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Medical Industry Week News

It’s good news this week for some of the biggest medical imaging companies

GE Healthcare, Siemens Healthcare, Philips Healthcare and Toshiba Medical Systems – with all four receiving tentative backing for their respective next-generation cardiac CT scanners in draft guidance drawn up by the National Institute for Health and Clinical Excellence (NICE) in its latest draft guidance on the subject.

Now available for a period of public consultation, the draft guidance specifically applies to the use of the Somatom Definition Flash CT scanner (Siemens), Aquilion One (Toshiba), Brilliance iCT (Philips) and Discovery CT750 (GE) in the NHS in England for people with suspected or known coronary artery disease (CAD) in whom imaging is difficult with earlier generation CT scanners. A review team looked at 24 studies, with the vast majority (20) using Siemens’ Somatom Definition Flash (1) or an earlier model, Somatom Definition (19). Interestingly, despite its glowing endorsement only two of the studies referenced actually used the cutting edge CT scanner technology. In 2007, CAD was estimated to have claimed 91,000 deaths in the UK.

CT scans are performed to evaluate the arteries of the heart, and can also be used to assess the function of the heart, the anatomy of the heart, and the degree of coronary calcification in the heart. The technology survived a review of five recognised models for assessing the cost effectiveness of next-generation cardiac CT scanners, including the Europa model, for the prognosis of people with CAD, and the York Radiation Model, which estimates the impact of imaging in terms of radiation dose on cancer mobidity and mortality.

The recent NICE clinical guideline on chest pain recommends CT coronary angiography and invasive coronary angiography to assess the state of arteries and identify significant narrowing in people with an estimated probability of coronary artery disease of 10 to 29 per cent and a calcium score of <400 or less. People with a calcium score >400 are considered difficult to image using earlier generation CT technologies. Other reasons that make CT imaging difficult are obesity, arrhythmias (irregular heart beat), high heart rates (above 70 beats per minute) or previous coronary stents or bypass grafts.

The latest generation cardiac CT scanners have technical features that aim to overcome these difficulties, including the ability to acquire images much faster than earlier generation CT scanners, better image quality and reduced radiation doses. The NICE guidance recommends the use of these scanners for first line imaging of the coronary arteries in people with suspected stable coronary artery disease who are difficult to image with earlier generation CT scanners and whose estimated probability of having CAD is 10 to 29 per cent. In addition, the draft guidance recommends their use in people with known CAD for first line evaluation of disease progression to establish the need for revascularisation where imaging with earlier generation CT scanners is difficult.

Imaging companies will not quite be celebrating at the moment as final guidance on this topic is not expected until the new year, but they will be quietly confident that there is now a recognised need for the technology within the National Health Service in the UK.

As the NHS cuts start to bite, could a treatment for varicose veins provide one of the answers?

Maybe not! But Medical Industry Week this week highlighted the rather grand suggestion that a non-surgical treatment for varicose veins could save the UK’s National Health Service over £17 million annually in healthcare costs, and help 7,000 patients avoid further treatment due to unsuccessful alternative treatments. It’s not going to solve all our problems, but if it’s true then it’s a good start!

All medical device companies like to big up their respective device and technologies from time to time, particularly when one considers that regulatory authorities from across the country are tightening the budgets.  So it remains to be seen whether VNUS’ claims are just marketing puff, but it’s interesting to see how companies are increasingly using costing as a sale push, in addition to all the stated benefits of improving healthcare.

Developed by US-based VNUS Medical Technologies, the VNUS Closure Procedure involves a hospital stay of a couple of hours, treatment under local, rather than general anaesthetic, and claims a much faster recovery time with most patients able to walk out of the treatment room unaided. The procedure is also much less resource-intensive than surgery to the NHS, particularly compared to conventional varicose vein stripping, which takes up a great deal of operating theatre time.

For the same costs, the company said this week that a further 25,000 patients could be treated earlier and avoid pain, or discomfort. Further savings are on offer as the procedure can be carried-out in a treatment room so it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and to reduce those all-important waiting-times.

On its own, the VNUS procedure may not represent a significant dent in the £20 billion of spending cuts that the NHS is faced with securing over the next four years, but getting on top of some of these, arguably less glamorous treatments could collectively make a positive impact on meeting this ambitious target. Medical Industry Week argues that it is time to take a closer look at these sort of treatments in a bid to meet a target that even the NHS Confederation says is unlikely to be achieved with the timescale.

This article was provided by Lawrence Miller, editor of Medical Industry Week, and the medical newsletters teamleader.

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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.