Impact of Continuous Positive Airway Pressure Termination on Permanent Work Disability in Obstructive Sleep Apnea: A French Nationwide ALASKA Database Analysis.

Three-year continuous positive airway pressure (CPAP) therapy termination rates are up to 50%, and therapy termination is associated with higher all-cause mortality and incident cardiovascular event risk. This study investigated the impact of CPAP therapy termination in the first year on long sick leave leading to permanent work disability in patients with obstructive sleep apnea based on data from the Nationwide Claims Data Lake for Sleep Apnoea (ALASKA). French national health insurance reimbursement system data were analyzed for all adults with OSA aged ≤62 years who started CPAP therapy in France in 2015 and 2016.

Evaluation of digital medical devices: How to take into account the specificities of these solutions?

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability.

CPAP resumption after a first termination and impact on all-cause mortality in France.

Background: Continuation of continuous positive airway pressure (CPAP) therapy after initial prescription has been shown to reduce all-cause mortality therapy termination. However, there is a lack of data on the rates and impact of resuming CPAP in patients with obstructive sleep apnoea (OSA). This analysis determined the prevalence of CPAP resumption in the year after termination, characterised determinants of CPAP resumption, and examined the impact of CPAP resumption on all-cause mortality.

Why and how can we improve patient and caregiver information for the proper use of their medical devices throughout the care pathway?

Information is generally a major pillar in the relationship of trust between the patient and their healthcare team. In the case of medical devices, which are operator-dependent and for which the proper "handling" of the device will directly affect its performance, information on the proper use becomes a major therapeutic issue. To do this, patients must have access to quality information about health products.

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis.

Background: Randomized controlled trials have failed to demonstrate an effect of CPAP therapy on mortality. However, these studies have a number of important limitations, including low CPAP adherence, patient selection, and a small number of mortality events.

Research Question: What are the effects of CPAP therapy termination in the first year on all-cause mortality in patients with OSA from the Nationwide Claims Data Lake for Sleep Apnea study?

Study Design And Methods: Data from the Système National des Données de Santé (SNDS) database, the French national health insurance reimbursement system, for all new CPAP users ≥ 18 years of age were analyzed.

Place of patient-reported outcomes & experiences measurements (PROMS/PREMS) in the assessment and pricing of Health technologies in France.

In the context of health technologies assessment, patient-reported outcome measures (PROMs) have become assessment criteria that are expected by evaluation agencies along with the other usual clinical criteria. PROMs instruments measure all aspects of patient experience in connection with their health: symptoms, activities of daily living (physical function, sleep, etc.), various aspects of health-related quality of life (QoL), compliance, global impression of change in wellbeing.

CPAP Therapy Termination Rates by OSA Phenotype: A French Nationwide Database Analysis.

The nationwide claims data lake for sleep apnoea (ALASKA)-real-life data for understanding and increasing obstructive sleep apnea (OSA) quality of care study-investigated long-term continuous positive airway pressure (CPAP) termination rates, focusing on the contribution of comorbidities. The French national health insurance reimbursement system data for new CPAP users aged ≥18 years were analyzed. Innovative algorithms were used to determine the presence of specific comorbidities (hypertension, diabetes and chronic obstructive pulmonary disease (COPD)).

Telemonitoring and experimentation in telemedicine for the improvement of healthcare pathways (ETAPES program). Sustainability beyond 2021: What type of organisational model and funding should be used?

Medical telemonitoring could be a significant lever for improving access to care and the cost-effectiveness of patient management, particularly for chronic conditions, by reducing hospital admissions. It also appears to be an opportunity to redesign the healthcare pathway and its organisation in a way that is suited to the demographic, economic, and technical challenges that our healthcare system must address. In order to prepare for the future of socialised financing of telemonitoring at the end of the ETAPES programme, participants at the round table worked on nine recommendations, based on an analysis of international literature and the French healthcare system.

New European medical device regulation: How the French ecosystem should seize the opportunity of the EUDAMED and the UDI system, while overcoming the constraints thereof.

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.).

Care pathway, towards the establishment of tailored funding: Reasons and criteria for success.

Care pathways are often at the forefront of political thinking about health care practices in France without ever finding a durable means for their extension. Closely linked to funding of healthcare system, they have, once again, been the object of so many economical discussions in 2017, as part of a more optimistic climate of governance which is therefore more open to change. Our changing system, the development and increasingly chronic nature of diseases, the scale of technological breakthroughs, these are all factors driving this topic forward.

What is the budget impact of a new treatment or new health technology arriving on the market?

In France, market access for innovative drugs (level I, II & III improvement of medical service rendered having significant impact on health insurance expenditure) involves medico-economic evaluation. In addition to cost-effectiveness analysis (CEA), budget impact analysis (BIA) can be performed, especially since the sustainability of the health insurance system has become a growing concern for all stakeholders. The members of the Giens 2016 round table discussed the contribution of BIA based on a review of the literature on distribution models, the participants' experiences including experience related to the modalities of hospital assessments, and examples from other countries.

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.

Post-approval studies in France, challenges facing medical devices.

Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting.

Medico-economic evaluation of health products in the context of the Social Security Financing Act for 2012.

The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico-economic evaluation of health products published a few days earlier (02 October 2012). The medico-economic evaluation (MEE), becomes an additional determinant for fixing the prices of health products by the Health products economic committee (Comité économique des produits de santé, CEPS) via the hierarchisation of treatment strategies, and thus modifies the market access conditions. Limiting the analysis to medicinal products and medical devices for which a major, important or moderate improvement in the medical service rendered (ASMR) or of the expected service (ASA) has been requested and presenting a significant budget impact on the Social Security expenses, excludes health products with ASMR or ASA with a lower level requested which often create complex price fixing problems and often have a major budget impact.