• Public health

The Medical Technologies Advisory Committee (MTAC) is the driver of the National Institute for Health and Clinical Excellence (NICE) Medical Technologies Evaluation Programme (MTEP). This aims to identify novel devices and diagnostics with plausible claims for advantages to patients and/or to the NHS. If evaluation supports the claims made by manufacturers for their products then their use will be promoted by NICE guidance. Typically, medical technologies guidance will state that ‘the case for adoption is supported by the evidence’ and specify the advantages and the cost savings of adopting the product, compared with current management. The guidance may also recommend specified research and the programme has capacity to foster research into promising technologies.

The MTEP considers all kinds of medical devices and diagnostics. These include genetic tests used for a medical purpose, software and certain other products, such as those produced by tissue engineering. Its design involved extensive consultation with a great variety of interested parties, including manufacturers, clinicians, commissioners of healthcare, health service managers and patients.

The programme deals with single technologies (products) and does not undertake evaluation of whole ‘classes’ of similar technologies. The aim is to provide guidance relatively quickly—ideally for novel devices and diagnostics that offer a ‘step-change’ in management. It is not practical to perform evaluations including a range of technologies (precisely which ones? what about those coming to market thereafter? will all the manufacturers wish to be involved?) and to deliver clear guidance in a reasonable time frame. However, products may be ‘routed’ (see below) into other NICE programmes that do evaluate multiple technologies.

Some clinicians have found the ‘single product’ principle difficult to accept. It is different to what they have expected from NICE in the past, but it has been introduced with a new aim in mind. Clinicians have been concerned about what guidance supporting the adoption of a particular product might mean for the use of other similar technologies (not least ones they favour in their own practices). Text above the recommendations in medical technologies guidance now addresses this, as follows: ‘The “case for adoption” is based on the claimed advantages of introducing the specific technology compared with current management of the condition…. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.’

Taken at face value, guidance simply supports the case for adoption of a particular product, but it is hoped that its effect will be to cause more general changes in clinical practice and in procurement behaviour. If manufacturers of competing technologies can demonstrate similar or better evidence for their products than one that has received supportive medical technologies guidance, and can offer them at equal or lower cost, then there is no reason why they should not promote them on those merits. There is also an opportunity for any manufacturer to notify their product for its own evaluation.

In practice, the programme works by manufacturers notifying products via the NICE website, using a notification form that poses explicit questions with advice on how best to present the answers. In particular, manufacturers need to describe in clear and simple terms their claims of advantages to patients and/or to the healthcare system, compared with current management. Advantages to patients may take the form of better clinical outcomes, greater convenience or improved acceptability. Advantages to the health service may include releasing facilities—for example by facilitating diagnosis or treatment as an outpatient rather than an inpatient; replacing a number of technologies with a single new one; or requiring fewer staff or less staff time to manage patients. Questions are also posed about costs and about contributions to the sustainability agenda (less energy use and less waste).

Manufacturers often contact the NICE team before notifying products. The MTEP team (based in the NICE Manchester office) provides advice and works closely with manufacturers if their products are selected for evaluation. The team checks that each product is eligible—it needs to fit the definition of a ‘medical technology’ and to be on the market or market-ready in the UK. They then develop the manufacturer's notification into a briefing document for MTAC, adding information about the estimated size of patient population likely to benefit from the technology and the impact of the condition being treated on health and on quality of life. At the same time they request the opinions of expert advisers (nominated by the manufacturers and by specialist organisations) and of relevant patient organisations—each using specially designed questionnaires.

MTAC considers the briefing note and decides whether to select the technology for evaluation. It is particularly influenced by technologies that have advantages that are clearly described, conceptually sound, plausible in practice and supported by sufficient proffered evidence. The comments of expert advisers are most influential: please do respond quickly if you are asked to provide advice—your input is crucial to this process. You do not need to be experienced in the use of the technology. What MTAC needs are the views of experts in the field about how they view the technology and its potential place in management. Patient organisations can also make valuable contributions but as yet few have chosen to do so.

When a technology has been selected by MTAC, the committee then ‘routes’ it for evaluation. A novel product offering a plausible step-change in management, but without an increase in cost (or similar benefit for less cost) is most likely to be routed for medical technologies guidance (produced by MTAC itself). Alternative routes are to the new NICE diagnostics assessment programme (for complex and/or costly diagnostics), to technology appraisals (for potentially high impact technologies with major cost implications), or possibly to the interventional procedures programme if the technology is integral to a procedure that is very new and of uncertain safety and efficacy.

Medical technologies guidance is produced quite quickly (within approximately 9 months) and is designed for single technologies with well-defined potential advantages and with no anticipated increase in overall cost. Cost modelling can take a medium term perspective: for example, a product might have a substantial acquisition cost, but its introduction might produce savings after 2 years of use—the guidance on SeQuent Please paclitaxel coated balloon angioplasty catheters for use in coronary arteries provides an example of this. Cost models need to be thoughtfully designed to take into account all aspects of the costs of the technology and its impact on both patient outcomes and on the care pathway, supported by as much direct evidence as possible. The focus of medical technologies guidance is on cost consequences—not ‘cost per quality-adjusted life-year’ (in contrast to the NICE technology appraisal programme).

The evidence presented to MTAC for the development of medical technologies guidance includes a detailed submission by the manufacturer, a commentary and critique of that submission by an external assessment centre contracted by NICE (which the manufacturer can check for factual accuracy), responses to questionnaires from nominated expert advisers and responses from relevant patient organisations.

In drafting medical technologies guidance, MTAC considers whether the claims of advantage for a technology, compared with current management, are supported by the evidence. A limited number of clear and credible claims makes this consideration more likely to produce a positive conclusion. Appropriate choice of comparator (‘current management’) is vital. Clear, unbiased and perceptive advice about current management is a particularly important aspect of the advice MTAC needs from clinical experts. If MTAC decides that some or all of the claims are supported (‘the case for adoption’) a recommendation is made to the NHS in England to consider adoption of the technology. This is accompanied by an explanation of the expected advantages and a description of the cost implications.

In addition, or alternatively, research recommendations may be made, in the form of ‘main recommendations’ (in section 1 of the guidance) specifying research that is then fostered by NICE. Such recommendations be will be made for technologies with potential for important benefits, but evidence that is not quite sufficient to show that the benefits are achieved in practice. Capacity is being built into the MTEP to facilitate the setting up of collaborations between manufacturers and the NHS for studies, which might include conventional randomised controlled trials, the introduction of technologies into defined NHS settings—for example, into selected hospitals, to obtain information on comparative effectiveness and cost; or more widespread dissemination, with data collection to address specific uncertainties.

If a product is not selected for evaluation at the briefing note stage, then the manufacturer receives a letter, with some information about MTAC's considerations. If a product is selected for medical technologies guidance but the evidence then fails to support claims of advantage, guidance is nevertheless published. This will describe which of the claimed advantages were supported by the evidence and which were not; and where research might resolve uncertainties that MTAC considered to be important to future use of the technology.

Like all NICE guidance, medical technologies guidance is subject to public consultation for 1 month. Notice of this consultation period is sent to all expert advisers and to relevant specialist organisations (defined in the original scope for the technology). In addition, anyone who has ‘registered an interest’ (by clicking on the link in the description of the developing guidance on the NICE website) will be alerted. Anyone who has ‘registered an interest’ with NICE in that area of clinical work will have the potential to find out about the development of guidance and the timing of consultation via links sent to them. Public consultation is very important: it gives clinicians and others an opportunity to influence guidance. Clear and cogent argument, supported by good reasons (and, better still, good evidence) may well persuade MTAC to make changes to the final guidance it presents to NICE for publication.

MTAC's mission is to identify technologies that will result in improvements for patients and efficiencies for the NHS. It will achieve this both by recommending specific products and by raising awareness of useful technological advances. Allied to this, I hope that its activities will encourage better research in the area of devices and diagnostics—both before manufacturers notify their products, and sometimes by fostering collaborative research for products with special promise. MTAC's deliberations rely heavily on advice from clinical experts: the time and effort that cardiologists and others offer for this is greatly appreciated.