Feature Article

By: B. Campbell, Medical Technologies Advisory Committee, National Institute for Health and Clinical Excellence, London

The Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) has been designed to identify new or innovative technologies that may offer advantages to patients and/or to the National Health Service. If evaluation supports advantages claimed by manufacturers, then NICE will publish guidance encouraging their adoption. The overall aim is to promote more rapid and widespread uptake of products, compared with the traditional slow and patchy dissemination that is common without the kind of impetus NICE guidance can provide.

 

MTEP considers all kinds of devices and diagnostic technologies, including software (as defined in EU directives). Genetic tests fall within this scope, provided they have a medical purpose, and other technologies (tissue engineered products, for example) may be considered.

 

Products are notified to the programme by manufacturers, who need to present claims of advantages to patients or to the healthcare system compared with current management. This ‘case for adoption’ needs to be well described, easily understood and plausible. Advantages to patients may take the form of better clinical outcomes, greater convenience or improved acceptability. Advantages to the health service might take the form of releasing staff or facilities by:

Claimed advantages are best presented in a numbered or bulleted list, so that each is crystal clear. The size of the patient population likely to benefit from the technology and the impact of the condition being treated are also part of the consideration, and sustainability (significant contributions through less energy use or less waste) is taken into account.

 

Notification of products is done via the NICE website, using a form that poses explicit questions and requests. In order to be eligible, products need to be CE marked (or about to be CE marked) and launched (or ready to be launched) into the NHS. The likelihood of a product being selected is maximised by presenting information in clear and easily understood language. Claimed advantages that span several conditions, care settings and patient groups are particularly difficult to evaluate. Focusing on advantages that are conceptually sound and supported by proffered evidence increases the likelihood of selection. A novel product offering a plausible step change in management, but without an increase in cost, is most likely to succeed.

 

The MTEP team at NICE is always pleased to offer advice about notification. The team engages significantly with manufacturers about any product selected for evaluation. Selection is done by the Medical Technologies Advisory Committee (MTAC), an independent advisory committee made up of clinicians, representatives of the medical device and diagnostics industries, scientists, lay members and others. The committee makes its decisions on the basis of a Briefing Note, which is developed by the NICE team on the basis of the manufacturer’s notification with input from clinical expert advisers and patient groups. When MTAC selects a product, the committee then routes it for the most appropriate type of evaluation. Possible routing options include the new Diagnostics Assessment Programme (for complex and/or costly diagnostics), Technology Appraisals (for potentially high-impact technologies with major cost implications) or the Interventional Procedures Programme (very new procedures of uncertain safety and efficacy).

 

The most frequent route for evaluation is to MTAC itself for Medical Technologies guidance. This guidance is produced relatively fast (within about nine months) and is intended for single technologies with well-defined potential advantages and no anticipated increase in 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 two years of use, which are then expected to continue. Cost models should take into account all aspects of the technology on the care pathway and on patient outcomes, supported by as much direct evidence as possible. They are required to produce data on cost consequences (not “cost per quality adjusted life year” in contrast with the Technology Appraisal Programme).

 

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

 

Medical Technologies guidance focuses on whether the claims of advantage are supported by the evidence. That is why a limited number of clear and credible claims is so important from the outset. A recommendation may be made to the NHS in England to consider adoption of the technology (with explicit reasons for doing so, including likely cost advantages). In addition, or alternatively, recommendations may be made for further research.

 

Medical Technologies guidance can suggest areas for research, like other NICE guidance, identifying important uncertainties and encouraging research to elucidate these. In addition, it can make more potent recommendations for research (as “main recommendations” in Section 1 of the guidance) specifying research that is then fostered. These recommendations will be made for technologies showing potential for important benefits, but that require more evidence to support the achievement of those benefits in practice. Capacity is being built into the MTEP to facilitate the setting up of collaborative research and data collection exercises, involving manufacturers and the NHS. These might take a variety of forms, including: 

 

There has been concern about the fact that Medical Technologies guidance will deal with single products. What if another manufacturer has just launched a similar product or is about to do so? What if another manufacturer’s product is the subject of better or more plentiful research evidence? What if a conceptually different product exists, which may offer similar advantages at the same or lesser cost? These and many similar concerns have been considered at length during development of the MTEP. A short passage of text is now included above Medical Technologies recommendations: “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.”

 

The text above is intended to make clear that the guidance is making no statement about similar products: indeed, manufacturers of similar products might “use” the guidance to promote their own, provided that they can present evidence to commissioners of equal or greater advantages and/or similar/lower cost. Alternatively—on those occasions when an “equivalent” product is on the market or market-ready—the manufacturer may choose to notify that product to the MTEP. This needs to be done before the start of Public Consultation on the first-notified product.

 

The pathway may pose dilemmas for manufacturers about whether and when to notify: for example whether to notify very early with less evidence, or a little later with more evidence to support their claims. If a product is not selected, then the manufacturer receives a letter about that decision, which includes information about MTAC’s considerations. Products may be renotified with an amended case for adoption and/or an enhanced evidence base and the MTEP team is happy to advise on this. If a product is selected for Medical Technologies guidance and the case for adoption is not supported, then guidance is nevertheless published. This will describe the claimed advantages; the respects in which they were or were not supported by the evidence; and, where research might resolve uncertainties, those that MTAC considered to be important for future use of the technology.

 

The essence of the MTEP is to nudge the NHS towards uptake of advantageous new technologies more rapidly than would otherwise be the case. It presents an opportunity for manufacturers to market their product with the explicit support of NICE guidance. It aims to promote better research in the medtech arena by requiring good evidence to underpin notifications, and also by selectively recommending and fostering collaborative research between manufacturers and the NHS. I hope that the prospect of working with NICE and of having products supported by NICE guidance will encourage manufacturers to notify products that are novel, advantageous to patients and the NHS, and supported by increasingly robust evidence.

 

is Chair of the Medical Technologies Advisory Committee,
National Institute for Health and Clinical Excellence, MidCity Place,
71 High Holborn, London WC1V 6NA, UK

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