EXECUTIVE SUMMARY
The CEDIT, a hospital based HTA agency of the Paris University hospital (AP-HP) assessed the value of endobronchial spirals in the treatment of severe pulmonary emphysema.
Technical aspects: The RePneu® implantable medical device consists of sterile nitinol (nickel titanium alloy) spirals that adopt a predetermined shape (other than straight) once in place in the bronchi, thus retracting the airways while aiming to restore the tensile forces within the pulmonary parenchyma.
Medical aspects: The RePneu® device is under evaluation at the French National Authority for Health (HAS). It has been evaluated in several studies and in particular through three clinical trials. No trial has compared the spirals with other endobronchial devices (valves, etc.) or with surgery. The REVOLENS and RESET trials provided evidence in favor of its efficacy but the clinical benefit is modest and several side-effects have been detected. The target population has been estimated by the manufacturer between 11 and 14 per million inhabitants, in other words a prevalence of about 700 to 900 patients in France.
Economic aspects: The manufacturer’s indicated list price is 1350€ per spiral. A patient usually undergo two fibroscopic procedures (two lobes treated) to put in place about 20-30 spirals in total. The REVOLENS clinical trial conducted in France comprises a health economic analysis concluding on a very high cost efficacy ratio (about 790 000 US$ / QALY) after one year. This trial will follow the patients for 5 years, allowing thus to better describe the clinical and economic evaluation results.
Organizational aspects: the procedure has to be carried out in an operating department, under general anesthesia or lighter sedation. It is performed at the occasion of a bronchial fibroscopy under radiographic guidance and lasts roughly 30 minutes.
Recommendations of CEDIT : awaiting the assessment from the HAS, and taking into account the low level of clinical effectiveness in the studied population and a cost/efficacy ratio deemed excessive, the CEDIT does not recommend the use of this device in the AP-HP health care facilities.
