NICE's early recommendation that relapsed multiple myeloma patients can receive bortezomib (Velcade) on the NHS - provided the manufacturer refunds the cost if the drug does not work - comes at a time of unprecedented scrutiny for the institute.
NICE is under examination until the autumn by the House of Commons Health Select Committee. It also faces a judicial review, on 25 June, when drugmakers Eisai and Pfizer, with the Alzheimer's Society as an interested party, challenge its recommendation to debar access to the cholinesterase inhibitor donezepil (Aricept) to patients with newly diagnosed mild Alzheimer's.
The draft bortezomib recommendation - that drugmaker Janssen-Cilag refund the NHS if patients' serum M-protein reduces by less than 50 per cent after four treatment cycles - has been welcomed in primary care.
Dr Jim Kennedy, RCGP prescribing spokesman, said: 'A lot of people in the NHS, especially GPs who do 90 per cent of the prescribing, will be interested in looking at outcome-based payments rather than inputs.'
The timing has set tongues wagging with accusations that NICE is bowing to its vocal critics.
It vehemently denies the charge, and Janssen-Cilag insists the refund scheme is 'entirely our idea'.
Doubts over processes
But, bortezomib aside, even NICE's supporters have doubts about its processes.
Dr Kennedy said: 'There are concerns about the level at which NICE sets its barrier for cost-effectiveness, and concerns about evidence.
'It takes evidence from randomised controlled trials but these are not possible for some interventions, especially in primary care.'
Richard Ley, from the Association of the British Pharmaceutical Industry (ABPI), agreed. 'The health technology assessment system that NICE uses is not flexible enough,' he said.
'Basing judgements on quality-adjusted life-years (QALYs) doesn't take enough into account.
'NICE does not look at whether a medicine has enabled someone to leave hospital and go home. It doesn't examine whether a medicine has reduced a patient's dependence on a carer.'
At the High Court this month, the Alzheimer's Society will argue that NICE has failed to evaluate the benefit of donezepil to carers, whose care time can be shortened by 90 minutes a day and, at £350 a week, has underestimated the true cost of full-time care.
NICE assesses value for money as an incremental cost-effectiveness ratio (ICER), measured as cost/QALY per patient. It then ranks ICERs into three tiers: less than £20,000; £20-30,000; and more than £30,000.
It has admitted to the Health Select Committee that it is reviewing the way it conducts technical appraisals, focusing on areas that have been questioned and those where methods have evolved in the past three years.
So is it on the back foot?
Absolutely not, said Professor Peter Littlejohns, NICE's clinical and public health director: 'Reviews of our technical manuals are conducted in a regular cycle and have nothing to do with the judicial review.'
It is also reviewing how it reaches the social value judgments that underpin its guidance. But this, said Professor Littlejohns, is to ensure NICE covers public health, its new area of responsibility.
NICE has denied to the Select Committee that its decisions are increasingly being challenged, denied that its decisions disadvantage the elderly, denied that it reaches judgements too slowly and rejected an intimation of cronyism on its appeal panels.
'NICE guidance is sometimes uncomfortable and on occasions controversial,' it has told the Committee.
Whether it is sometimes ill-founded is what the High Court and Select Committee will soon be deciding.
Crucial dates for NICE:
- 25 June 2007: Judicial review at London's High Court - NICE versus manufacturers Eisai and Pfizer, with the Alzheimer's Society as an interested party.
- Autumn 2007: Conclusion of examination of NICE by the Commons Health Select Committee.