The Scottish Medicines Consortium (SMC) was established in 2001 as a consortium of NHSScotland’s 14 Health Boards to provide them with a single source of advice about the value of each new medicine and the patients who would most benefit. The SMC is, to a large degree, a counterpart to the National Institute for Health and Clinical Excellence (NICE), which was established as an agency of the National Health Service (NHS) in 1997. Both agencies were established at a time when vast numbers of new drugs were becoming available to address concerns about the best use of resources and to tackle wide local variations in commissioning practices leading to a situation dubbed as a ‘postcode lottery’, whereby patients’ addresses determine access to particular treatments.

Both the SMC and NICE base their recommendations on a review of evidence of clinical and cost effectiveness for a particular medicine. Whilst there are significant differences in the way in which they operate, many of the underlying issues and themes in the debate about access to modern medicines are common to both the situation in Scotland and that in England and Wales. One of the major differences between the SMC and NICE is the length of time taken to make a recommendation about a new medicine [Ref: Scotsman]. In about ninety percent of cases the SMC reach a recommendation within four months of a drug becoming available, compared to 12-14 months for NICE whose processes involve a longer period of analysis and several rounds of consultation. However, both organisations are confronted with intensely difficult decisions to make about which new, but expensive, drugs to recommend and both have been dogged by controversy [Ref: Scotsman].

Can we put a price on life?
As with NICE, a key task for the SMC is to provide guidance as to whether a new treatment is better than current standard practice. One of the tools both organisations use in this decision making process is the ‘cost per quality adjusted life year’ (or QALY) compared to the existing standard treatment. Whilst neither organisation officially stipulates a cost per QALY threshold, it is widely understood that when the cost of a technology falls below £20,000 per QALY cost is unlikely to be an issue. When costs go above this level the justification for recommending the technology needs to be very strong and recommendations for treatments costing in excess of £30,000 per QALY are very rare.

Many commentators, including those that are sympathetic to the task of the SMC, have questioned the integrity of such cost assessments, asking, for example: ‘How can you quantify the improvements in the life of a carer if a dementia patient gets a drug that slows their deterioration?’ Similarly, critics of NICE argue that the figures used for determining cost effectiveness are plucked out of thin air and lack scientific credibility [Ref: Independent]. Recent research coming out of the University of Newcastle and elsewhere finds that the public values life far more highly than NICE – between £35,000 and £70,000 a year [Ref: Northern Echo]. A particular point of contention has been the question of how we value treatments that extend the lives of terminally ill patients by months. In Scotland, the recent case of Michael Gray who submitted a public petition to the Scottish Government to secure funding for a bowel cancer treatment caught the media attention and generated much sympathy for patients desperate for ‘end of life’ treatments [Ref: Herald]. NICE has recently announced that it will allow greater flexibility in the recommendations that can be made about the use of end of life treatments.

As an indication that the SMC and NICE are placing too stringent hurdles in front of new drugs, a serious complaint has been made that the UK lags behind other comparable countries in its uptake of new drug treatments. According to the Association of the British Pharmaceutical Industry (ABPI), the trade organisation for drug manufacturers, an extra investment of £403m a year is needed for the UK to achieve the existing average per capita expenditure on cancer medicines in comparable European countries [Ref: Scotsman]. There have also been wide discussions about the sharing out of drugs. But, concerned about rising drug bills, other governments have expressed an interest in learning from the work of NICE [Ref: NY Times]. With a limited NHS budget, it is argued that some patients are bound to lose out and therefore tough decisions have to be made.

Drug rationing is a necessary evil?
Whilst NICE rejects the idea that it is in the business of rationing drugs, and points out that questions of affordability are for government only, it is widely regarded as playing a role in helping to control the growth of NHS expenditure on drugs. Indeed, a recent House of Commons Health Select Committee Report on NICE argues that drug rationing in the NHS is essential [Ref: Parliament], suggesting that there should be calls for more appraisal, not less, by NICE [Ref: Guardian]. From 2002 the NHS was put under a duty to provide funding to cover NICE recommendations and NICE point out that their recommendations have lead to around an additional £2 billion pounds of drugs expenditure on the NHS.

In Scotland, Dr Ken Paterson, the chairman of the SMC, has also sought to put patients’ expectations into perspective, reportedly arguing that it is unrealistic to expect the NHS to fund new drugs costing tens of thousands of pounds that only prolong life by a few weeks or months [Ref: Scotland on Sunday]. Breakthrough Breast Cancer has challenged this statement, arguing that drug costs in Scotland are a modest part of the total cancer care budget [Ref: Scotland on Sunday]. Paterson has also, controversially, raised the question of whether the latest medicines should be prioritised for younger patients over the elderly when hard decisions have to be made [Ref: Herald]. Additionally, he has suggested some pharmaceutical companies deliberately over-emphasise the benefits of their drugs [Ref: Scotland on Sunday]. The chairman of NICE, Professor Sir Michael Rawlins, has lambasted the pharmaceutical industry for overpricing vital new medicines to boost profits [Ref: Guardian]. In the interview Rawlins warns of perverse incentives for pharmaceutical company executives to hike the prices of new drugs to help maintain high profits as they enter a period where a lot of their big earning drugs are coming off patent.

Deterring innovation or a counter to special pleading?
According to the ABPI the current situation deters innovation and undermines patient access to modern medicines, especially in the case of rare diseases with small target populations [Ref: ABPI]. Andy Powrie-Smith, Director of ABPI Scotland, argues that ‘Scotland needs to be seen as a place that fosters innovation’ and that this involves supporting ‘the innovation of new drugs by giving them to patients’ [Ref: Herald]. The SMC and NICE counter [Ref: NICE] that the promise of new treatments is a factor they consider when deciding whether the high cost of a new drug justifies its use within the NHS [Ref: BMJ]. Others have criticised the relationship between drugs companies and patient advocacy groups, implying that the funds that drug companies provide to patient groups area tacit way of exerting high profile moral pressure on the SMC to recommend their expensive new drugs [Ref: Independent]. Anne Johnstone, the respected Scottish commentator, has recently questioned whether it is a case of ‘Those who shout loudest seem to get what they want’ and warned that cancer, with its well-organised and predominantly middle-class lobby, is ‘grabbing more and more NHS money and attention’ [Ref: Herald]. The ABPI counter that there are strong codes of conduct governing such donations within the industry and that the relationship is a transparent one.

Who decides?
However, whilst the SMC has become a fulcrum for debate over access to and the cost of a wide array of new drug treatments, the underlying issues are much bigger than whether the SMC has acted effectively. The role of Health Boards in deciding how to implement SMC guidance; the responsibility of politicians towards setting health care priorities; the effectiveness of the pharmaceutical industry; the burdens of regulation; the patient choice agenda and the role of the media in focusing attention on emotive individual cases all need to be taken into consideration and weighed up in this debate. Perhaps one central question raised is whether a national body providing general guidance, based on necessarily uncertain data, can ever satisfy the demands and anxieties of individual patients.