Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

Clinical and economic impact of malnutrition per se on the postoperative course of colorectal cancer patients.

BACKGROUND & AIMS: To assess the medico-economic impact of malnutrition in patients who underwent surgery for colorectal cancer. METHODS: We performed post-hoc analyses of data from the Alves et al. prospective study. Using standard criteria of malnutrition, 2 groups were created a posteriori: Well-nourished (WN) and Mal-nourished (MN) patients. The 2 groups were statistically adjusted for age, cancer status, and scheduled surgery. Individual costs were valued using the French National Cost Study. Postoperative morbidity, mortality, hospital length-of-stay (LOS), and discharge setting were compared. We defined 3 scenarios, the most accurate estimate and its upper and lower limits, to assess the economic impact of malnutrition. RESULTS: 453 patients were included in the analyses. Complication and mortality rates were not significantly different between the 2 groups. MN patients had a mean LOS 3.41 days significantly longer than WN patients (p = 0.017). In MN patients, the cost of hospital stay was increased by around 3360 €, creating an annual impact of 10,159,436 € for French non-profit hospitals. CONCLUSIONS: Malnutrition in colorectal cancer surgical patients is associated with an increased LOS resulting in significant budget impact. Further studies are needed to investigate this impact and the related cost-benefit of perioperative specialized nutritional support and implementation of the ERAS protocol in this homogeneous category of patients.

[Cost of dialysis in France]. / Coût de la prise en charge de la dialyse en France.

The provision of care for patients with end-stage chronic renal failure is an important medical and economic challenge for the Health Insurance. Previous studies have shown a lower cost for home dialysis. More recently, studies have confirmed identical short-term survival rates between haemodialysis and peritoneal dialysis. Notwithstanding, home dialysis techniques utilization remains weak in France. This work aims at: determining the average annual cost of dialysis, per patient and per technique of dialysis, and assessing the global annual cost of dialysis in France, from the Health Insurance perspective. Methodologically, this article provides a static estimation of the cost of dialysis. Costs related to co-morbidities of end-stage chronic renal failure have not been considered. Standard patient care schemes have been outlined by a multidisciplinary expert committee, for each dialysis technique, and have been valorised using publicly available data and tariffs recorded in 2005. Our result show that home dialysis techniques are the less costly, with an average annual cost per patient of 49.9, 49.7 and 50.0 k euro respectively for home haemodialysis, automated peritoneal dialysis, and continuous ambulatory peritoneal dialysis. Autodialysis, autonomous in-center haemodialysis and in-center haemodialysis respectively cost 59.5, 62.3 and 81.5 k euro per patient and per annum. The total 2005 cost of dialysis for the Health Insurance is estimated at 2.1 billion euro. Therefore, the development of alternative techniques to in-center haemodialysis, such as home dialysis or autonomous in-center haemodialysis, autodialysis being already well developed, could generate savings for the Health Insurance. From the patient's perspective, it could also allow the enlightened choice of the best customized technique, less guided by local offer than by medical or social criteria, as well as by the patient's own opinion.