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The Maynard Doctrine: Time for NICE to get nastier

Professor Alan Maynard OBE celebrates his ascension into the pantheon of the British Empire with a typically pro-Establishment disquisition on the need for NICE to get nastier in the recessionary climate for 2009.

The NHS faces a profound financial “squeeze” due to the global recession and the British Government’s attempts to mitigate the products of lax regulation of the financial sector.

At the same time as the funding capacity of the NHS is being challenged, there are two significant sources of increased demand for care: the elderly, and technological change.

The former is triumph of the post-war Welfare State. Successive cohorts of the elderly are living longer, better-quality lives. However, there seems to be little evidence of any compression of morbidity in the last years of life; and as a consequence the elderly appear to be requiring increased levels of funding.

The other significant source of cost inflation is the technology appraisals of the national institute for Health and Clinical Excellence - NI(H)CE. The inflationary impact of NICE since 1999 is approximately £2 billion. On average, full NICE appraisals take two years and cost £250,000 each. Inevitably, this has meant that the evaluation of new treatments have been selective - giving rise to patient challenges to PCTs.

A SIGN of wasteful duplication
In Scotland, the Scottish Medicines Consortium has appraised all new technologies within six months and offers advice (as opposed to mandatory “guidance” from NICE) to the Health Boards that make investment decisions. Comparing the products of the swift SMC and the slower and more expensive NICE appraisals shows that their decisions are remarkably similar (House Of Commons Health Select Committee 2008).

’Why should the English, Welsh and Irish taxpayers pay more for NICE when their NHS decision-makers could use the SMC advice at no extra cost?

Investment in NICE is now to be increased considerably, so that it can do appraisals swiftly like the SMC. The nice (and NICE) issue is why should the English, Welsh and Irish taxpayers pay more for NICE when their NHS decision-makers could use the SMC advice at no extra cost? This duplication of effort is as remarkable as it is wasteful.

At the same time as NICE is getting more investment, there is increased interest in the financial cut-off point. Since 1999 NICE has used a cut off of approximately £30,000 per quality-adjusted life year (QALY). In practice, this has meant that any new technology with a cost per QALY less than £20,000 was easily approved and those with a cost per QALY between £20,000 and £30,000 usually got approved after discussion. Often such approvals are for limited sub-sets of patients; and can be the product of optimistic reading of often poor clinical evidence provided by the drug companies.

Individuals in NICE have indicated that this cut-off be index linked i.e. related to cost inflation in the NHS. Now in response to political, industry and patient pressure throughout 2008, there is to be a higher and more generous cut off for “end of life “ technologies; where end of life seems to be defined as the last two years of life.

The difficulties of defining this concept and applying it to rare diseases will be considerable. The nice (and NICE) issue is that this decision to ignore the efficiency rule and apply an arbitrary equity value judgement is inherently unfair for those not in the last two years of life.

Since 1999 NICE has kept to the cost-QALY rule, and not used any sort of equity weighting as they deemed it both contentious and difficult to devise. Now this position is to be abandoned. However, the more obvious solution would be to aggressively reduce the prices of products whose clinical effectiveness is limited according to evidence from company trials.

The inevitable debate which this will produce will divert attention from another crucial issue: the need to use appraisal technology to eliminate existing products that are not cost-effective. The NHS financial crisis requires NICE to pay much more attention to marginal technologies already being used in the NHS, as their elimination will free resources to provide better patient care.

Three New Year’s Resolutions for NICE
NICE enters 2009 needing to confront three issues.

Firstly, the need for it to become nastier. Instead of making it easier for technologies to be used in the NHS, it should lower the cut-off – to, for instance, somewhere at or below £20,000 per QALY.

Secondly instead of playing poker with NHS resources and raising the cut-off for end-of-life technologies to circa £70,000 per QALY, it should use the same modest and prudent cut-off for all technologies (e.g. £20,000 per QALY), and works much harder to acquire a price setting role to turn back the greed of pharmaceutical companies marketing marginally-beneficial products.

Finally, as advocated since before the birth of NICE, the Government should require it to provide guidance about removing existing, marginal products from the NHS. This is urgently required to free up resources to treat increased patient demand in a period of what will be considerable parsimony.

House of Commons Health Select Committee (2008). The National Institute for Health and Clinical Excellence, House of Commons, HC-27-4, January, 2008.