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15 result(s) for "Mounié, Michaël"
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Economic impact of generic antiretrovirals in France for HIV patients’ care: a simulation between 2019 and 2023
Background In a context where the economic burden of HIV is increasing as HIV patients now have a close to normal lifespan, the availability of generic antiretrovirals commonly prescribed in 2017 and the imminence of patent expiration are expected to provide substantial savings in the coming years. This article aims to assess the economic impact of these generic antiretrovirals in France and specifically over a five-year period. Methods An agent-based model was developed to simulate patient trajectories and treatment use over a five-year period. By comparing the results of costs for trajectories simulated under different predefined scenarios, a budget impact model can be created and sensitivity analyses performed on several parameters of importance. Results The potential economic savings from 2019 to 2023 generated by generic antiretrovirals range from €309 million when the penetration rate of generics is set at 10% to €1.5 billion at 70%. These savings range from €984 million to €993 million as the delay between patent and generic marketing authorisation varies from 10 to 15 years, and from €965 million to €993 million as the Negotiated Price per Unit (NPU) of generics at market-entry varies from 40 to 50% of the NPU for patents. Discussion This economic savings simulation could help decision makers to anticipate resource allocations for further innovation in antiretrovirals therapies as well as prevention, especially by funding the Pre-Exposure Prophylaxis (PrEP) or HIV screening.
Cost-utility of cochlear implantation in single-sided deafness and asymmetric hearing loss: results of a randomized controlled trial
Objectives To determine the Incremental Cost-Utility Ratio (ICUR) of cochlear implantation in the treatment of adult patients with single-sided deafness (SSD) and asymmetric hearing loss (AHL). Methods This prospective multicenter pragmatic study including a randomized controlled trial (RCT) enrolled 155 subjects with SSD or AHL. Subjects chose a treatment option between: abstention, Contralateral Routing Of the Signal hearing aids, Bone Conduction Device or Cochlear Implant (CI). Participants who opted for CI were then randomized between two arms: “immediate CI” where the cochlear implantation was performed within one month and “initial observation” where subjects were first observed. The ICUR of CI was determined at 6 months follow-up by comparing the two arms. Utility was measured using EuroQoL- 5 dimensions (EQ-5D), to calculate the gain in Quality-Adjusted Life Years (QALY). Individual costs were extracted from the French National Health Insurance database. A Markovian MultiState (MMS) model assessed the ICUR evolution over the lifetime horizon. Results Among the 155 included participants, 51 opted for a CI and were randomized. For a 6 months follow-up period, the ICUR was €422,279/QALY gained after CI. Using the MMS model, the ICUR of CI decreased to €57,561/QALY at 10 years follow-up, €38,006/QALY at 20 years, and dropped to €26,715 at 50 years. In the participants with severe tinnitus, mean ICUR was €31,105/QALY at 10 years. Conclusions CI can be considered as an efficient treatment in SSD and AHL from 20 years follow-up in the global population, and before 10 years follow-up in patients with severe associated tinnitus.
Healthcare resource consumption prior to asthma-related death: a nationwide descriptive study
Background: Although asthma mortality declined sharply until the mid-2000s, a stagnation in mortality has been observed over the past decade in different countries. Objective: The objective of this study is to describe healthcare resource consumption for patients who died from asthma in France. Method: This study was conducted using data from the French National Health Data System. Patients who died from asthma between 2013 and 2017 were identified by the ICD10 codes J45 and J46. Health care consumption data were collected. Patients were categorized into four categories according to age: ⩾75, (18–75), (12–18), (0–12). Daily doses of ICS were categorized according to GINA guidelines. Results: A total of 3829 patients were included. No ICS or an inadequate ICS dose was observed in 43.8%, 50.6%, 48.1%, and 54.0% of patients aged ⩾75, (18–74), (12–18), and (0–12) years, respectively. Dispensation of six or more SABA canisters was observed in 37.2%, 49.0%, and 70.3% of patients aged of ⩾75, (18–75), and (12–18) years, respectively. Omalizumab dispensation rate was very low [1.1% and 2.8% in patients aged ⩾75 and (18–75) years)]. The proportion of patients with a pulmonologist office visit was 13.8% and 14.6% in patients ⩾75 and (18–75) years, respectively. A lung function test was noted in only 18.6%, 28.3%, and 25.9% of patients ⩾75, (18–75) and (12–18) years, respectively. Conclusion: Half of the patients who died from asthma received inadequate ICS doses and only a small proportion had access to biological therapies. Less than 15% were referred to a specialist.
Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study
Introduction Telemonitoring in type 2 diabetes (T2D) is mainly based on glucose monitoring. A new type of connected device which routinely gathers data on weight, physical activity and food intake could improve patients’ diabetes control. The main aim of this study was to assess the efficacy of an at-home interventional programme incorporating such devices and lifestyle education software on diabetes control, i.e., change in HbA1c, compared to standard care. Methods This multicentre study randomly assigned 282 people with T2D to either a telemonitoring group (TMG) or a control group (CG) for a 1-year intervention period. While routine follow-up was maintained in the CG, TMG subjects were provided with interactive lifestyle educational software (with artificial intelligence algorithms) and connected objects (blood glucose meters, scales and actimeters) for use in their own homes and were remotely monitored by their diabetologists. Changes in HbA 1c were compared between groups using a mixed linear model. Results The mean HbA 1c dropped from 7.8 ± 0.8% (62 mmol/mol) to 7.4 ± 1.0% (57 mmol/mol) in the TMG and from 7.8 ± 0.8% (62 mmol/mol) to 7.6 ± 1.0% (60 mmol/mol) in the CG, resulting in an intergroup difference of − 0.16 ( p  = 0.06) in favour of TMG, after adjustment for confounding factors. Within TMG, the decrease in HbA 1c was greater in frequent users: − 0.23% ( p  = 0.03) in the case of connections to telemonitoring synthesis above the median and − 0.21% ( p  = 0.05) in the case of connections to tele-education software above the median compared to the CG. Significant weight loss was observed in the TMG but only in women ( p  = 0.01). Findings The EDUC@DOM telemonitoring and tele-education device did not highlight a significant decrease in HbA1c levels compared to routine management although a slight, albeit significant improvement in glycaemic control was observed in the frequent user subgroup as well as significant weight loss but only in women. A high level of satisfaction with the connected device was recorded amongst all participants. Trial Registration This trial was registered in the Clinical Trials Database on September 27, 2013, under no. NCT01955031 and bears ID-RCB number 2013-A00391-44.
Cost of care pathways before and after appropriate and inappropriate transfers to the emergency department among nursing home residents: results from the FINE study
Background Transfers of nursing home (NH) residents to the emergency department (ED) is frequent. Our main objective was to assess the cost of care pathways 6 months before and after the transfer to the emergency department among NH residents, according to the type of transfer (i.e. appropriate or inappropriate). Methods This was a part of an observational, multicenter, case-control study: the Factors associated with INappropriate transfer to the Emergency department among nursing home residents (FINE) study. Sixteen public hospitals of the former Midi-Pyrénées region participated in recruitment, in 2016. During the inclusion period, all NH residents arriving at the ED were included. A pluri-disciplinary team categorized each transfer to the ED into 2 groups: appropriate or inappropriate. Direct medical and nonmedical costs were assessed from the French Health Insurance (FHI) perspective. Healthcare resources were retrospectively gathered from the FHI database and valued using the tariffs reimbursed by the FHI. Costs were recorded over a 6-month period before and after transfer to the ED. Other variables were used for analysis: sex, age, Charlson score, season, death and presence inside the NH of a coordinating physician or a geriatric nursing assistant. Results Among the 1037 patients initially included in the FINE study, 616 who were listed in the FHI database were included in this economic study. Among them, 132 (21.4%) had an inappropriate transfer to the ED. In the 6 months before ED transfer, total direct costs on average amounted to 8,145€ vs. 6,493€ in the inappropriate and appropriate transfer groups, respectively. In the 6 months after ED transfer, they amounted on average to 9,050€ vs. 12,094€. Conclusions Total costs on average are higher after transfer to the ED, but there is no significant increase in healthcare expenditure with inappropriate ED transfer. Support for NH staff and better pathways of care could be necessary to reduce healthcare expenditures in NH residents. Trial registration clinicaltrials.gov, NCT02677272.
Waterborne disease outbreak detection: a simulation-based study
Waterborne disease outbreaks (WBDOs) remain a public health issue in developed countries, but to date the surveillance of WBDOs in France, mainly based on the voluntary reporting of clusters of acute gastrointestinal infections (AGIs) by general practitioners to health authorities, is characterized by low sensitivity. In this context, a detection algorithm using health insurance data and based on a space–time method was developed to improve WBDO detection. The objective of the present simulation-based study was to evaluate the performance of this algorithm for WBDO detection using health insurance data. The daily baseline counts of acute gastrointestinal infections were simulated. Two thousand simulated WBDO signals were then superimposed on the baseline data. Sensitivity (Se) and positive predictive value (PPV) were both used to evaluate the detection algorithm. Multivariate regression was also performed to identify the factors associated with WBDO detection. Almost three-quarters of the simulated WBDOs were detected (Se = 73.0%). More than 9 out of 10 detected signals corresponded to a WBDO (PPV = 90.5%). The probability of detecting a WBDO increased with the outbreak size. These results underline the value of using the detection algorithm for the implementation of a national surveillance system for WBDOs in France.
Healthcare Costs Associated with Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm Among Older Patients
Introduction Potentially inappropriate medication prescribing (PIP) among older patients is associated with an increased risk of adverse events and hospitalization, and sometimes increased healthcare costs. Objective The aim of this study was to explore the association between healthcare costs and PIP exposure among older patients. Methods Analyses were conducted using data from the Multidomain Alzheimer Preventive Trial (MAPT). A computer algorithm was constructed to detect PIP based on various different explicit criteria-based tools, and the results were expressed in number of medication-related potential non-compliances (MRNCs). A prescription was considered potentially inappropriate if there were one or more MRNCs. We performed a cost analysis from the French National Health Insurance perspective, and also performed a multivariate analysis to identify the association between healthcare costs and PIP (number of MRNCs). Results The computer algorithm analyzed medication prescribing from included patients ( N  = 1525 aged 75.3 ± 4.4 years; 64% women [ n  = 978]). PIP was associated with increased total healthcare costs and non-medication healthcare costs after adjusting for potential confounders. We also noted that healthcare costs tended to increase with the number of MRNCs. The mean additional healthcare costs were €517, €921, and €1669 per patient and year for patients with one or two MRNCs, three or four MRNCs, and five or more MRNCs, respectively, in comparison with patients with appropriate medication prescriptions. Conclusion These observations led us to conclude that interventions focused on reducing PIP could result in savings. Trial Registration ClinicalTrials.gov: NCT00672685.
Salvage brachytherapy with or without external beam radiotherapy for oral or oropharyngeal squamous cell carcinomas in previously irradiated areas: carcinologic and toxicity outcomes of 25 patients
The aim of this study was to assess outcomes of salvage brachytherapy for oral and oropharyngeal squamous cell carcinoma in previously irradiated areas. This was a retrospective study with 25 patients, treated between 1997 and 2016 for primary (21 cases) or recurrent (4 cases) oral or oropharyngeal squamous cell carcinomas in previously irradiated areas. Fifteen patients were treated with salvage brachytherapy (BT) alone, while 10 patients additionally received external beam radiotherapy (EBRT). Median BT dose was 45 Gy (range, 15-64 Gy), and a median total cumulative dose was 57 Gy (range, 40-70 Gy). Patient age, tumor stage, radiotherapy dose, and time between first treatment and recurrence were analyzed as prognostic factors. Median overall survival (OS) was 16 months. Patients with less advanced (T1) tumors survived significantly longer (27 vs. 14.5 months, = 0.046). Five patients experienced a local recurrence, and only one of them was treated with a total dose greater than 60 Gy. In multivariate analysis, patients with T1 lesions had a significant higher OS rate compared to patients with larger lesions (HR = 6.25, 95% CI: 1.18-33.1%, = 0.031). Patients who received more than 60 Gy had a non-significant, 80% increased OS than those treated with a lower dose ( = 0.072). There was four grade 3 acute toxicities, and no grade 3 or more late toxicities. Multimodal treatment, including salvage BT, may offer a curative option for selected patients with an acceptable risk of severe toxicity for the treatment of primary or recurrent tumors in previously irradiated areas.
Cost-Effectiveness Evaluation of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Study
Introduction Telemedicine programs using health technological innovation to remotely monitor the lifestyles of patients with type 2 diabetes (T2D) can improve glycaemic control and thus reduce the incidence of complications as well as management costs. In this context, an assessment was made of the 1-year and 2-year cost-effectiveness of the EDUC@DOM telemonitoring and tele-education program. Methods The EDUC@DOM study was a multicentre randomized controlled trial conducted between 2013 and 2017 that compared a telemonitoring group (TMG) to a control group (CG) merged with health insurance databases to extract economic data on resource consumption. Economic analysis was performed from the payer perspective, and direct costs and indirect costs were considered. The clinical outcome used was the intergroup change in glycated haemoglobin (HbA1c) levels from baseline. Missing economic data were imputed using multiple imputation, and fitted values from a generalized linear mixed model were used to calculate the incremental cost-effectiveness ratio (ICER). Bootstrapped 95% confidence ellipses were drawn in the cost-effectiveness plan. Results The main analysis included data from 256 patients: 126 in the TMG and 130 in the CG. Incremental costs over 1 and 2 years were equal to €2129 and €5101, respectively, in favour of the TMG. Once imputed and adjusted for confounding factors, the TMG trends to a 21% cost decrease over 1 and 2 years of follow-up (0.79 [0.58; 1.08], p  = 0.1452 and 0.79 [0.61; 1.03], p  = 0.0879, respectively). The EDUC@DOM program led to a €1334 cost saving and a 0.17 decrease in HbA1c over 1 year and a €3144 cost saving and a 0.14 decrease in HbA1c over 2 years. According to the confidence ellipse, EDUC@DOM was a cost-effective strategy. Conclusion This study provides additional economic information on telemonitoring and tele-education programs to enhance their acceptance and promote their use. In the light of this work, the EDUC@DOM program is a cost-saving strategy in T2D management. Trial registration This trial was registered in the Clinical Trials Database on 27 September 2013 under no. NCT01955031 and bears ID-RCB no. 2013-A00391-44.