From a media perspective, a NICE headline is generally a bad headline. Despite this, the controversial NHS regulator could have some good news for the medical device sector. On Target Editor Chris Ross interviews Professor Sir Michael Rawlins.

The National Institute for health and Clinical Excellence (NICE) is well-accustomed to criticism.

Whether from angry patient groups, frustrated pharmaceutical companies or just mainstream journalists hungry for controversy, the important work of the NHS regulator is forever scrutinised and quite often contested. An interview with its Chairman, published in The Times earlier this year, described NICE as the “organisation that decides whether or not you die for want of a medical treatment. And decides it not on the basis of whether your life will be saved, but whether it is cost-effective to save your life.”

Finding a balance

These are challenging times for an independent body charged with finding a balance between economics and human tragedy, within the context of a healthcare system that cannot withstand the escalating cost of innovation and the growing impact of an ageing population. Last month, the High Court ordered a judicial review into how NICE reached its recent conclusion on Alzheimer’s drugs. The repercussions could be huge.

The medical devices industry has managed to avoid much of the media attention that accompanies NICE decisions, so much so that observers may be unaware that the organisation regulates medtech in the same way that it does pharmaceuticals. Its purpose, says Professor Sir Michael Rawlins, Chairman of NICE, talking exclusively to On Target, is to establish an affordable standard of healthcare for the NHS. “Fundamentally, the role of NICE is nothing to do with pharmaceuticals or devices, in one sense. Like all other healthcare systems, and this is nothing unique to the NHS, there is an inappropriate variation in the quality of care. We are mandated to ensure that the standard of healthcare is as high as we can afford across all sectors of healthcare.”

Not just HTAs

Professor Sir Michael concedes that the appraisal of pharmaceuticals has always generated “the most heat” for NICE, but that the appraisals aspect is only a small part of what the organisation does. “Technology appraisals look at either single technologies, like pharmaceuticals, devices or diagnostics, or ones within the same classification. About a third of the appraisals we have conducted so far have been devices, although people aren’t generally as aware of this. One of the first appraisals we did looked at hips, and we’ve also, for example, made some recommendations about implantable defibrillators. However, in some ways, a more important component of our work is our Guidelines programme.”

NICE Guidelines

The Guidelines Programme looks at the management of conditions. It does, of course, involve drugs and devices, but it also tackles other sorts of care. “We make Guidelines on procedures, referral to hospital or tertiary care, and all the other factors that are important when you are looking after patients: when should you use clinical psychologists? When should you use occupational therapists? How quickly should a patient get up out of bed after an operation? These are concerned with a pathway of care, rather than products specifically.”

Cost-containment

The strongest allegation against the work of NICE is that it favours cost-containment over innovation. Critics have long re-branded it as the National Institute of Cost-Effectiveness. It is a comment that Professor Sir Michael acknowledges, and one that he feels wider public opinion has begun to accept. “To some extent they are right. It is about cost-effectiveness a lot of the time. I’m unashamed about that. The more thoughtful writers now accept that we have to make the money we devote to healthcare go as far as we can. There is an increasing realisation that there is not an open chequebook for the NHS.”

Disinvestment – the device is right

However, the accusation that such a cost-containing philosophy stifles innovation is dismissed by Professor Sir Michael. He points to a relatively recent new programme NICE has introduced that focuses on what he terms “disinvestment” – the concept of stopping doing things that don’t work, or moving towards ways of conducting healthcare that improve health outcomes and quality of life, but are less expensive. This, he says, is a massive opportunity for the medical device sector. “The concept of disinvestment is actually very important from the point of view of devices. Some devices do stop you having to have major surgery and are some of the things we would wish to see more widely used. For example, for women with heavy periods, there are ways of destroying the lining of the womb – the endometrium – that don’t involve having a hysterectomy. The NHS does 50,000 hysterectomies a year. Women stay in hospital for a week and end up heavily scarred. There are now implantable devices that burn the endometrium and destroy it. These can be done as a day case with no surgery – although you may need to have a general anaesthetic – and women don’t end up scarred.”

Commissioning guidelines

This is just one example of how the medical device industry can limit the resources required of the NHS, and produce health outcomes that are an improvement on historical treatments. Clearly, this provides ample food for thought for sales and marketing professionals in the medtech industry. If your product can help save NHS money by changing a pathway of care, but can deliver an improvement in patient quality of life, it will undoubtedly lead to a competitive advantage and increased uptake. To this end, NICE has also developed a new programme that provides commissioning guides in order to give commissioners the advice they need. “NICE Commissioning Guides derive from our Guidelines, and are there to help commissioners decide what they should be purchasing and what they should stipulate in their contracts when they do.

“Some devices do stop you having to have major surgery. These are some of the things NICE would wish to see more widely used…”

They cover the quality of the service that should be stipulated, and the volume. For example, we have recently published a commissioning guide to upper GI endoscopy, giving advice as to what should be expected from an endoscopy and how many commissioners should be contracting each year, depending on their population size.”

Supply-side reform

This programme is very much aligned to new NHS supply-side reforms, which are providing true opportunities for medical device and pharmaceutical manufacturers to work in partnership with the NHS and influence service redesign.

The sustained focus on the cost of healthcare, as underpinned by the work of NICE, is a necessary and accepted way of life in the modern NHS. It is also widely criticised, as healthcare reaches a crossroads where what is financially right and what is morally right appear to go in different directions.

This is not, however, an argument in which innovation is slain by economics. The medical device industry has an opportunity to demonstrate its true value to healthcare in the UK by using its innovative potential to drive down costs while improving the quality of care. It has the support of the NHS’s most important regulator. You see, it’s true: NICE is not always nasty.

For further information on the role of NICE and to access its guidelines, visit www.nice.org.uk.