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1.
Obes Facts ; 16(6): 606-613, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37879296

RESUMO

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


Assuntos
Gastos em Saúde , Obesidade , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Gastos em Saúde/estatística & dados numéricos , Renda , Obesidade/economia , Obesidade/epidemiologia , Sobrepeso/economia , Sobrepeso/epidemiologia , Inquéritos e Questionários , França/epidemiologia
2.
Lancet Reg Health Eur ; 32: 100686, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37520145

RESUMO

Background: Two randomised controlled trials (RCTs) have previously shown that telemedical monitoring of diabetic foot ulcer (DFU) reduces the number of visits to the outpatient clinic, without losing treatment efficacy or increasing costs. Here we present the results of an open-label, randomised controlled trial designed to investigate whether telemonitoring, provided by an expert nurse (with extensive experience in DFU and trained in remote monitoring), reduces the hospital stay and the associated costs for a patient with DFU (TELEPIED trial). Methods: Eligible patients (n = 180) were randomly allocated to: (i) a control group, in which they received standard care, and (ii) an intervention group, in which they received asynchronous telemedicine follow-up by the expert nurse. The primary outcome was the cumulative hospital days over 12 months. The main secondary outcomes were (i) direct healthcare costs (estimated in a collective perspective), (ii) wound healing and (iii) amputation rates. ITT (intention-to-treat) population was analysed. Findings: In the ITT population, cumulative hospital days were significantly higher in the control group (13.4 days [95% CI 9.0-17.8]) than in the intervention group (7.1 days [2.8-11.5]) (p = 0.0458, ANCOVA model). Cumulative direct costs over 12 months were 7185 € (95% CI 5144-9226) in the control group and 3471 € (95% CI 1430-5512) in the intervention group (p = 0.0120). The percentage of wounds healed and amputation rate were not significantly different between groups. Similar results were found with the PP population. Interpretation: The implementation of a telemedical intervention with an expert nurse could lead to a length of hospitalization and direct costs that were two times lower compared to conventional follow-up. This lower medical and economic burden was obtained without losing effectiveness on the rate of healing, nor increasing the amputation rate. Additional studies are required to confirm these findings. Funding: This study was designed, funded and conducted by CERITD (Study and Research Centre for Intensification of Diabetes Treatment, Evry, France), Genopole GIP, 20 rue Henri Desbruères, 91030 EVRY Cedex and Laboratoires URGO, 15 Avenue d'Iéna, 75116 Paris Cedex, France. The findings and conclusions in this study are those of the authors and do not necessarily represent the views of the sponsor. The corresponding author (DD) certify that authors were not precluded from accessing data in the study, and they accept responsibility to submit for publication.

3.
Therapie ; 76(6): 549-557, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34053732

RESUMO

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


Assuntos
COVID-19 , Pesquisa Farmacêutica , Indústria Farmacêutica , França , Humanos , SARS-CoV-2
4.
Pharmacoecon Open ; 5(2): 211-219, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33215332

RESUMO

OBJECTIVE: Our objectives were to describe the basal insulin treatment regimens most widely used in a real-world setting in France and to estimate the associated treatment costs in people with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional observational study was conducted (November 2017-February 2018) among adult patients with T2DM requiring basal insulin therapy for their own use in a representative sample of pharmacies. Costs were compared between patients treated with three recently marketed insulins (glargine 300 U/ml [Gla-300], biosimilar glargine 100 U/ml [Gla-100] and a fixed-ratio combination of insulin degludec and liraglutide) and those treated with three established basal or intermediate insulins: branded glargine 100 U/ml, insulin detemir and neutral protamine Hagedorn insulin [NPH]). RESULTS: Overall, 1933 patients were analysed. Gla-300 accounted for 59.9% of novel basal insulin prescriptions, and branded Gla-100 accounted for 67.9% of established insulin prescriptions. Recent insulins were more frequently associated with glucagon-like peptide-1 (GLP-1) analogues. Results confirmed a lower rate of severe hypoglycaemia with Gla-300 than with Gla-100. On average, weekly total costs of treatment with all basal insulins were not significantly different, except with detemir, where they were higher. CONCLUSION: New basal insulins are expected to be integrated into clinical practice. This analysis shows that their use does not impact upon the management cost of insulin therapy in people with T2DM.

5.
Value Health ; 23(8): 985-993, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32828226

RESUMO

OBJECTIVE: France has included health economic assessment (HEA) as an official criterion for innovative drug pricing since 2013. Until now, no cost-effectiveness threshold (CET) has been officially proposed to qualify incremental cost-effectiveness ratios (ICERs). Although the French health authorities have publicly expressed the need for such reference values, previous initiatives to determine these have failed. The study aims to propose a locally adapted method for estimating a preference-based value for a quality-adjusted life-year (QALY) based on a rational approach to public policy choices in France. METHODS: We used the official French value of statistical life (VSL) of €3 million (USD 3.25 million), proposed in 2013 by the French General Commission on Strategy and Prediction. We first estimated the value of life-year (VoLY) by age category according to life expectancy and official discounts recommended for HEA in France. We then estimated a value of statistical QALY (VSQ) by weighting VoLYs with demographic data and French EQ-5D-3L tariffs. RESULTS: The estimated average VoLYs and VSQs were €120 185 (USD 130 000) and €147 093 (USD 159 022), respectively, assuming a discount rate of 2.5% and €166 205 (USD 179 681) and €201 398 (USD 217 728), respectively, assuming a discount rate of 4.5%. CONCLUSION: Assuming that, as in other public domains, equity in access to healthcare across all disease areas and between all users is desirable, we propose an estimate of VSQ that is consistent with this goal. Our estimates of €147 093 (USD 179,681) to €201 398 (USD 217 728) should be perceived as breakeven costs for a QALY rather than a market access threshold. Such VSQs could be used as reference values for ICERs in HEA in France.


Assuntos
Análise Custo-Benefício/métodos , Análise Custo-Benefício/normas , Anos de Vida Ajustados por Qualidade de Vida , França , Humanos , Modelos Econométricos , Preferência do Paciente , Valores de Referência
6.
Diabetes Ther ; 11(2): 535-548, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31953694

RESUMO

INTRODUCTION: Diabetes is a growing epidemic that imposes a substantial economic burden on healthcare systems. This study aimed to evaluate the cost of managing type 2 diabetes (T2D) with dipeptidyl peptidase 4 inhibitors (DPP4Is) using real-world data. METHOD: This longitudinal study used data from the French EGB (Echantillon Généraliste des Bénéficiaires) database. The annual average direct healthcare cost of treating patients with T2D was calculated 3 years prior and 3 years after initiation of DPP4I therapy. Actual total ambulatory and hospital care expenditure for the 3 years after DPP4I initiation was compared to projected costs. The distribution of costs across all care modalities was assessed over the 6-year period. RESULTS: Ambulatory and hospital care expenditure data for 919 patients with T2D starting DPP4I therapy alone or in combination in 2013 were analyzed. A total of 526 patients (57.2%) were still being treated with DPP4I 3 years after DPP4I initiation. Regardless of the treatment regimen, the ambulatory and hospital care costs increased above projected costs in the first year following DPP4I initiation, and then declined during the second and third years to levels in line with or below projected values for patients using DPP4Is as an add-on therapy. The increase in total expenditure in the first year following DPP4I initiation and the subsequent decline in costs in the second and third years were both associated with general trends in consumption across all aspects of patient care. CONCLUSION: Despite an initial increase in healthcare expenditure, concomitant with reevaluation of patient care, this study showed that initiation of DPP4Is as an add-on therapy in French patients with T2D was associated with care expenditure that was in line or below predicted values within the 3 years following treatment initiation. Additional studies are required to evaluate the economic impact of the long-term treatment benefits.

7.
Artigo em Inglês | MEDLINE | ID: mdl-30863045

RESUMO

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


Assuntos
Benzoxazinas/economia , Benzoxazinas/uso terapêutico , Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Custos de Medicamentos , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Idoso , Benzoxazinas/efeitos adversos , Broncodilatadores/efeitos adversos , Simulação por Computador , Redução de Custos , Análise Custo-Benefício , Progressão da Doença , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , França , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Brometo de Tiotrópio/efeitos adversos , Resultado do Tratamento
8.
J Diabetes Sci Technol ; 13(6): 1161-1168, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-30862245

RESUMO

Benefits of telemedicine have been proven in the field of diabetes. Among a number of technical solutions, Diabeo® has been studied in both type 1 and type 2 diabetes with intensive insulin therapy. This digital therapeutic system contains a self-monitoring glucose logbook and offers automated insulin dose recommendations thanks to a fully customizable algorithm. In addition, the cloud-based dedicated software also has features to facilitate remote monitoring, including a platform for diabetes nurses who perform coaching and treatment adjustment. A detailed description of this telemedicine system is provided, as well as results of completed clinical studies. In particular, TeleDiab 1's positive results on HbA1c in type 1 diabetes are detailed. We conclude with a discussion of the role of this telemedicine system within the landscape of mobile apps for diabetes.


Assuntos
Automonitorização da Glicemia/instrumentação , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Telemedicina/métodos , Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Pessoal de Saúde , Humanos , Aplicativos Móveis
9.
J Thorac Oncol ; 14(6): 1012-1020, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30776447

RESUMO

INTRODUCTION: A multicenter randomized clinical trial in France found an overall survival benefit of web-based patient-reported outcome (PRO)-based surveillance after initial treatment for lung cancer compared with conventional surveillance. The aim of this study was to assess the cost-effectiveness of this PRO-based surveillance in lung cancer patients. METHODS: This medico-economic analysis used data from the clinical trial, augmented by abstracted chart data and costs of consultations, imaging, transportations, information technology, and treatments. Costs were calculated based on actual reimbursement rates in France, and health utilities were estimated based on scientific literature review. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively. Average annual costs of experimental and control surveillance approaches were calculated. The incremental cost-effectiveness ratio was expressed as cost per life-year gained and QALY gained, from the health insurance payer perspective. One-way and multivariate probabilistic sensitivity analyses were performed. RESULTS: Average annual cost of surveillance follow-up was €362 lower per patient in the PRO arm (€941/year/patient) compared to control (€1,304/year/patient). The PRO approach presented an incremental cost-effectiveness ratio of €12,127 per life-year gained and €20,912 per QALY gained. The probabilities that the experimental strategy is very cost-effective and cost-effective were 97% and 100%, respectively. CONCLUSIONS: Surveillance of lung cancer patients using web-based PRO reduced the follow-up costs. Compared to conventional monitoring, this surveillance modality represents a cost-effective strategy and should be considered in cancer care delivery.


Assuntos
Internet , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/terapia , Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Análise Custo-Benefício , França/epidemiologia , Humanos , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/métodos , Estadiamento de Neoplasias , Resultado do Tratamento
10.
Pharmacoecon Open ; 2(2): 209-219, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29623622

RESUMO

OBJECTIVES: Our objects was to estimate the direct healthcare costs of type 2 diabetes mellitus (T2DM) in France in 2013. METHODS: Data were drawn from a random sample of ≈600,000 patients registered in the French national health insurances database, which covers 90% of the French population. An algorithm was used to select patients with T2DM. Direct healthcare costs from a collective perspective were derived from the database and compared with those from a control group to estimate the cost of diabetes and related comorbidities. Overall direct costs were also compared according to the diabetes therapies used throughout the year 2013. RESULTS: Cost analysis was available for a sample of 25,987 patients with T2DM (mean age 67.5 ± standard deviation 12.5; 53.9% male) matched with a control group of 76,406 individuals without diabetes. Overall per patient per year medical expenditures were €6506 ± 10,106 in the T2DM group as compared with €3668 ± 6954 in the control group. The cost difference between the two groups was €2838 per patient per year, mainly due to hospitalizations, medication and nursing care costs. Total per capita annual costs were lowest for patients receiving metformin monotherapy (€4153 ± 6170) and highest for those receiving insulin (€12,890). However, apart from patients receiving insulin, costs did not differ markedly across the different oral treatment patterns. CONCLUSION: Extrapolating these results to the whole T2DM population in France, total direct costs of diagnosed T2DM in 2013 was estimated at over €8.5 billion. This estimate highlights the substantial economic burden of this condition on society.

11.
Eur J Health Econ ; 19(4): 533-544, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-28547724

RESUMO

OBJECTIVES: Pneumocost is a prospective study that aimed at documenting the costs of the management of patients hospitalized with a pneumococcal pneumonia and the post-discharge costs during a 6-month period in the French context. METHODS: Billing data were used to document hospital costs. Resource use during the follow-up period was collected through phone interviews at month 1, 3 and 6. Descriptive statistics and multivariate analyses were performed. We used generalized linear models with log-link functions to estimate parameters associated with hospital and follow-up costs of patients. RESULTS: Five hundred twenty-four patients were enrolled in 40 public centers from October 2011 to April 2014. Average age was 63 (SD 17); 55.0% of them were male. Average length of stay was 15 days (SD 23). Average cost of stay for the French Sickness Fund was €7293 (SD €7363). Average cost of follow-up was €1242 (SD €3000) and decreased steadily through time. When controlling for patient's socioeconomic characteristics, severity of disease and hospital stay, results showed a concave relationship between hospital costs and age. Obesity, the severity of the disease and comorbidities were associated with constantly increasing inpatient costs. Concerning follow-up costs, we found the same concave relationship with age, while gender, a history of pneumonia and severity of the disease were the most important predictors of high costs after discharge. CONCLUSION: Pneumocost is the first French study providing a robust estimation of the cost of managing invasive pneumococcal pneumonia in the French context.


Assuntos
Infecções Comunitárias Adquiridas/economia , Custos Hospitalares/estatística & dados numéricos , Pneumonia/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , França , Hospitalização , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
12.
Sante Publique ; 28(6): 781-789, 2016 Dec 19.
Artigo em Francês | MEDLINE | ID: mdl-28155773

RESUMO

Increased costs cannot be exclusively attributed to the consequences of insulin prescription. Any initiative designed to accelerate acquisition of patient autonomy would be likely to reduce the costs observed after switching to insulin, provided this initiative is adapted to the patient’s health profile, diabetes history and available medical resources..


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/economia , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina/economia , Insulina/uso terapêutico , Idoso , Custos e Análise de Custo , França , Humanos , Lactente , Masculino , Pessoa de Meia-Idade
13.
Vasc Health Risk Manag ; 11: 417-25, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26229480

RESUMO

AIM: We aimed to compare the frequency of severe hypoglycemia leading to hospitalization (HH) and emergency visits (EV) for any cause in patients with type 2 diabetes mellitus exposed to dipeptidyl peptidase 4 (DPP4) inhibitors (DPP4-i) versus those exposed to insulin secretagogues (IS; sulfonylureas or glinides). METHODS: Data were extracted from the EGB (Echantillon Généraliste des Bénéficiaires) database, comprising a representative sample of ~1% of patients registered in the French National Health Insurance System (~600,000 patients). Type 2 diabetes mellitus patients exposed to regimens containing either a DPP4-i (excluding treatment with IS, insulin, or glucagon-like peptide 1 analog) or IS (excluding treatment with insulin and any incretin therapy) between 2009 and 2012 were selected. HH and EV during the exposure periods were identified in both cohorts. A similar analysis was conducted considering vildagliptin alone versus IS. Comparative analyses adjusting for covariates within the model (subjects matched for key characteristics) and using multinomial regression models were performed. RESULTS: Overall, 7,152 patients exposed to any DPP4-i and 1,440 patients exposed to vildagliptin were compared to 10,019 patients exposed to IS. Eight patients (0.11%) from the DPP4-i cohort and none from the vildagliptin cohort (0.0%) were hospitalized for hypoglycemia versus 130 patients (1.30%) from the IS cohort (138 hospitalizations) (P=0.02 and P<0.0001, respectively). Crude rates of HH/1,000 patient-years were 1.4 (95% CI: 0.7; 2.4) in the DPP4-i cohort, 0.0 in the vildagliptin cohort (95% CI: 0.0; 4.0), versus 5.6 (95% CI, 4.7; 6.6) in the IS cohort (P<0.0001). After adjustments, rates per 1,000 patient-years of HH were 1.4 (95% CI: 0.7; 2.4) with DPP4-i versus 7.5 (95% CI: 6.0; 9.2) with IS (P<0.0001), and 0.0 (95% CI: 0.0; 4.0) with vildagliptin versus 13.6 (95% CI: 10.4; 17.5) with IS (P<0.0001). Adjusted EV rates were also significantly lower with all DPP4-i or with vildagliptin, as compared to IS (P<0.0001). Consistent results were found when considering only treatment initiations for all compared cohorts. CONCLUSION: HH and EV were significantly less frequent in patients exposed to any DPP4-i or to vildagliptin versus IS. These real-life data should be considered in the benefit/risk evaluation of the drugs.


Assuntos
Adamantano/análogos & derivados , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Hipoglicemia/tratamento farmacológico , Hipoglicemia/epidemiologia , Nitrilas/uso terapêutico , Pirrolidinas/uso terapêutico , Adamantano/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Diabetes Mellitus Tipo 2/complicações , Feminino , França/epidemiologia , Humanos , Hipoglicemia/complicações , Seguro Saúde , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Compostos de Sulfonilureia , Vildagliptina
14.
Therapie ; 69(4): 323-8, 2014.
Artigo em Inglês, Francês | MEDLINE | ID: mdl-25230355

RESUMO

Decree No. 2012-1116 of 2 October 2012 on medico-economic assignments of the French National Authority for Health (Haute autorité de santé, HAS) significantly alters the conditions for accessing the health products market in France. This paper presents a theoretical framework for interpreting the results of the economic evaluation of health technologies and summarises the facts available in France for developing benchmarks that will be used to interpret incremental cost-effectiveness ratios. This literature review shows that it is difficult to determine a threshold value but it is also difficult to interpret then incremental cost effectiveness ratio (ICER) results without a threshold value. In this context, round table participants favour a pragmatic approach based on "benchmarks" as opposed to a threshold value, based on an interpretative and normative perspective, i.e. benchmarks that can change over time based on feedback.


Assuntos
Benchmarking/normas , Análise Custo-Benefício , Atenção à Saúde/economia , Equipamentos e Provisões/economia , Órgãos Governamentais/legislação & jurisprudência , Programas Nacionais de Saúde/economia , Preparações Farmacêuticas/economia , Tecnologia Biomédica/economia , França , Invenções/economia , Anos de Vida Ajustados por Qualidade de Vida
15.
Med Sci (Paris) ; 30(5): 584-7, 2014 May.
Artigo em Francês | MEDLINE | ID: mdl-24939547

RESUMO

Economics was only recently considered as a dimension of health technology assessment in France. Yet there are always limits in resources that we collectively agree to devote to health. A comparative "economic" appraisal is therefore needed to guide health choices and contribute to price regulation. Methodologies are based on the determination of incremental cost-effectiveness ratios compared with a reference. The interpretation of these ratios is never isolated from the context of the decision. Health economic evaluation is not involved in healthcare rationing, but it contributes to the rationality of decisions in the interest of the overall population.


Assuntos
Auditoria Clínica , Atenção à Saúde/economia , Auditoria Clínica/métodos , Análise Custo-Benefício , Interpretação Estatística de Dados , França , Custos de Cuidados de Saúde , Humanos
17.
Therapie ; 68(4): 253-63, 2013.
Artigo em Inglês, Francês | MEDLINE | ID: mdl-23981264

RESUMO

The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico-economic evaluation of health products published a few days earlier (02 October 2012). The medico-economic evaluation (MEE), becomes an additional determinant for fixing the prices of health products by the Health products economic committee (Comité économique des produits de santé, CEPS) via the hierarchisation of treatment strategies, and thus modifies the market access conditions. Limiting the analysis to medicinal products and medical devices for which a major, important or moderate improvement in the medical service rendered (ASMR) or of the expected service (ASA) has been requested and presenting a significant budget impact on the Social Security expenses, excludes health products with ASMR or ASA with a lower level requested which often create complex price fixing problems and often have a major budget impact. This latter concept remains to be defined in detail. The MEE envisaged for the first registration must include the need to confirm or refute the initial hypotheses especially concerning the actual position in the therapeutic strategy at the time of renewal of the registration. For the first registration, the conventional reference to European prices guaranteeing a minimum price to innovative medicinal products, the medico-economic models submitted by the industry to the French Drug Authority (Haute autorité de santé, HAS) must be used to guide the compilation of new data to be requested at the time of the registration renewal and to negotiate the level of the discounts in the framework of a price-volume agreement, if applicable. The MEE will allow comparing the result of the analysis to the model hypothesis at the time of the renewal of the registration, which may contribute to the renegotiation (either up or down) of the price of health goods. The costs related to obtaining new data must be controlled. In order for the MEE to allow confirming the relationship between the price requested and the benefit expected, the group privileges the definition of reference values with an indicative and non-normative value, likely to evolve with time rather than a threshold. Concerning the evaluation procedure: the time to market access must not be lengthened; while the possibility of regular meetings between the industry and the HAS is recommended to avoid methodological divergences. A transitory period should allow the implementation of the entire evaluation procedure which must also take into account the specificities of health products registered before the 3 October 2013.


Assuntos
Custos de Cuidados de Saúde , Legislação Médica , Garantia da Qualidade dos Cuidados de Saúde , Previdência Social/economia , Tecnologia Biomédica/economia , Tecnologia Biomédica/instrumentação , Tecnologia Biomédica/legislação & jurisprudência , Interpretação Estatística de Dados , França , Custos de Cuidados de Saúde/normas , Humanos , Legislação de Dispositivos Médicos , Garantia da Qualidade dos Cuidados de Saúde/economia , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/métodos , Projetos de Pesquisa , Previdência Social/legislação & jurisprudência , Previdência Social/organização & administração
18.
BMC Pulm Med ; 13: 15, 2013 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-23517484

RESUMO

BACKGROUND: Current asthma management guidelines are based on the level of asthma control. The impact of asthma control on health care resources and quality of life (QoL) is insufficiently studied. EUCOAST study was designed to describe costs and QoL in adult patients according to level of asthma control in France and Spain. METHODS: An observational cost of illness study was conducted simultaneously in both countries among patients age greater or equal to 18 with a diagnosis of asthma for at least 12 months. Patients were recruited prospectively by GPs in 2010 in four waves to avoid a seasonal bias. Health care resources utilization of the three months before the inclusion was collected through physician questionnaires. Asthma control was evaluated using 2009 GINA criteria over a 3-month period. QoL was assessed using EQ-5D-3L®. RESULTS: 2,671 patients (France: 1,154; Spain: 1,517) were enrolled. Asthma was controlled in 40.6% [95% CI: 37.7%-43.4%] and 29.9% [95% CI: 27.6%-32.3%] of French and Spanish patients respectively.For all types of costs, the percentage of patients using health care resources varied significantly according to the level of asthma control. The average cost (euros/3-months/patient) of controlled asthma was €85.4 (SD: 153.5) in France compared with €314.0 (SD: 2,160.4) for partially controlled asthma and €537.9 (SD: 2,355.7) for uncontrolled asthma (p<0.0001). In Spain, the corresponding figures were €152.6 (SD: 162.1), €241.2 (SD: 266.8), and €556.8 (SD: 762.4). EQ-5D-3L® score was higher (p<0.0001) in patients with controlled asthma compared to partially controlled and uncontrolled asthma in both countries (respectively 0.88; 0.78; 0.63 in France and 0.89; 0.82; 0.69 in Spain). CONCLUSIONS: In both countries, patients presenting with uncontrolled asthma had a significantly higher asthma costs and lower scores of Qol compared to the others.


Assuntos
Asma/economia , Asma/terapia , Custos de Cuidados de Saúde/estatística & dados numéricos , Qualidade de Vida , Adolescente , Adulto , Idoso , Asma/epidemiologia , Comorbidade , Feminino , França/epidemiologia , Pesquisas sobre Atenção à Saúde , Gastos em Saúde/estatística & dados numéricos , Recursos em Saúde/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Análise de Regressão , Estudos Retrospectivos , Espanha/epidemiologia , Adulto Jovem
20.
Int J Public Health ; 57(1): 149-58, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21710187

RESUMO

OBJECTIVE: To evaluate the cervical cancer (CC) reduction at individual and population level following different prevention strategies (age-specific vaccination and/or screening) in France. METHODS: A lifetime Markov model was constructed with 11 health states covering the progression from human papillomavirus (HPV) infection to the development of precancerous lesions, CC and death. A screening module took into account the effects of detection and early treatment. Cohorts of girls were entered into the model at age 11 years; the model was run for 95 years using one-year cycles. RESULTS: Vaccination combined with screening substantially reduced the incidence of precancerous lesions and CC compared with screening alone. Vaccination was beneficial regardless of age at vaccination, but the greatest benefit was obtained with an early vaccination. The clinical results were the best for vaccination at 11-13 years when lifetime horizon was considered, and for vaccination at 15-17 years for shorter observation period. CONCLUSION: The model results indicate that HPV vaccination offers additional protection against CC when combined with screening. The optimum starting age for vaccination varies depending on the observation period duration.


Assuntos
Papillomaviridae/imunologia , Vacinas contra Papillomavirus/uso terapêutico , Saúde Pública , Neoplasias do Colo do Útero/prevenção & controle , Adolescente , Criança , Estudos de Coortes , Feminino , França , Humanos , Cadeias de Markov , Infecções por Papillomavirus/prevenção & controle
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