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NICE one NICE - What about the gap in affordability?

R K Mohindra   (13 August 2007)

NICE one NICE - What about the gap in affordability? 13 August 2007
R K Mohindra, Cardiology NE2 3NT Send response to journal: Re: NICE one NICE - What about the gap in affordability?	The National Institute of Clinical Excellence (NICE) has been bolstered by the recent Court decision in relation to Donepezil.1 The effect of all this is to leave NICE in a strong position to build a complete cost-effectiveness framework surrounding healthcare provided by the NHS. For example it is presently consulting on new guidance that would revise its previous guidance2 and declare the use of drug-eluting stents for coronary percutaneous intervention not cost-effective.3 Emboldened by this court decision it is unlikely to back down in the face of any counter -lobby. It is important to realise that NICE is simply another face of the Government. It was created by this Government in 1999.4 Under directions issued by the Secretary of State for Health NICE is empowered to provide guidance to the NHS.5 Initially NICE did not take affordability into account.6 But under current regulations when formulating guidance NICE must have regard, inter alia, to the “broad balance of clinical benefits and costs”. Under other directions7 issued by the Secretary of State for Health Primary Care Trusts and NHS Trusts must make available the treatments approved by the NICE guidance. Interestingly NICE has set a level of £20000 per QUALY below which treatments are normally assessed solely on a cost-effectiveness basis. Above this level the acceptability of use of NHS resources for the treatment becomes an increasingly relevant factor.8 Value judgements are implicit9 and abound. But whatever the arguments NICE recognises the existence of finite resources and its role in fairly distributing those resources.10 This together with the court decision means that explicit rationing is here and that it is here to stay. Where to now? The shadow cast by NICE decisions creates an affordability gap within healthcare provision in the NHS. This gap lies in the space between NICE approved treatments and clinically proven (i.e. evidence based) treatments. It is cast by NICE value judgements. Such value judgements may not be shared by individual patients. The argument of maximising the outcomes from a given resource is the justification for NICE based rationing. But in the affordability gap there is a case for permitting patient co-payments within the NHS. On this model the NHS would provide everyone with NICE approved treatments equally and free at the point of delivery. But patients could opt to pay a top up fee within their NHS care and receive non-NICE approved treatments that fell into the affordability gap. Such an approach would permit co-payments made by patients within the NHS to extend to situations where they could affect the choice of treatment actually delivered. But co-payments would only operate where the NHS promise of funding the best available care for all patients had already been broken. The justification for such an approach would be that of maximising outcomes from a given resource. If the co- payments only apply to evidence based treatments that would otherwise not be delivered outcomes would be improved for no extra cost to the NHS albeit within the NHS framework. If the price of improving outcomes is a bitter political pill to swallow then it should be considered by a Government that is introducing explicit rationing by NICE. Particularly if it believes that maximising outcomes is what healthcare is about. This case has been made explicitly for drug-eluting stents elsewhere.11 It’s strength will be revealed if we indeed find ourselves in receipt of NICE guidance declaring drug-eluting stents to lack cost- effectiveness. 1 Eisai Limited v The National Institute For Health And Clinical Excellence (NICE) [2007] EWHC 1941 2 NICE. Guidance on the use of coronary artery stents. Technology appraisal 71 Oct 2003 3 NICE. Appraisal Consultation Document. Drug-eluting stents for the treatment of coronary artery disease (part review of NICE technology appraisal guidance 71) 4 National Institute for Clinical Excellence (Establishment and Constitution) Order (SI 1999/220) 5 Directions and Consolidating Directions to the National Institute for Health and Clinical Excellence 2005 as amended by Directions to the National Institute for Health and Clinical Excellence 2007 6 Rawlins MD; Culyer AJ. National Institute for Clinical Excellence and its value judgments. BMJ 2004;329;224-227 7 Para 2 and 4 Directions to Primary Care Trusts and NHS Trusts in England (2003) concerning Arrangements for the Funding of Technology Appraisal Guidance from the National Institute for Clinical Excellence (NICE) made using powers granted to the secretary of State for Health under the National Service Act 1977. 8 para 6.2.6.10 National Institute of Clinical Excellence. Guide to the Methods of Technology Appraisal. (April 2004) 9 Although in the past (8 June 2005) the Education and Debate editorial committee of the BMJ did not regard NICE decisions as being best described as value judgements. Personal communication Timothy Delamonthe 10/06/2005. 10 Rawlins M, Dillon A. NICE discrimination. J Med Ethics 2005;31:683 -684 11 Mohindra RK, Hall, JA. Desmond's non-NICE choice: dilemmas from drug-eluting stents in the affordability gap. Clinical Ethics 2006;1(2):105-8(4) Competing interests: None declared