On Friday it was announced that abiraterone, a new prostate cancer drug, will not be made routinely available to NHS patients before receiving chemotherapy. The decision has been criticised by patient groups and scientists alike – a statement from the Institute of Cancer Research condemned the decision as “plainly illogical”. Despite the drug having been proven to increase the health and life expectancy of patients, it was rejected after failing to meet the cost-effective threshold required.
Unfortunately, this case isn’t uncommon. Since 2012, 22 new cancer drugs have been rejected for use in the NHS –making up 61 per cent of the cancer treatments analysed during the period. Indeed, earlier this month, headlines were dominated by news that the NHS would not fund a new treatment for breast cancer. Each of these stories provokes angry responses from both patients and pharmaceutical companies, who accuse the decision-making process behind commissioning drugs of being “broken”.
But how does the NHS decide what drugs patients should have access to? Facing a “financial crisis”, the question of where the NHS should allocate its finite resources is becoming increasingly relevant.
In England and Wales, the National Institute for Health and Care Excellence (Nice) deals with these challenges. Set up by the government in 1999, Nice is tasked with deciding which drugs and treatments the NHS should fund, and which patients should receive them. Working under strict budgets and with pharmaceutical companies eager to make profits from their expensively-priced medicines, it’s unsurprising that Nice often faces criticism for the decisions they make.
To compare which treatments should and shouldn’t be commissioned, Nice analyses each for their cost-effectiveness, using a scale known as quality-adjusted-life-years, or QALYs. The idea is to estimate the additional life expectancy gained by the patient, while also accounting for their quality of life during that time. For instance, a drug which gave you five years of life at perfect health would equate to five QALYs, as would a drug which extended your life by ten years at half of that quality of life, and so on. The “cost-per-QALY” is then calculated, and compared to a threshold value before deciding whether the drug provides enough value to be commissioned. This threshold is currently set at £30,000 per quality-adjusted life year.
This system raises obvious ethical dilemmas and the concept of placing a monetary value on human life is a common cause for concern. Yet all healthcare systems have finite resources, meaning that difficult decisions have to be made. Current guidelines are based on a utilitarian approach, which aims to maximise the quality of life that patients benefit from.
The QALY-based system also faces practical challenges. A report in 2013 condemned such decision-making as “mathematically flawed”. Arguing that a patient’s attitudes towards their quality of life vary dramatically with age, the researchers behind the study established that it was impossible to accurately calculate the long-term QALY benefit for many treatments. This is problematic for a system that relies on estimating the QALYs gained by a patient until the point of their death. Indeed, the study stated that the UK wasn’t using a “scientific way to classify and prioritise drugs” – a worrying conclusion for all involved in healthcare.
Further challenges are raised regarding the way QALYs are measured, and questions are asked about whether it is possible to quantify something as abstract as quality of life. Currently, Nice asks patients to complete a self-reported survey, known as the EQ-5D, in order to do so. This measures quality of life in five main areas; mobility, pain, mental health and the ability of patients to care for themselves and to carry out daily activities.
However, such an arbitrary rating system also raises concern for certain groups of patients, such as those with disabilities. The thinking is that disabled patients record a lower quality of life on criteria such as mobility in such surveys, and are therefore likely to have a lower QALY benefit calculated for any potential treatments. Worryingly, since such data affect whether treatments are made available, any discriminatory effect is likely to impact on what treatments are accessible to patients. Considering that patients often adjust to their disabilities and lead immensely valuable and meaningful lives, the concept of using assigned markers like mobility in such decision-making does seem somewhat ableist.
More generally, there are also limitations to using crude self-rated surveys to measure a patient’s health. Unlike disease, which can be quantified by diagnostic markers or observable systems, illness is a much more subjective concept, based on a patient’s perception of their own health. You can measure quality of life using a number of different criteria, including that based on functionality, wellbeing and what is perceived as a socially acceptable level of health.
Further challenges are met when considering that some diseases leave patients unable to fill in such surveys, rendering any patient-determined prediction of quality of life impossible. Although doctors could estimate the quality of life on behalf of patients in these cases, this would mean that a medical professional would have to assign a value to their patient’s life. In its most extreme form, this could result in doctors ultimately determining whether a patient receives a life-saving treatment.
While many of these dilemmas are largely hypothetical and confined to academic debates, the challenges surrounding diseases such as dementia are meaning that such questions are becoming increasingly relevant.
Painful choices
Critics also accuse the QALY-based system of ageism. Since older patients theoretically have fewer years of life to gain by receiving treatments, the QALY-approach does effectively discriminate against the elderly by calculating a lower QALY measurement compared to younger patients.
This poses a difficult question: is one year of life always equal? Assuming full health, is an 80-year-old as entitled to an extra year of life as a teenager diagnosed with a terminal illness? Nice’s current guidelines suggest not – the organisation raises their economic threshold for treatments for patients who have a significantly shortened life expectancy. Similarly, the Cancer Drug Fund was set up to pay for medications that would not normally be deemed cost-effective under Nice guidelines. Exceptions can therefore be made to the QALY-commissioning system, although intense scrutiny regulates such decisions.
Yet the irregularities between our own healthcare system and that of a strict QALY-based system become even more noticeable when considering our general approach to healthcare. As many have argued, the most cost-effective way to increase society’s QALYs is to prescribe cheap medications which have an overall net benefit.
These medications – such as statins which, lower cholesterol – can, when given to a large cohort of patients, save a sizeable proportion of lives by preventing events such as heart attacks. But we don’t routinely prescribe such treatments. Rather than saving “statistical lives”, we choose to treat patients who are currently ill, despite this often not being the most cost-effective way to extend lives. Although this may be in part due to fears of “over-medicalising” our lives, one could also argue that we create a dichotomy between preventative treatments and those which intervene to alleviate or cure disease. Such an argument suggests that the reason we focus on curing patients instead of preventing future diseases is that we have a greater duty to care for those who are currently ill than we do to extend the overall quality of life and life expectancy of the population.
However, this argument is also problematic, and soon reveals itself as a largely arbitrary distinction between preventative and intervention treatments, influenced by disease-specific diagnostic methods. For example, consider cancer treatment. Fifty years ago, the point where treatment was classed as an intervention might have been when a tumour was first physically noticed by the patient. Now, however, a routine mammogram could provoke an intervention treatment so early in the progression of the disease that it would have once been classified as a preventative measure.
Importantly, while cancer care has benefited from these modern advancements in diagnostic methods, many other diseases haven’t, highlighting just how false the distinction between prevention and intervention is. As research and diagnostic developments for different diseases progress at different rates, it seems wholly unreliable to base commissioning decisions on such an arbitrary distinction. Regardless, a purely rational, mathematical approach, that would leave unwell patients without treatment in order to extend “statistical” lives elsewhere, seems callous and insensitive – perhaps a reminder why QALYs should not be used in isolation when deciding which drugs to commission.
Utilitarian ethics
Many of the ethical dilemmas that surround the QALY-based approach can be summarised by questioning whether we want our commissioning system to focus on maximising the overall benefit of a population of patients, or whether we want to achieve equality among patients.
Yet what does equality actually mean in this case? The obvious response might be that our approach to commissioning treatments should have the aim of every patient living to the same age – after all, this might initially appear to be the most “equal” health outcome. However, this depends entirely on your definition of what equal healthcare is.
Aristotle is credited with the concept that society should “treat equals equally and unequals unequally”. The idea is that it is acceptable for individuals to be receive unequal treatment if their personal situation dictates that such treatment is justified.
The implication of such thinking in a healthcare setting is that genetic factors might predispose to disparities between the health of patients. Whether we should aim to rectify these inequalities, or allocate patients equal medical attention regardless of any predisposition, poses a dilemma.
Thankfully, our society values the notion that everyone is equal from birth, and there is a general consensus that our healthcare system should try to counter any inherent inequalities in the health of patients. For instance, it is easy to justify allocating more resources to a patient with a genetic condition instead of commissioning extra preventative measures for a healthy patient. While we treat these patients “unequally”, we do so to balance out natural disadvantages, and this is a key principle of a socialised healthcare system like the NHS.
However, society holds a rather different attitude towards lifestyle choices that individuals make, and it is often suggested that patients should be held more accountable for their own health. Indeed, the media are often keen to promote suggestions that alcoholics or obese patients have less of a right to healthcare than other members of society.
Apart from the obvious flaws in such an argument (genetic links have been found to both obesity and substance abuse), there is a wider question about how far our healthcare system should try to exert control over a patient’s lifestyle. It’s relatively common to vilify drug addicts and alcoholics, but what extent should society pursue such a moralising approach, if any? Factors like diet and exercise are linked to a wide array of medical conditions – should we withhold treatment for patients who don’t conform to prescribed health guidelines in these areas? Do we refuse to treat extreme sports injuries because the patient chose to participate in risky behaviour? What about patients involved in car crashes, another optional activity?
A healthcare approach so fixated with holding patients to account for their actions soon seems inconsistent and troublesome. Yet to reject any element of so-called “personal responsibility” in healthcare would have us rationing treatments in such a way where patients receive disproportionate care at the expense of others. Nonetheless, if we’re to strive for “equal” healthcare, it’s important to clarify what we mean; living to an equal life expectancy, receiving equal treatment regardless of your inherent predisposition to disease, or a compromise between the two. This scenario just represents another example of the challenges of determining which treatments we fund.
Unattractive alternatives?
Despite its flaws, the QALY-based system does ensure that a consistent and rational approach is maintained in the commissioning of medical treatments. In fact, Nice was first introduced to combat “postcode lotteries”, where a patient’s chance of receiving different treatments would depend on where they lived. The QALY approach also safeguards healthcare from populism, ensuring that treatments are commissioned on the basis of the clinically proven benefit they provide. Likewise, QALYs allow these judgements to be standardised across a plethora of diseases, which ensures that taboo areas of healthcare, such as mental health, are not neglected.
It would be unfair to criticise the QALY-based approach without considering other alternative methods of deciding which treatments to commission. After all, the problem of quantifying life is a complex and multifaceted one.
One suggestion is to base drug commissioning guidelines on a measure known as Healthy Year Equivalents, or HYEs. This uses a similar system to QALYs, but allows consideration for how the benefits of a given treatment might adjust over time. Hence, it is suggested that HYEs better represent a patient’s preferences compared to current methods. This was a major criticism of the “mathematically flawed” QALY-approach, and the HYEs may provide benefit in improving Nice’s commissioning guidelines.
Looking across the world, the vast majority of countries use a QALY-based system. However, exceptions do exist. Germany, for instance, use a system known as the Efficiency Frontier, which compares the efficiency of a new medication with that of existing treatments. It is thought that this was designed in part to avoid the political nature of debate in drug commissioning decisions. Yet critics maintain that the Efficiency Frontier suffers from many of the same ethical dilemmas that a QALY-based system encounters.
Meanwhile, the USA remains fiercely opposed to a QALY-based approach, with Sarah Palin once dismissing commissioning groups like Nice as “death panels”. In fact, the Affordable Care Act (commonly known as Obamacare) prohibited the use of QALY-based thresholds in drug commissioning.
Pharmaceutical companies have also proposed alternative systems of commissioning drugs, recommending a method known as the Value Based Assessment, which considers a broader approach to measuring the value of drugs beyond strict QALY criteria. Interestingly, Scotland have recently adopted this kind of approach, although the new criteria is yet to have been used to justify the commissioning of any new treatments.
Arguing along similar lines, a representative from the Association of the British Pharmaceutical Industry suggested that more funding should be allocated to drugs generally, pointing out that “the UK medicines bill is 0.9 per cent of GDP”. This doesn’t seem unreasonable – Nice’s threshold value for the cost-effectiveness of drugs hasn’t changed since 1998, despite inflation of 28 per cent over that period. Moreover, it’s argued that the use of medications can often prevent more expensive treatments in the long term.
Yet one health economist I spoke to urged the importance of treating suggestions from such partisan sources with caution. Indeed, he was wary about the criticisms targeted towards Nice’s system of commissioning drugs, suggesting that the QALY approach was only to blame in so far as that it highlighted “uncomfortable truths” about the finite resources of our healthcare system. Likewise, he suggested that much of the reason pharmaceutical companies are so keen to see reform of the commissioning system is that measures such as QALYs regularly show their drugs to be largely cost-ineffective. Given the huge profits that are to be made in the pharmaceutical industry, it’s unsurprising that Nice receive frequent criticism about their method of decision-making.
Perhaps we should be careful of unfairly criticising Nice’s QALY-based approach while there is no clear alternative currently available. The age-old problem of quantifying life is one, at least for the foreseeable future, which we will continue to struggle with.
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