Effectiveness and cost of hepatitis C virus cryoglobulinaemia vasculitis treatment: From interferon-based to direct-acting antivirals era.

BACKGROUND: The net benefits of new hepatitis C virus (HCV) direct-acting antiviral drugs (DAA) in patients with cryoglobulinaemia vasculitis (CryoVas) are unknown. OBJECTIVE: To analyse the effectiveness and cost of all treatments used for HCV-CryoVas in the DAA vs pre-DAA era. METHODS: A chart review of all HCV-CryoVas patients who received antivirals from 1993 to 2016 in a tertiary centre was performed. Treatment effectiveness was analysed for clinical, immunological and virological responses. Cost analyses included anti-HCV treatments, non-antiviral drugs, plasmapheresis, dialysis and hospitalizations. We compared main data in the pre-DAA vs DAA period. RESULTS: About 201 HCV-CryoVas patients were included (women, 53.2%; mean age, 59.2 years; Metavir score F3-F4, 36.7%; genotype 1, 64.2%). Patients in the DAA era (n=27) compared to those in the pre-DAA era (n=174) showed higher rates of clinical (96.3% vs. 78.6%), immunological (89.5% vs. 77.1%), and sustained virological response (75.0% vs. 42.8%). Death rate was 14.8% vs. 24.4% respectively. In the DAA compared to pre-DAA era, mean cost of anti-HCV drugs increased from 11 855 to 57 632 € while mean CryoVas-related cost decreased for both hospitalizations (from 33 510 to 21 347€) and non-antiviral treatments (from 17 347 to 11 397€). CONCLUSION: Improved antiviral efficacy of HCV drugs in the DAA era led to increased clinical and immunological efficacy and a lower death rate. Use of DAAs was associated to higher costs for HCV drugs while costs related to both hospitalizations and non-antiviral treatments decreased.

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.

Incidence and costs of bleeding-related complications in French hospitals following surgery for various diagnoses.

BACKGROUND: Limited information is available on the epidemiology and economics of bleeding during surgery in France. METHOD: The objective of this study was to examine the incidence, costs and length of stay (LOS) of bleeding-related complications during various surgical procedures. RESULTS: Amongst all 88 different surgical DRGs recognised by the French database 24 (totalling 321,657 hospitalisations) yielded WB rates ≥10% (range 10.3-25.3%). The highest DRG rates were for transplantations, cardiac and major orthopaedic surgery, vascular and solid organ surgery. CONCLUSIONS: The present study for France demonstrates a significant increase of hospital LOS and associated costs following post-surgical bleeding, supporting the need for blood conservation strategies.

Do two intravenous iron sucrose preparations have the same efficacy?

BACKGROUND: Intravenous (i.v.) iron sucrose similar (ISS) preparations are available but clinical comparisons with the originator iron sucrose (IS) are lacking. METHODS: The impact of switching from IS to ISS on anaemia and iron parameters was assessed in a sequential observational study comparing two periods of 27 weeks each in 75 stable haemodialysis (HD) patients receiving i.v. iron weekly and an i.v. erythropoiesis-stimulating agent (ESA) once every 2 weeks. Patients received IS in the first period (P1) and ISS in the second period (P2). RESULTS: Mean haemoglobin value was 11.78 ± 0.99 g/dL during P1 and 11.48 ± 0.98 g/dL during P2 (P = 0.01). Mean serum ferritin was similar for both treatment periods (P1, 534 ± 328 µg/L; P2, 495 ± 280 µg/L, P = 0.25) but mean TSAT during P1 (49.3 ± 10.9%) was significantly higher than during P2 (24.5 ± 9.4%, P <0.0001). The mean dose of i.v. iron per patient per week was 45.58 ± 32.55 mg in P1 and 61.36 ± 30.98 mg in P2 (+34.6%), while the mean ESA dose was 0.58 ± 0.52 and 0.66 ± 0.64 µg/kg/week, respectively (+13.8%). Total mean anaemia drug costs increased in P2 by 11.9% compared to P1. CONCLUSIONS: The switch from the originator IS to an ISS preparation led to destabilization of a well-controlled population of HD patients and incurred an increase in total anaemia drug costs. Prospective comparative clinical studies are required to prove that ISS are as efficacious and safe as the originator i.v. IS.

Inpatient costs of endophthalmitis evaluated for the whole of France.

BACKGROUND: Endophthalmitis is a severe condition that requires hospitalization with at least day care. Information on the incidence rate, costs and consequences of endophthalmitis is scarce. OBJECTIVE: To estimate the number of patients with endophthalmitis hospitalized in France, as well as the average costs and hospital budget consequences. METHODS: French Programme de Médicalisation des Systèmes d'Information (PMSI) data for 2006, derived from the official DRG classification, were analysed. Data were extracted concerning the following primary diagnoses: 'purulent endophthalmitis', 'other endophthalmitis' and 'endophthalmitis associated with another disease'. Two durations of hospitalization were compared: the actual duration and a weighted DRG duration. The cost of hospitalization was weighted by the average DRG cost + daily hospital costs x the difference between the actual and weighted DRG days in hospital. All costs are presented in euro, year 2007 values. RESULTS: A total of 1518 patients (mean age 68.7 years; 47.1% male) experienced 1725 hospitalizations for endophthalmitis, including 1416 cases (82.1%) admitted to public hospitals. The majority of patients (79.1%) were classified by DRG codes that did not specify endophthalmitis (DRG 02M03Z). Most patients (1342) were given a drug injection and 510 underwent vitrectomy. Four patients died in hospital and 75 were transferred to other hospitals. The actual duration of hospitalization for endophthalmitis in public hospitals was 8.1 days (mean), whereas the average weighted DRG duration was 5.1 days, which underestimated the actual duration by 3 days. The average hospital cost was 3688 euro per patient, totalling 6,361,119 euro per annum for all public and private hospitalizations in France, including 223,723 euro as day care. If hospital funding was wholly based on DRG tariffs, the budget for endophthalmitis would be severely underestimated. The DRG inclusion of 'severe acute ocular infections' as a proxy for endophthalmitis dramatically underestimated its true cost by approximately 30%. CONCLUSION: For health economic evaluations, it is inappropriate to use DRG classifications as proxies for endophthalmitis. Expressed more generally, hospitalization cost analyses should not be based on any specific DRG, but always on the clinically relevant primary diagnosis. The PMSI clustering algorithm underestimates the hospital budgets required for endophthalmitis. Lastly, the PMSI (exhaustively reporting all hospitalizations) is best suited to capturing yearly endophthalmitis incidence rates, average costs and national health expenditure.

Heparin-induced thrombocytopenia: an estimate of the average cost in the hospital setting in France.

Heparin-induced thrombocytopenia is a severe drug adverse effect with possible dramatic consequences. The risk is 0.1% to 5%. The costs of heparin-induced thrombocytopenia in France were estimated using the Programme Médicalisé des Systèmes d'Information (PMSI) national discharge database. Hospitalizations with heparin-induced thrombocytopenia were identified using diagnostic codes. Costs were assessed from the perspective of the French Sickness Fund or hospitals. Heparin-induced thrombocytopenia could be the reason of admission or could occur during the stay and lead to a different tariff or to additional costs associated with extra length of stay. Direct costs were also estimated from experts' opinions. A sensitivity analysis was performed from data collected in 1 center. During 2005, 445 hospitalizations with heparin-induced thrombocytopenia codes were identified. For 45 patients, the main diagnosis was heparin-induced thrombocytopenia; for the remaining 400 patients, heparin-induced thrombocytopenia occurred during the hospital stay. Tariffs and extra costs were used to estimate an overall average cost of 3230 for heparin-induced thrombocytopenia. For patients with heparin-induced thrombocytopenia as main diagnosis, the average cost was 3400; for the patients with heparin-induced thrombocytopenia that occurred during the stay, 1910 was due to an increased of the tariff and 3348 to an increased length of stay. Estimated direct costs of an episode were 3350 to 3700. Different methods were used to arrive at an estimated cost of 3500 for a heparin-induced thrombocytopenia episode for inpatients. One limitation of the study is that heparin-induced thrombocytopenia tends to be underreported by physicians during hospitalization.

Cost effectiveness of travoprost versus a fixed combination of latanoprost/timolol in patients with ocular hypertension or glaucoma: analysis based on the UK general practitioner research database.

OBJECTIVE: This study aimed to compare the cost effectiveness of travoprost versus a fixed combination of latanoprost/timolol as first-line therapies for ocular hypertension or glaucoma. METHODS: Patient charts were extracted from the UK General Practitioner Research Database. Patients with ocular hypertension or glaucoma who received first-line treatment with either travoprost or latanoprost/timolol and were followed up for >6 months were included. Treatment failure was defined as a treatment change or a glaucoma intervention (laser therapy or surgery). Time to treatment failure was compared using a Cox model and adjusted by the propensity score method. RESULTS: Eligible patients received either travoprost (n=639) or latanoprost/timolol (n=176). Their mean age was 70 years at diagnosis and 48.2% of patients were male. Patient characteristics did not differ significantly between treatment groups. Treatment failure rates at 1 year were 31.3% (travoprost) and 39.4% (latanoprost/timolol) and yielded a hazard ratio for failure in favour of travoprost (0.75; p<0.04) after adjusting for age, sex, co-morbidities and duration of follow-up. Adjusted annual costs of glaucoma management were significantly (p<0.001) less with travoprost (pound215.86) than with latanoprost/timolol (pound327.83). CONCLUSIONS: In everyday practice, travoprost was maintained longer than latanoprost/timolol as first-line therapy for glaucoma. The mean daily costs of travoprost were 50.8% less per patient than those of latanoprost/timolol. Despite adjustments, these results might be confounded, at least partially, by disease severity.

Modelling the lifetime economic consequences of glaucoma in France.

OBJECTIVE: To estimate the lifetime economic consequences of glaucoma in France. METHODS: A Markov model estimated the average discounted outcome and cost of glaucoma treatment over a patient's lifetime. Clinical states were defined as first- to fourth-line drugs, no treatment, laser therapy, surgery, blindness and death. After each failure (always after the fourth-line drug) patients could receive either laser treatment or surgery followed by no treatment, or a new treatment. A societal perspective was adopted. Sensitivity analyses were performed. RESULTS: Discounted medical costs were euro 7,322 for ocular hypertension treatment (OHT) and euro 8,488 for a glaucoma patient. Social costs of OHT and glaucoma patients exceeded medical costs. First-line use of the most effective drug would reduce medical and social costs. Societal willingness to pay for the vision benefit would equal the medical costs. Treatment initiated with the most effective drug is a cost saving strategy. CONCLUSIONS: Public health decisions in glaucoma treatment should take a broad economic view embracing the lifetime duration of the disease. There is still a place both within and outside the healthcare system for therapeutic innovations with important economic consequences that bring high added value to patients.

Economic burden of chemotherapy-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck in France: real-world data from the permanent sample of national health insurance beneficiaries.

Aims: Overall survival (OS) of patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is extremely poor. New therapeutic options emerge but need to establish their economic value. The objective was to describe the direct and related costs of R/M SCCHN in France. Materials and methods: We selected all adult patients treated with chemotherapy for R/M SCCHN between 1 January 2009 and 31 December 2014 from the permanent sample of the French national health insurance database (EGB). Data were analyzed from the index date (first chemotherapy) until patients' death or 31 December 2015. "Treatment period" and "end-of-life" (EoL) (from last chemotherapy until death) were distinguished. Costs included all hospitalizations for SCCHN and ambulatory care. Costs of hospitalized and non-hospitalized adverse events (AEs) were estimated. Results: Among 267 patients identified, 85% were men, 44% had metastases at the index date and the mean age was 62.0 years (±9.9). The most common tumor location was oropharynx (29%) but 39% of patients had multiple locations. Median OS was 9.3 (95% CI: 7.9-11.8) months for the overall population. The average total direct cost per patient was €49,954, broken down into €32,908 (95% CI: 29,525-36,290) for hospitalizations and €17,047 (14,941-19,152) for ambulatory care. Main cost drivers were drug acquisition and administration (€14,538) during the treatment period (209 days on average) and palliative care (€3,750) during the EoL period (125 days). Regarding related costs, around 12% of patients received disability pensions (€1,397 per patient [624-2,171]) and sick leave payments (€1,592 [888-2,297]). "Metabolism and nutrition disorders" and "Infections and infestations" were the most expensive hospitalized AEs (€1,513 and €1,180 per patient, respectively). Febrile neutropenia was the most expensive non-hospitalized AE (€766 per patient). Conclusions: This analysis of real-world data confirms the poor prognosis of patients with R/M SCCHN and provides cost data for future economic evaluations.

Modelling lifetime cost consequences of ReSTOR in cataract surgery in four European countries.

BACKGROUND: To compare the lifetime costs of liberating patients from spectacles after cataract surgery by implanting the multifocal intraocular lens (IOL) 'ReSTOR' versus monofocal IOLs in France, Italy, Germany and Spain. METHODS: A Markov model was created to follow patient cohorts from cataract surgery until death. Prevalence rates of patients not needing spectacles after cataract surgery were obtained from clinical trials. Resource utilisation included implant surgery, IOLs, spectacles, visits to ophthalmologists and eye centres, transport, and time lost by patients. Economic perspectives were those of Society and Sickness Funds (SFs). RESULTS: The mean number of spectacles purchased after ReSTOR was 1.34-1.61 and after monofocal IOLs 6.05-7.27. From the societal perspective, total cost estimates discounted by 3% were between 3,551 euros and 4,052 euros with ReSTOR compared to 3,989 euros and 5,548 euros with monofocal IOLs. Undiscounted savings related to ReSTOR ranged from 815 euros to 2,164 euros. From the SFs' perspective total cost estimates discounted by 3% were between 2,150 euros and 2,524 euros with ReSTOR compared to 2,324 euros and 2,610 euros with monofocal IOLs. Savings related to ReSTOR, once costs discounted, ranged from 61 euros to 219 euros. Discount and spectacle freedom prevalence rates were the most sensitive parameters. CONCLUSION: The bulk of the savings related to ReSTOR were realized outside the SF. From both a societal and SF perspective, savings, after a 3% discounting, achieved by liberating patients from spectacles counterbalanced the initially higher cost of ReSTOR. ReSTOR is a cost saving alternative to spectacles for patients requiring cataract surgery.

Intraocular pressure control with latanoprost/timolol and travoprost/timolol fixed combinations : a retrospective, multicentre, cross-sectional study.

OBJECTIVE: The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 hours after instillation. METHODS: Patients with ocular hypertension or primary open angle glaucoma stabilized on TT or TL were included in this retrospective cross-sectional study. Data on demographics, medical history and previous treatments were extracted from the patients' medical records. Last treatment instillation times and IOP values were recorded at clinic visits. Treatments were compared by analyses of variance, logistic regressions and propensity scores adjusted for confounding factors. RESULTS: Out of 316 patients included, 124 instilled TT, 192 instilled TL and 266 (84.2%) overall had instilled their eye drops within 24 hours. The patients' mean age was 64.5 years and 51.6% were female. Treatment groups were comparable except for longer disease and treatment durations in TL recipients. Worse eye mean IOPs were 25.8 mmHg at diagnosis and 21.9 mmHg on starting their designated fixed combination treatment. The best IOP control was provided by TT instillations (mean IOP 17.1 and 19.0 mmHg in the TT and TL groups, respectively; p < 0.001). This difference was reinforced by results in the subgroup of patients who instilled treatment >24 hours prior to IOP measurement (mean IOP 17.0 and 20.3 mmHg in the TT and TL groups, respectively; p < 0.004). Also, 82.6% of TT patients satisfied their ophthalmologists' IOP targets versus 51.1% of TL patients (p < 0.001). All significant differences persisted after adjustment for confounding factors. CONCLUSION: This study, conducted in routine ophthalmic practice, confirmed published clinical trial results showing that TT provides better IOP control than TL when measured in the morning, and that travoprost has longer-lasting residual effects than latanoprost when IOP is measured >24 hours after instillation. However, readers should interpret these findings in the context of a cross-sectional observational study conducted in a naturalistic setting.

Costs and persistence of brimonidine versus brinzolamide in everyday glaucoma care: an analysis conducted on the UK General Practitioner Research Database.

OBJECTIVE: To compare the persistence and costs of brimonidine versus brinzolamide therapy according to data collected by the UK General Practitioner Research Database (GPRD). METHODS: Patients with diagnoses of ocular hypertension or glaucoma, or treated for glaucoma by surgery or laser therapy were identified. Selected patients were prescribed either brimonidine or brinzolamide as monotherapy. Treatment failure was defined as a glaucoma prescription change (adding, removing or replacing a drug, or initiating surgery or laser therapy). Times to treatment failure were compared with an adjusted Cox model using a propensity score method. RESULTS: A total of 2,172 patients received brimonidine and 485 brinzolamide. Mean age was 69.5 years and 46.4% were male. Age and gender did not differ significantly whereas disease duration was longer with brinzolamide. Treatment failure at 1 year was experienced by 47.7% of patients given brinzolamide and by 55.9% given brimonidine (p<0.001). The hazard ratio for failure was less with brinzolamide (0.79: p<0.001) compared to brimonidine, after adjusting for age, gender, comorbidities and duration of follow-up. Adjusted annual costs of glaucoma management (in pound2005) were significantly (p<0.0042) lower with brinzolamide (pound196) than brimonidine (pound230). CONCLUSIONS: According to data from everyday practice collected by the UK GPRD, brinzolamide was found to be more persistent than brimonidine when given as glaucoma monotherapy. Patients continued longer with brinzolamide treatment at a lower cost.

Effectiveness and cost of contraception in France (FACET study): a cohort study from the French National Healthcare Insurance Database.

OBJECTIVE: To assess the effectiveness and costs associated with contraceptive methods based on real-world data in France. STUDY DESIGN: A cross-sectional cohort study based on data from a representative sample of the French National Healthcare Insurance Database (Echantillon Généralistes des Bénéficiaires (EGB)) was performed between January 1st 2006 and December 31st 2012. Women aged 15 years or older and users of at least one reimbursed contraceptive method between January 1st 2012 and December 31st 2012 were selected. The outcome of interest was unintended pregnancy, defined as pregnancies occurring after at least one month since the dispensation of a contraceptive method. The mean annual costs of contraceptive methods (in 2012 Euros) were collected in the database from a health system perspective. Costs were expressed for the first year of use, considering the next years of use and taking into account or not the cost of unplanned pregnancies. RESULTS: A population of 48,090 women representative of the 4,664,730 French women with a reimbursed contraceptive method was identified in the EGB in 2012: 68.6% used at least one reimbursed oral contraception (OC), 30.2% used at least one intrauterine devices (IUD) (LGN-IUS 52 mg, 17.6%; copper, 13.1%) and 5.1% used at least one etonogestrel implant. Unplanned pregnancies rates ranged from 0.6% with LNG-IUS 52 mg and 0.8% with the etonogestrel implant to 4.8% with 1st and 2nd generation combined OCs. The mean annual costs of contraception for the first year of use ranged from €145 for 1st-2nd generation combined oral contraceptions (COCs) to €308 for LNG-IUS 52 mg taking into account the next years of use, the etonogestrel implant was associated with the lowest mean annual cost (€88). When costs of unplanned pregnancies were taken into account, the mean annual cost of contraception for the first year of use was lower for progestin-only OC (€251) and copper IUD (€257) compared to etonogestrel implant (€300) and LNG-IUS 52 mg(€323). CONCLUSION: This real-world study suggests that Long-acting reversible contraceptives (LARCs) (i.e. implant and IUDs) should be considered for a broader use to prevent unplanned pregnancies and related abortions in France both from a public health and economic perspective.

Public health impact of neovascular age-related macular degeneration treatments extrapolated from visual acuity.

PURPOSE: To estimate the potential public health impact of treatment with new medications intended to preserve vision in patients with neovascular age-related macular degeneration (AMD). METHODS: A Markov model was used to simulate the natural history of AMD over the lifetime of patients with diagnosed neovascular AMD from clinical trials and epidemiologic surveys. It applied to a cohort of patients aged 75 years, with newly diagnosed neovascular AMD in one eye, whose visual acuity was 0.7 logMAR. Probabilities were calculated for the risk of AMD in the remaining eye and for premature mortality. Results of the model were expressed as the duration of low vision (worse eye VA>1.0 and better eye VA>0.7 logMAR) and blindness (bilateral VA >1.0 logMAR). Health consequences of blindness and low vision were estimated for depression, hip fractures, institutionalization, and life expectancy. RESULTS: For AMD patients with a 50% probability of VA >1.0 logMAR at 1 year, in one eye, the probability of lifetime bilateral blindness was >47%. The patients would live approximately 7 years with monocular vision >1.0 logMAR and an additional 4 years with bilateral blindness and a >15% probability of depression due to AMD. Life expectancy was decreased by approximately 2 years, >90/1000 patients would sustain a new hip fracture, and 1.5% of the patients would require institutional care for visual impairment due to AMD. To achieve a defined public health outcome (visual impairment and consequent comorbidity), it was necessary for the VA effectiveness of new treatments to increase in parallel with disease severity. CONCLUSIONS: Comorbidity related to visual impairment contributes significantly to the public health impact of AMD. Aggressive lesions need highly effective treatments. Models may be used to compare the public health impact of placebo-controlled clinical trial results.

Vasodilators and nootropics as predictors of dementia and mortality in the PAQUID cohort.

OBJECTIVES: To assess the effects of treatment for memory impairment and the Ginkgo biloba extract (EGb 761) on dementia, mortality, and survival without dementia. DESIGN: Prospective community-based cohort study. SETTING: France. PARTICIPANTS: Three thousand five hundred thirty-four subjects aged 65 and older. MEASUREMENTS: Information on drug consumption was obtained by interview and visual assessment of patients' medicine chests. Active screening of dementia was performed every 2 years over a 13-year period. The independent effects of treatment for memory impairment and the Ginkgo biloba extract on the risks of dementia and death were estimated using Cox proportional hazards models, adjusted for potentially confounding factors (including comorbidities). RESULTS: The initial consumption of Ginkgo biloba did not modify the risk of dementia (relative risk (RR)=1.16, 95% confidence interval (CI)=0.84-1.60), whereas the consumption of other treatments for memory impairment was associated with a higher risk of dementia (RR=1.35, 95% CI=1.11-1.63). Subjects who took Ginkgo biloba had a significantly lower risk of mortality in the long term (RR=0.76, 95% CI=0.62-0.93), even after adjustment for potentially confounding factors. The initial consumption of treatment for memory impairment other than Ginkgo biloba did not modify the risk of mortality. CONCLUSION: These results suggest that treatment with EGb 761 may increase the probability of survival in the elderly population. These findings need to be corroborated and further assessed using randomized, controlled trials.

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.

Management and cost analysis of cancer patients treated with G-CSF: a cohort study based on the French national healthcare insurance database.

OBJECTIVES: To describe the management and costs associated with G-CSF therapy in cancer patients in France. METHODS: This study analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer. Then the costs and characteristics of patients associated with the use of different G-CSF products were analyzed in the sub-set of breast cancer patients. RESULTS: The most frequent malignancies in the database population were breast cancer (23.3%), hematological malignancies (22.2%), and lung cancer (12.4%). The reimbursed G-CSF was pegfilgrastim in 34.1% of cases, lenograstim in 26.7%, and filgrastim in 17.9%. More than one G-CSF product was reimbursed to 21.3% of patients. The total annual reimbursed health expenses per patient, according to the type of G-CSF, were €27,001, €24,511, and €20,802 for patients treated with filgrastim, lenograstim, and pegfilgrastim, respectively. Ambulatory care accounted for, respectively, 35%, 38%, and 41% of those costs. In patients with breast cancer, ambulatory care cost was €7,915 with filgrastim, €7,750 with lenograstim, and €6,989 with pegfilgrastim, and the respective cost of G-CSF was €1,733, €1,559, and €3,668. CONCLUSION: All available G-CSF products have been shown to be effective in cancer patients, and both daily G-CSFs and pegylated G-CSF are recommended in international guidelines. Nevertheless, this analysis of G-CSF reimbursement indicates that the choice of product can markedly affect the total cost of ambulatory care.

Economic impact of ulipristal acetate on surgical procedures for uterine fibroids in France.

OBJECTIVE: To assess the budget impact of using ulipristal acetate (UPA) 5 mg to treat women with uterine fibroids (UF) causing moderate to severe symptoms. DESIGN: We modelled trends in the number of surgical procedures for symptomatic UF, with and without the use of UPA for preoperative or intermittent treatment and assessed the budget impact of UPA use from the French national healthcare insurance system perspective. SETTING: A French national hospital database (PMSI) that records admissions and relative procedures to public and private hospitals. PARTICIPANTS: Women eligible for surgical procedures for uterine fibroids. MAIN OUTCOME MEASURES: Economic impact of UPA treatment. RESULTS: This study based on observational retrospective data shows that the current use of UPA in its preoperative indication was associated with 5645 fewer surgeries from 2013 to 2015. Extrapolation suggests 17 885 fewer surgeries from 2016 to 2019. Overall, preoperative use of UPA results in substantial cost savings for the French national healthcare insurance system, with a cumulated budget impact estimated at €-5 million from 2013 to 2015 and €-13.5 million from 2016 to 2019. In addition, treating women nearing the menopause (≥48 years old) with intermittent treatment from 2017 to 2019 could produce an incremental cost saving of €19 million. CONCLUSIONS: This study shows that the use of UPA in women eligible for surgical procedures for UF is associated with considerable savings for the French national healthcare insurance system in both preoperative and intermittent indications by decreasing the need to perform surgeries.

Ready-to-use pre-filled syringes of atropine for anaesthesia care in French hospitals - a budget impact analysis.

BACKGROUND: Patient safety is improved by the use of labelled, ready-to-use, pre-filled syringes (PFS) when compared to conventional methods of syringe preparation (CMP) of the same product from an ampoule. However, the PFS presentation costs more than the CMP presentation. OBJECTIVE: To estimate the budget impact for French hospitals of switching from atropine in ampoules to atropine PFS for anaesthesia care. METHODS: A model was constructed to simulate the financial consequences of the use of atropine PFS in operating theatres, taking into account wastage and medication errors. The model tested different scenarios and a sensitivity analysis was performed. RESULTS: In a reference scenario, the systematic use of atropine PFS rather than atropine CMP yielded a net one-year budget saving of €5,255,304. Medication errors outweighed other cost factors relating to the use of atropine CMP (€9,425,448). Avoidance of wastage in the case of atropine CMP (prepared and unused) was a major source of savings (€1,167,323). Significant savings were made by means of other scenarios examined. The sensitivity analysis suggests that the results obtained are robust and stable for a range of parameter estimates and assumptions. STUDY LIMITATIONS: The financial model was based on data obtained from the literature and expert opinions. CONCLUSION: The budget impact analysis shows that even though atropine PFS is more expensive than atropine CMP, its use would lead to significant cost savings. Savings would mainly be due to fewer medication errors and their associated consequences and the absence of wastage when atropine syringes are prepared in advance.