ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT.

Objectives: Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment.

Methods: Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance.

Review of the role of NICE in promoting the adoption of innovative cardiac technologies.

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system.

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS.

Objectives: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system.

Methods: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products.

The Health Technology Assessment of companion diagnostics: experience of NICE.

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future.

Usefulness of a short-term register for health technology assessment where the evidence base is poor.

Unlabelled: This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure).

Methods: Coverage of the register during 2004-07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICE's original guidance from 2003.

How should accredited specialists be trained to do new procedures?

When and how specialists should receive training to perform newly introduced procedures is a topic which has received relatively scant attention. The demands of clinical governance and the prospect of revalidation make this an issue which clinicians and their specialist organisations cannot ignore. NICE has been advised by specialist clinical advisers to make recommendations about training in its guidance, but wanted both to review the literature and to consider the views of specialists on how this might best be done.