The Medical Technology Blog

Guest contributor, Louise Campbell, an undergraduate with the University of Southampton, examines the impact of the National Institute of Clinical Excellence and how judges remain reluctant to be seen as driving healthcare policy

Ageing population and lower healthcare costs leave regulatory authorities with a big headache. NICE faces up to the challenges of 21st Century healthcare

Ever since the NHS was created in the UK it has lurched from financial crisis to financial crisis and this year is no exception. Out of 137 NHS Foundation Trusts in the UK that submitted plans to the independent regulator, Monitor, this year, 11 listed themselves within the two highest financial risk ratings and a further ten say they will experience a high level of financial risk.   Consequently, the NHS ‘postcode lottery’ – where a patient’s location will have a bearing on the treatment they can receive – and its apparent inability to treat patients with the most effective and expensive drugs and treatments can only be expected to increase.

Before medical devices drugs are prescribed or given on the NHS they are scrutinised and recommended by the National Institute for Health and Clinical Excellence (NICE) which evaluates them for cost effectiveness. NICE has been blamed for the start of explicit, national “rationing” on the NHS, but it has also been faced the challenge of lowering the possibility of a ‘postcode lottery’ over the years through issuing uniform practice guidance, that, though not compulsory, drive the policies that Primary Care Trusts (PCT) should be following. This was  highlighted in a successful legal challenge in 2000 against North West Lancashire Health Authority, in which three transsexuals successfully challenged a decision to refuse funding for gender reassignment surgery. In this case, it was shown 34 out of 41 other authorities made some provision for funding such surgery and that a policy which effectively amounted to a ‘blanket ban’ in one locality would therefore recognise that treatment would depend upon where the patient lived.

Essentially, NICE is a non-governmental agency with a key role of evaluating the clinical effectiveness of treatments versus the associated cost burden.  The guidelines are passed onto the NHS with advice as to whether the technology is for routine or restricted use on the NHS. The NHS is constrained by a crippling budget, yet demand is always rising for its services, creating a climate for difficult and often unpopular decisions.

Ultimately, it will be the individual PCT that decides whether certain technology is used in treatment based on NICE’s recommendations. If a PCT refuses to treat a person with certain drugs or surgery, to challenge the decision involves a lengthy expensive, judicial review process. Case law also suggests that Judges are reluctant to get involved in the allocation of NHS resources as shown in a challenge against Cambridge Health Authority by a young girl and her father that attracted much media attention. In this case, potentially lifesaving treatment was refused to a ten year-old girl due to the success rate/cost ratio.

In another recent case, a 22st man lost his legal challenge against North Staffordshire PCT over its refusal to pay for gastric band surgery. Social factors do not have to be considered by PCTs in making their decision. Failure to consider such factors was ruled not to be in contravention of his human right to respect for private and family life under Article 8 of the European Convention of Human Rights. Some align the decision to an inherent prejudice against the obese. However, despite an envisaged long term saving by the claimant as the operation may cure his diabetes and related illness, the money is not always available in the short term. NICE recommendations suggest that people may be eligible for the surgery if they are morbidly obese which, for the purpose of the guidelines, means if they have a body mass index (BMI) of 40 or more or they have a BMI of between 35 and 40 and other significant disease (for example, diabetes, high blood pressure) that may be improved if they lose weight. Many PCTs chose to have the BMI threshold at above 50 as a way of controlling the cost-burden.

However, this is not to say that judges will not get involved should the situation demand as it was in case of a breast cancer sufferer who challenged her health authority and the Secretary of State for Health on their decision not to give her the drug Herceptin when they were giving it to others. The claimant proved the PCT’s decision process was “irrational” as the policy could not be rationally explained. The PCT would provide the drug in ‘exceptional circumstances’ but could not discern a threshold for what these circumstances were.

Over the past 18 months, two life-saving drugs have also been denied on the NHS after cost recommendations by NICE. In January 2010, lifesaving drugs Dasatinib and Nilotinib, which are supplied in Scotland and parts of Europe, were refused to cancer patients in England. Both drugs cost around £30,000 per year but could increase life expectancy by decades. At this time, NICE claimed the decision was based on a lack of robust evidence that the drugs are effective or more effective than those available, despite hearing evidence from clinical experts that the drugs are effective.

NICE also recently proposed not to recommend the drug Lucentis to treat the eye condition diabetic macular oedema (DMO) on the NHS, a decision which Diabetes UK and three other charities are challenging and campaigning against on the basis of a call for a proper consultation allowing stakeholders to submit their comments. The charities are also urging Novartis, the drug manufacturer, the Department of Health and NICE to reconsider the option of a Patient Access Scheme so that a maximum number of patients can benefit from this sight saving treatment.  The Lucentis injections have the potential to save the sight of thousands. Whilst the treatment is expensive, the Institute is accused of failing to consider the long-term effects of their decision. If people lose their sight, much of their independence is gone and costs for the NHS will ultimately rise despite a short-term saving.

Some think it ludicrous that potential life-saving treatment and treatment that enables a person to continue to live independently is denied when the NHS will offer cosmetic procedures such as Breast Enlargement surgery and Rhinoplasty. It’s a debate that is likely to increase in frequency over the next decade as the NHS grapples with an ageing population and a reduction in healthcare expenditure.

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