Experimentation to favor innovation: Promoting the success of Article 51 transformation projects.

Article 51 of the French social security financing act for 2018 creates a derogatory funding system to support experimentation with new ways of organizing care pathways. The growing interest local leaders have expressed for this very open framework has led to a large number of candidate projects presented to public authorities in charge of the system. In order to sustain this dynamic movement and favor the success of these experimental projects, our work focused on clarifying the roles and responsibilities of project leaders and the need for a specific evaluation system that takes into account the evolving nature of these projects and the need for operational adaptability. We propose three levels of evaluation (feasibility, intermediary results and impact assessment) needed to decide on generalizing a given experiment based on its intermediary results, or on the contrary, terminating projects not meeting feasibility expectations. Our work emphasizes the importance of networking and of developing favorable conditions for fruitful collaboration between participating stakeholders-healthcare professionals, health providers, economic partners, learned societies-interested in improving the performance of care pathways.

Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases.

Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database. These databases, although developed for other purposes, have already been used for many years with regard to post-registration studies (PRS). The use thereof will continue to increase with the recent creation of the French National Health Data System (SNDS [2016 health system reform law]). At the same time, other databases are available in France, offering an illustration of "product use under actual practice conditions" by patients and health professionals (cohorts, specific registries, data warehouses, etc.). Based on a preliminary analysis of requests for PRS, approximately two-thirds appeared to have found at least a partial response in existing databases. Using these databases has a number of disadvantages, but also numerous advantages, which are listed. In order to facilitate access and optimise their use, it seemed important to draw up recommendations aiming to facilitate these developments and guarantee the conditions for their technical validity. The recommendations drawn up notably include the need for measures aiming to promote the visibility of research conducted on databases in the field of PRS. Moreover, it seemed worthwhile to promote the interoperability of health data warehouses, to make it possible to match information originating from field studies with information originating from databases, and to develop and share algorithms aiming to identify criteria of interest (proxies). Methodological documents, such as the French National Authority for Health (HAS) recommendations on "Les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes). Principes et méthodes" [Post-registration studies on health technologies (medicinal products, medical devices and procedures). Principles and methods] should be updated to incorporate these developments.

Hospital-based health technology assessment in France: A focus on medical devices.

Hospital-based health technology assessment (HTA) guides decisions as to whether new healthcare products should be made available within hospital structures. Its extension to medical devices (MDs) makes it possible to analyse several relevant aspects of these healthcare products in addition to their clinical value, and such evaluations are of interest to national health authorities, other healthcare establishments and industry. The aim of this work was to formulate several recommendations for a blueprint for hospital-based HTA for MDs in France. Five themes based on the work of the European Adopting hospital-based HTA in the EU (AdHopHTA) project were defined. Each member of the roundtable was then allocated a documentation task based on their experience of the theme concerned, and a literature review was carried out. An inventory of hospital-based HTA was performed and six recommendations aiming to strengthen and improve this approach were put forward: (1) encouragement of the spread of the hospital-based HTA culture and participation in communications and the promotion of this approach to hospital decision-makers; (2) adaptation of hospital-based HTA to the needs of decision-makers, taking into account the financial timetable and strategic objectives of the healthcare establishment; (3) harmonisation of the dossiers requested from industry between healthcare establishments, based on a common core; (4) promotion of the sharing of hospital-based HTA data under certain conditions, with data dissociable from the HTA report and the use of a validated methodology for the literature review; (5) creation of a composite indicator reflecting data production effort and the sharing of HTA activities, to be taken into account in the distribution of funds allocated for teaching, research and innovation missions considered of general interest; (6) the transmission of information directly from local to national level by pioneering centres. This work highlights the major issues at stake in hospital-based HTA and the need to valorise such activities in France.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

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.

Impact of bariatric surgery on the medical management and costs of obese patients in France: an analysis of a national representative claims database.

BACKGROUND: Bariatric surgery (BS) procedures are increasing but few studies have investigated their influence on medical management and costs in France. METHODS: The "Echantillon Généraliste des Beneficiaires" (EGB) is a 1/97 representative sample (n = 520,000 in 2011) of a national claims database covering about 80 % of the population. Adult patients treated for the first time with BS from January 2007 to December 2009 were identified, and a cohort including 350 patients was constituted with a 2-year follow-up before and after this primary procedure date (T). All items of reimbursed medical consumption and comorbidities over this period were identified. A comparison on the consumed resources and costs of BS was performed over time using multivariate models. RESULTS: The annual per capita reimbursed health expenses evolved from 2633 (±3124) in year (T - 2) to 3557 (±3380) in (T - 1), to 4240 (±3840) in (T + 1) (excluding procedure cost), and to 3755 (±5037) in (T + 2) with differences according to the type of surgery. In 39 % of patients, the evolution of those costs between (T - 2) and (T + 2) decreased by 5 %. In multivariate models, the significant factors were the presence of diabetes or hypertension medications before the procedure. Most items of medical consumption increased over the period pre- and post-procedure and started to decrease in (T + 2). CONCLUSIONS: Although this series contains mostly gastric bandings, which were less likely to affect comorbidities, the workup for preparing BS was probably an opportunity to benefit from a general clinical assessment which has generated extra short-term medical consumption and expenses began decreasing without allowing return on investment.

Bariatric surgery trends in France: 2005-2011.

BACKGROUND: Bariatric surgery underwent a dramatic change in the past decade in France. The objective of this study was to examine elective bariatric surgical procedures from 2005 to 2011 in France and to determine trends in the use of the procedure. METHODS: Data were extracted from the National Hospital Database. All admissions involving a bariatric surgery procedure were included. Procedures authorized by the Public Health Authority for the treatment of morbid obesity, including the adjustable gastric banding (AGB), vertical banded gastroplasty (VBG), gastric bypass (GB), sleeve gastrectomy (SG), and biliopancreatic diversion (BPD), either by laparotomic or laparoscopic approach, were retrieved. Revisional procedures, such as band removal or repositioning, band changing, and access device revisions, were also evaluated. RESULTS: We observed a 2.5-fold increase in bariatric procedures, from 12,800 in 2005 to 31,000 in 2011. Sleeve gastrectomy and gastric bypass became the most common bariatric procedures in France in 2011, whereas adjustable gastric banding has been decreasing since 2007. During the analysis period, about 50,000 revisional procedures were performed. The number of hospitals (private or public) providing bariatric surgery has considerably increased. However, most of the activity remains confined to a small number of centers, as 50% of all bariatric surgeries are carried out in 12% of hospitals. Bariatric procedures are predominantly performed in private hospitals. CONCLUSIONS: In France the number of bariatric procedures increased considerably between 2005 and 2011. The type of procedures changed, with a constant decrease of AGB and an important increase of SG and GB. Most bariatric procedures are still performed in low volume activity hospitals and in private hospitals.

Rate, type, and cost of pelvic organ prolapse surgery in Germany, France, and England.

OBJECTIVE: To estimate the rate, type and costs of surgical interventions for pelvic organ prolapse (POP) in Germany, France, and England. STUDY DESIGN: We identified the number, rate, and type of hospital admissions for pelvic floor surgery in 2005 from national hospital activity databases in each country: the German Hospital Episode, the French Medical Care Program Information System, and the National Health Service England Hospital Episode Statistics. Costs to the payer were estimated using the Diagnosis-Related Group reimbursement rates for each country. RESULTS: In 2005, the number (rate) of admissions for POP surgery was 36,854 (0.87 per 1000 women) in Germany, 36,679 (1.14 per 1000 women) in France, and 28,959 (1.13 per 1000 women) in England. Admissions for POP surgery constituted 10.4%, 16.7% and 16.9% of all admissions for female genital tract therapeutic interventions in Germany, France and England, respectively. At least 20% of hysterectomies were performed for the primary indication of POP. 57.4%, 45.0%, and 40.1% of all admissions for POP surgery included a hysterectomy. The costs to payers were 144,236,557 euro, 83,067,825 euro, and 81,030,907 euro in Germany, France, and England, respectively. CONCLUSION: Burden and costs associated with POP surgery are substantial in the three countries studied. Thus, programs aimed at reducing the burden of this disease are desirable.