This is just one more example of the growing financial pressure on the NHS. It has big implications for how far the service will stay abreast of cutting edge, if sometimes only incremental, advances in medical technology in general, and pharmaceuticals in particular. This is a big issue.
It has come to a head because over the past year or two, as the money has got ever tighter, NHS England has held back on implementing a small number of recommendations from the National Institute of Health and Care Excellence – despite the theory that the service, certain circumstances excepted, should implement all the cost-effective treatments that NICE recommends within 90 days.
So, for example, there was a delay in funding new treatments for hepatitis C because of their cost, despite NICE concluding that the treatments are cost effective. There is the on-going legal dispute about whether the NHS or local authorities should fund PrEP – the HIV pre-exposure prophylactic drug.
Once upon a time, this was not an issue. NICE was launched in 1999 shortly before the NHS entered the longest sustained period of real-terms spending growth in its history. NICE’s recommendations – despite ruling out some new treatments as insufficiently cost effective – added to NHS spending. But, the odd very minor hiccup aside, that could be afforded. And furthermore, if the question were ever to arise, a formal position had been taken that NICE would make its recommendations on cost effectiveness unsullied by the question of whether the NHS could afford a particular decision. Should this ever become an issue it would be reserved to ministers. They, not NICE, would decide whether the NHS could afford it. Up until recently, however, and with the exception of a higher value being given to ’end-of-life’ treatments after 2009, the issue has not arisen. Now, it is here in spades.
The answer, according to a joint consultation document from NHS England and NICE, is that from April next year if a recommendation is going to cost the NHS £20 million or more a year in any of its first three years, NICE will ’signal the need for a commercial agreement between the company and NHS England’. In other words, presumably, NHS England will seek to negotiate a lower price. If the company lowers its price sufficiently, the new technology – chiefly drugs – will be adopted. Where that can’t be agreed, NHS England may ask NICE to propose a longer period than the standard 90-day adoption for new treatments. In other words, NICE will recommend how quickly or slowly it can be adopted ‘without causing disruption to other services’.
In ways that are not made entirely clear in the consultation document, this will somehow sit alongside ‘patient access schemes’. Under these, where a drug is too expensive to be judged cost effective by NICE, the company can negotiate some form of discount – usually an undisclosed price cut – with the Department of Health so that patients do get the treatment. There are some 80 of these in existence.
This new proposal sounds a bit like that – but for cases where a sufficiently lower price cannot be agreed for something that NICE has already judged to be cost effective. Patients will get access, but only partially and slowly – with the judgement of how quickly that will happen certain to vary case by case and depending on criteria that are not clear.
This raises a whole bunch of important questions, many of which cannot be answered in the few days since the consultation was published. Why £20 million? Why not £10 million or £100 million?
More importantly, should NICE be involved in this way? To many in the pharmaceutical industry and to many of the academics and others involved in NICE’s appraisal committees, keeping the assessment of cost effectiveness separate from the question of affordability has been an important principle. It keeps the ‘science’ of cost effectiveness assessment pure. Affordability is a different question and there may well be risks in muddling the two – and under these proposals it will be NICE recommending how fast something should be adopted to be ‘affordable’. Should that purity – that NICE neither negotiates price nor judges affordability – be maintained?
And should affordability really be a question for either NICE or NHS England? Under the original set-up, affordability was reserved to ministers but somehow, silently, seems to have been transferred to NHS England under the Lansley reforms. But there is a case that what is ‘affordable’ in cases like this – how far should the NHS stay at the cutting edge of expensive technologies? – is in fact a political question, not a managerial one for the commissioning board (NHS England), or one to be handed over, in part at least, to a quango (NICE) set up for an entirely different purpose.
These are key issues that need to be thoroughly and widely debated over the next few weeks. Let there be no doubt what this is about. It is an admission by two NHS bodies that in the current financial circumstances the service will no longer stay abreast of advances in medical technology to the degree that it has been able to over the better part of the past two decades. The implications for patients are obvious. Should why that is the case – and what should be done about it – be an issue for ministers, not managers?