If the weather isn’t hot this summer, the politics certainly are - with the forecast for it to get warmer yet.
In the midst of an ongoing consultation on the draft NHS Constitution, we are almost at the end of a six-month ‘national debate’ about the future funding of social care. Not long after, Mike Richards’ review of co-payments will report in October – with massive implications for NHS finance. An announcement on changes to the formulae that distributes money to PCTs will follow hot on its heels. Recent decisions from NICE have linked local variations and the co-payment review to priority-setting, and also reopened the rationing debate.
As rainy economic news continues, and inflation nudges towards 5%, debates on the distribution of social resources are hotting up, making for a sticky social climate and humid start to the new political season.
Controversy over NICE decisions
The decision not to fund four new drugs for advanced stage kidney cancer hit the headlines last Thursday. The debate has rolled on since, making headlines again yesterday - http://www.guardian.co.uk/society/2008/aug/11/nhs.health; http://www.timesonline.co.uk/tol/news/uk/health/article4499847.ece?&EMC-Bltn=QKZ9E9.
The story has developed today, with headlines about the broader role of NICE.
One of the reasons for the furore was the strong reaction of some doctors. In the Daily Mail, Professor John Wagstaff, from the South West Wales Cancer Institute, used strong language to condemn the UK to the worst survival rates. “It is hard to imagine how NICE could reach this decision”, he wrote. In his view, one of the new drugs represents ‘the most important development in 30 years’. In the Times, Professor Jonathan Waxman wrote that the decision was both “absurd and arrogant”. He said the money saved was paltry, and questioned the “quality of life” measure employed by NICE.
Many people will have first heard the story on BBC Radio 4’s Today programme.
The director of Cancer Research UK began by telling Evan Davies that he was supportive of NICE. His concern is to do with the framework being used to make decisions. “Our supporters at CRUK are perplexed by this”. They want to know why participation investments in clinical trials weren’t leading to improved treatments.
Evan Davies agreed there is a gap between what patients expect and the economic evaluation process, and asked NICE clinical director Peter Littlejohns for his response. Littlejohns defended their methodology, saying it gave all important groups a say – “it is the most robust system internationally”.
Professor Littlejohns told the FT that the kidney drugs had the potential “to extend progression-free survival by five to six months, but at a cost of £20,000 to £35,000 per year, This translates into a cost per quality adjusted life year of between £71,500 and £171,300”, well above the figure NICE normally is guided by, of up to £30,000 per year.
Nothing provokes debate quite like cancer as an issue. One in three people will develop some form of cancer. This fact and increased knowledge about variations in survival rates creates a strong interest. In yesterday’s press alone, there were 22 stories about cancer drugs. 3 negative headlines included: “cancer patients three times more likely to consider suicide”; “postcode lottery left 1,300 cancer patients to die; “cancer care in chaos”. The one positive headline was, “new cancer trial that offers hope to thousands”.
Funding research but not clinical advances?
As an organisation, CRUK put a lot of money into research for cancer, a higher proportion than the European average; and yet this is not being translated into available treatments. Its director said the rest of Europe saw Britain as a poor relation – as the lowest user of cancer drugs across Europe.
A campaigner, Kate Spall, makes a similar point. “We plough billions into cancer research, but the benefits of that research – some remarkable drug treatments – are not available to all who need them. Patients are disregarded and given up on because they cannot get the drugs they need”.
John Black, the new President of the Royal College of Surgeons, told the Daily Telegraph that a portion of the large amount spent on cancer research could be used better. He argues that surgery is comparatively clinically effective and cost-effective, but the surgical option isn’t discussed much because ‘drug companies face no incentive for successful surgery’. While new expensive drugs offer a few extra months of life, something like 40% of cancer cures are achieved with a scalpel.
The cost of drugs
In the FT, regular health columnist, Margaret McCartney said, ‘if the pharmaceutical companies manufacturing these drugs wanted to make them “cost effective” then they could reduce the cost until they are’.
On the Today show, Evan Davies asked Peter Littlejohns of NICE whether the cancer drug companies are sekeing to make too large a make-up. Davies asked if NICE could say to drug companies that if by charging a different rate, the drugs would become cost-effective? Littlejohns replied, “yes, that could happen, but it would depend on the Department of Health.” He was keen to avoid the politics of the situation.
The director of Cancer Research UK questioned whether costs were really prohibitive. “People have this impression that cancer drugs account for a huge amount. In practice, we spend 10% of the drug budgets on cancer drugs. There is a need for a more patient-centred assessment.”
An interesting point was made by Dr Graham R Williamson, commenting on a story in the Telegraph online. He notes among arguments for the introduction of new drugs, that Interferon is not effective for most patients. ‘If it is ineffective for most patients and gives terrible implications, why on earth has it been prescribed (at great cost to the NHS and therefore to the taxpayer) for this condition? NICE must also have a role in decommissioning treatments as well as commissioning new ones.
Standing up for NICE
Andrew Dillon, the chief executive of NICE, wrote to the Times to defend NICE in the face of fierce criticism. He wanted to correct a few issues: ‘since 1999 we have assessed 56 treatments (not 407) for cancer. In only four cases has either the clinical or cost-effectiveness of the treatments caused us to recommend against general use in the NHS.’
‘Cancer is a devastating illness and it is right that the NHS should make treating it a priority, But it is because the NHS has a responsibility to spread its resources fairly that it is essential that we should assess cancer drugs as rigorously as the other treatments we are asked to look at’.
In today’s Independent, Jeremy Laurance has dug out NICE’s Social Value Judgements which was placed on its website last month. It explicitly says that even if a drug is clinically effective, if will not be supported if the cost is too high. The Independent notes the advice ‘overules advice from NICE’s own citizen’s council, which two years ago recommended that the body should adopt “a rule of recue’ as an essential mark of a humane society. The new report says that spending too much one patient may deny care to others http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/nhs-should-not-save-patients-lives-if-it-costs-too-much-says-watchdog-891501.html.
Some parts of the UK fund treatments, others don’t
Yesterday’s survey from the Rarer Cancers Forum (funded by Roche, as only the FT pointed out) made a lot of headlines. Their Freedom of Information requests to English PCTs showed widespread variation in patients gaining access to drugs. Their data shows that 26 per cent of people appealing to have drugs either not yet evaluated or rejected by NICE were refused treatment. Extrapolating the returns, they suggest that ‘more than 1,300 patients across the country may have been denied life-extending drugs.
'seventy-five per cent of those appealing PCT decisions to deny drugs do ultimately get the drugs through appeal'
What is interesting, to me at least, is that seventy-five per cent of those appealing PCT decisions to deny drugs do ultimately get the drugs through appeal. Clearly, decisions made are not hard and fast.
The level of variation is illustrated by the fact that 11 of the 62 PCTs asked ‘approved all the requests made to their exceptional cases panel, while 2 PCTs approved none of the requests’.
The Rarer Cancers Forum (RCF) report makes a good point. The information they acquired is not collected ‘by the vast majority of PCTs. ‘This paucity of data will render it impossible for many PCTs to meet the spirit of the commitment in the draft constitution to transparency on funding decisions. It will also make it difficult for some PCTs to assess their adherence to the duties they have under the NHS Act.’
Reaction to the findings and the beginnings of this debate suggest that while localism and devolution are buzzwords in the NHS, it seems that people do not want local variation of services. The RCF report was uncomfortable with the ‘widespread discretion’ enjoyed by local commissioners where a drug has yet been assessed by NICE.
The return of the rationing debate
Writing in the Times, Libby Purves widened the discussion into rationing, more generally: http://www.timesonline.co.uk/tol/comment/columnists/libby_purves/article4498748.ece . She said that ‘some of the lay comments and arguments about the decision have been far too simple, like that of Billy Bragg on BBC Radio 4's 'Any Questions'. Such purists condemn all rationing and refusal of expensive treatment, saying from high principle that the NHS must look after everyone, in every way that has been invented, and should always be funded to do so’.
There is broadening acceptance that this isn’t possible. Recent analysis from the Social Attitudes Survey, by Peter Taylor-Gooby shows this. Libby Purves notes another pressure for rationing. ‘We now classify as illnesses things that once were accepted as mere misfortune: infertility, addiction, old-age, gloom, unusual physical appearance’.
Rationing in the NHS occurs now. The problem is that the way it occurs is very unclear to most people. Libby Purves concludes by admitting that she has no answers. ‘But as a nation we really do have to sit down and agree on what is in the core national entitlement, and what is not’. This achieved, ‘we would know where we are’.
What are people suggesting will resolve this situation?
There are four broad suggestions to resolve problems.
Be more explicit about rationing
Former Lib Dem health spokesman, Evan Harris (now science spokesman) wrote to the Times to say, ‘it is time to rename NICE, the National Institute of Cost-Effectiveness and Rationing, to give it more freedom to act rationally and fairly and to hold politicians to account for their decisions on funding’. He says that the questioned isn’t whether we should ration but how.
But it is not clear, in this approach, how the public would hold decision makers to account, and how the public could be fully involved about decisions.
Making NICE assess decisions more quickly
One solution that is often cited is that NICE should assess drugs more quickly. A Department of Health spokeswoman told the Guardian that the draft NHS constitution would address the problem by speeding up the process of appraising new drugs’.
The problem, though, is what do you do when if NICE reject the innovation?
Clear guidance from the government to PCTs on how to deal with exceptional cases
In some circumstances, it may be that the general population will not benefit from a drug, but that a small group might. The Rare Cancers Forum want greater clarity on dealing with ‘exceptional cases’. They want uniform criteria, noting that ‘many PCTs are applying social criteria, including personal circumstances, whilst many others are not’. They would like to see national guidance ‘on how PCTs should make decisions on exceptional cases’. They believe ‘PCTs should be assessed on how well they implement this guidance as part of the World Class Commissioning Performance Framework’. They want PCTs to respond within five days, with an additional five days for an appeal.
For some, the only solution to the problem is co-payments. Karol Sikora, writing in the Telegraph, believes our system is at fault. He notes that the drugs rejected by NICE last week are available to patients in Europe and North America. ‘Either Britain is wrong, and the other countries right or we are along in making a rational decision’. He notes that more drugs are personalised, ‘guided by new diagnostics which allow cancer-causing abnormalities in individual patients to be detected’. Because ‘the NHS is running out of money’ and cannot sanction drugs for smaller groups, he says the October report on co-payments ‘will inevitably suggest that these should be permitted.
Will the forthcoming Government review on the future of copayments make the situation clearer?
The front page of today’s Telegraph says that NICE ‘is drawing up place to provide patients with independent medical guidance on treatments for diseases such as cancer. ‘They could then decide if they want to pay for them privately rather than opting for the free drugs, which can be less effective.
‘Speaking to The Daily Telegraph, Andrew Dillon, the chief executive, revealed his organisations was preparing to play a central role if the Department of Health give the go-ahead to so called “co-payments” in the autumn. “If the Government wants to go in that direction we are absolutely the right organisation to support the process for doing so”.
Norman Lamb has welcomed the idea. “One of the big dangers of allowing people to top-up their treatment is that consumers aren’t informed and they can be susceptible in a moment of crisis to pressure from pharmaceutical companies. These drugs can be very expensive and I would welcome the provision of a source of independent, reliable advice”.
It seems we are heading towards co-payments. The debate has not followed typical left-right lines. The debate has become about where we draw the line.
Some are so afraid that the line will be drawn in the wrong place that they would rather not draw a line at all, and instead defend the current situation. The problem with this approach is that there is no clear line to be held at present. As has been shown, patients in some PCTs are able to access drugs while patients in others are not.
At the other extreme, there will be some who call for a full move to insurance. On September 7th, Reform will publish a vision for health and will likely draw on fears about long-term funding and the expense of drugs to argue for a much greater role for insurance.
Could the review lead to a top-up insurance market?
On Radio 4’s Today Programme, Evan Davies asked whether the debate over the kidney cancer drugs could lead to a top-up insurance market for pharmaceuticals. He suggested this would mean that poorer people could have access to drugs as well as billionaires – they could save for the eventuality.
Several case studies have been used to highlight the problem. Former bricklayer, Andrew Crabb was profiled in the Times. He says his health has improved dramatically, by taking one of the drugs rejected by NICE, ‘but he and his wife, Dianne, must now find more than £3,000 every six weeks to pay for it’. He says he may have to sell his house. An insurance policy could have helped Mr Crabb pay for the drug, but would he have taken a policy? As far as I know, he hasn’t been asked. He did tell the Times that he has being paying National Insurance all his life – “so why shouldn’t I get it?”
Will the consultation on the draft NHS Constitution make the situation more clear?
The challenge for the Government is to use the copayment review and the consultation on an NHS constitution to try and clarify the entitlement of England’s citizens.
Just over a year ago, the BMA published 'A Rational Way Forward' (2007), which argued that an NHS Constitution should set out the “core” services funded and guaranteed by the central government. I have to declare an interest, as the author of that report, and still supportive of its position. In hindsight, my main regret is the use of the word “core”. People associate it with an eaten apple, with all the best of the fruit outside the core. A better word might have been ‘universal services’.
This debate will intensify between now and October.