Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study.

OBJECTIVES: To describe the long-term effectiveness and safety of certolizumab pegol in patients with moderate-to-severe rheumatoid arthritis (RA) in a real-world setting in France. METHODS: ECLAIR was a 3-year longitudinal, prospective, observational, multicentre study. The primary objective was to describe the EULAR response after 1 year of certolizumab pegol treatment. Other endpoints included DAS28, clinical disease activity index, health assessment questionnaire disability index, fatigue assessment scale, patient's assessment of arthritis pain, patient and physician global assessments of disease activity, patient quality of life, and long-term safety. RESULTS: A total of 792 patients were enrolled, of whom 776 comprised the safety set, and 733 the full analysis set. In the full analysis set, 559, 469 and 430 patients had a 12-, 24- and 36-month visit, respectively. This included 378, 296 and 246 patients still receiving certolizumab pegol at these visits. The percentage of EULAR responders was 75.3% (305/405 patients with an available EULAR response) at 12, 76.5% (261/341) at 24, and 79.6% (226/284) at 36 months. Among those still receiving certolizumab pegol, the percentage of EULAR responders was 81.7% (237/290) at 12, 81.1% (185/228) at 24, and 87.3% (158/181) at 36 months. Sustained improvements were observed in other effectiveness outcomes. Overall, 45.1% (350/776) of patients experienced 776 adverse drug reactions. No new safety signals were identified. CONCLUSIONS: This is the first prospective, observational study of an anti-TNF treatment in France. The results confirm the effectiveness and safety profile of certolizumab pegol treatment in patients with RA in a real-world setting.

Quality of life and utility decrement associated with Clostridium difficile infection in a French hospital setting.

BACKGROUND: Clostridium difficile infection (CDI) is associated with a substantial Quality of life impact on patients that has not been so far measured with a generic validated instrument. METHODS: A prospective study was performed in 7 French acute-care settings in patients presenting with a bacteriologically-confirmed CDI. The EQ-5D-3 L was filled in by patients at 7 ± 2 days after CDI diagnosis to describe their state of health at that date as well as their state of health immediately before the CDI episode (baseline). Individual utility decrement was obtained by subtracting the corresponding utilities. The Quality Adjusted Life Year (QALY) loss was calculated by multiplying the days spent from baseline to the date of the interview, by the decrement of utility. A multivariate analysis of variance of the utility decrement according to CDI and patients characteristics was performed. RESULTS: Eighty patients were enrolled (mean age: 69.4 years, 55% females). The utility scores dropped from a mean 0.542 (SD: 0.391) at baseline to 0.050 (SD: 0.404) during the CDI episode with a mean adjusted utility decrement of 0.492 (SD: 0.398) point. This decrement increased significantly with CDI severity (Zar score ≥ 3) (p = 0.001), in patients with a positive baseline utility (p = 0.032), in women as compared to men (p = 0.041) and in patients aged more than 65 years (p = 0.041). No association with the Charlson index was found. The associated QALY loss not integrating the excess mortality was 0.028 (SD: 0.053). CONCLUSIONS: The impact on quality of life of CDI episodes is major and translates in a substantial QALY loss despite their short duration.

Persistence and adherence to single-tablet regimens in HIV treatment: a cohort study from the French National Healthcare Insurance Database.

OBJECTIVES: To compare adherence and persistence (continuous treatment with a prescribed medication) in HIV adult patients who received combination ART (cART) as a once-daily single-tablet regimen (STR) versus other administration schedules. METHODS: A representative random sample of the French National Healthcare Insurance Database was used. Adherence and persistence were compared according to their administration schedules using χ(2) and survival analyses. STRs were marketed in France in 2009 and the study period was selected to allow a sufficient number of patients with an STR and a relevant duration of follow-up. RESULTS: During the period covered (2006-11), 362 HIV-positive adult antiretroviral-naive patients (566 lines of treatments) were selected. The mean rates of adherence were 89.6% for the STR (tenofovir/emtricitabine/efavirenz; n = 76), 86.4% for cART with >1 pill once daily (n = 242) and 77.0% for cART with >1 daily intake (n = 248; P < 0.0001 versus STR). Kaplan-Meier estimations of persistence after 2 years of treatment were 79.1% for the STR, 53.3% for cART with >1 pill once daily and 51.8% for cART with >1 daily intake (P = 0.001; log-rank test). Sensitivity analyses confirmed these results. After excluding treatment sequences showing a switch from tenofovir/emtricitabine plus efavirenz to the similar STR, the rates of persistence were 80.3% for the STR (n = 60), 77.3% for atazanavir-containing cART (n = 96) and 68.3% for darunavir-containing cART (n = 56) at 18 months (global P = 0.006). CONCLUSIONS: These results suggest that persistence is higher in HIV patients treated with an STR compared with other administration schedules. Significant benefit in terms of adherence was observed with the STR in comparison with regimens with >1 daily intake but no difference was observed when comparing with regimens involving >1 pill once daily.

Respiratory syncytial virus-related hospital stays in adults in France from 2012 to 2021: A national hospital database study.

BACKGROUND: Respiratory syncytial virus (RSV) causes lower respiratory tract infections (LRTI) that may lead to hospitalization or death. The present study aimed to assess the burden of RSV infections in hospitalized adults. METHODS: RSV-related hospitalizations were identified from the nationwide hospital claims database in France (PMSI) from 2012 to 2021 using ICD-10 codes J12.1, J20.5, J21.0 or B97.4, and outcomes assessment focused on 2016-2020. In-hospital outcomes included length of stay, need for intensive care (ICU) and in-hospital all-cause mortality. Post-discharge outcomes included 30-day readmission for decompensation, 90-day RSV-related readmission, and 30 and 60-day in-hospital mortality. RESULTS: A cumulated number of 17 483 RSV-related stays were identified representing a rate of 72.0 cases per million stays. The outcomes assessment included 12,987 patients: 55.8 % were females and the mean age was 74.1 ± 16.4 years, with 57 % ≥ 75 years. Most of patients (78.6 %) had at least one comorbidity, mainly chronic respiratory (56.3 %) and cardiovascular diseases (41.3 %), or diabetes (23.5 %). A co-infection was found in 22.4 %, primarily bacterial (12 %). The mean length of stay was 12.3 ± 13.1 days. Overall, 10.9 % were admitted to an ICU and in-hospital mortality was 7.3 %. In-hospital outcomes were higher in cases of co-infection. Among 12 033 patients alive at discharge from the index stay, 6.5 % were readmitted with RSV within 90 days, 8.1 % for decompensation within 30 days, and 5.6 % died within 60-day. CONCLUSION: This study demonstrated the high burden of RSV infections in older adults and those with chronic conditions, and the need for preventive strategies.

ESPERA study: applicability of the new ILAE criteria for antiepileptic drug resistance of focal epilepsies in current clinical practice.

A European observational cross-sectional study, ESPERA, was conducted in France and Spain in 2010. A random sample of neurologists, including specialists in epilepsy, prospectively enrolled adult patients treated for focal epilepsy with at least two antiepileptic drugs (AEDs) in combination. Investigators were asked to classify AED responsiveness of each enrolled patient according to the new 2009 ILAE criteria. These classifications were then reviewed by three experts. Potential factors of misclassification were then analyzed in order to evaluate the applicability of the new ILAE criteria for antiepileptic drug resistance in current clinical practice. Because of their complexity, use of the new ILAE criteria needs to be supported by relevant information and training to be adequately applied by neurologists in everyday practice.

[The investment of pharmaceutical industry in hospital clinical research: an estimate for france in 2010]. / L'investissement industriel en recherche clinique à l'hôpital : une estimation pour la France en 2010.

The objective of this study was to estimate the investment of pharmaceutical industry in hospital clinical research in France for 2010. The method consisted in combining data extracted from various sources about volumes of patients and unit costs per patient according to phase (I, II and II) and therapeutic domains. The numbers of French patients enrolled were estimated through an extraction of the National Institute of Health (NIH) database. Unit costs per patient were estimated from a sample of 54 clinical studies covering the most frequent combinations of phases and therapeutic domains and documented independently by 5 international companies. We identified 1, 178 clinical studies ongoing in 2010, having included a total of about 73, 000 French patients. Among these studies, 40.3% and 12.8% concerned Onco-Haematology and Rare Diseases respectively. The total annual investment from industry was estimated at 488 million euros, comprising 83.6 M€ of medical honoraria (17%), 73 M€ of hospital extra cost (15%), 99 M€ of drug provision (20%) and 232 M€ of internal cost for french affiliates (48%).

Epidemiology and disease burden of tuberous sclerosis complex in France: A population-based study based on national health insurance data.

OBJECTIVE: Tuberous sclerosis complex (TSC) is a rare multisystem disorder, often associated with epilepsy. This retrospective study aimed to identify patients with TSC, including those with epilepsy, from a French healthcare claims database, and to report incidence, prevalence, and healthcare costs and resource utilization. METHODS: The anonymized French health insurance database (SNDS) covers almost the entire French population. Patients with TSC were identified as having ≥1 International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code Q85.1 or a long-term disease (LTD) registration over the inclusion period (2006-2017). Patients with an ICD-10 epilepsy code or who were dispensed ≥1 antiseizure medication (ASM) in the same year or after their TSC diagnosis were identified as having TSC with epilepsy. Newly diagnosed patients over the inclusion period constituted the incident cohort. Healthcare costs (patients with recorded costs only), healthcare resource use, and ASM dispensation are reported for patients with 2018 data. RESULTS: In 2018, 3139 prevalent patients with TSC were identified (crude prevalence, 4.69 per 100 000); the incident cohort comprised 2988 patients (crude incidence, 0.44 per 100 000). Among patients with TSC, 67% (2101/3139) had epilepsy (mean [standard deviation, SD] age: 28.8 [18.8] years; male: 48%). Among patients with epilepsy, total mean (SD) annual healthcare costs were €11 413 (27 620) per capita (outpatient, 63%; inpatient, 37%), 46% were hospitalized during 2018 (mean [SD]: 1.8 [10.9] acute care visits per patient), and 65% visited a hospital specialist. Among patients with epilepsy, medication (mean [SD]: €4518 [12 102] per capita) was the greatest contributor (63%) to outpatient costs, and in 2018, 74% were dispensed ≥1 different ASM and 9% were dispensed ≥4 ASMs. SIGNIFICANCE: TSC with epilepsy was associated with substantial healthcare costs and resource utilization, particularly outpatient and medication costs. Many patients with TSC with epilepsy were prescribed multiple ASMs, suggesting refractory epilepsy.

Patterns of Use and Clinical Outcomes with Long-Acting Somatostatin Analogues for Neuroendocrine Tumors: A Nationwide French Retrospective Cohort Study in the Real-Life Setting.

INTRODUCTION: Long-acting somatostatin analogues such as lanreotide autogel (LAN) and octreotide long-acting release (OCT) are recommended as first-line treatment for patients with neuroendocrine tumors (NETs). However, only few real-world studies have compared the two medications. This retrospective, observational cohort study used a French claims database to compare patterns of use with LAN vs. OCT in patients with NETs. METHODS: Data on LAN and OCT patterns of use were obtained retrospectively from the National System of Health Data (SNDS), a national French claims database. Patients 18 years of age or older who initiated treatment for NETs between 2009 and 2016, and who received at least six subsequent dispensings of first-line LAN or OCT during the first year of treatment, were included. A subgroup analysis was performed on patients with gastroenteropancreatic (GEP)-NETs. RESULTS: Patients receiving LAN (n = 2327) vs. OCT (n = 2090) had greater median treatment duration (31.8 months vs. 22.1 months, respectively; p < 0.0001; log-rank test) and were less likely to discontinue treatment; adjusted hazard ratio (HR) 0.74 (95% confidence interval [CI] 0.69-0.80). In year 1, a significantly lower percentage of patients receiving LAN vs. OCT switched treatments (10.4% vs. 22.2%, respectively; p < 0.0001), received an average monthly dose per trimester above recommended dose (3.0% vs. 7.3%, respectively; p < 0.0001), and used rescue medication (3.1% vs. 10.0%, respectively; p < 0.0001). Dispensing of pancreatic enzymes was significantly higher in patients receiving LAN than OCT (16.4% vs. 13.9%, respectively). In the subgroup of patients with GEP-NETs, those receiving LAN (n = 1478) vs. OCT (n = 1278) had greater treatment duration and less treatment discontinuation, switching, dosage above the recommended dose, and rescue medication use, but no significant difference in dispensing of pancreatic enzymes or time to second-line treatment. CONCLUSION: These real-world data suggest potential clinical and economic advantages of LAN over OCT in the management of patients with NETs in the French population.

Trends in postmenopausal osteoporosis treatment in France during the period 2007-2016: A nationwide claims database analysis.

PURPOSE: To describe the trends in the pharmacological management of postmenopausal osteoporosis in France during the period 2007-2016. METHOD: This cross-sectional, yearly repeated study of patients in France used the nationwide claims database 'Échantillon Généraliste de Bénéficiaires' (EGB), covering a 1 in 97 representative sample of approximately 600,000 individuals insured by the main French public insurance scheme. For women aged 50-89 years, prescriptions for all anti-osteoporosis medications (AOMs) marketed in France during the study period (bisphosphonates alone or used in combination with calcium, selective estrogen receptor modulators, strontium ranelate, teriparatide or denosumab) were identified in each calendar year. Initiation of any AOM in a calendar year was defined by the absence of a prescription for any AOM within the 2 previous calendar years. Incidence was calculated for all AOM prescriptions and initial prescriptions for AOM. RESULTS: Marked changes were observed in the rates of women receiving any AOM, with a slight increase from 2007 to 2009 (from 10.22 to 10.42 per 100 patient-years [PY]), then a plateau in 2009-2010, followed by a rapid and more than twofold decrease until 2016 (from 10.39 to 5.02 per 100 PY). The decrease in the overall rate of women initiating an AOM showed a rapid halving from 2007 to 2012 (from 2.56 to 1.15 per 100 PY), followed by a plateau in the range of 0.90-1.0 per 100 PY during the period 2013-2016. In contrast, the use of calcium/vitamin D has been rapidly increasing as the only prevention and exclusive intervention for postmenopausal osteoporosis, from 10.6% of women in 2007 to 47.7% in 2016. The profile of patients initiating AOM changed substantially over the 10-year period. Despite a stable mean age of approximately 69 years, an increasing proportion of women with severe chronic comorbidities (from 34.9% to 43.3%), history of fractures (from 7.8% to 13.3%) or high-dose steroid use (from 2.9% to 8.4%) was observed. The decline of AOM initiation was associated with a marked reduction of prescriptions during the study period: by 64.2% for primary care physicians; by 36.7% for specialty doctors; and by 18.4% for rheumatologists. CONCLUSION: These findings suggest a general trend toward an AOM uptake that is increasingly limited to a fraction of patients who are at high risk of fractures. In the context of an aging population and declining prescription rates for AOM, these data highlight an increasing treatment gap among women in France with osteoporosis, which is similar to that seen in other European countries and in the USA.

Economic burden of coronary artery disease or peripheral artery disease in patients at high risk of ischemic events in the French setting: a claims database analysis.

Aims: Estimate the direct costs of high-risk patients presenting with coronary artery disease (CAD) or peripheral artery disease (PAD) in France.Materials and methods: This retrospective cohort study used a representative claims database, the "Echantillon Généraliste de Bénéficiaires" (EGB), to identify patients presenting with CAD or PAD between 2011 and 2016. Among those, patients meeting the COMPASS trial selection criteria were selected, as well as controls matched on age and sex. Direct costs (Euros 2016) were estimated in a societal perspective by comparing case and controls.Results: The adult population presenting with CAD or PAD in the EGB in 2016 was estimated at 29,888 individuals, representing a crude prevalence rate of 5.44%. After using the documented selection criteria of the COMPASS study, this population (COMPASS-like) was estimated at 17,369 individuals (58.1% of the CAD and/or PAD total population). Among them, a proportion of 11.5% presented with CAD + PAD. Compared with the original COMPASS population, patients were older (76.5 vs 68.2 years) and with a lower male predominance (60.0% vs 78.2% males). Compared with controls, the COMPASS-like population was characterized by a higher annual mortality (5.9% vs 3.5%) and the presence of more comorbidities on top of CAD and/or PAD. The annual per capita extra direct cost of the COMPASS-like population was estimated at €4,284, with a main contribution from inpatient care (58.9%). This extra cost was higher in the PAD ± CAD sub-group (€5,552) and the CAD + PAD sub-group (€8,067).Limitations: The EGB had limitations about several clinical features defining high-risk patients that may lead to bias in our estimates.Conclusions: Due to the high prevalence of CAD and/or PAD and the associated high unit costs, this population generates a significant economic burden, which is higher among patients with PAD and in those presenting simultaneously with both conditions.

Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study.

OBJECTIVE: To evaluate the performance of clinical criteria for predicting late treatment failure in patients with early non-response to certolizumab pegol (CZP). METHODS: A protocol-specified analysis of interim data from ECLAIR, a 3-year longitudinal, prospective, observational, multicentre study of patients with active rheumatoid arthritis (RA) initiating CZP treatment in France, was conducted. Clinical measures assessed were Clinical Disease Activity Index (CDAI), Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28(ESR)) and Health Assessment Questionnaire Disability Index (HAQ-DI). Early non-response was measured at 3 months (M3) and failure to achieve low disease activity (LDA) at 12 months (M12). RESULTS: 574/792 enrolled patients were treated at M3. The numbers available for predictability analyses were 532 (CDAI), 434 (DAS28(ESR)) and 496 (HAQ-DI). Of the three indices evaluated, the highest predictor of non-response value was observed for the CDAI (88.8% (95% CI 81.0 to 94.1)), indicating that up to 88% of patients identified as non-responders at M3 failed to achieve LDA at M12, regardless of baseline disease severity or treatment history. The specificity for this measure was also very high (96.0%), indicating that less than 5% of patients who achieved CDAI response at M12 had not responded at M3. Similar predictability was observed for DAS28(ESR), but only in patients with high disease activity at baseline and/or those previously treated by a biological disease-modifying antirheumatic drug. CONCLUSION: CDAI non-response at M3 is a predictor of failure to achieve the therapeutic target of LDA at M12 in patients with RA initiating treatment with CZP.

Therapeutic management of uncomplicated gastroesophageal reflux disease in france in 2005: Potential cost savings of omeprazole substitution.

BACKGROUND: Proton pump inhibitors (PPIs) cost the French health care system >€1 billion in 2005, and ~50% of PPI prescriptions were for the treatment of gastroesophageal reflux disease (GERD). OBJECTIVES: This study aimed to describe the current use of PPIs for GERD, to estimate the total annual costs of treatment, and to evaluate the economic impact of the various possible substitutions among PPIs available for this indication in France. METHODS: Data from a sample of patients aged ≥20 years who visited their general practitioner (GP) at least once in 2005 for uncomplicated, symptomatic GERD were retrieved from the Thales database (a group of 1200 representative GPs connected to a computerized network). Costs of the prescriptions presented for reimbursement and costs of those reimbursed by the French health care insurance system were analyzed. We then evaluated the economic consequences of replacing full-dose generic omeprazole (after substitution from brand-name omeprazole by the pharmacists) with other compounds that are indicated for mild symptoms at half dose (ie, lansoprazole 15 mg, pantoprazole 20 mg, rabeprazole 10 mg, and esomeprazole 20 mg). The results were adjusted to account for the proportions of patients who had full health care coverage and the treatment duration as reported in the database. RESULTS are presented from the perspective of the French health care insurance system. RESULTS: In 2005, a total of 122,571 patients (mean age, 55.7 years; 45.5% men; 13.8% with a history of at least 1 gastrointestinal disorder) met the inclusion criteria. Extrapolated to the French population, this sample corresponded to ≈5.7 million people (ie, 13% of the adult population who visited a GP during the year). PPIs were prescribed as first-line treatment for GERD in 84.1% of the consultations (14.3% in association with other antiulcer drugs). Omeprazole, as a proprietary or generic drug, was prescribed most often (78.9%) and at full dose (20 mg), while other compounds (lansoprazole, pantoprazole, rabeprazole, and esomeprazole) were prescribed at half dose in 64.3% of cases. The extrapolated annual cost of PPIs reimbursed for this indication was €465.02 million at a mean reimbursement level of 72.7%. Brand-name omeprazole still accounted for ≈11% of the total cost reimbursed. Complete replacement of brand-name omeprazole with its generic counterpart would have reduced costs by €18.35 million (a decrease of 4.3% in the total reimbursed expenditure). The switch from generic full-dose omeprazole to a half dose of other PPIs would have allowed further savings ranging from €2.59 million (with lansoprazole) to €13.19 million (with pantoprazole). CONCLUSION: In accordance with recent recommendations for the treatment of uncomplicated GERD and based on the 2006 PPI pricing, switching from branded full-dose omeprazole to generic omeprazole or to the use of half doses of other PPIs may allow cost savings in France.

[Budget impact analysis of Pradaxa thromboprophylaxis after total hip or total knee replacement]. / Bénéfice économique de Pradaxa en thromboprophylaxie après prothèse totale de hanche ou de genou.

Venous thromboembolism is a serious disease that can be life-threatening in case of pulmonary embolism or induce major sequelae. Patients undergoing major orthopaedic surgery represent a population at high risk of venous thromboembolism. Recently Pradaxa has demonstrated its efficacy and safety versus enoxaparin in 2 pivotal trials. Beyond these clinical benefits on the treatment duration observed, the budget impact model's objective was to assess, from the French Sickness Funds perspective for retail market, the consequence of the introduction of this new drug on French setting for a theoretical, representative sample of 1,000 patients in each indication. The cost saving estimated by the model was in excess of 36,000 Euros per 1,000 procedures for total hip replacements. A univariate sensitivity analysis showed that the budget impact was robust and remained positive with the utilisation of Pradaxa in all cases tested.

Profile of Women Initiated on Denosumab and Pattern of Use in a Restricted Postmenopausal Osteoporosis Indication: A French Database Analysis Over the Period 2013-2014.

INTRODUCTION: French authorities have approved the reimbursement of denosumab as a second-line therapy after bisphosphonates (BPs) in women presenting with postmenopausal osteoporosis (PMO) at high risk of fracture. By using a nationally representative claims database, we analyzed the pattern of denosumab use. The objectives of this study were to describe the profile of women initiated with denosumab over the 14-month period after launch and to check as far back as possible for the appropriateness of its use regarding the restrictions brought by French health authorities. METHODS: A retrospective study using a national representative claims database, i.e., the "Echantillon Généraliste des Bénéficiaires" (EGB), was performed. The population was composed of women aged ≥ 40 years old who had an initiation of a PMO treatment in 2013 or 2014. The denosumab women's profiles were compared with those of women that started any other PMO treatment (except denosumab) over the same period. RESULTS: In 2013 and 2014, we identified 256 women who initiated denosumab. Denosumab was primarily prescribed by specialists (75%) compared with the other PMO treatments (37.6%). Patients on denosumab were significantly older, 73.2 versus 69.1 years old, and they more frequently had a history of fractures (20.7% versus 17.4%, NS) and chronic uptake of high-dose steroids (25% versus 22.8%, NS). Of the women initiated with denosumab, 93.8% had undergone a previous PMO treatment (during the 2005-2014 period). In 92.9% of cases, it was a BP alone or in association. CONCLUSION: This study suggests satisfactory compliance of prescribers concerning the restriction of the reimbursed indication of denosumab in second line after bisphosphonates with 6.2% possible inappropriate prescriptions. FUNDING: Amgen.

Burden of severe spondyloarthritis in France: A nationwide assessment of prevalence, associated comorbidities and cost.

OBJECTIVES: To estimate the number of patients with severe spondyloarthritis (SpA) in France, describe their comorbidities and document and value their healthcare resource consumption. METHODS: Data were retrieved from an insurance claims database covering a 1/97 random sample of the French population. All patients benefiting from full insurance coverage ("ALD") for severe SpA in 2012 (including cases with structural damage and/or frequent flares) were identified, together with a control group frequency-matched by age and gender. Severe comorbidities were documented through ALD categories. Healthcare resource consumption was documented and valued from the payer's perspective. Rates of comorbidities and costs were compared in SpA patients versus controls using non-parametric testing. RESULTS: Overall, 827 patients with ALD status for severe SpA were identified (control group: n=2.481), corresponding to a prevalence rate of 0.18% [0.17-0.19] for SpA with ALD in the general population. Severe comorbidities more frequent in patients with SpA than in controls included inflammatory bowel disorders (odds ratio: 15.0 [6.2-36.2]), hypertension (2.5 [1.6-3.9]), atrial fibrillation (4.3 [1.9-9.6]) and major depressive disorder (2.1 [1.3-3.6]). Mean per capita annual direct healthcare expenditure was 3.6 [3.2-4.1]-fold higher in SpA patients (€6,122 [€5,838-€6,406]) than in controls (€1,682 [€1,566-€1,798]). Extrapolating to all patients in France, total healthcare cost attributable to severe SpA patients was €391 [€355-€426] million, with medication accounting for 53.8% of this cost. CONCLUSIONS: The burden of severe SpA in France is substantial, due to the high prevalence, high direct costs and associated comorbidities.

Migraine burden and costs in France: a nationwide claims database analysis of triptan users.

Objectives: To estimate the burden of migraine in the population of French patients identified as specific migraine acute treatment users compared to a control group. Methods: A cross-sectional retrospective analysis was performed on the Echantillon Généraliste des Bénéficiaires claims database, a 1/97 random sample of the French public insurance database. A representative sample of all adults with at least one delivery of triptans, ergot derivatives or acetylsalicylic acid/metoclopramide (all drugs with a specific label in migraine acute treatment - SMAT) in 2014 was selected with a control group matched on age, gender and geographic region. Among triptan users, a sub-group of over-users was defined according to their level of triptan uptake expressed in defined daily doses (DDD - a standard daily dose of treatment of acute migraine) per month over 3 months and more, was also compared with controls. The cost analysis was performed in a societal perspective for direct costs. Sick leave indirect costs were estimated using the human capital approach. Results: In total 8639 SMAT users (mean age: 44.6 years; 78.7% women) were selected representing a crude prevalence rate of 1.7%. The annual per capita total healthcare expenditures were higher by €280 in this group compared to controls (€2463 vs. €2183). Triptans contributed 47.8% to this extra cost. They used significantly (p < .0001) more frequently than controls antidepressants (20.8% vs. 11.0%), anxiolytics (29.4% vs. 18.8%) and analgesics (53.8% vs. 35.8%). The per capita annual productivity loss associated with sick leave was higher by €295 (€1712 vs. €1417). Among triptan users, there were 2.9% over-users. This last group was characterized by substantially higher per capita annual extra direct (+ €1805) and indirect costs (productivity loss +€706) compared to controls. Conclusions: Due to its high prevalence, migraine costs generate a significant societal burden. The group of over-users concentrates high per capita direct and indirect costs.

Irritable bowel syndrome in France: quality of life, medical management, and costs: the Encoli study.

AIM: To assess the proportion of physician-diagnosed irritable bowel syndrome (IBS) patients who conform to Rome II criteria, and evaluate the impact of IBS on quality of life (QoL) and costs in France. METHODS: This cross-sectional study collected information retrospectively from the preceding year. Physicians (randomly selected) enrolled their first four IBS patients during the study period. Patients were classified (secondarily) according to Rome II criteria. IBS-related costs during the previous year were estimated. RESULTS: Of the 452 physician-diagnosed IBS patients (mean age 53.9+/-14.9 years; 75.4% women), 23% did not meet the diagnostic criteria; 36.5% met all diagnostic criteria, and 32% experienced severe or very severe abdominal pain/discomfort (Subjects' Global Assessment of relief). IBS patients had lower QoL (SF-36 scale) than the general French population, and Rome II patients had the lowest QoL. Most prescriptions treated abdominal pain (72%) and bloating (58%). Approximately 8% of patients had been hospitalized due to IBS during the preceding year. The average total annual direct cost/patient was 756 euro. CONCLUSIONS: These data confirm that IBS involves large direct medical costs in France, and that IBS patients experience lower QoL than the general population. A small and not significant economic difference between the Rome II and non-Rome II IBS patient groups was observed.

[Cost of obesity in France]. / Evaluation du coût associé à l'obésité en France.

OBJECTIVE: To estimate the costs associated with obesity in France. METHODS: We used data from the 2002 survey on health and social protection as well as health care consumption data from the EPAS sample of the national health insurance funds. After excluding those younger than 18 years, pregnant women and people diagnosed with cancer, we classified subjects as underweight, normal weight, or obese and then studied two subpopulations: (P1) obese patients (body mass index (BMI) >or= 30 kg/m2) and (P2) patients who were obese or overweight (BMI >or= 27 kg/m2) and had additional cardiovascular risk factors: hypertension, dyslipidemia, type 2 diabetes, myocardial infarction (present or history), transient ischemic attack, intermittent claudication or sleep apnea. The Heckman approach was used to adjust for several factors. RESULTS: The study included 4651 individuals, with a mean age was 47 years. The obesity prevalence rate was estimated at 10.7% for P1; the P2 prevalence was 16.0%. Average healthcare costs for the entire study group were 1534 euro, 1105 euro for ambulatory care (72%) and 429 euro (28%) for inpatient care. Costs for obese subjects (P1 and P2) averaged 2500 euro, twice the costs for normal-weight people (1263 euro). After taking into account age, sex, socioeconomic status, alcohol consumption and smoking, the 100% reimbursement rate for chronic diseases (all else being equal), the extra cost of obesity, compared with normal weight, was estimated between 506 euro (P1) and 648 euro (P2). CONCLUSION: The annual total cost of obesity was estimated to range from 2.1 to 6.2 billion euros in 2002 and account for 1.5 to 4.6% of total health expenditures in France.