Out-of-Pocket Expenses in Households of People Living with Obesity in France.

BACKGROUND/OBJECTIVES: Overweight and obesity result in a substantial economic burden in both low- and high-income countries. Moreover, this burden is often underestimated because it only partially accounts for unreimbursed out-of-pocket expenses (OOPE) related to obesity. The objective of our study was not only to evaluate OOPE incurred by people with obesity in relation to their disease with respect to direct medical expenditures and direct non-medical expenditures but also the proportion of people living with obesity who have forgone obesity-related healthcare due to the costs of such care. METHODS: An observational descriptive survey was conducted among people with class II/III obesity attending six obesity treatment centers in France. Volunteer adult participants completed a written/phone questionnaire on their related expenditures over the last 6 months for current expenditures and over the last 5 years for occasional ones. The costs were expressed in 2022 EUR. RESULTS: 299 people participated (age: 46 years [SD: 13.9], women: 72%, BMI ≥40 kg/m2: 62% and 48% with comorbidities). 65% had a professional activity. 83% declared that they had OOPE related to obesity representing annually EUR 2027/individual on average (5% of the household revenue), including weight loss and nutritional products, vitamins, meal programs, gym memberships, psychologists, but mainly adapted clothing, additional travel costs, and others. 15% of the respondents had to modify their professional activity due to obesity and 15% forwent some medical care in the last 12 months. CONCLUSIONS: OOPE is a significant part of the economic burden of obesity. Despite some limitations due to the specificities of the participants and because some costs may be more related to social activities affected by obesity than to healthcare, it seems important to consider these expenditures in cost estimates for obesity.

Economic Evaluation of Telerehabilitation: Systematic Literature Review of Cost-Utility Studies.

BACKGROUND: Telerehabilitation could benefit a large population by increasing adherence to rehabilitation protocols. OBJECTIVE: Our objective was to review and discuss the use of cost-utility approaches in economic evaluations of telerehabilitation interventions. METHODS: A review of the literature on PubMed, Scopus, Centres for Review and Dissemination databases (including the HTA database, the Database of Abstracts of Reviews of Effects, and the NHS Economic Evaluation Database), Cochrane Library, and ClinicalTrials.gov (last search on February 8, 2021) was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The inclusion criteria were defined in accordance with the PICOS (population, intervention, comparison, outcomes, and study design) system: the included studies had to evaluate patients in rehabilitation therapy for all diseases and disorders (population) through exercise-based telerehabilitation (intervention) and had to have a control group that received face-to-face rehabilitation (comparison), and these studies had to evaluate effectiveness through gain in quality of life (outcome) and used the design of randomized and controlled clinical studies (study). RESULTS: We included 11 economic evaluations, of which 6 concerned cardiovascular diseases. Several types of interventions were assessed as telerehabilitation, consisting in monitoring of rehabilitation at home (monitored by physicians) or a rehabilitation program with exercise and an educational intervention at home alone. All studies were based on randomized clinical trials and used a validated health-related quality of life instrument to describe patients' health states. Four evaluations used the EQ-5D, 1 used the EQ-5D-5L, 2 used the EQ-5D-3L, 3 used the Short-Form Six-Dimension questionnaire, and 1 used the 36-item Short Form survey. The mean quality-adjusted life years gained using telerehabilitation services varied from -0.09 to 0.89. These results were reported in terms of the probability that the intervention was cost-effective at different thresholds for willingness-to-pay values. Most studies showed results about telerehabilitation as dominant (ie, more effective and less costly) together with superiority or noninferiority in outcomes. CONCLUSIONS: There is evidence to support telerehabilitation as a cost-effective intervention for a large population among different disease areas. There is a need for conducting cost-effectiveness studies in countries because the available evidence has limited generalizability in such countries. TRIAL REGISTRATION: PROSPERO CRD42021248785; https://tinyurl.com/4xurdvwf.

France's competitiveness in global pharmaceutical research: The situation is improving.

AIMS: The French pharmaceutical companies' association (LEEM) biennially carries out a study on the attractiveness of France in pharmaceutical clinical research. This study aims to measure France's global competitiveness for international clinical trials (CT) and assess its strengths and areas of excellence. METHODS: A descriptive and comparative analysis was conducted using the data from both the ClinicalTrials.gov registry for the 2015-2019 period and those reported in a national web-based database (OSCAR) involving the major pharmaceutical companies operating in France in 2018-2019. OSCAR allows to describe the administrative authorization and starting process for all drug trials conducted in France. RESULTS: Among 8607 worldwide drug trials initiated in 2019, 34.3% (n=2.954) were funded exclusively by pharmaceutical companies (52.1% in France). On average, France was involved in 10.5% of all global industrial CTs launched over 2018-2019, still ranking in the 4th position among European countries. Early-phase trials represented 17.3% of trials conducted by the drug companies in France, versus 25% in Germany and 29% in United Kingdom. Oncology remains an area of excellence in France with 18.7% of all worldwide CTs conducted in this therapeutic area over the study period involving at least some French centres, ranking France 2nd among European countries. The median of total deadline before the first patient inclusion of 204 days in 2018-2019 with no marked improvement as compared to 2016-2017 period. However, the delay getting initial trial authorization was slightly reduced and an overall deadline of 167 days was observed for CTs entered the pilot phase initiated recently by the European regulation. CONCLUSION: After ten difficult years, areas of excellence, such as oncology and rare diseases and more recently, the outstanding mobilization for the COVID-19 research, have enabled France to maintain its pharmaceutical research. Furthermore, a set of additional decisions would strengthen this position in the next years.

Real-world cost-effectiveness of etonogestrel implants compared to long-term and short term reversible contraceptive methods in France.

BACKGROUND: To estimate the cost-effectiveness (CE) of etonogestrel implants compared to other long-term and short-term reversible contraceptive methods available in France. RESEARCH DESIGN AND METHODS: A 6-year Markov model compared effectiveness between the implant and six other contraceptive methods in sexually active, not-pregnancy-seeking French females of reproductive age. Contraception efficacy, switch rates and outcomes were based on French current medical practice. Incremental CE ratios (ICERs) were calculated as incremental cost per unintended pregnancy (UP) avoided. Efficiency frontier was plotted to identify cost-effective methods. Uncertainty was explored through sensitivity analyses. RESULTS: The implant was on the efficiency frontier along with combined oral contraceptive pill (COC) and copper IUD. Implant avoids between 0.75% and 3.53% additional UP per person-year compared to copper IUD and second generation COC, respectively, with an ICER of €2,221 per UP avoided compared to copper IUD. For the 240,000 French women currently using the implant, up to 8,475 UPs and up to 1,992 abortions may be prevented annually. CONCLUSION: With more unintended pregnancies avoided and comparable costs to copper IUD, the implant is a cost-effective option among long-term and short-term reversible contraceptive methods.

Hospitalization costs and risk of mortality in adults with nonalcoholic steatohepatitis: Analysis of a French national hospital database.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has reached high prevalence, paralleling the obesity pandemic. The aggressive form of the disease, nonalcoholic steatohepatitis (NASH), is characterized by fatty infiltration and inflammation of the liver, can progress to compensated cirrhosis (CC) and end-stage liver disease (ESLD: decompensated cirrhosis [DCC] and hepatocellular carcinoma [HCC]), and may ultimately require liver transplantation (LT). Real-world data on the burden of NAFLD/NASH are limited. This study aimed to evaluate the clinical and economic burden of NAFLD/NASH to the French hospital system. METHODS: This retrospective cohort study used data from the French PMSI-MCO database. Adults with NAFLD/NASH diagnosis identified between 2009 and 2015 were categorized into disease severity cohorts (NAFLD/NASH, CC, DCC, HCC, and LT). Demographic and clinical data were assessed at the index (diagnosis) date. Hospitalization resource utilization and costs were assessed in the pre- and post-index periods. Rates of liver disease progression and death were evaluated for each cohort. FINDINGS: During the median follow-up of 34.8 months, of the 131,656 patients included, 1491 patients developed CC (1.1%), 7846 developed DCC (5.9%), 1144 developed HCC (0.9%), and 52 required LT (0.04%). The diagnosis of NAFLD/NASH was associated with increasing annual costs: €7736 vs €5076 before the diagnosis. Rates of comorbidities, hospitalization resource utilization, and costs increased with disease progression. The rate of death at seven-year follow-up was 7.9% in NAFLD/NASH, CC: 18.0%, DCC: 34.9%, and HCC: 48.8%. INTERPRETATION: NAFLD/NASH is associated with high economic burden and imparts substantial risk of negative clinical outcomes and mortality at all stages of disease.

Long-term cost-effectiveness of the fixed-dose combination of tiotropium plus olodaterol based on the DYNAGITO trial results.

PURPOSE: Combinations of long-acting bronchodilators are recommended to reduce the rate of COPD exacerbations. Evidence from the DYNAGITO trial showed that the fixed-dose combination of tiotropium + olodaterol reduced the annual rate of total exacerbations (P<0.05) compared with tiotropium monotherapy. This study aimed to estimate the cost-effectiveness of the fixed-dose combination of tiotropium + olodaterol vs tiotropium monotherapy in COPD patients in the French setting. PATIENTS AND METHODS: A recently developed COPD patient-level simulation model was used to simulate the lifetime effects and costs for 15,000 patients receiving either tiotropium + olodaterol or tiotropium monotherapy by applying the reduction in annual exacerbation rate as observed in the DYNAGITO trial. The model was adapted to the French setting by including French unit costs for treatment medication, COPD maintenance treatment, COPD exacerbations (moderate or severe), and pneumonia. The main outcomes were the annual (severe) exacerbation rate, the number of quality-adjusted life-years (QALYs), and total lifetime costs. RESULTS: The number of QALYs for treatment with tiotropium + olodaterol was 0.042 higher compared with tiotropium monotherapy. Using a societal perspective, tiotropium + olodaterol resulted in a cost increase of +€123 and an incremental cost-effectiveness ratio (ICER) of €2,900 per QALY compared with tiotropium monotherapy. From a French National Sickness Fund perspective, total lifetime costs were reduced by €272 with tiotropium + olodaterol, resulting in tiotropium + olodaterol being the dominant treatment option, that is, more effects with less costs. Sensitivity analyses showed that reducing the cost of exacerbations by 34% increased the ICER to €15,400, which could still be considered cost-effective in the French setting. CONCLUSION: Treatment with tiotropium + olodaterol resulted in a gain in QALYs and savings in costs compared with tiotropium monotherapy using a National Sickness Fund perspective in France. From the societal perspective, tiotropium + olodaterol was found to be cost-effective with a low cost per QALY.