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The introduction of new healthcare technologies requires an appropriate discourse between clinicians who identify problems to be overcome and industrial partners who provide potential solutions. New products go through a tight regulatory process before they can be widely used. Although this process is somewhat different for medical devices than for drugs, the principles are the same: demonstration of proof of principle and safety, and identification of patients most likely to benefit. However, their use nowadays depends as much on a demonstration of cost effectiveness as on clinical effectiveness. Cost-effectiveness analysis requires quantification of both clinical effect and overall costs of different treatments.
In the UK the balance between clinical effectiveness and cost effectiveness is determined by the National Institute of Health and Clinical Excellence (NICE). NICE has just published its updated technology appraisal following its latest review of the use of drug-eluting stents (DES), and reaffirms that these products should be used in coronary angioplasty in patients with long lesions (>15 mm), or in those with lesions in small vessels (<3 mm), because it is in these groups that the use of DES can be shown to be cost effective. It has, however, added a new statement, indicating that this cost effectiveness is dependent on the price differential between bare metal stents (BMS) and DES.1
The process by which NICE performs its appraisals includes a call for evidence from all interested stakeholders as well as the production of an assessment report (AR) and later, an appraisal consultation document (ACD, in effect the first draft of the guidance). The AR summarises the findings of an independent Assessment Group, who are commissioned by NICE to perform a systematic review of the published data and undertake an economic evaluation based on the clinical evidence. On this occasion, the Appraisals Committee has had …
Competing interests: MAdB has received travel grants and research funds from, and has sat on advisory boards of, some manufacturers of drug-eluting stents.