NICE medical technology guidance: devices and diagnostics
- Correspondence to Professor Bruce Campbell, Chairman Medical Technologies Advisory Committee, National Institute for Health and Clinical Excellence MidCity Place, 71 High Holborn, London WC1V 6NA, UK;
- Accepted 28 July 2011
- Published Online First 13 September 2011
In a previous issue of Heart, I described the NICE Medical Technologies Evaluation Programme.1 The Medical Technologies Advisory Committee (MTAC) started its work at the end of 2009, selecting devices and diagnostics notified by manufacturers, and routing them for guidance development. Products are selected on the basis of evidence of claimed advantages to patients and/or to the health service compared with current management. Published evidence and the advice of nominated clinical experts are fundamental to the selection decision. Technologies are then routed for the most appropriate type of evaluation, including evaluation by the new NICE Diagnostics Assessment Programme. The most usual route is to MTAC itself, for publication of medical technologies guidance. Among the early technologies to have had MTAC evaluation, three relate to the heart, and each helps to illustrate the challenges of producing this novel type of NICE guidance.
The Sequent Please paclitaxel-coated balloon catheter (B Braun Medical, B Braun Vascular systems, Berlin, Germany) was the first product to be evaluated by MTAC.2 The resulting medical technology (MT) guidance supported the case for its adoption in the NHS for specific groups of patients—namely, patients with in-stent stenoses of bare metal stents; patients in whom only a short duration of clopidogrel treatment is desirable; and in situations where placement of further stents is not possible.
It is important to emphasise that MT guidance deals only with the case for adoption in the NHS of single products. In selecting Sequent Please and in routing it for medical technologies guidance, the Committee was mindful that various paclitaxel and other drug-eluting balloon catheters are available. However, it considered that Sequent Please had promise and …