Donepezil: Nicely done NICE. What about the gap in affordability though?

The National Institute of Clinical Excellence (NICE) has been bolstered by a recent Court decision and is beginning to flex its powers of rationing. Dobbs J sitting in the English High Court heard an appeal by way of judicial review from a decision of the appeal committee of NICE.[1] In a 139 paragraph judgement given on 10^th August 2007 he decided that NICE:

1. had the power to issue guidance declaring the use of Donepezil (an anticholinesterase inhibitor that has proven benefits for patients suffering from Altzheimer’s disease) to lack cost-effectiveness in patients with mild to moderate disease and;
2. had not been irrational in its approach nor procedurally unfair in the way it had reached it’s decision.

The appellant (Eisai Limited) was merely a consultee in the process and had been treated appropriately by NICE during the evaluation process. NICE’s victory was not complete. It had a duty in relation to ensuring that its guidance complied with anti-discrimination laws. In its guidance as issued it had failed to completely discharge that duty because of its excessive reliance upon the ability of individual clinicians to deal with the clinical assessment of patients who suffered language problems or learning difficulties.

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 declaring the use of drug-eluting stents in the treatment of coronary artery disease not cost-effective. Emboldened by this court decision it is unlikely to back down in the face of any lobby supporting the continuing use of such stents within the NHS given funding constraints.

Interestingly NICE has set a level of £20000 per QUALY below which treatments normally be 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.[2] Value judgements abound[3] but whatever the arguments rationing is here, and here to stay. The beauty of doing it through NICE is that such rationing becomes transparent and arguably socially just (despite its vulnerability to pressure groups).

It is important to realise that NICE is simply another face of the Government. NICE 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] Under these regulations in formulating such guidance NICE must have regard, inter alia, to the “broad balance of clinical benefits and costs”. Under other directions[6] issued by the Secretary of State for Health Primary Care Trusts and NHS Trusts must make available the treatments approved by the NICE guidance.

The transformation of rationing by queuing to rationing by restricting the scope of treatment is the net result of Labour policy. It lies in the hands of the Secretary of State for Health to alter the guidance issued to NICE. But radical changes seems unlikely to occur. Labour needs to face the electorate with open hands and admit what it has done.

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:

1. NICE approved treatments. Such treatments must be funded within the NHS. And;
2. those treatments that NICE deems to lack cost-effectiveness yet have been clinically proven to be effective (i.e. possess a firm evidence base for their efficacy). Such treatments do not have to be funded within the NHS.

There is a third class of treatments that lack an evidence based provingtheir efficacy. We will ignore these save to observe that NICE should discriminate ineffective treatments from those that are not cost-effective.

NICE creates the affordability gap by making value judgements. When NICE declares that a particular treatment is not cost effective it is in effect saying that from the perspective of the paying authority, ie. the NHS, the price of such treatments is not worth the cost. The problem is that this perspective may not be shared by the individual patient. The individual patient who falls into the affordability gap is left in a position where they are denied an evidence based treatment on the basis that a third party payer has not valued it highly enough.

Moreover the only way in which this patient can receive such a treatment is by receiving the full treatment pivately. There is no provision for mixing private care and NHS care within the current NHS structure.

Co-payments in the affordability gap

There is a coherent case to be made for changing the situation to permit patients to make top up co-payments and receive NICE non-approved treatments within the context of their NHS care.

Such an approach would break the taboo of no payment by patients at the point of care where such payments might affect the choice of treatment. But co-payments could only validly operate where the covenant of funding the best available care for all patients had already been broken by this Government. If this covenant had not been broken there would be no affordability gap and no case to be made for co-payments.

Inequality

Any equality would only be manifest in the affordability gap. The wider the Government permits this gap to be the wider greater the inequlaities that would arise. The delivery of NICE approved treatments would continue to be equally available to all being centrally funded throughout the NHS. To this extent the principle of social justice would still be served.

The argument justifying any arising inequality rests on the the argument that outcomes should be maximised for a given resource. Mobilising personal assets to fill the affordability gap would not increase NHS spending but would improve outcomes.

This same maximising arguement is the justification for NICE based rationing. It is only fair that if outcomes can be further improved by co-payments in the affordability gap the Government must accept this argument. That is if it truly believes that maximising outcomes is what healthcare is about.

There is particularly a case for this reasoning to apply to drug-eluting stents.[7]

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[1]Eisai Limited v The National Institute For Health And Clinical Excellence (NICE) [2007] EWHC 1941

[2] para 6.2.6.10 National Institute of Clinical Excellence. Guide to the Methods of Technology Appraisal. (April 2004)

[3] Although in the past (8 June 2005) the Education and Debate editorial committee of the BMJ have not regarded NICE decisions as being best described as value judgements. Personal communication Timothy Delamonthe 10/06/2005.

[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] 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.

[7] 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)

(c) R Mohindra