ABSTRACT
The Thopaz+ portable digital system was evaluated by the Medical Technologies Advisory Committee (MTAC) of the National Institute for Health and Care Excellence (NICE). The manufacturer, Medela, submitted a case for the adoption of Thopaz+ that was critiqued by Cedar, on behalf of NICE. Due to a lack of clinical evidence submitted by the manufacturer, Cedar carried out its own literature search. Clinical evidence showed that the use of Thopaz+ led to shorter drainage times, a shorter hospital stay, lower rates of chest drain re-insertion and higher patient satisfaction compared to conventional chest drainage when used in patients following pulmonary resection. One comparative study of the use of Thopaz+ in patients with spontaneous pneumothorax was identified and showed shorter drainage times and a shorter length of hospital stay compared to conventional drainage. No economic evidence was submitted by the manufacturer, but a simple decision tree model was included. The model was improved by Cedar and showed a cost saving of £111.33 per patient when Thopaz+ was used instead of conventional chest drainage in patients following pulmonary resection. Cedar also carried out a sub-group analysis of the use of Thopaz+ instead of conventional drainage in patients with pneumothorax where a cost saving of £550.90 was observed. The main cost driver for the model and sub-group analysis was length of stay. The sub-group analysis was based on a single comparative study. However, the MTAC received details of an unpublished audit of Thopaz+ which confirmed its efficacy in treating patients with pneumothorax. Thopaz+ received a positive recommendation in Medical Technologies Guidance 37.
Subject(s)
Chest Tubes/standards , Drainage/methods , Drainage/standards , Monitoring, Physiologic/methods , Monitoring, Physiologic/standards , Practice Guidelines as Topic , Technology Assessment, Biomedical/standards , Cost-Benefit Analysis , HumansABSTRACT
ENDURALIFE™-powered cardiac resynchronisation therapy defibrillator (CRT-D) devices were the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the treatment of heart failure. Boston Scientific (manufacturer) submitted a case for the adoption of the technology, claiming that it has a longer battery life resulting in a longer time to CRT-D replacement. Other claimed benefits were fewer complications associated with replacement procedures, fewer hospital admissions, less time spent in hospital and reduced demand on cardiology device implantation rooms. The submission was critiqued by Cedar, an external assessment centre. The submitted clinical evidence showed that ENDURALIFE-powered devices implanted during the period 2008-2010 were superior, in terms of longevity, to other devices at that time. Submitted economic evidence indicated that, because of a reduction in the need for replacement procedures, ENDURALIFE-powered devices were cost saving when compared to comparator devices. Cedar highlighted uncertainty of the applicability of the clinical evidence to devices marketed today. The Medical Technologies Advisory Committee noted that this was unavoidable due to the follow-up time required to study battery life. Clinical experts noted that increased battery life is an important patient benefit. However, centres use devices from multiple manufacturers to negate pressure on clinical services in the event of a major device recall. The clinical and economic evidence showed benefits to the patient, and further analysis requested by the committee suggested that ENDURALIFE-powered CRT-Ds may save between £2120 and £5627 per patient over 15 years through a reduction in the need for replacement procedures. ENDURALIFE-powered CRT-D devices received a positive recommendation in Medical Technologies Guidance 33.