A medication produced by Pfizer, who announced profits of £1.3bn last year. Photo: Scott Olson/Getty Images
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NHS drugs, Aristotle and health economics: the problem of quantifying the value of life

In light of the news that new cancer medications won’t be made available to NHS patients, it’s worth exploring the difficulties of drug commissioning.

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.

George Gillett is a freelance journalist and medical student. He is on Twitter @george_gillett and blogs here.

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John McDonnell interview: "We’re going to destroy Osborne’s credibility"

The shadow chancellor on the Spending Review, Jeremy Corbyn's leadership and why trade unions will have to break the law. 

When I interviewed John McDonnell in March, before the general election, he predicted that Labour would be the largest party and confessed to a “sneaking feeling that we could win a small majority – because I think the Tory vote is really soft”. As the long-standing chair of the Socialist Campaign Group, McDonnell anticipated leading the resistance inside Labour to any spending cuts made by Ed Miliband. Eight months later, he is indeed campaigning against austerity – but as shadow chancellor against a Conservative majority government.

I meet McDonnell in his new Westminster office in Norman Shaw South, a short walk down the corridor from that of his close friend and greatest ally, Jeremy Corbyn. The day before George Osborne delivers his Spending Review and Autumn Statement, his desk is cluttered with economic papers in preparation for his response.

“The message we’re trying to get across is that this concept of the Tories’ having a ‘long-term economic plan’ is an absolute myth and they’re in chaos, really in chaos on many fronts,” he tells me. McDonnell points to the revolt against cuts to tax credits and policing, and the social care crisis, as evidence that Osborne’s programme is unravelling. On health, he says: “He’s trying to dig out money as best as he can for the NHS, he’s announced the frontloading of some of it, but that simply covers the deficits that there are. Behind that, he’s looking for £22bn of savings, so this winter the NHS is going to be in crisis again.”

Asked what Labour’s equivalent is to the Tories’ undeniably effective “long-term economic plan” message, he said: “I don’t think we’re going to get into one-liners in that way. We’ll be more sophisticated in the way that we communicate. We’re going to have an intelligent and a mature economic debate. If I hear again that they’re going to ‘fix the roof while the sun shines’ I will throw up. It’s nauseating, isn’t it? It reduces debate, intellectual debate, economic debate, to the lowest level of a slogan. That’s why we’re in the mess we are.”

Having abandoned his original support for the Chancellor’s fiscal charter, which mandated a budget surplus by 2020, McDonnell makes an unashamed case for borrowing to invest. “The biggest failure of the last five years under Osborne is the failure to invest,” he says. “Borrowing at the moment is at its cheapest level, but in addition to that I’m not even sure we’ll need to borrow great amounts, because we can get more efficient spending in terms of government spending. If we can address the tax cuts that have gone ahead, particularly around corporation tax, that will give us the resources to actually start paying again in terms of investment.”

He promises a “line-by-line budget review” when I ask whether there are any areas in which he believes spending should be reduced. “My background is hard-nosed bureaucrat . . . we’ll be looking at where we can shift expenditure into more productive areas.”

From 1982 until 1985, John McDonnell, who is 64, was chair of finance at the Greater London Council under Ken Livingstone. After vowing to defy the Thatcher government’s rate-capping policy he was sacked by Livingstone, who accused him of manipulating figures for political purposes. “We’re going to look like the biggest fucking liars since Goebbels,” the future mayor of London told him. McDonnell, who later described Livingstone’s account as “complete fiction”, has since resolved his differences with the man now co-chairing Labour’s defence review.

After his election as the MP for Hayes and Harlington in 1997, McDonnell achieved renown as one of New Labour’s most vociferous opponents, rebelling with a frequency rivalled only by Corbyn. His appointment as shadow chancellor was the most divisive of the Labour leader’s reshuffle. “People like Jeremy even if they don’t agree with him. People don’t like John,” one MP told me at the time. Mindful of this, McDonnell has sought to transform his image. He has apologised for his past praise of the IRA and for joking about assassinating Margaret Thatcher, rebranding himself as a “boring bank manager”. But there are moments when his more radical side surfaces.

He told me that he supports workers breaking the law if the trade union bill, which would limit the right to strike, is passed. “It’s inevitable, I think it’s inevitable. If the bill is introduced in its existing form and is used against any particular trade unionist or trade union, I think it’s inevitable that people will resist. We established our rights by campaigning against unjust laws and taking the risk if necessary. I think that’s inevitable and I’ll support them.”

“Chaos” might be how McDonnell describes Osborne’s position but the same term is now daily applied to Labour. The party is riven over air strikes in Syria and the renewal of Trident and MPs are ever more scornful of Corbyn’s leadership.

While Corbyn has so far refused to offer Labour MPs a free vote on Syria, McDonnell says that he favours one and would oppose military action. “My position on wars has always been that it’s a moral issue and therefore I veer towards free votes . . . We’re waiting for Cameron’s statement; we’ll analyse that, there’ll be a discussion in shadow cabinet and in the PLP [Parliamentary Labour Party] and then we’ll make a decision. I’m still in a situation where I’ve expressed the view that I’m opposed to the bombing campaign or engagement. I think the history of the UK involvement in the Middle East has been a disaster, to say the least . . .This isn’t like the Second World War where you have a military campaign – you defeat the enemy, you sign a peace agreement and that’s it – this is asymmetric warfare. In addition to the risks that are in the battlefield there’s a risk in every community in our land as a result of it.”

Would he want any of the 14 former shadow cabinet members who refused to serve under Corbyn to return? “All of them, we’re trying to get them all back. We’ve got Yvette [Cooper] helping us on a review we’re doing about the economy and women . . . It’s an open door policy, I’m trying to meet them all over these next few weeks.”

Livingstone, a member of Labour’s National Executive Committee, recently called for Simon Danczuk, who revealed details of a private meeting with Corbyn in the Mail on Sunday, and Frank Field, who told me that MPs should run as independents if deselected, to be disciplined. But McDonnell takes a more conciliatory line. “With Simon [Danczuk] in particular and the others, it’s just a matter of saying look at the long-term interests of the party. People don’t vote for a divided party. They’ll accept, though, that within a party you can have democratic debate. As I said time and time again, don’t mistake democracy for division. It’s the way in which you express those different views that are important. All I’m saying is let people express their views, let’s have democratic engagement but please don’t personalise this. I think there’s a reaction within the community, not just the party, against personalised politics. It’s not Jeremy’s style, he never responds in that way. It’s unfortunate but we’ll get through it. It’s just minor elements of it, that’s all.”

McDonnell disavows moves by some in Momentum, the Corbyn-aligned group, to deselect critical MPs. “What we’re not into is deselecting people, what we want to try and do is make sure that everyone’s involved in a democratic engagement process, simple as that.

“So I’ve said time and time again, this isn’t about deselection or whatever. But at the same what we’re trying to say to everybody is even if you disagree, treat each other with respect. At the height of the debates around tuition fees and the Iraq war, even though we had heated disagreements we always treated each other with mutual respect and I think we’ve got to adhere to that. Anyone who’s not doing that just lets themselves down, that’s not the culture of the Labour Party.”

In private, the 90 per cent of MPs who did not support Corbyn’s leadership bid speak often of how and when he could be removed. One point of debate is whether, under the current rules, the Labour leader would automatically make the ballot if challenged or be forced to re-seek nominations. McDonnell is emphatic that the former is the case: “Oh yeah, that’s the rule, yeah.”

McDonnell’s recent media performances have been praised by MPs, and he is spoken of by some on the left as a possible replacement if Corbyn is removed or stands down before 2020. His speech to the PLP on 23 November was described to me by one shadow minister as a “leadership bid”. But McDonnell rules out standing in any future contest. “No, no, I’ve tried twice [in 2007 and 2010], I’m not going to try again, there’s no way I would.”

Despite opinion polls showing Labour as much as 15 points behind the Conservatives, McDonnell insists that the party can win in 2020. “Oh definitely, yeah, you’ll see that. I think this next year’s going to be pivotal for us. We’re going to destroy Osborne’s credibility over the next six months. But more importantly than that, we can’t just be a negative party . . . we’re going to present a positive view of what Labour’s future will be and the future of the economy.

“Over the next 18 months, we’ll be in a situation where we’ve destroyed the Tories’ economic reputation and we’ve built up our own but we’ll do it in a visionary way that presents people with a real alternative.”  

George Eaton is political editor of the New Statesman.