Impact of socio-economic position on health and quality of care in adults with Type 2 diabetes in France: the Entred 2007 study.

AIM: To describe the association between socio-economic position, health status and quality of diabetes care in people with Type 2 diabetes in France, where people may receive full healthcare coverage for chronic disease. METHODS: Data from a national cross-sectional survey performed in people pharmacologically treated for diabetes were used. They combined data from medical claims, hospital discharge, questionnaires for patients (n = 3894 with Type 2 diabetes) and their physicians (n = 2485). Socio-economic position was assessed using educational level (low, intermediate, high) and ability to make ends meet (financial difficulties vs. financially comfortable). RESULTS: People with diabetes reporting financial difficulties were more likely to be smokers (adjusted odds ratio 1.4; 95% CI 1.1-1.6) and obese (adjusted odds ratio 1.3; 95% CI 1.2-1.6) and to have poorer glycaemic control (HbA1c > 64 mmol/mol (8%); adjusted odds ratio 1.4; 95% CI 1.1-1.8), than those who were financially comfortable. They were more likely to have their diabetes diagnosed because of complications (adjusted odds ratio 1.6; 95% CI 1.3-2.0). They were also more likely to have coronary and podiatric complications (adjusted odds ratios 1.3; 95% CI 1.1-1.6 and 1.7; 95% CI 1.4-2.2, respectively). They benefited more often from full coverage (adjusted odds ratio 1.3; 95% CI 1.1-1.6), visited general practitioners more often (ratio of estimated marginal means 1.2; 95% CI 1.1-1.2) but specialists less often (adjusted odds ratio 0.7; 95% CI 0.6-0.8 for a visit to private ophthalmologist). They also felt less well informed about their condition. CONCLUSIONS: Despite frequent access to full healthcare coverage, socio-economic position has an impact on the diagnosis of diabetes, health status and quality of diabetes care in France.

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.

Design of a prospective, longitudinal cohort of people living with type 1 diabetes exploring factors associated with the residual cardiovascular risk and other diabetes-related complications: The SFDT1 study.

Type 1 diabetes mellitus (T1DM) is associated with a high risk of cardiovascular (CV) complications, even after controlling for traditional CV risk factors. Therefore, determinants of the residual increased CV morbidity and mortality remain to be discovered. This prospective cohort of people living with T1DM in France (SFDT1) will include adults and children aged over six years living with T1DM, recruited throughout metropolitan France and overseas French departments and territories. The primary objective is to better understand the parameters associated with CV complications in T1DM. Clinical data and biobank samples will be collected during routine visits every three years. Data from connected tools, including continuous glucose monitoring, will be available during the 10-year active follow-up. Patient-reported outcomes, psychological and socioeconomic information will also be collected either at visits or through web questionnaires accessible via the internet. Additionally, access to the national health data system (Health Data Hub) will provide information on healthcare and a passive 20-year medico-administrative follow-up. Using Health Data Hub, SFDT1 participants will be compared to non-diabetic individuals matched on age, gender, and residency area. The cohort is sponsored by the French-speaking Foundation for Diabetes Research (FFRD) and aims to include 15,000 participants.

Flu vaccine coverage for recommended populations in France.

OBJECTIVES: To estimate the size of the populations targeted by the French recommendations of the High Council for Public Health (French acronym HCSP) regarding vaccination against seasonal flu and to estimate vaccination coverage rates in these populations. PATIENTS AND METHODS: The analysis was conducted on a representative sample of patients retrieved from the French Health Insurance databases during three influenza seasons (2012-2013, 2013-2014, 2014-2015). Patients targeted by the influenza vaccination recommendations were identified based on their sociodemographic characteristics and disease identification algorithms during each season. Vaccine coverage rates were estimated based on reimbursed influenza vaccines. Results were extrapolated using indirect standardization to the overall French population. RESULTS: Populations targeted by the recommendations were estimated after extrapolation to 17.6, 17.8, and 18.0 million for the 2012-13, 2013-14, and 2014-15 influenza seasons, respectively. The vaccination coverage rates in these target populations were respectively estimated at 32.1%, 31.9%, and 32.1%; i.e. 44.2%, 43.1%, and 42.7% for individuals aged ≥65 years and 12.9%, 13.2%, and 13.7% for individuals ˂65 years of age presenting a risk justifying vaccination. CONCLUSIONS: Immunization coverage against influenza in France remains well below the target of 75% set by the World Health Organization. Multiple strategies combining communication, education, access program, and professional engagement could be implemented to improve this situation.

Prevalence of diagnosed type 2 diabetes mellitus in the French general population: the INSTANT study.

AIMS: To estimate the prevalence of diagnosed type 2 diabetes mellitus in the French general population. Secondary objectives were to evaluate treatments and diabetic complications. METHODS: In this cross-sectional epidemiological survey, a representative sample of the French adult population was selected using a stratified quota method: 10,038 individuals were evaluated by a standardized face-to-face interview. The diagnosis of type 2 diabetes was determined on the basis of replies to six questions using a specific algorithm. Data were collected on risk factors, diabetes history, familial antecedents and diabetic complications. These patients also identified their treatments from an exhaustive list. RESULTS: The prevalence of type 2 diabetes was 5.08% in men and 4.11% in women, and rose progressively after the age of 50. Of these, 79 patients (13.4%) received no pharmacological treatment, 477 (80.9%) were taking an oral antidiabetic drug and 134 (22.7%) were taking insulin. Renal and ocular complications were reported by 6.8% and 21.0%, respectively, of the patients. Also, 10.4% had been hospitalized at some time of that year for a diabetes-related problem. The most frequently reported treatments were metformin and sulphonylureas, used by more than 50% of the patients. In addition, 380 patients (65.9%) claimed to be following a diet and 228 (39.2%) were consulting a dietitian. CONCLUSION: The prevalence of treated and untreated type 2 diabetes mellitus in France was 4.57%.

[Assessing the incidence of papillomavirus infections in France]. / Estimation de l'incidence des infections à papillomavirus en France.

High-risk oncogenic human papillomavirus (HR-HPV) are strongly associated with squamous cell carcinoma and adenocarcinoma of the uterine cervix. Relatively detailed data on prevalence of HR-HPV infections by age in France are available in several cytologically normal women populations but none on incidence. These latter data may be obtained according to the relationship between prevalence and incidence due to the spontaneous viral clearance over time. The study has shown that HR-HPV infections incidence changes slightly according to the selected hypotheses for the viral clearance and that a peak is reached at about 12% for the women aged 22. A relatively high incidence is observed at older age classes with about 4% at 60 years old. These results are close to that observed in other countries even if the incidence peak appears slightly lower and happens later. Nevertheless, the model did not include possible viral reactivation or reinfection that could modify the incidence curve angle. The incidence of the HR-HPV infections is essential to define vaccination strategies and to determine the women ages at which the vaccine could be optimally administered.

[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.

Prevalence of macrovascular complications and cardiovascular risk factors in people treated for diabetes and living in France: the ENTRED study 2001.

AIM: The aim of this study is to estimate the prevalence of macrovascular complications and cardiovascular risk factors among people with diabetes living in France and to compare these prevalences with other national estimates. METHODS: We randomly sampled 10,000 people who received one or more reimbursements for insulin or oral hypoglycaemic treatment from the major national medical insurance system during the period October-December 2001; 3646 of the 10,000 people completed a questionnaire; for a subgroup of 1718 people, their care providers completed a medical questionnaire. RESULTS: The prevalence of diagnosed macrovascular complications was of 17% according to patients (angina or myocardial infarction, 15%; coronary revascularization, 9%) and of 20% overall, according to physicians (angina or myocardial infarction, 16%; coronary revascularization, 6%; stroke, 5%). Macrovascular complications were more frequent in people with type 2 than type 1 diabetes, reflecting an age effect. The prevalences of cardiovascular risk factors in type 1 and type 2 diabetes were: current smoking, 35 and 14%; overweight, 28 and 42%; obesity, 9 and 36%; blood pressure superior to 130/80 mmHg, 29 and 59%; LDL cholesterol superior or equal to 3.4 mmol/l, 18 and 26%, respectively. CONCLUSIONS: Compared with other European countries, elevated blood pressure is more frequent in people with diabetes living in France; compared with US estimates, the prevalence of macrovascular complications is lower, glucose control better and blood pressure control poorer in France. These data, observed in a country with widespread access to care and at low cost to the patient, nevertheless demonstrate an urgent need for improving the cardiovascular risk profile of people with type 1 and type 2 diabetes, both with and without macrovascular complications.

[Economic consequences of biological monitoring and medical complications of injectable anticoagulants in France]. / Conséquences économiques du suivi biologique et des complications médicales en lien avec l'utilisation des anticoagulants injectables en France.

AIM: To assess the frequency of platelet monitoring and bleeding risks associated with the use of injectable anticoagulants in a real life setting and to estimate the associated costs. METHOD: An analysis of the 2013 data from a random sample of ≈600,000 patients registered in the French National Health Insurances reimbursement database was conducted to identify platelet counts performed during injectable anticoagulants exposure period and treatment interruptions due to heparin-induced thrombocytopenia or transfusion. Events were then valued to establish associated costs. RESULTS: Overall 15,985 adult patients representing a cumulated injectable anticoagulants exposure time of 12,264 months were selected. Treatment sequences involved unfractionated heparin (2.8%), low molecular weight heparin (86.9%), and fondaparinux (13.1%). Patients treated with unfractionated heparin were older (77 vs. 57 and 59 years) with longer treatment duration (32.6 vs. 25.1 and 21 days). After statistical adjustment, the average monthly number of platelet counts was 1.36-fold lower in patients treated with fondaparinux compared to low molecular weight heparin (P<0.0001). No difference was found between low molecular weight heparin and fondaparinux regarding the incidence of bleeding with transfusion (P=0.76) or hospitalized thrombocytopenia (P=0.82). Extrapolated for the whole country, the estimated costs for biological monitoring were € 21.6 million for low molecular weight heparin and € 0.9 million for fondaparinux. CONCLUSION: Significantly fewer platelet counts were performed among patients treated with fondaparinux than among patients receiving low molecular weight heparin without additional bleeding risk. This finding should be taken into account when assessing the costs of such treatments.

Epidemiology and costs of diabetes treated with insulin in France.

Extrapolating from the results of the 1998 and 2000 French National Sickness Insurance Fund surveys, it can be estimated that at the end of 2002, 3.4% of the French population, i.e. 2,150,000 individuals, had diagnosed type 1 or type 2 diabetes mellitus. Among these individuals, 2,050,000 were taking drug treatments and about 100,000 were treated with diet alone. About 16.3% of diabetics given drug treatments were taking insulin, alone or in combination with oral antidiabetic drugs, i.e. approximately 447,000 individuals including 316,000 (70.6%) with type 2 diabetes. Regarding all individuals with type 2 diabetes, the percentage treated with insulin (alone or in combination with oral antidiabetic drugs) increased from 12.3% in 1998 to 16.5% in 2002, for a mean increase of 7.4% per year. This rate is globally corroborated, although the study periods are not exactly comparable, by changes in sales volumes for insulin observed over recent years showing an even more rapid mean annual growth of 13.4%. The difference between these two estimates suggests that either the mean dose of insulin delivered is increasing or that the increase in the number of treated diabetics is underestimated by the National Sickness Insurance Fund. Mean age of patients treated with insulin alone (type 1 and type 2 diabetics considered together) was 56.3 years with a median of 60 years and a sex ratio (M/F) close to 1 (0.9). There are no national data detailing monitoring practices in insulin-treated patients. Published analyses focus on type 2 diabetics treated with oral antidiabetic drugs and often exclude patients taking insulin. Blood glucose control is poor (HbA1c>8%) in approximately one-third of patients with type 2 diabetes and different studies have shown that in France among subjects with type 2 diabetes 3.1% are taking two oral antidiabetic drugs or more at maximal doses and have poorly controlled blood glucose levels. The percentage of insulin-treated diabetics is increasing steadily, but remains lower than observed in other European countries (generally reported in the 24% to 30% range). This special situation in France could fade out in upcoming years with better awareness of the importance of metabolic control, improved insulin therapy in this context, and improved conditions for use of insulin.

[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.

[Medical resources consumption of type 2 diabetics in France in 1998]. / Consommation de soins et de biens médicaux des diabétiques de type 2 en France en 1998.

The research objective of CODE-2 study was to estimate the total direct medical resources use of type 2 diabetes in France and in Europe. Only French data are provided in this paper. Total medical resources consumption of type 2 diabetics on a 6 months retrospective period were collected through a national practitioner survey (including both general practitioners and diabetology/endocrinology specialists). This survey was completed for 751 patients. Data collected were then extrapolated to be representative of all type 2 diabetics in France. Average medical resources consumption of a type 2 diabetic per year is 3 350 US$ (1 US$ =6FF). This figure is a minimum because some costs were underestimated in the study. Extrapolated to all diagnosed and treated type 2 diabetics in France, this expenditure is 4.3 billion US$ and accounts for 3.8 % of the total medical resources consumption in France (prevalence of type 2 diabetes reaches 2.5 % in the general population). Among this consumption, 24.1 % is directly related to diabetes, 26.7 % to potential related diabetes complications and 49.2 % to other diseases. Time since diagnosis, current treatment type and complications are the main factors which increase such consumption. CODE-2 study reveals the high level of medical resources consumption associated with type 2 diabetes complication. It confirms that more efficient therapeutical strategies are needed to avoid these complications.

Managing type 2 diabetes in France: the ECODIA survey.

In order to describe the profile and medical management of type 2 diabetes patients in France, a descriptive cross-sectional survey was conducted in 1999 among a national random sample of 311 general practitioners and 51 specialists. A practitioner questionnaire was designed to collect information on a representative sample of 4,119 patients presenting with type 2 diabetes. Data collected included demographic and clinical information and a full description of diabetes management over a 6-month retrospective period. Over 50% of the patients were more than 67 years old; 54% were male. Diabetes had been diagnosed 8.9 years earlier on average, most frequently (73%) during a visit not related to diabetes' symptoms or complications. 42% of patients had a BMI > or =30 kg/m(2), 46% were hypertensive (BP > 140-80 mmHg), 53% had a LDL-Cholesterol over 1.3 g/l. Overall, 33% of patients had at least one diabetic complication. 60% of patients had had at least one HbA1c dosage in the last 6 months. Among them, 31% had a HbA1c level over 8% and 35% between 6. 5% and 8%. 85% of patients were treated with oral anti-diabetic drugs, 9.5% with diet and exercise only and 5% with insulin. Sulfonylureas were the most commonly prescribed anti-diabetic agent, either alone or in combination. This survey confirms that the management of patients with type 2 diabetes is still often inappropriate in France despite recent progress. Improved disease management and monitoring is required in France as in other developed countries.

[Epidemiology, management and costs of type 2 diabetes in France in 1998]. / Epidémiologie, prise en charge et coût du diabète de type 2 en France en 1998.

Almost 10 years after the Saint Vincent declaration, a large effort was undertaken in France to improve medical care of type 2 diabetes and to limit the dreadful complications of this pathology. As expert recommendations grow in number, it appears necessary to update knowledge on the epidemiological, medical care, and cost aspects of this illness in France. In this aim, a systematic review of the medical and economic literature on type 2 diabetes was performed. Prevalence of type 2 diabetes probably reaches 2.2% in the general population, which represents 1.3 million people in France. Among these people, almost 60% are overweighted, 50% suffer high blood pressure and 30% have a treated dyslipaemia. Coronary pathologies concern 20% to 30% of type 2 diabetes patients, neuropathies 10% to 30% and ocular problems 10% to 35%. Medical care consumption of type 2 diabetes patients probably represents almost 20,000 FF per patient and per year, i.e., twice the average medical care consumption in the French population. Yet, these estimates should be considered with caution since a lot of uncertainty remains on the epidemiological, medical care, and cost aspects of type 2 diabetes in France. As diabetes has become a national public health priority, it is important to initiate new studies to have precise indicators in these different fields.

Economic evaluation of enoxaparin sodium versus heparin in unstable angina. A French sub-study of the ESSENCE trial.

OBJECTIVES: To perform an evaluation from the societal perspective of the cost of treatment with enoxaparin sodium versus unfractionated heparin (UFH) in patients with unstable angina and non-Q wave myocardial infarction in France. DESIGN: Four complementary cost-minimisation analyses based on the results of the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) international trial were conducted. We assessed differences in medical resource consumption and in duration of hospital stay in the whole study population (n = 3171) and for the French patients (n = 133). RESULTS: Results were consistent for the study group as a whole and for the French subgroup. Among patients treated with enoxaparin sodium, there was a statistically significant reduction in the use of angiography and percutaneous transluminal coronary angioplasty (whole group study: p = 0.024 and 0.006, respectively) and a trend towards shorter lengths of hospital stay. The differences in angiography and angioplasty rates led to estimated average net cost savings with enoxaparin sodium of French Francs (FF)1555 per treated patient (whole study population) and FF9993 (French subgroup) [1996 values]. The analyses based on the duration of hospital stay resulted in estimated net cost savings with enoxaparin sodium of between FF1014 per treated patient (whole study population) and FF2804 (French subgroup). CONCLUSION: Our study confirmed earlier results which show that enoxaparin sodium is cost saving in the treatment of unstable angina.

Cost effectiveness of a low-molecular-weight heparin in prolonged prophylaxis against deep vein thrombosis after total hip replacement.

The risk of late-occurring deep vein thrombosis and pulmonary embolism after total hip replacement persists for at least 3 weeks after hospital discharge. Recent clinical trials have demonstrated that prolonged prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH), significantly reduces this risk. We used a decision-analysis model to determine the incremental outcomes associated with the routine use of such prophylaxis, administered during hospitalisation for total hip replacement and for 3 weeks after discharge, instead of short term prophylaxis administered only during hospitalisation. For a hypothetical cohort of 100,000 patients undergoing hip surgery, prolonged LMWH prophylaxis saved between 601 and 783 additional lives compared with prophylaxis stopped at discharge. This was obtained at a net direct marginal cost ranging from 1118 to 1300 French francs (F) per patient. The cost-effectiveness ratio ranged from F11,158 to F34,591 per life-year saved and from F23,532 to F35,268 per venous thromboembolic event (routinely diagnosed and treated) avoided. Prolonged LMWH anticoagulant prophylaxis with enoxaparin is more effective in routine practice after elective hip surgery than conventional short term perioperative prophylaxis in terms of the number of deaths or thromboembolic events avoided. Such prophylaxis also appears to be clearly cost effective, using French cost data.

[Epidemiology and costs of lung cancer in France]. / Epidémiologie et coûts du cancer du poumon en France.

There were 21,850 cases of newly diagnosed lung cancers in France in 1995. This figure corresponds to an incidence rate (standardized to the population of Europe) of 66.5 per 100,000 men and 8.9 per 100,000 women. The incidence is age-related and reaches a peak between 70 and 74 years of age for men and between 75 and 79 years of age for women. The incidence also varies by region and the highest rates were observed in east of France. Non-small-cell lung cancers represent 80% of all lung cancers. Between 1985 and 1995, as a result of changes in tobacco consumption, the incidence rates increased by 56% in women and by 5% in men under the age of 65. The incidence rates in France are close to the average rates observed in Europe. In 1995, lung cancers led to 23,900 deaths in France (mortality rate standardized to Europe: 36.6 per 100,000). 85% of deaths due to lung cancer occurred among men. Prognosis of lung cancer remains poor and has not improved appreciably over the last two decades. 58% of all patients died during the first year and 82% during the three years following lung cancer diagnosis. Survival rates appear to be better for patients with non small cell lung cancer than for patients with small cell lung cancer. Few studies have addressed the economics of lung cancer in France. Cost-of-illness studies of lung cancer were published mainly in Canada, the Netherlands and Australia. These analyses have included descriptive works as well as economic models based on theoretical diagnostic and treatment algorithms.

Budget impact model for determining the costs of introducing inhaled salmeterol/fluticasone propionate combination for the management of persistent asthma in France.

A budget impact model was used to estimate the effect of introducing inhaled salmeterol/fluticasone propionate combination on asthma drug-related costs in France. The model is based on disease prevalence, drug use, drug acquisition cost and sales forecasting data specific to France. It takes the perspective of social security and has a time horizon of 1 year. All drug acquisition costs are adjusted for the average rate of reimbursement of asthma medications in France (77.3%). All costs are expressed in euros. The model shows that if patients receiving concurrent salmeterol plus fluticasone propionate (or budesonide plus formoterol switch to combined salmeterol/fluticasone propionate, the anticipated annual savings would be 2,691,580 and 1,916,966 euros, respectively. On a fixed budget 4067 additional patients could be treated if salmeterol/fluticasone propionate is substituted for concurrent salmeterol plus fluticasone propionate and an additional 2939 patients if the combination is used to replace concurrent budesonide plus formoterol. Overall, using sales forecasting data to estimate how many patients will switch to the new combination from their current therapy, it is estimated that the introduction of salmeterol/fluticasone propionate will increase the national expenditure in France on asthma medications by a maximum of 3%. This budget impact model shows that the introduction of inhaled salmeterol/fluticasone propionate combination is likely to have minimal impact on asthma-related medication costs in France. Moreover, the available data on the salmeterol/fluticasone propionate combination suggest that it is clinically effective, cost-effective and affordable to the French healthcare system.

[Cost of hospitalizations for adverse drug effects]. / Coût des hospitalisations pour effet indésirable médicamenteux.

The French network of Regional Pharmacovigilance Centres evaluated in 1997 the prevalence of adverse effects of drugs (AED). In 1998, and again with the support of the French Drug Agency, in collaboration with the company CEMKA for economic evaluations, the incidence of AED-related hospitalizations in the medical department of French public hospitals was studied. The evaluation was performed over 14 consecutive days in 62 hospital departments, which were selected randomly. The total number of 3137 patients were hospitalized for a mean duration of 9 days and they were using a mean number of six different drugs. Taking into account the number of about 4 million patients admitted per year in the hospitals represented, it was estimated that the total number of AED-related hospitalizations amounts to about 130,000 annually (CI95%: 100,916-156,620). Using established cost calculations for hospitalized days (AP-HP, results of 1996) the mean cost for an AED-related hospitalization was estimated to be about FF16,000.

[An epidemiological model of genital herpes for assessment of potential impact of therapy and prophylaxis: application to France]. / Un modèle épidémiologique de l'herpès génital pour l'évaluation des interventions thérapeutiques et prophylactiques.

OBJECTIVES: This study was performed to quantify the development of the number of cases of genital herpes and to assess the impact of different treatment strategies in France. METHOD: A model for the natural history of herpes simplex virus genital infection is presented and applied to the French population. The model encompasses infection by herpes simplex virus type 1 (HSV-1) or type 2 (HSV-2), first episodes, recurrences, viral shedding and the effect of treatment on infected individuals. RESULTS: In the Year 2000, 270,000 individuals would have suffered from genital herpes in France. A total annual cumulated number of 1.5 million episodes of recurrence and 23 million days of viral shedding were estimated. Seventy percent of viral shedding occurred in sub-clinical seropositive individuals. The expected number of attributable neonatal deaths remained very low. Systematic treatment of clinical episodes might reduce the number of days with lesions (- 27 p. 100), and is also effective on viral shedding (symptomatic: - 50 p. 100). Continuous treatment of the most severe patients (>or=6 recurrences per Year) might reduce viral shedding slightly more (- 85 p. 100). Antiviral treatment might have a major impact on the quality of life of these patients but would only slightly curb the number of new infections. DISCUSSION: This model tries to integrate the various data currently available at international level on the epidemiology of genital herpes. However, many aspects are still not well documented and remain uncertain. It is therefore necessary to define various assumptions in order to simulate the natural history of the disease in a population. The lack of French data especially on the HSV-1 and HSV-2 seroprevalence profiles reinforces these uncertainties. Our results should hence be considered as exploratory. However, this modeling approach is the only possible way to integrate the multiple parameters describing the pathology and predicting of the public health impact of different interventions. This model is an open tool which may be modified when new data become available.