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ObjectiveClinical data comparing diagnostic strategies in the management of Helicobacter pylori-associated diseases are limited. Invasive and noninvasive diagnostic tests for detecting H. pylori infection are used in the clinical care of patients with dyspeptic symptoms. Modelling studies might help to identify the most cost-effective strategies. The objective of the study is to assess the cost-effectiveness of a ‘test-and-treat’ strategy with the urea breath test (UBT) compared with other strategies, in managing patients with H. pylori-associated dyspepsia and preventing peptic ulcer in the UK.DesignCost-effectiveness models compared four strategies: ‘test-and-treat’ with either UBT or faecal antigen test (FAT), ‘endoscopy-based strategy’ and ‘symptomatic treatment’. A probabilistic cost-effectiveness analysis was performed using a simulation model in order to identify probabilities and costs associated with relief of dyspepsia symptoms (over a 4-week time horizon) and with prevention of peptic ulcers (over a 10-year time horizon). Clinical and cost inputs to the model were derived from routine medical practice in the UK.ResultsFor relief of dyspepsia symptoms, ‘test-and-treat’ strategies with either UBT (€526/success) and FAT (€518/success) were the most cost-effective strategies compared with ‘endoscopy-based strategy’ (€1317/success) and ‘symptomatic treatment’ (€1 029/success). For the prevention of peptic ulcers, ‘test-and-treat’ strategies with either UBT (€208/ulcer avoided/year) or FAT (€191/ulcer avoided/year) were the most cost-effective strategies compared with ‘endoscopy-based strategy’ (€717/ulcer avoided/year) and ‘symptomatic treatment’ (€651/ulcer avoided/year) (1 EUR=0,871487 GBP at the time of the study).Conclusion‘Test-and-treat’ strategies with either UBT or FAT are the most cost-effective medical approaches for the management of H. pylori-associated dyspepsia and the prevention of peptic ulcer in the UK. A ‘test-and-treat’ strategy with UBT has comparable cost-effectiveness outcomes to the current standard of care using FAT in the UK.

BACKGROUND Data from clinical trials comparing Helicobacter pylori (H. pylori) management strategies in patients with dyspepsia are limited. Cost-effectiveness simulation models might help to identify the optimal strategy. OBJECTIVE To assess the cost-effectiveness of the H. pylori "Test and Treat" (T&T) strategy including the use of urea breath test (UBT) vs symptomatic treatment (ST) and vs upper gastrointestinal endoscopy (UGE) as a first procedure in patients with dyspepsia. METHODS Three main strategies: "T&T" strategy including the use of UBT, "UGE" and "ST" have been compared using cost-effectiveness models developed in accordance with the Spanish medical practice. For the model simulations, a time horizon of 4 weeks was considered for the endpoint "Dyspepsia symptoms relief" and 10 years when using "Peptic ulcer avoided" and "Gastric cancer avoided" endpoints. RESULTS For the endpoint "Dyspepsia symptoms relief", T&T strategy appears to be the most cost-effective (883€/success) compared to UGE strategy and to ST strategy (respectively 1628€ and 990€/success). For the endpoint "Probability of peptic ulcer", the T&T strategy appears to be the most cost-effective (421€/peptic ulcer avoided/y) compared to UGE strategy and ST strategy (respectively 728€ and 632€/peptic ulcer avoided/y). For the endpoint "Gastric cancer avoided", the T&T strategy appears to be the most cost-effective (524€/gastric cancer avoided/y) compared to UGE strategy and "ST" strategy (respectively 716€ and 696€/gastric cancer avoided/y). CONCLUSIONS T&T strategy including the use of UBT is the most cost-effective medical approach for management of dyspepsia and for the prevention of ulcer and gastric cancer.

Background The FLURESP project is a public health project funded by the European Commission with the objective to design a methodological approach in order to compare the cost-effectiveness of existing public health measures against human influenza pandemics in four target countries: France, Italy, Poland and Romania. This article presents the results relevant to the French health system using a data set specifically collected for this purpose. Methods Eighteen public health interventions against human influenza pandemics were selected. Additionally, two public-health criteria were considered: 'achieving mortality reduction ≥40%' and 'achieving morbidity reduction ≥30%'. Costs and effectiveness data sources include existing reports, publications and expert opinions. Cost distributions were taken into account using a uniform distribution, according to the French health system. Results Using reduction of mortality as an effectiveness criterion, the most cost-effective options was 'implementation of new equipment of Extracorporeal membrane oxygenation (ECMO) equipment'. Targeting vaccination to health professionals appeared more cost-effective than vaccination programs targeting at risk populations. Concerning antiviral distribution programs, curative programs appeared more cost-effective than preventive programs. Using reduction of morbidity as effectiveness criterion, the most cost-effective option was 'implementation of new equipment ECMO'. Vaccination programs targeting the general population appeared more cost-effective than both vaccination programs of health professionals or at-risk populations. Curative antiviral programs appeared more cost-effective than preventive distribution programs, whatever the pandemic scenario. Conclusion Intervention strategies against human influenza pandemics impose a substantial economic burden, suggesting a need to develop public-health cost-effectiveness assessments across countries.

Over the years, a number of criticisms have been raised about the robustness of the Quality-Adjusted Life Years (QALY) indicator and its use in cost-utility analyses; however, costs/QALY are still nowadays recommended as reference case by several Health Technology Assessment (HTA) agencies from some Commonwealth countries, such as the National Institute for Health and Care Excellence (NICE) in the UK, claiming that no alternatives exist to allocate health care resources.This review presents a selection of robust alternative methodologies that could be used to support HTA decisions more accurately and more fairly than using the QALYs, including for determining the level of patient access and reimbursement coverage to healthcare interventions. Expert commentary: Because of the scientific complexity of the situations raised by existing and innovative health technologies and interventions, there is currently no single alternative paradigm to propose at this time, but a spectrum of additional analytical techniques which could handle various outcomes including costs and health consequences, and which are not based on a simple multiplicative formula.

Surgical treatment strategies for mitral valve disease have progressively shifted toward repair given the better survival outcomes with this type of intervention. However, valve repairs and valve replacement may require reoperations with time. In the absence of clinical trials assessing the effectiveness of various mitral surgical treatments with time, we propose to develop cost-effectiveness models to compare sequential treatment strategies.Three simulation models were carried out to assess the cost-effectiveness of mitral valve repair as first-line treatment, compared with either mechanical or biologic valve replacements. Efficacy data were derived from both the published literature and from a specific clinical cohort of 582 patients treated for this condition. Using the French public health care system perspective, relevant direct costs were derived using a local resource utilization assessment and official costing data sources.Over 10 years, costs per success were significantly lower (p0.01) for the mitral valve repair strategy versus biologic or mechanical valve replacements (€35,550, €49,492, and €54,634 per success, respectively). Over 20 years, costs per success were significantly lower (p0.01) for the mechanical valve replacement strategy compared with the mitral valve repair and biologic valve replacement (€94,763, €100,053, and €147,484 per success, respectively).Considering the increased referral rate in older patients with degenerative mitral valve disease, and their shorter life expectancy, these results show that when medically required and technically practicable, mitral valve repair should be considered as the first-line strategy.

Objective: The main objective was to compare the cost-effectiveness of therapeutic options in moderate or severe rheumatoid arthritis (RA) when a clinical response to a first TNF-blocker, either etanercept (ETA), adalimumab (ADA), or infliximab (INF), is insufficient. Methods: Effectiveness criteria were defined as remission (RS), low disease activity (LDAS), and moderate to high disease activity (MHDAS). Cost-effectiveness was derived as cost per day in RS and in LDAS using simulation modelling to assess six sequential biologic strategies over 2 years. Each sequential treatment strategy was composed of three biologic agents and included a first anti-TNF agent, ETA, ADA or INF, followed by either abatacept (ABA) or rituximab (RTX) as a second therapeutic option in case of an insufficient response, followed by another anti-TNF agent in case of further insufficient response. Results: Over two years and taking into account biologic costs, the following estimated mean costs per day in RS and LDAS were respectively of � 829 and � 428 for the biologic sequence composed of ADA-ABA-ETA, � 1292 and � 516 for the sequence ADA-RTX-ETA, � 829 and � 429 for the sequence ETA-ABA-ADA, � 1292 and � 517 for the sequence ETA- RTX-ADA, � 840 and � 434 for the sequence INF-ABA-ETA, and � 1309 and � 523 for the sequence INF-RTX-ETA. Conclusion: The treatment sequences including ABA as the second biologic option appear more cost-effective than those including RTX in a patients with moderate to severe RA and an insufficient response to a first anti-TNF agent.

To assess the cost-effectiveness of abatacept compared to different biologic treatment strategies for moderate to severe rheumatoid arthritis based on current medical practices in Canada. A model was constructed to assess the cost-effectiveness of various biologic treatments over a 2-year time horizon, using two effectiveness endpoints: “low disease activity state” (LDAS) and “remission”. Abatacept, as first biologic agent after an inadequate response to DMARDs, provides greater treatment success rate for achieving LDAS (29.4% versus 15.6%) and remission (14.8% versus 5.2%), and appears significantly more cost-effective compared to the sequential use of anti-TNF agents (p < 0.001). Abatacept, as second biologic agent after an inadequate response to one anti-TNF agent, provides greater treatment success rate for achieving LDAS (17.1% versus 10.2%) and remission (7.4% versus 3.9%) and appears significantly more cost-effective compared to the sequential use of anti-TNF agents (p < 0.001). Abatacept is a cost-effective strategy in patients with an inadequate response to DMARDs or to one anti-TNF agent.

To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model.Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 years were obtained from the Prevention of Relapses and disability by Interferon-beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study. The area under the Expanded Disability Status Scale (EDSS) score-time curve was used as a measure of disability and the effectiveness of therapy was expressed as EDSS-months of disability prevented. Costs were calculated for the UK and France, and results were projected to 10 and 20 years using a time series regression model.Over 10 years, treatment with IFNbeta-1a 44mug subcutaneously three times weekly prevented 121 EDSS-months of additional disability at a cost of Euros (euro)732 each (year of costing 2000). Over 20 years, 321 EDSS-months were saved at a cost of euro359 per month (year of costing 2000).This analysis indicated that IFNbeta-1a 44mug subcutaneously three times weekly is cost effective in RRMS and that treatment becomes increasingly cost effective over time.

Purpose: To evaluate the relative cost-effectiveness of recombinant and urinary follicle-stimulating hormone (FSH) in assisted reproduction techniques in the Spanish National Health Service.

Objective: To compare the cost effectiveness of recombinant human FSH (Gonal-F; Serono, Inc., Randolph, MA) and urinary FSH (Fertinex; Serono, Inc.) for ovarian stimulation during IVF with or without intracytoplasmic sperm injection for the treatment of infertility. Design: Clinical decision analysis techniques (the Markov model) were used to model the direct medical costs per patient during assisted reproductive technology. Main Outcome Measure(s): Clinical and economic outcomes of two different ovarian stimulation protocols (recombinant human FSH or urinary FSH) during three treatment cycles were considered. Result(s): More ongoing pregnancies were achieved, with fewer stimulation cycles, after recombinant human FSH (Gonal-F) than after urinary FSH (Fertinex) (40,665 versus 37,890). In addition, recombinant human FSH was also found to be more cost effective per ongoing pregnancy. From a societal perspective, the mean cost per pregnancy was $40,688 for recombinant human FSH versus $47,096 for urinary FSH. From the insurers' perspective, the mean cost/pregnancy for recombinant human FSH was $28,481 versus $32,967 for urinary FSH. Conclusion(s): Recombinant human FSH (Gonal-F) is not only more efficient clinically than urinary FSH (Fertinex), but also more cost effective. This analysis illustrates the point that the economic effectiveness of a drug depends less on its acquisition costs and rather more on the clinical outcomes associated with its use.

BACKGROUND The purpose of this study was to undertake an economic evaluation to compare the cost-effectiveness of recombinant (r)FSH with urinary (u)FSH for attaining clinical pregnancy with assisted reproduction. METHODS Mathematical modelling was utilized incorporating a Markovian decision framework and a Monte Carlo simulation. Statistical representations of recurrent events over time were incorporated into a decision analysis involving fresh and frozen cycles in any sequence (after the first fresh embryo transfer cycle) over three successive assisted reproduction attempts. The mean values of transition probabilities were derived from randomized controlled clinical trials and published reports. The distributions of these transition probabilities were agreed upon by a panel of experts. Cost data for procedures and drugs were derived and validated according to the perspectives of the National Health Service and private clinics in the UK. RESULTS The study involved 5000 Monte-Carlo simulations of treatment on a Markov cohort of 100 000 patients. The total number of pregnancies attained was significantly higher in the rFSH (40 575) compared with the uFSH (37 358) group. The cost per successful pregnancy was significantly lower for rFSH (5906 pounds sterling) compared with uFSH (6060 pounds sterling) and overall, fewer cycles of treatment were required with rFSH to achieve an ongoing pregnancy. The incremental cost-effectiveness ratio is 4148 pounds sterling for each additional clinical pregnancy with rFSH. CONCLUSIONS In addition to the increased effectiveness of rFSH in ART, this study demonstrated that it is more cost-effective and more efficient than uFSH in attaining an ongoing pregnancy.

Objectives To assess the cost-effectiveness of three colorectal-cancer (CRC) screening strategies in France: fecal-occult-blood tests (FOBT), computed-tomography-colonography (CTC) and optical-colonoscopy (OC). Methods Ten-year simulation modeling was used to assess a virtual asymptomatic, average-risk population 50–74 years old. Negative OC was repeated 10 years later, and OC positive for advanced or non-advanced adenoma 3 or 5 years later, respectively. FOBT was repeated biennially. Negative CTC was repeated 5 years later. Positive CTC and FOBT led to triennial OC. Total cost and CRC rate after 10 years for each screening strategy and 0–100% adherence rates with 10% increments were computed. Transition probabilities were programmed using distribution ranges to account for uncertainty parameters. Direct medical costs were estimated using the French national health insurance prices. Probabilistic sensitivity analyses used 5000 Monte Carlo simulations generating model outcomes and standard deviations. Results For a given adherence rate, CTC screening was always the most effective but not the most cost-effective. FOBT was the least effective but most cost-effective strategy. OC was of intermediate efficacy and the least cost-effective strategy. Without screening, treatment of 123 CRC per 10,000 individuals would cost €3,444,000. For 60% adherence, the respective costs of preventing and treating, respectively 49 and 74 FOBT-detected, 73 and 50 CTC-detected and 63 and 60 OC-detected CRC would be €2,810,000, €6,450,000 and €9,340,000. Conclusion Simulation modeling helped to identify what would be the most effective (CTC) and cost-effective screening (FOBT) strategy in the setting of mass CRC screening in France.

Background. The objective of this simulation model was to assess the cost-effectiveness of different biological treatment strategies based on levels of disease activity in Spain, in patients with moderate to severe active RA and an insufficient response to at least one anti-TNF agent.Methods. Clinically meaningful effectiveness criteria were defined using DAS28 scores: remission and Low Disease Activity State (LDAS) thresholds. Monte-Carlo simulations were conducted to assess cost-effectiveness over 2 years of four biological sequential strategies composed of anti-TNF agents (adalimumab, infliximab), abatacept or rituximab, in patients with moderate to severe active RA and an insufficient response to etanercept as first biological agent.Results. The sequential strategy including etanercept, abatacept and adalimumab appeared more efficacious over 2 years (102 days in LDAS) compared to the same sequence including rituximab as second biological option (82 days in LDAS). Cost-effectiveness ratios showed lower costs per day in LDAS with abatacept (427 €) compared to rituximab as second biological option (508 €). All comparisons were confirmed when using remission criteria.Conclusion. Model results suggest that in patients with an insufficient response to anti-TNF agents, the biological sequences including abatacept appear more efficacious and cost-effective than similar sequences including rituximab or cycled anti-TNF agents.

Aims: We assess the cost-effectiveness of dental implant first-line strategy vs. fixed partial denture strategy in patients suffering from one single missing tooth. Materials and methods: The model used a simulation decision framework over a 20-year period. Potential treatment switches can occur every 5 years. Transition probabilities come from literature, epidemiological reports or expert opinions. They have been programmed using specific distribution ranges to simulate the patients' and practice variability, and to take into account parameter uncertainty. Direct medical costs have been assessed according to a cost survey. Probabilistic sensitivity analyses were conducted using 5000 Monte-Carlo simulations, generating confidence intervals of model outcomes. Results: We found that mean cost-effectiveness of the bridge strategy is higher than the implant strategy. Conclusion: Implant as the first-line strategy appears to be the ‘dominant’ strategy, considering the lower overall costs and the higher success rate.

Objective. To assess by simulation the cost-effectiveness of intrathecal baclofen (ITB) therapy compared with conventional medical treatments for patients with disabling spasticity and functional dependence caused by any neurological disease. Methods. Two models were created to simulate therapeutic strategies for managing severe spasticity, one with and one without the use of ITB, to assess various treatment sequences over 2 years based on current medical practices in France. Successful treatment at each evaluation was defined as a combination of: (1) the increased patient and caregiver satisfaction as assessed by goal attainment scaling (GAS), and (2) a decrease of at least 1 point on the Ashworth score. Probabilistic sensitivity analyses were performed using 5000 Monte-Carlo simulations taking into account specific distribution curves for direct costs and effectiveness parameters in each treatment option. Results. The model simulations suggest that including ITB as a first option strategy in the management of function of severely impaired patients with disabling spasticity results in a higher success rate (78.7% vs 59.3%; P < .001). In addition, the ITB therapy model revealed a lower cost (59 391 vs 88 272; P < .001) and an overall more favorable cost-effectiveness ratio (75 204/success vs 148 822/success; P < .001), compared with conventional medical management without ITB. Conclusion. Within the assumptions of our modeling, ITB therapy evaluated by a combination of treatment success criteria at 6-month intervals over a 2-year period may be a cost-effective strategy compared to conventional medical management alone.

International audience; OBJECTIVES:To compare effectiveness, associated cost of outcomes and cost-effectiveness of a single annual infusion of zoledronic acid versus current treatment strategies plans for postmenopausal osteoporosis in France.METHODS:Twelve simulation-based models were built to investigate three types of fractures: vertebral (VF), non-vertebral excluding hip (NVF) and hip (HF), comparing two groups: zoledronic acid and current postmenopausal antiosteoporotic treatment strategies. Two effectiveness comparability assumptions have been tested: specific agent efficacy values, and same standard efficacy values for all active agents. Direct medical costs included drug costs, medical visits, monitoring and fracture management. Adherence levels were integrated into the model under the assumption that non-adherent patients had treatment effects similar to the levels of placebo effectiveness.RESULTS:Using the most conservative assumption (same standard efficacy values for all active agents), zoledronic acid strategy results in less vertebral, non-vertebral and hip fractures than other current antiosteoporotic treatment options over 3 years: 12.04% vs. 14.18%, 10.61% vs. 11.28% and 2.82% vs. 4.64% respectively, (pCONCLUSION:Zoledronic acid is a cost-effective treatment strategy regardless of fracture type or effectiveness comparability assumptions.

To assess effectiveness, cost, and cost-effectiveness of ranibizumab versus the current medical practices of treating age-related macular degeneration in France.A simulation decision framework over 1 year compared ranibizumab versus the usual care using two effectiveness criteria: the "visual acuity improvement rate" (greater than 15 letters on the ETDRS scale) and the "rate of legal blindness avoided". Two decision trees included various sequences of current treatments, with or without ranibizumab.Ranibizumab appeared significantly more effective than the usual care (p0.001), providing greater treatment success rate of visual acuity improvement (48.8% versus 33.9%). The cost of the ranibizumab strategy was higher (9,123 euros over 1 year for ranibizumab versus 7,604 euros for the usual care) but the average cost-effectiveness was lower--18,721 euros/success for ranibizumab versus 22,543 euros/success for usual care (p0.001). Considering the "legal blindness avoided" success criterion, the ranibizumab strategy appeared significantly more effective (p0.001), providing greater treatment success rate for of legal blindness avoided than usual care (99.7% versus 93.1%) although it was more expensive (9,196 euros over 1 year for ranibizumab versus 5,713 euros for the usual care).Ranibizumab significantly improved the rate of visual acuity improvement and reduced the rate of legal blindness. Ranibizumab appeared significantly more cost-effective than the usual treatments in terms of visual acuity improvement.

Introduction: The focus on cost-containment imposed by shrinking national health care budgets is increasingly putting pressure on investigators to demonstrate that newer interventions are not only effective but also cost-effective. In the area of assisted reproductive technology (ART) a shift in usage is occurring from urinary derived to biotechnology – derived (recombinant) gonadotropins for ovarian stimulation. Provision of treatment with ART often involves several cycles of treatment, each associated with multiple steps with varying outcomes at each step. To take into account all the situations that are possible during the repeated cycles of treatment when trying to evaluate different ovarian stimulation regimens is a complex task that requires large numbers of subjects to adequately address the cost-effectiveness of these therapies. A more efficient approach is to employ modeling techniques that can easily be applied to the different national health care systems. The objective of this study was to compare the cost-effectiveness of rec ombinant(r) FSH with urinary(u) FSH in the UK, USA, Germany and Spain.