ReCell® spray-on skin system for treating skin loss, scarring and depigmentation after burn injury: a NICE medical technology guidance

The gold standard treatment for deep burns is an autologous skin graft; in larger burns this may be meshed to increase the area covered. However, long-term aesthetic and functional outcomes of graft scars may be poor. ReCell® is a medical device that processes skin samples in the operating theatre into a cell suspension to be sprayed or dripped onto a wound. It is claimed to improve healing and scar appearance. This device was evaluated by the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme. Two groups were defined: ReCell compared to conventional dressings in shallower burns, and meshed grafts plus ReCell compared to meshed grafts alone in larger deeper burns. The manufacturer’s clinical evidence submission included three papers and eight conference abstracts. The External Assessment Centre (EAC) excluded two of these and added seven abstracts. In general, the evidence did not fit the defined groups, but suggested that ReCell was clinically comparable to skin grafts for partial thickness burns; however, ReCell is not used in this way in the UK. The manufacturer submitted an economic model in which ReCell treatment of partial thickness burns reduced the requirement for later skin grafts. This indicated that ReCell alone was cost saving in comparison to conventional dressings. The EAC indicated that this model was clinically inappropriate, but data were not available to populate a new model. NICE Medical Technologies Guidance 21 recommended that additional research was needed to address the uncertainties regarding the potential benefits of ReCell

The Urolift System for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a NICE medical technology guidance

As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer’s submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published ‘marked improvement’ in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting