Effectiveness and safety of belantamab mafodotin in patients with relapsed or refractory multiple myeloma in real-world setting: The ALFA study.

OBJECTIVES: The aim of this noninterventional, retrospective ALFA study was to describe belantamab mafodotin effectiveness and safety in patients with relapsed/refractory multiple myeloma in a real-world setting in France. METHODS: Response rate, progression-free survival (PFS), overall survival (OS), and safety were assessed. RESULTS: Among the 184 patients initiating belantamab mafodotin treatment, the overall response rate was 32.7% (≥very good partial response [VGPR] 20.4%, partial response [PR] 12.3%). The median PFS (mPFS) was 2.4 months (95% confidence interval [CI]: 1.9, 3.3), and median OS (mOS) was 8.8 months (95% CI: 6.3, 11.6). According to best response, mPFS was 20.6 months (95% CI: 12.1, not reached [NR]) in patients with ≥VGPR and 7.1 months (95% CI: 4.6, 9.4) in patients with PR; mOS was NR in patients with ≥VGPR and 17.5 months (95% CI: 7.7, NR) in patients with PR. For both OS and PFS, no differences were found in subgroups of interest. The adverse events (AEs) reported in 159 patients (86.4%) were mostly ocular AEs. CONCLUSIONS: ALFA, the largest real-world cohort conducted so far, confirms the results of belantamab mafodotin as reported in the DREAMM-2 clinical trial. The clinical benefit is significant as long as the patient is a responder.

Survival outcomes for patients with multiple myeloma in France: A retrospective cohort study using the Système National des Données de Santé national healthcare database.

OBJECTIVE: Evaluate the overall survival (OS) of patients with multiple myeloma (MM) at different treatment stages in France. METHODS: This retrospective observational cohort study used data from the French National Health Insurance database to study patients with MM (diagnosis 2013-2019). Patient outcomes included OS (all-cause mortality), time-to-next treatment (TTNT), and duration of therapy (DoT) from initial diagnosis, the start of different lines of therapy (LOTs), triple-class exposure (TCE), and subsequent treatment following TCE. The Kaplan-Meier method analyzed "time-to-event" data. RESULTS: From diagnosis, death rates increased from 1% at 1 month to 24% at 2 years; median OS was 63.8 months (N = 14 309). Median OS from the start of LOTs declined from 61.0 months (LOT1) to 14.8 months (LOT4). Median OS from TCE start was 14.7 months. There was a large variation in TTNT within LOTs (e.g., LOT1: bortezomib + lenalidomide: TTNT = 26.4 months, OS = 61.7 months; lenalidomide: TTNT = 20.0 months, OS = 39.6 months); DoT was similar for LOT1 and LOT2, then progressively declined at LOT4. Patients with stem cell transplant, younger age, and less comorbidity had better survival outcomes. CONCLUSIONS: Patients with MM face a poor prognosis after relapse to multiple LOTs and TCE, demonstrating a worsening of survival outcomes. Access to novel therapies may improve outcomes.

Assessing the treatment pattern, health care resource utilisation, and economic burden of multiple myeloma in France using the Système National des Données de Santé (SNDS) database: a retrospective cohort study.

BACKGROUND: Real-world data on health care resource utilisation (HCRU) and costs for French patients with multiple myeloma (MM) are limited due to the quickly evolving MM treatment landscape. This retrospective, national-level study quantified the MM economic burden in France. METHODS: The study included patients with newly diagnosed MM from the Système National des Données de Santé coverage claims database between 2013 and 2018 who received active treatment within 30 days of diagnosis. HCRU included hospitalisations, drugs, consultations, procedures, tests, devices, transport, and sick leave. Costs were annualized to 2019 prices. Drug treatments, reported by line of therapy (LOT), were algorithmically defined using drug regimen, duration of therapy, and gaps between treatments. Analyses were stratified by stem cell transplantation status and LOT. RESULTS: Among 6413 eligible patients, 6229 (97.1%) received ≥ 1 identifiable LOT; most received 1 (39.8%) or 2 LOT (27.5%) during follow-up. Average annual hospitalisation was 6.3 episodes/patient/year (median duration: 11.6 days). The average annual cost/patient was €58.3 K. Key cost drivers were treatment (€28.2 K; 39.5% of total HCRU within one year of MM diagnosis) and hospitalisations (€22.2 K; 48.6% of total HCRU costs in first year). Monthly treatment-related costs increased from LOT1 (€2.447 K) and LOT5 + (€7.026 K); only 9% of patients received LOT5 + . At LOT4 + , 37 distinct regimens were identified. Hospitalisation costs were higher in patients with stem cell transplantation than total population, particularly in the first year. CONCLUSIONS: This study showed a high economic burden of MM in France (€72.37 K/patient/year in the first year) and the diversity of regimens used in late-line treatments.

Consequences of Radiothermal Ageing on the Crystalline Morphology of Additive-Free Silane-Crosslinked Polyethylene.

The radiothermal ageing of silane-crosslinked low-density PE (Si-XLPE) films was studied in the air under three different γ dose rates (8.5, 77.8, and 400 Gy·h-1) at a low temperature close to ambient (47, 47, and 21 °C, respectively). Changes in crystalline morphology were investigated using a multi-technique approach based on differential scanning calorimetry (DSC), wide- (WAXS) and small-angle X-ray scattering (SAXS), and density measurements. In particular, the changes in four structural variables were accurately monitored during radiothermal ageing: crystallinity ratio (XC), crystalline lamellae thickness (LC), long period (Lp), and interlamellar spacing (La). Concerning the changes in XC, a perfect agreement was found between DSC and WAXS experiments. Successive sequences of self-nucleation and annealing (SSA) were also performed on aged Si-XLPE samples in the DSC chamber in order to assess the thickness distribution of crystalline lamellae. This method allowed the thermally splitting of the melting domain of Si-XLPE into a series of elementary melting peaks, with each one characterised by a distinct thickness of crystalline lamellae. DSC (used with the SSA method) showed a slight increase in LC during the oxidation of Si-XLPE, while SAXS confirmed a catastrophic decrease in La. The critical value of the interlamellar spacing characterising the ductile/brittle transition of Si-XLPE was found to be of the same order of magnitude as that for linear polyethylene (LaF≈6 nm). This structural end-of-life criterion can now be used for predicting the lifetime of Si-XLPE in a nuclear environment.

A New Kinetic Modeling Approach for Predicting the Lifetime of ATH-Filled Silane Cross-Linked Polyethylene in a Nuclear Environment.

This study focuses on the degradation of a silane cross-linked polyethylene (Si-XLPE) matrix filled with three different contents of aluminum tri-hydrate (ATH): 0, 25, and 50 phr. These three materials were subjected to radiochemical ageing at three different dose rates (8.5, 77.8, and 400 Gy·h-1) in air at low temperatures close to ambient (47, 47, and 21 °C, respectively). Changes due to radio-thermal ageing were investigated according to both a multi-scale and a multi-technique approach. In particular, the changes in the chemical composition, the macromolecular network structure, and the crystallinity of the Si-XLPE matrix were monitored by FTIR spectroscopy, swelling measurements in xylene, differential scanning calorimetry, and density measurements. A more pronounced degradation of the Si-XLPE matrix located in the immediate vicinity of the ATH fillers was clearly highlighted by the swelling measurements. A very fast radiolytic decomposition of the covalent bonds initially formed at the ATH/Si-XLPE interface was proposed to explain the higher concentration of chain scissions. If, as expected, the changes in the elastic properties of the three materials under study are mainly driven by the crystallinity of the Si-XLPE matrix, in contrast, the changes in their fracture properties are also significantly impacted by the degradation of the interfacial region. As an example, the lifetime was found to be approximately halved for the two composite materials compared to the unfilled Si-XLPE matrix under the harshest ageing conditions (i.e., under 400 Gy·h-1 at 21 °C). The radio-thermal oxidation kinetic model previously developed for the unfilled Si-XLPE matrix was extended to the two composite materials by taking into account both the diluting effect of the ATH fillers (i.e., the ATH content) and the interfacial degradation.

Towards a Kinetic Modeling of the Changes in the Electrical Properties of Cable Insulation during Radio-Thermal Ageing in Nuclear Power Plants. Application to Silane-Crosslinked Polyethylene.

The radio-thermal ageing of silane-crosslinked polyethylene (Si-XLPE) was studied in air under different γ dose rates (6.0, 8.5, 77.8, and 400 Gy·h-1) at different temperatures (21, 47, and 86 °C). The changes in the physico-chemical and electrical properties of Si-XLPE throughout its exposure were determined using Fourier transform infrared spectroscopy coupled with chemical gas derivatization, hydrostatic weighing, differential scanning calorimetry, dielectric spectroscopy and current measurements under an applied electric field. From a careful analysis of the oxidation products, it was confirmed that ketones are the main oxidation products in Si-XLPE. The analytical kinetic model for radio-thermal oxidation was thus completed with relatively simple structure-property relationships in order to additionally predict the increase in density induced by oxidation, and the adverse changes in two electrical properties of Si-XLPE: the dielectric constant ε' and volume resistivity R. After having shown the reliability of these new kinetic developments, the lifetime of Si-XLPE was determined using a dielectric end-of-life criterion deduced from a literature compilation on the changes in R with ε' for common polymers. The corresponding lifetime was found to be at least two times longer than the lifetime previously determined with the conventional end-of-life criterion, i.e., the mechanical type, thus confirming the previous literature studies that had shown that fracture properties degrade faster than electrical properties.

Atomic Scale Mechanisms Controlling the Oxidation of Polyethylene: A First Principles Study.

Understanding the degradation mechanisms of aliphatic polymers by thermal oxidation and radio-oxidation is very important in order to assess their lifetime in a variety of industrial applications. We focus here on polyethylene as a prototypical aliphatic polymer. Kinetic models describing the time evolution of the concentration of chain defects and radicals species in the material identify a relevant step in the formation and subsequent decomposition of transient hydroperoxides species, finally leading to carbonyl defects, in particular ketones. In this paper, we first summarize the most relevant mechanistic paths proposed in the literature for hydroperoxide formation and decomposition and, second, revisit them using first principles calculations based on Density Functional Theory (DFT). Our results partially confirm commonly accepted reaction energies, but also propose alternative, more favourable, reaction paths. We highlight the influence of the environment-crystalline or not-on the outcome of some of the studied chemical reactions. A remarkable result of our calculations is that hydroxyl radicals play an important role in the decomposition of hydroperoxides. Based on our findings, it should be possible to improve the set of equations and parameters used in current kinetic simulations of polyethylene radio-oxidation.

Humid and Thermal Oxidative Ageing of Radiation Cured Polymers-A Brief Overview.

This article deals with the long-term behaviour of radiation cured polymers. Among the wide variety of possible ageing modes, the attention is focused on two key processes for users of radio-cured polymers: humid ageing of polymer glasses and thermal oxidative ageing of rubbers. These two processes are illustrated by numerous results coming from literature or our own research works. In both cases, the consequences of the structural modifications on the use properties (in particular, on mechanical properties) are described. It is found that the ageings of radiochemically and thermally cured polymers are not so different. It is thus concluded that a great part of the very abundant literature published on the ageing of thermally cured polymers remains exploitable for radio-cured polymers.

A budget impact analysis comparing a Hydrofiber® ; dressing to an alginate dressing in managing exuding venous leg ulcers in France.

An Excel model was developed to compare total costs (including primary and secondary dressings only) of Hydrofiber(®) ; dressing (2010 branded price) versus an alginate dressing (generic or branded price) in managing exuding venous leg ulcers considering mean wear time and mean duration of exudate management phase, from the French Social Security perspective over 5 years (2011-2015). Budget impact (based on prevalence of venous leg ulcers in France) was estimated as the difference between scenario 1 (Hydrofiber(®) ; versus alginate dressing usage proportion increasing slightly per year) and Scenario2 (proportion remaining at 2010 levels). Annual costs and net savings per patient for the dressings were calculated in analyses 1 and 2. Analysis 1 (28-day mean exudate management phase for both Hydrofiber(®) ; and alginate dressing groups): total costs 66·82€ Hydrofiber(®) ;, 70·08€ generic alginate, 77·0€ branded alginate; net savings 3·26€ and 10·18€ for Hydrofiber(®) ; versus generic and branded alginate. Analysis 2 (mean exudate management phase of 22·2 versus 28 days for Hydrofiber(®) ; versus alginate): total costs 52·92€, 70·08€ and 77·0€, and net savings 17·10€ and 24·02€, accordingly. Total cost savings (budget impact scenario 1 minus scenario 2): Analysis 1 - 223 107€ and 696 304€ for Hydrofiber(®) ; versus generic and branded alginate dressings, respectively; Analysis 2 - 1 169 845€ and 1 643 042€ accordingly. Sensitivity analyses indicated that results are reliable. This conservative analysis shows that effective exudate management using Hydrofiber(®) ; dressing can produce sizeable cost savings.

The cost of managing HIV infection in highly treatment-experienced, HIV-infected adults in France.

BACKGROUND: Highly active antiretroviral therapy (HAART) has greatly enhanced HIV management, lowering the risk of clinical disease progression and death by substantially improving HIV-induced immune deficiency. Lower CD4 cell counts have consistently been associated with higher direct costs of HIV patient care. The aim of this study was to analyze HIV costs of care in France at different levels of HIV-induced immune deficiency (as measured by the CD4 cell count) using recent data from treatment-experienced patients. METHODS: This analysis used data from the French Hospital Database in HIV, containing data on approximately 50% of the French HIV population. Patients were included in the analysis if they had visited a participating centre from 2003 to 2005, had CD4 cell counts determined at least twice during the study period, and had been prescribed at least two nucleoside reverse transcriptase inhibitors, one non-nucleoside reverse transcriptase inhibitor and two protease inhibitors since their first consultation. Resources consumed were counted and aggregated according to the CD4 cell count level. Standard costs were applied. RESULTS: Periods with the lowest CD4 cell counts were associated with increased prescription rates of antiviral agents (other than anti-HIV agents), antiparasitic drugs and antimycobacterial agents. Antiretroviral treatments accounted for 80% of all medications prescribed during the study period. Hospitalization rates decreased with increasing CD4 cell counts, with 0.72 hospitalizations per patient-year for those with CD4 cell counts of 50 cells/mm³ or less compared with 0.05 per patient-year for patients with CD4 cell counts greater than 500 cells/mm³. There was a clear trend towards lower mean healthcare costs per patient-year with decreasing immune deficiency; from €34,286 to €12,361. CONCLUSIONS: Our study showed an association between the degree of HIV-induced immune deficiency (measured by CD4 cell count) and the costs of managing HIV infection among highly pre-treated, HIV-infected individuals in France in the HAART era.

Modelling the budget impact of darunavir in the treatment of highly treatment-experienced, HIV-infected adults in France.

BACKGROUND: A key element for payers in the assessment of the economic profile of a medication is its anticipated impact on the evolution of healthcare budgets. OBJECTIVES: To forecast the impact of the use of darunavir with low-dose ritonavir 600/100 mg twice a day (bid) in highly treatment-experienced, HIV-infected adults who have failed one or more protease inhibitor (PI)-containing regimen on the budget of the French Sickness Fund (French healthcare system) over a 3-year time horizon. METHODS: A transition state model based on disease severity was developed that compared the evolution of antiretroviral and non-antiretroviral-related direct costs of care in the target population over 3 years (2007-2009) under two scenarios: (1) darunavir enters the French market in year 1; (2) darunavir is not available to the target population during 2007-2009. Model inputs were derived from a targeted analysis of the French hospital database in HIV, the darunavir POWER 1 and 2 trials and other relevant clinical studies. RESULTS: In the scenario where darunavir was available from year 1, the proportion of patients in the lower, more costly CD4 cell count strata (≤ 100 cells per mm³) was consistently lower than in the scenario without darunavir in each year of the model (17.0% vs 19.2%, 13.9% vs 18.3% and 10.8% vs 16.8% for years 1, 2 and 3, respectively). As a result, over the entire 3-year period, the net increase of antiretroviral drug costs (+ 5.6 million Euros; €), resulting from the substitution of older, cheaper PIs by darunavir, is expected to be fully compensated by savings in hospitalization costs (€-9.7 million) and expenditures for other HIV-related (non-antiretroviral) medications (€-7.3 million), leading to a net saving of €11.4 million or 2.9% of the total budget in the scenario without darunavir. Various sensitivity analyses confirmed these projected savings. CONCLUSION: The use of darunavir/ritonavir (DRV/r) 600/100 mg bid, in combination with other antiretroviral agents, in highly pre-treated, HIV-infected adults who have failed one or more PI-containing highly active antiretroviral therapy regimen is not expected to increase the budget of the French healthcare system, in comparison with a scenario without darunavir. Further research is needed to estimate the budget impact of the use of DRV/r in less treatment-experienced, HIV-infected individuals in France.

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.

Cost-effectiveness of atorvastatin in the prevention of cardiovascular events in diabetic patients: a French adaptation of CARDS.

INTRODUCTION: We estimated the cost-effectiveness of atorvastatin in the primary prevention of cardiovascular events in patients with type 2 diabetes using data from the Collaborative AtoRvastatin Diabetes Study (CARDS). METHODS: A total of 2838 patients aged 40-75 years with type 2 diabetes and no documented history of cardiovascular disease and without elevated low-density-lipoprotein cholesterol were recruited in the UK and in Ireland. Patients were randomly allocated to atorvastatin 10mg daily (n=1428) or placebo (n=1410) and were followed up for a median of 3.9 years. Direct treatment costs and effectiveness were analysed to provide estimates of cost per event avoided and cost per life-year gained over the trial period and over a patient's lifetime. RESULTS: The incremental cost-effectiveness ratio over the trial period was estimated to be Euro 3862 per clinical event avoided. Over the patient's lifetime, the incremental cost per life-year gained was Euro 2506 when considering cardiovascular deaths, and Euro 1418 per year when considering all-cause death. CONCLUSIONS: Primary prevention of cardiovascular disease with atorvastatin is cost-effective in patients with type 2 diabetes, with the incremental cost-effectiveness ratio for this intervention falling within the current acceptance threshold.

Cost-effectiveness analysis of vaccination against rotavirus with RIX4414 in France.

BACKGROUND: It is estimated that annually 300 000 cases of rotavirus-induced gastroenteritis (RVGE) occur in children aged up to 5 years in France. A two-dose vaccine against rotavirus infection (RIX4414; Rotarix, GlaxoSmithKline), has been shown to be highly effective against severe RVGE. OBJECTIVE: This study evaluated the cost effectiveness of general vaccination against rotavirus using RIX4414 in France. METHODS: A Markov model simulated RVGE events and the associated outcomes and costs relating to general vaccination of infants against rotavirus infection using RIX4414 (Rotarix) in a birth cohort of children aged up to 5 years in France with a combined adjustment for age distribution with the seasonality of the infection. Costs and outcomes were estimated from a limited societal perspective, including direct medical costs paid out of pocket or by third-party payers, as well as the proportion of direct medical costs reimbursed by the health authorities. Indirect costs were not included in the base-case analysis. The primary outcome measure was the incremental cost per QALY. RESULTS: Vaccination with RIX4414 incurred an incremental cost of 44 583 Euro per QALY at a public price of 57 Euro per vaccine dose. Univariate sensitivity analyses showed that the parameters with the largest influence on the results were the transition probabilities of severe diarrhoea, seeking medical advice and emergency visits, utility scores of diarrhoea (mild) in children and infants, and the discount rate for benefits. Probabilistic multivariate sensitivity analysis confirmed these results. The acceptability curve indicated that 94% of the results were under an informal threshold of 50 000 Euro per QALY. Comparing our results with those of a recently published study using pooled data for two rotavirus vaccine products in France, the main differences are explained by differences in model structure and in data input values. They include a different age distribution of the infection, shorter duration of the at-risk period (3 years instead of 5 years), different vaccine efficacy, different unit cost data, different disease duration, and different disutility values for the health states in the model. There is a need for agreed standards to improve comparability of results from different studies. CONCLUSIONS: The results demonstrate that a generalized vaccination strategy with RIX4414 would be cost effective in France from a limited societal perspective, depending on the baseline assumptions for disease progression and on utility scores selected.

[Cost/effectiveness analysis of adjuvant therapy with trastuzumab in patients with HER2 positive early breast cancer]. / Evaluation économique du trastuzumab en traitement adjuvant du cancer du sein précoce surexprimant HER2.

Trastuzumab (Herceptin), a recombinant, humanised, monoclonal-antibody that targets human epidermal growth factor receptor 2 (HER2), has been approved as an adjuvant therapy for HER2-positive early breast cancer. The aim of this study was to assess the incremental cost-effectiveness ratio of this treatment compared with adjuvant therapy alone in the French setting. A cost-effectiveness analysis was performed using a Markov state transition model. The transition probabilities were estimated from the interim results of the Hera trial. Unit costs data were mainly estimated in a French Oncology Center (Georges-François Leclerc, Dijon). The model estimated that overall mean survival of patients treated with trastuzumab was 20.08 years versus 16.23 in the observation group (3.85 life-years gained). For 1 000 patients with a 10-year follow-up, an adjuvant therapy with trastuzumab would avoid 49.7 loco-regional recurrences, 179.5 distant recurrences and 133.4 deaths. The incremental discounted cost of trastuzumab therapy over a lifetime horizon was estimated at 27594 euro per patient in association with a discounted gain of 2.27 life-years. In accordance with the techniques of economical evaluation, the utilization of trastuzumab as an adjuvant therapy in patients with early HER2 positive breast cancer improves patient survival with an acceptable cost-effectiveness ratio in the French setting (incremental cost-effectiveness ratio of 12,148 euros /LYG).

Estimated annual costs of prophylaxis and treatment of venous thromboembolic events associated with major orthopedic surgery in France.

Venous Thromboembolism (VTE) remains a major complication following orthopedic surgery despite heparin prophylaxis. Clinical consequences associated with this complication are deep vein thrombosis (DVT), pulmonary embolism, and long-term consequences of DVT, especially Postthrombotic syndrome (PTS). The purpose of the present study was to estimate the annual direct costs of VTE following major orthopedic surgery of the lower limb in France. This cost of illness study was performed by using available information from health system databases (1999) and literature and specific surveys (2002). Direct costs were calculated by using estimates of the number of patients with major orthopedic surgery in France during one year. Patients presenting with VTE were identified from the national disease-related group inpatient database. Additional resource consumption was identified by comparison with disease-related groups without the VTE complications. Ambulatory care costs after hospitalization, for recurrences and PTS, were estimated from specific surveys of general practitioners and venous disease specialists. Total annual costs of VTE associated with major orthopedic surgery for the French Sickness Fund were estimated to be approximately 60 million euros over 1 year with 28 million euros for inpatient care and 30 million euros for recurrences and PTS.

Hepatitis B management costs in France, Italy, Spain, and the United Kingdom.

GOALS: To estimate the costs associated with the management of chronic hepatitis B (CHB) and its sequelae in France, Italy, Spain, and the United Kingdom from the perspective of the healthcare payer. BACKGROUND: The World Health Organization estimates that the disease sequelae related to hepatitis B account for 1 million deaths annually worldwide. Northern Europe is a low endemic area, while Mediterranean regions are classified as intermediate endemic areas. The introduction of vaccination programs in France, Italy, and Spain in recent years has lowered the hepatitis B incidence rates. STUDY: The purpose of this study was to identify the medical management patterns of CHB patients in France, Italy, Spain, and the United Kingdom and estimate the economic burdens of CHB-related disease states for each country. A central questionnaire was used to collect data from specialist physicians in four countries, and responses were collated into management patterns for chronic active hepatitis, compensated and decompensated cirrhosis, and hepatocellular carcinoma. RESULTS: The average cost by disease state for each European country was found to increase across the identified disease states reflecting disease progression. Year-2001 average annual disease state costs per patient were estimated to be as follows: CHB, 1,093 euro-3,396 euro; compensated cirrhosis, 1,134 euro-3,997 euro; decompensated cirrhosis, 5,292 euro-8,842 euro; hepatocellular carcinoma, 3,731 euro-9,352 euro; and, from published sources, liver transplant surgery, 25,165 euro-84,568 euro. CONCLUSION: The cost of CHB is variable both within and between European countries. The association of disease progression with increased cost of disease management suggests that measures to prevent or delay its progression would be economically beneficial.