RESUMO
The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.