Costs and management of patients with hemophilia A in France: the Hemraude study.

OBJECTIVE: The Hemraude study was conducted to describe the profile of patients with HA, disease management, and economic burden in a collective perspective. METHODS: This retrospective study was conducted using the French administrative healthcare claims database SNIIRAM/SNDS. Male patients treated for hemophilia A with a long-term illness (ALD) status or invalidity were included in the study between January 1, 2016 and December 31, 2017. Patients were classified in six treatment groups: no treatment, on-demand FVIII, prophylactic FVIII, FVIII in immune tolerance induction (ITI) protocol, on-demand bypassing agents, and prophylactic bypassing agents. Patients treated with FVIII in ITI protocol and those treated with bypassing agents are deemed to have developed inhibitors. HA patients were compared to a control population without coagulation disorder and matched (ratio 1:3) on age and sex. RESULTS: A total of 4172 patients were included in the analysis, aged on average 35.2 years, 5.3% had HIV infection, and 8.8% had hepatitis B or C. In 2017, half of the patients received no treatment for HA, 46.7% were treated with FVIII (25% on demand, 20.6% with prophylaxis, and 1.1% ITI), 1.5% with bypassing agents. Patients treated with prophylactic treatments, either inhibitor or non-inhibitor, were less likely to be hospitalized for severe bleeding compared to patients receiving on-demand treatments. The average annual costs for HA management per patient were 72,209.60 €. The highest costs were observed in patients treated with FVIII in ITI protocol and those receiving prophylactic bypassing agents. CONCLUSION: Direct costs of HA treatments for HA may be very high especially in the small percentage of patients developing inhibitors or treated with ITI protocol.

Two year continuation rates of contraceptive methods in France: a cohort study from the French national health insurance database.

OBJECTIVE: The aim of this study was to evaluate the continuation rates of reimbursed contraceptive methods in French real-world conditions. METHODS: A retrospective cohort study using a representative sample of the national health insurance database, the General Sample of Beneficiaries (Echantillon Généralistes des Bénéficiaires [EGB]), was performed between 2006 and 2012. Selected women were ≥15 years of age and had started a reimbursed contraceptive method between 2009 and 2012 without prior reimbursement for an implant or an intrauterine contraceptive method between 2006 and 2008. The outcome of interest was the continuation rates, defined as the probability of women initiating a contraceptive method and continuing to use the same method over time. Continuation rates were assessed for up to 2 years. Only the first contraceptive method used during the study period was considered in the analysis. Non-parametric Kaplan-Meier survival analysis was used to assess continuation rates. RESULTS: A population of 42,365 women representative of the 4,109,405 French women initiating any reimbursed method between 2009 and 2012 was identified in the EGB: 74.5% of women used oral contraceptives, 12.8% the levonorgestrel-releasing intrauterine system (LNG-IUS), 9.2% the copper intrauterine device (Cu-IUD) and 3.5% the subdermal etonogestrel (ENG) implant. The 2 year continuation rates varied from 9.1% for progestin-only oral contraceptives, 27.6% for first to second generation combined oral contraceptives (COCs) and 33.4% for third generation COCs to 83.6% for the ENG implant, 88.1% for the Cu-IUD and 91.1% for the LNG-IUS. CONCLUSION: This study conducted in real-world conditions showed that long-acting reversible contraceptive (LARC) methods remain rarely used in France despite high continuation rates over 2 years. Increasing the use of LARC methods is therefore a public health priority.

[Costs of healthcare resource consumption after a myocardial infarction in France: An estimate from a medicoadministrative database (GSB)]. / Coût des consommations de soins après un infarctus du myocarde en France : une estimation à partir de l'échantillon généraliste des bénéficiaires (EGB).

OBJECTIVE: To estimate the costs of healthcare resource consumption in the year preceding and the year following a myocardial infarction (MI). PATIENTS AND METHODS: A historical cohort of patients experiencing an MI in France between 2007 and 2011 was extracted from the échantillon généraliste de bénéficiaires, a 1/97th sample of all beneficiaries of public health insurance in France. RESULTS: A total of 1920 patients experiencing an MI were identified. Two-thirds were men and the mean age was 67 years; 20.6% had diabetes, 37.6% hypercholesterolaemia and 82.4% hypertension. From a societal perspective, the annual costs of medical consumption related to hospitalisations increased from € 4548 before the MI to € 6470 in the following year. Costs of community care rose from € 2932 to € 6208. This increase concerned all components of community healthcare: costs associated with medical transportation increased fourfold, those associated with consultations and laboratory tests tripled, medication costs doubled and costs of paramedical services also increased, but to a lesser extent. It should be noted that the cost of hospitalisation for the index MI (€ 5876) is not included in the above costs. CONCLUSION: From a society perspective, the cost of healthcare resource consumption increased threefold in the year following an MI.

[Management and costs of chronic pulmonary obstructive disease in France in 2011]. / Prise en charge et coûts de la bronchopneumopathie chronique obstructive en France en 2011.

OBJECTIVES: To estimate the prevalence of treated chronic obstructive pulmonary disease (COPD) and its associated costs by stage of severity. METHODS: The study was conducted on the 2011 data of the french general beneficiary sample database (EGB). EGB is a 1/97th sample of the whole population of the beneficiaries of the main compulsory national health insurances. COPD cases and the level of severity of the disease have been identified using new algorithms established from the available parameters in EGB. Costs were estimated using a collective perspective. RESULTS: The minimal prevalence of treated COPD was estimated at 3.8% in patients of 40 years and older and 1.9% regardless of the age of individuals. This population was predominantly male (58.2%) with a mean age of 68.8 years (±12.7). A total of 6.2% of patients had a health-care utilization suggestive of a very severe stage of COPD and 8.1%, 13.8% and 71.9% suggestive of severe, moderate and mild stages respectively. Over one year, 28.8% of patients visited a specialist respiratory physician, 5.0% were hospitalized (≥24h) for COPD and 6.7% died. Patients experienced an average of 1.7 (±1.5) exacerbations per year and only 61.4% received specific pharmacological treatment for COPD during the year. The average yearly health-care cost of a patient with COPD was estimated at €9382, with €5342 directly related to COPD. CONCLUSION: This study based on medico-administrative databases confirms the high epidemiological and economic burden of COPD in France.

Management of focal epilepsy in adults treated with polytherapy in France: the direct cost of drug resistance (ESPERA study).

PURPOSE: To estimate the direct costs associated with the current management of focal epilepsy in adults treated with a combination of antiepileptic drugs (AEDs) in France and the supplementary costs of drug resistant epilepsy as defined by the International League Against Epilepsy (ILAE) in 2009. METHODS: ESPERA was a multicentre, observational, cross-sectional study conducted in France in 2010. A random sample of neurologists, including specialists in epilepsy, prospectively enrolled adults with focal epilepsy treated with a combination of AEDs. Investigators classified their patients according to the 2009 ILAE criteria for drug resistance and this classification was then reviewed by two experts. All items of healthcare resource use associated with epilepsy over the previous year were documented retrospectively and valued from a societal perspective. RESULTS: Seventy-one neurologists enrolled 405 patients. After experts' review, 70.6% of patients were classified with drug-resistant epilepsy, 22.4% with drug-responsive epilepsy and 7% with undefined epilepsy. The mean annual epilepsy-related direct costs per patient were €4485±€4313 in patients with drug-resistant epilepsy compared to €1926±€1795 in patients with drug-responsive epilepsy. In these two groups, costs of AEDs were estimated at €2603 and €1544, respectively. Patients with drug-resistant epilepsy were more often hospitalised (mean annual cost: €1270 vs. €97) and underwent more additional tests (mean annual cost: €194 vs. €53). CONCLUSION: The direct cost of focal epilepsy in adults on AED combinations was estimated at €3850/patient/year. Drug resistance, as defined by the 2009 ILAE criteria, resulted in significant extra costs which varied with seizure frequency.

[Adult patients treated for focal epilepsy with antiepileptic drugs (AEDs) in combination in France: description according to the 2009 ILAE definition of AED resistance (ESPERA study)]. / Patients adultes traités par une association d'antiépileptiques pour une épilepsie focale en France: description et mode de prise en charge selon les nouveaux critères de définition de la pharmacorésistance (étude ESPERA).

AIMS: To describe the adult population treated with antiepileptic drugs (AEDs) in combination for focal epilepsy according to the definition of AED resistance proposed by the International League Against Epilepsy (ILAE) in 2009 and to evaluate its implementation in current practice. METHODS: ESPERA was a multicenter, observational, cross-sectional study with a clinical data collection covering the past 12 months conducted by neurologists. Classifications according to AED responsiveness established by investigators for each enrolled patient were revised by two experts. RESULTS: Seventy-one neurologists enrolled 405 patients. Their mean age was 42.7 years (sex-ratioM/F 0.98). According to the investigators, 60% of epilepsies were drug-resistant, 37% drug-responsive and 3% had an undefined drug-responsiveness. After revision of experts, 71% of epilepsies were classified as drug resistant, 22% as responsive and 7% as undefined. Among the participating neurologists, 76% have made at least one error in classifying their patients according to the 2009 ILAE definition of AED resistance. Because of epilepsy, 24% of patients (age≤65) were inactive and 42% could not drive (respectively 29 and 49% of patients with AED resistant epilepsy). Half of patients had at least one other chronic condition. Number of prescribed drugs in combination and health care resource utilisation were significantly higher in patients with drug-resistant epilepsies than in patients with drug responsive epilepsies. CONCLUSION: ESPERA study shows that the use of new definition of drug-resistance in everyday practice seems difficult without any additional training and that the social and professional disability is frequent in adults with focal epilepsies treated with polytherapy.

[Efficacy of moxifloxacin in treating bacterial conjunctivitis: a meta-analysis]. / Efficacité de la moxifloxacine dans le traitement de la conjonctivite bactérienne aiguë : une méta-analyse.

PURPOSE: To estimate the effectiveness of moxifloxacin instillation in the treatment of bacterial conjunctivitis. PATIENTS AND METHODS: Five randomized clinical trials on moxifloxacin were identified, three versus placebo, one versus ofloxacin, and another versus levofloxacin. The effectiveness parameters included clinical efficacy and drop-out rates for all reasons including lack of efficacy. The fixed and random effects were estimated on intent-to-treat populations. Models for risk ratios and risk differences as well as tests for study homogeneity were computed. RESULTS: Patients treated with moxifloxacin dropped out less frequently (OR=2.22 [1.62-3.03]; p<0.001), had less treatment failure (OR=3.61 [2.30-5.65]; p<0.001), and experienced clinical cure more often (OR=1.59 [1.21-2.04]; p=0.001) than placebo-treated patients. In comparison to ofloxacin, patients treated with moxifloxacin had fewer drop-outs for reasons other than treatment failure (OR=1.92 [1.28-2.89]; p=0.02) and fewer drop-outs for treatment failure (OR=2.53 [1.41-4.56]; p=0.002). CONCLUSION: This meta-analysis demonstrated the clinical efficacy of moxifloxacin compared to placebo. Fewer patients dropped out from moxifloxacin treatment compared to ofloxacin.

Lifetime costs and effectiveness of ReSTOR compared with a monofocal IOL and Array-SA40 in the Netherlands.

PURPOSE: To estimate the lifetime cost consequences for society and the National Health Service (NHS) of bilateral monofocal (SI40NB) or multifocal (ReSTOR or Array-SA40) intraocular lense (IOL) implantation after cataract surgery. SETTING: Public hospital in the Netherlands. METHODS: A Markov model simulated three cohorts of patients followed 69 until 100 years of age, or death. Spectacle independence rates for each IOL were adjusted to the results of a randomized clinical trial that compared monofocal and multifocal Array-SA40 IOL implants, together with a prospective cohort of patients implanted with ReSTOR. Adjustment was performed using the propensity score method in a multivariate analysis. Resource consumption was estimated from a dedicated Dutch survey. Dutch unit costs were applied to spectacles, cataract surgery, IOLs, visits to ophthalmologists, optometrists, transport, and spectacle cleaning materials. Cost discounted at 4% and undiscounted economic results were calculated. RESULTS: Spectacle independence rates were 86.0% for ReSTOR, 8.7% for monofocal IOLs, and 8.5% for Array-SA40. Patients lived without needing spectacles for 12.9 years after ReSTOR, for 1.4 years after monofocal IOLs, and 1.3 years after Array-SA40. ReSTOR patients bought 6.4 fewer pairs of spectacles than monofocal patients. Lifetime discounted cost consequences for the society were ReSTOR euro3969, monofocal IOLs euro4123, and Array-SA40 euro5326. Corresponding costs for the NHS were euro2415, euro2555, and euro2556, respectively. CONCLUSIONS: ReSTOR IOLs provided higher levels of spectacle independence than monofocal SI40NB or multifocal Array-SA40 IOLs resulting in savings, compared to a monofocal, over the period modelled of euro315 for society and euro140 for the NHS.

[Validation study of the BDI/TDI scores in chronic obstructive pulmonary disease]. / Etude de validation de l'échelle BDI/TDI dans la bronchopneumopathie chronique obstructive.

BACKGROUND: The Baseline and Transition Dyspnoea Indices (BDI/TDI) provide measurements of breathlessness and of its impact on activities of daily living. OBJECTIVES: To assess, in France, the measurement characteristics of the BDI/TDI scores. METHOD: A multicentric cohort of 103 patients with mild to severe COPD was questioned by both a medical and a paramedical investigator at enrollment and again 6 months later. RESULTS: Concordance between investigators was good for all the sub-scores of the BDI, but less satisfactory for the TDI score. The BDI score was significantly correlated with all spirometric data. Conversely, the TDI score only correlated significantly with change in the FEV1. Both scores correlated highly with the modified Medical Research Council score, the St George Respiratory Questionnaire and with their evolution. The average TDI score was close to 0 in stable patients indicating good reproducibility of this Index. Changes in the TDI score were closely associated with changes in global health assessment by physicians, less so when assessed by patients. CONCLUSION: The BDI-TDI scores appear to be valid instruments for the measurement of dyspnoea in COPD patients and, less significantly, for measurement of its change over time.

Modelling lifetime cost consequences of toric compared with standard IOLs in cataract surgery of astigmatic patients in four European countries.

OBJECTIVE: To compare the lifetime costs of freeing astigmatic patients from spectacles after bilateral cataract surgery implanting toric intraocular lenses (IOLs: i.e., Acrysof Toric) versus monofocal IOLs, in France, Italy, Germany and Spain. METHODS: A Markov model followed patient cohorts from cataract surgery until death. Prevalence rates of patients not needing spectacles and the types of spectacles prescribed for those requiring them were obtained from clinical trials and national surveys. The economic perspective was societal. Mortality rates were incorporated into the model. Discount rates were applied. A sensitivity analysis was performed on non-discounted costs. RESULTS: Fewer patients with toric IOLs needed spectacles for distance vision than patients with monofocal IOLs. With monofocal IOLs more than 66% of patients needed complex spectacles compared to less than 25% implanted with toric IOLs. In France and Italy, toric IOLs reduced overall costs relative to otherwise high spectacle costs after cataract surgery. Savings were 897.0 euros (France), 822.5 euros (Germany), 895.8 euros (Italy) and 391.6 euros (Spain), without discounting. On applying a 3% discount rate the costs became 691.7 euros, 646.4 euros, 693.9 euros and 308.2 euros, respectively. CONCLUSIONS: Bilateral toric IOL implants in astigmatic patients decreased spectacle dependence for distance vision and the need for complex spectacles. The economic consequences for patients depended on the national spectacle costs usually incurred after cataract surgery.

Intermediate visual acuity without spectacles following bilateral ReSTOR implantation.

PURPOSE: This survey determined uncorrected visual acuity (VA) at near, intermediate, and far distances in cataract patients implanted with ReSTOR, and assessed patient satisfaction. METHODS: Consecutive cataract patients implanted bilaterally with ReSTOR were followed up at least 4 months. The Early Treatment Diabetic Retinopathy Study scale was used to measure VA for near (40 cm), intermediate (50, 60, and 70 cm), and distance vision, with VAs expressed in logMAR and adjusted for distance using Bennett's (1993) formula. Satisfaction was self-rated on a visual analogue scale ranging from 0 (poor) to 10 (high). RESULTS: Twenty-four consecutive patients (mean age 67.6 years) were operated upon by a single surgeon and followed up for a mean of 336.5 days after second eye surgery. Average postoperative VAs for uncorrected distance were 0.06 logMAR and intermediate VAs were 0.21 logMAR at both 50 cm and 60 cm and 0.22 logMAR at 70 cm. These levels of uncorrected intermediate VA would allow patients to read Word computer text in Times New Roman font 8 zoomed to 100%, at 70 cm from the monitor screen. The authors found that23/24 patients (96%) no longer wore spectacles. The remaining patient required correction for astigmatism as this refraction error is not yet correctable by ReSTOR. Average selfrated satisfaction was 8.54. CONCLUSIONS: In an everyday surgical practice, none of the studied bilateral ReSTOR cataract patients without astigmatism required spectacles when followed up 6 months or later. Intermediate VA was compatible with reading and led to high patient satisfaction.