected a decision about how to treat an illness or condition.

This kind of impact, and the glut of health information on the internet, means it is essential for patients to ensure that the information they are accessing is of a high quality. Some websites peddle 'snake oil' and much information is so partial or inaccurate as to be dangerous. The NHS Evidence kitemark system provides an ideal opportunity to democratise access to healthcare and ensure that patients are able to access high-quality clinical information.

Introducing co-payments
With more patients likely to be purchasing directly medicines that are not available on the NHS, such information will be even more important. At the time of writing, the Secretary of State for Health, Alan Johnson, is widely expected to confirm that NHS patients are to be allowed to 'top-up' their care by paying privately for drugs that have been recommended by their consultant but are not funded by an NHS Trust.

To date, many Trusts have told patients they would forfeit their NHS treatment if they took the decision to fund the purchase of drugs themselves.

Johnson will no doubt seek a solution that will not lead to an apparent two-tier health system. The introduction of co-payments will remove some of the pressure from NICE and will mean it faces less exposure to life and death decisions. The announcement will also create the need to ensure that patients in difficult circumstances are able to make informed decisions about their treatment with access to the most comprehensive information.

Without referring to any practical arrangements, Andrew Dillon, NICE chief executive, has already indicated in this publication (PM, October 2008) the organisation's willingness to play its part. "We're in a good position to make sure patients who may want to consider making a co-payment are able to make that decision with all the information available to them". Of course, such a public demonstration of NICE's value to patients could do much to improve its reputation.

Quoted elsewhere, Dillon has suggested that the scale of the expansion in NICE's remit will require its budget to be tripled over four years. With a slowdown in health spending, efficiency drives and the impact of a recession, this is a tall order.

Indeed, NICE's £30m a year budget and the proportion spent on communications has already been the subject of one flawed attack by the Conservatives (the communications budget is largely used for informing GPs about new guidelines, not promotional activity). Regardless, it is clear that NICE will require greater funds simply in order to keep pace. The need to produce, and then review, guidelines will continue to create a snowball of work.

In 2010, the number of guidelines will reach 120 and it is difficult to see how NICE can be responsible for producing more new guidelines of the same quality while comprehensively reviewing its existing guidelines.

Catalysts for change
Current NICE chairman, Professor Sir Michael Rawlins, will be stepping down next year and, following the recent government reshuffle, Lord Darzi was given ministerial responsibility for NICE. A new chairman and fresh ministerial direction may well create a catalyst for change and inject new interest in tackling pressing problems and grasping some of the most interesting opportunities at NICE.

One such opportunity, which is likely to see rapid growth, is in the provision of consultancy services by NICE. This promises an attractive source of significant income. The plan is to focus initially on the provision of services to foreign governments. NICE has already formed a small division, with staff on mid-term contracts, and is looking to appoint external experts, individuals and organisations. It has secured a small grant from the Department for International Development for work in Ghana, Colombia and Jordan where tailored projects will aim to improve access to medicines and increase transparency in decision-making.

NICE is also in preliminary discussions with other low and middle income countries, including Turkey.

An additional strand of the institute's consultancy services due for rapid expansion is the provision of scientific advice to companies seeking to tap into NICE's experience in health technology assessments (HTAs). It is expected that the first meetings with corporate clients will take place before the end of the year with more than a dozen contracts signed before March 2009.

NICE has already run a trial with Novartis to assess how advice on design and conduct of pre-marketing trials might be mutually beneficial. The intention would seem to be to offer this service to all companies on a chargeable basis. With obvious benefits in terms of improving trials, results and approval, there is likely to be no shortage of interest from the commercial sector.

Risk-sharing
Risk-sharing on the funding of medicines is nothing new. Despite there still being doubts over its viability, it is undergoing something of a renaissance. It is likely that this will be another area where NICE and industry will work more closely together in the future.

The latest risk-sharing arrangement ensured the provision of Lucentis to patients with wet age-related macular degeneration. Under the deal, the NHS will pay for up to 14 Lucentis injections in each eye, starting with each patient's first affected eye. NICE's initial assessment of the treatment found in favour of treating only the better-seeing eye once both eyes had been affected, but later draft versions of the guidance were amended after angry responses from patients and stakeholders.

The new guidance rests on a dose-capping agreement between Novartis (the manufacturer of Lucentis) and the Department of Health, under which the company will pay the drug cost of treating patients who require more than 14 injections. It follows a small number of similar agreements, including one between the NHS and J&J for the supply of Velcade.

Risk-sharing may increase patient access to drugs but it is also potentially complex, with an administration and auditing burden. Some of this burden may well fall to NICE to manage and it will play an important part in establishing the possibilities and parameters of such deals.

Value-based pricing
Looking further ahead, NICE is also likely to play a central role in any move to introduce value-based pricing; a system which would pay pharmaceutical companies on the clinical benefits of their drugs. The Office of Fair Trading (OFT) has strongly recommended such a scheme, calculating that a value-based scheme could release in the region of £500m per year. Over time, the OFT has said, value-based pricing would also provide companies with stronger incentives to invest in drugs for those medical conditions where there is greatest patient need.

Under the OFT scenario there would be a need for a credible institution to carry out cost-effectiveness assessments. The OFT is clear that, at least in the short term, it expects that NICE would play a major role.

The Shadow Secretary of State for Health, Andrew Lansley, has come out strongly in favour of a system of value-based pricing. While he would be unlikely to overturn the current PPRS if he made it into the Department.

The Author
Richard Robinson is an account director, healthcare public affairs at Fleishman-Hillard

5th December 2008

From: Healthcare

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