E-vita open plus for treating complex aneurysms and dissections of the thoracic aorta: a NICE medical technology guidance.

The E-vita open plus is a one-stage endoluminal stent graft system used for treating complex aneurysms and dissections of the thoracic aorta. The National Institute for Health and Care Excellence (NICE), as a part of its Medical Technologies Evaluation Programme (MTEP), selected this device for evaluation and invited the manufacturer, JOTEC GmbH, to submit clinical and economic evidence. King's Technology Evaluation Centre (KiTEC), an External Assessment Centre (EAC) commissioned by the NICE, independently critiqued the manufacturer's submissions. The EAC considered that the manufacturer had included most of the relevant evidence for the E-vita open plus, based on international E-vita open registry data for 274 patients, but had provided only limited evidence for the comparators. The EAC therefore conducted a systematic review and meta-analysis of all comparators to supplement the information, and found ten additional studies providing outcome data for the three two-stage comparators. The EAC noted that the cost model submitted by the manufacturer did not include key complications during the procedures. The EAC developed a new economic model incorporating data on complications along with their long-term costs. The revised model indicated that the E-vita open plus might not provide cost savings when compared with some of the comparators in the short-term (1 year), but would have high cost savings in the long-term, from the second year onwards. The NICE Medical Technologies Guidance MTG 16, issued in December 2013, recommended the adoption of the E-vita open plus in selected patients within the National Health Service in England.