Check up time for NICE

The National Institute for Health and Clinical Excellence has recently undergone its second ‘check up’ from the Health Select Committee since its inception. In its report, the committee sets out its vision of reform;

The cost effectiveness of treatment should be judged in terms of the wider social benefits they would bring, including the benefits to carers

There should be closing working with PCT’s on implementing guidance and some elements should be made mandatory

There should be faster assessments of treatments at the time of licensing

The committee also recommended that clinical guidance be made easier for patients to understand and cost thresholds linked to PCT budgets.

Neil Hunt is chief executive of the Alzheimer’s Society

“This report is a welcome evaluation of NICE processes and methodology. We appreciate that NICE have a difficult job to do in tough circumstances but there is scope for change. These recommendations present an opportunity for NICE to evolve and adopt a fairer system for all.

“Fast tracking new appraisals will have many benefits and we hope it will help eliminate postcode prescribing of new treatments. It is important that people are given access to effective treatments as quickly as possible, regardless of where they live.

“It is also imperative that the wider social benefit of drug treatments be considered to ensure we are not robbing Peter to pay Paul. In the case of the Alzheimer’s drugs appraisal, treatments were restricted despite many wider social and economic benefits to society including to carers. Although providing support is something that most carers gladly do, it is extremely stressful and takes a large toll on people’s physical and mental health. If a drug means a person being cared for can be alone in a house, regain a sense of humour or cooperate in tasks like bathing, the benefits to carers are immense.

“The recommendations are good news for carers of people with dementia and for other long term conditions where a narrow approach risks missing important benefits of treatments and where the benefits extend beyond the person with the illness to their carer.

“Moving away from drug treatments, the Committee also found that implementation of clinical guidelines was patchy and slow. The Committee recommended improving implementation, for example by making some elements of clinical guidelines mandatory and changing terminology so that patients can better understand their rights to treatment. The dementia clinical guidelines contain a range of really helpful evidence based recommendations. People with dementia and carers will really benefit from its implementation so it is helpful that the Committee recommended ways of working with PCTs to implement guidelines.

“The challenge for the future is to see the Health Select Committee recommendations implemented. Recommendations from the Committee’s 2002 inquiry have still not been taken up so we hope these recommendations do not sit on a shelf and gather dust.”

Rosie Barnes is chief executive of the Cystic Fibrosis Trust

It often appears to be bureaucrats and administrators who are responsible for denying important drugs to patients. Whilst we do have to accept that expenditure on health cannot be infinite, are these the right people to decide what is worth the investment and what is not?

Such decisions are not easy, but they have to be made. Should they be left to local decision makers – primary care trusts, or local health boards? Is equality of care irrespective of geographical location important? Is our health service really a national one, the NHS, or should it be allowed to become a series of quite different local health services?

Families affected by these decisions are ordinary, local families coping with conditions like cystic fibrosis, which most of them had barely heard of, never mind understood, before their child was diagnosed. With the help of expert care and modern medicine, children with CF can now expect to live well into adulthood. However doctors and nurses caring for those with CF have to fight endlessly to be able to prescribe some drugs which have proven benefits.

The holy grail for those with CF is, of course, a cure. Whilst a complete cure is still some way off, we are close to identifying a treatment which we hope and indeed expect will treat the underlying cause of the disease in the CF lung, as opposed to trying to hold back the symptoms. As lung disease claims 90% of the lives lost to CF, this is of huge importance to CF families, as demonstrated by the fact that they and their friends have raised most of the £15 million necessary to get the research this far, and will raise the next £15 million which we hope will bring it to fruition.

Who will decide if the product thus developed should be prescribed by the NHS and to whom?

A decision of this nature should not be made locally, whereby some children would have the possibility of a normal length and quality of life, whilst others were condemned to a life of endless and difficult treatment, with deteriorating lung function and a considerably shortened life. It should be made nationally, on behalf of the Department of Health, by a body of those expert in the care of those with CF and by patient and community representatives. NICE are ideally placed to do this, but they must do it quickly and they must do it independently of their political masters, whoever they may be at the time. It could be your child, it could be my child. We owe them this opportunity to be able to breathe normally, which the rest of us take for granted.

Pat Hanlon is trustee of Kidney Cancer UK

Kidney Cancer UK broadly welcomes the recommendations of the Select Committee, at least so far as they go. The proposals to speed assessments and to seek legislation empowering NICE to take wider societal benefits into account are recommendations with which KCUK can quite readily find itself in agreement. But KCUK is disappointed that the committee seems to have endorsed the use of a cost-effectiveness ratio, the cost per Quality Adjusted Life Year (QALY) as the fundamental benchmark informing NICE assessments.

Many kidney cancer patients have questioned the appropriateness of deciding upon the economic worth of a new course of treatment on the basis of cost per QALY for which an upper bound, if not limit, has been set at £30,000. To begin with, why £30,000? Why not £60,000? Or why not £90,000? In an article in The Times in January 2007, Sir Michael Rawlins, chairman of NICE, admitted that the figure itself is ‘pretty arbitrary’. It seems to be set more in line with what the NHS can currently afford rather than with any true assessment of the overall net benefit of the new treatment. To get at that, one really needs a full-blown cost-benefit analysis. In a cost-effectiveness analysis the accent is, naturally enough, very much on costs. In a cost-benefit analysis the evaluation is more even-handed, asking the question whether, in total, the benefits of the new treatment are greater than the costs.

Does a QALY represent total benefits? In our view it does not. Consider the case of a patient who on learning that her exceptional needs case for funding of a new drug for metastatic renal cell carcinoma (Sunitinib) had been accepted by her local PCT and that, as she saw it, she was now going to have an extra year or two to live. She spoke very enthusiastically about her plans. One was struck forcibly by the rigour with which she had thought things through. Of course, having cancer often does have the effect of concentrating the mind wonderfully. But in the mind of this patient the concept of a Quality Adjusted Life Year has only a very limited meaning. The benefits of remaining alive are much, much more than that. The problem is that the ‘much, much more’ plays no part in the evaluation at all.

Some new targeted drugs are ushering in a ‘revolution’ in the treatment of advanced kidney cancer. But the present system under which new drugs are appraised for their cost-effectiveness badges from NICE is hindering progress in this area. It leads to postcode lotteries with the chances of patients receiving treatment depending more and more upon where they live. It increases the (hidden) opportunity costs of clinicians’ time, when so much of it has to be spent negotiating exceptional needs cases and counselling patients through all the uncertainties involved in the process. Arguably—and most critically—it has the effect of slowing down the adoption of new technologies, possibly explaining why cancer survival rates in the UK are failing to improve as fast as they are in other countries across the world.

Whilst some of these issues were noted in the Committee’s report, they did not perhaps receive as much emphasis as they might have done.

Jayne Spink is director of policy and research at the MS Society

The Health Select Committee’s review is a timely contribution to the debate on healthcare provision. We agree with HSC that NICE works in difficult circumstances, but this does not diminish the frustrations experienced by people navigating their entitlements in the NHS. Many of these frustrations are exemplified by the impact of NICE practices on people affected by MS.

Multiple Sclerosis is the most common disabling neurological condition affecting young adults. There is no cure and there are limited effective therapies available. There is much scope for NICE guidance to impact positively on the lives of people with MS, and conversely a significant risk of social injustice should access to effective treatments be denied where effective but cheaper alternatives may simply not exist.

There is a very limited range of drugs available to people with MS, a situation exacerbated by the length of time it can take for a drug to be appraised by NICE. Often people have to wait months or years before their PCT will fund access to a new treatment, even though early access can be essential. We are pleased that the HSC recognises this flaw and we support their call for all drugs to be briefly assessed at the time of licensing and a report published prior or at the launch time.

MS can have a devastating impact on a person’s ability to remain in employment and the levels of informal caring they require. NICE methodology does not adequately address the costs to patients and carers and to society and the economy in general. In their current consultation on technology appraisal methodology, NICE excludes considerations relating to productivity costs and costs not borne by the NHS and PSS. An onus should be placed on central government to consider how best these hidden but nonetheless very real costs to society and our economy are taken into consideration.

In 2002, the HSC recommended a shift of emphasis of NICE’s work away from appraisals of specific treatments or interventions in isolation and a consequent expansion of the guidelines programme. The 2008 report is clear that the key to success is implementation, a view with which the MS Society wholeheartedly agrees. The MS Guideline (2003) is a prime example of NICE guidance failing to raise standards across the country. For those with MS, receiving the standards of care recommended by NICE remains a postcode lottery. Implementation of the MS guideline is not centrally monitored, nor is there always the necessary clinical engagement on a local level. There must be a fundamental shift in this practice if we are to ensure that published guidelines do not sit and gather dust.