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Background and Objectives: Most countries test donations for HIV, HCV and HBV using serology with or without nucleic acid testing (NAT). Cost-utility analyses provide information on the relative value of different screening options. The aim of this project was to develop an open access risk assessment and cost-utility analysis web-tool for assessing HIV, HCV and HBV screening options (http://www.isbtweb.org/working-parties/transfusion-transmitted-infectious-diseases/). An analysis for six countries (Brazil, Ghana, the Netherlands, South Africa, Thailand and USA) was conducted. Materials and Methods: Four strategies; (1) antibody assays (Abs) for HIV and HCV + HBsAg, (2) antibody assays that include antigens for HIV and HCV (Combo) + HBsAg, (3) NAT in minipools of variable size (MP NAT) and (4) individual donation (ID) NAT can be evaluated using the tool. Country-specific data on donors, donation testing results, recipient outcomes and costs are entered using the online interface. Results obtained include the number infections interdicted using each screening options, and the (incremental and average) cost-utility of the options. Results: In each of the six countries evaluated, the use of antibody assays is cost effective or even cost saving. NAT has varying cost-utility depending on the setting, and where adopted, the incremental cost-utility exceeds any previously defined or proposed threshold in each country. Conclusion: The web-tool allows an assessment of infectious units interdicted and value for money of different testing strategies. Regardless of gross national income (GNI) per capita, countries appear willing to dedicate healthcare resources to blood supply safety in excess of that for other sectors of health care.

Rationale: Isoniazid preventive therapy is effective in reducing the risk of tuberculosis (TB) in persons living with HIV (PLWH); however, screening must exclude TB disease before initiating therapy. Symptom screening alone may be insufficient to exclude TB disease in PLWH because some PLWH with TB disease have no symptoms. The addition of chest radiography (CXR) may improve disease detection.Objectives: The objective of the present analysis was to compare the costs and effects of the addition of CXR to the symptom screening process against the costs and effects of symptom screening alone.Methods: Using data from Botswana, a decision analytic model was used to compare a "Symptomonly'' policy against a "Symptom+CXR'' policy. The outcomes of interest were cost, death, and isoniazid-and multidrug-resistant TB in a hypothetical cohort of 10,000 PLWH. Measurements and MainResults: The Symptom+CXR policy prevented 16 isoniazid-and 0.3 multidrug-resistant TB cases; however, because of attrition from the screening process, there were 98 excess cases of TB, 15 excess deaths, and an additional cost of U. S. $127,100. The Symptom+CXR policy reduced deaths only if attrition was close to zero; however, to eliminate attrition the cost would be U. S. $2.8 million per death averted. These findings did not change in best-and worst-case scenario analyses.Conclusions: In Botswana, a policy with symptom screening only preceding isoniazid-preventive therapy initiation prevents more TB and TB-related deaths, and uses fewer resources, than a policy that uses both CXR and symptom screening.

P>A systematic review and meta-analysis were performed to determine and compare the sensitivity and specificity of PCR-based and culture-based diagnostic tests for methicillin-resistant Staphylococcus aureus (MRSA). Our analysis included 74 accuracy measurements from 29 publications. Nine tests were evaluated: the PCR-based Genotype MRSA Direct and IDI-MRSA, the chromogenic media CHROMagar, Chromogenic MRSA Medium, MRSA ID, MRSA Select and ORSAB, and the nonchromogenic culture media MSA-Cefoxitin and MSA-Oxacillin. For four chromogenic media, incubation periods of 18-24 and 48 h were evaluated. Considerable heterogeneity was detected in most analyses. A significantly higher sensitivity was found for the overall PCR pooled estimate (92.5; 95% CI 87.4-95.9) and the chromogenic media after 48 h of incubation (87.6; 95% CI 82.1-91.6) compared to the overall sensitivity of chromogenic media after 18-24 h (78.3; 95% CI 71.0-84.1). The specificity of chromogenic media after 18-24 h (98.6; 95% CI 97.7-99.1) was higher than the specificity of PCR (97.0; 95% CI 94.5-98.4) but declined after 48 h of incubation (94.7; 95% CI 91.6-96.8).The most sensitive chromogenic medium after 18-24 h of incubation was Chromogenic MRSA Medium (sensitivity: 89.3; 95% CI 72.8-96.3), whereas the most specific chromogenic medium after 18-24 h of incubation was MRSA Select (specificity: 99.4; 95% CI 98.6-99.7). After 48 h of incubation, MRSA Select had the highest sensitivity (93.2; 95% CI 83.5-97.0), whereas CHROMagar had the highest specificity (96.4; 95% CI 91.3-98.5). This meta-analysis showed statistically significant differences in diagnostic accuracy between several of the tests and the test methods evaluated. A reduction of the incubation time of chromogenic media (from 48 to 18-24 h) increases specificity but reduces sensitivity.

BACKGROUND: The goal of our research was to actively involve decision makers in the economic assessment of screening strategies in their region. This study attempted to accomplish this by providing an easy-to-use Web interface at http://www.bloodsafety.info that allows decision makers to adapt this model to local conditions. STUDY DESIGN AND METHODS: The cost-effectiveness was compared of 1) adding antigen screening to antibody screening for hepatitis C virus (HCV) and human immunodeficiency virus (HIV); 2) adding nucleic acid amplification testing (NAT) on hepatitis B virus (HBV), HCV, and HIV in minipool (pool of 6 [MP6] and 24 [MP24]) to antibody screening and hepatitis B surface antigen (HBsAg) screening; and 3) individual-donation NAT on HBV, HCV, and HIV to antibody screening and HBsAg screening for Ghana, Thailand, and the Netherlands. RESULTS: The combination of HCV antibody-antigen combination (combo) and HIV combo added to antibody screening in Ghana and Thailand was cost-effective according to the WHO criteria. MP24-NAT screening in Ghana was also cost-effective. MP24-NAT on HBV, HCV, and HIV was not cost-effective compared to the other screening strategies evaluated for the Netherlands. Large regional differences in cost-effectiveness were found for Thailand. CONCLUSION: The young transfusion recipient population of Ghana in combination with a high risk of viral transmission yields better cost-effectiveness for additional tests. The advanced age of the transfused population of the Netherlands and a small risk of viral transmission gives poor cost-effectiveness for more sensitive screening techniques. It was demonstrated that a global health economic model combined with a Web interface can provide easy access to risk assessment and cost-effectiveness analysis.

The estimation of the HIV-AIDS epidemic by means of back-calculation (BC) has been difficult since the introduction of highly active anti-retroviral therapy (HAART) because the incubation time distributions needed for BC were poorly known. Moreover, it has been assumed that if the general public is aware that effective treatments are available then the majority of infected people would be known, and therefore a hidden epidemic was assumed not to exist. Nevertheless, it was suspected that not every infected person would come to the attention of health-care providers, and therefore estimates independent of the patients' registration were necessary. In this paper, the incubation time distributions for HIV treated with the HAART regimen are derived from a cohort study. By using estimates of the proportion treated according to the HAART regimen and the incubation time distributions estimated in the era before the implementation of HAART (pre-HAART), new marginal population incubation time distributions for each of the three risk groups (homosexuals, drug users and others) were constructed. The BC was performed using an empirical Bayesian approach based on the latter incubation time distribution. Copyright (C) 2007 John Wiley & Sons, Ltd.

We have developed a web-based user-interface (web interface) to enhance the usefulness of health-economic evaluations to support decision making (http://pcv.healtheconomics.nl). It allows the user to interact with a health-economic model to evaluate predefined and customized scenarios and perform sensitivity analysis. To explore its usefulness, it was applied to an evaluation of cost-effectiveness of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine (PCV7), that was used to support a policy decision on the inclusion of PCV7 in the national vaccination program (NVP) of the Netherlands. We used a decision-tree analytic model to project the impact of infant vaccination with four doses of PCV7 on an annual cohort of infants born in the Netherlands. The base-case analysis includes the beneficial effects on unvaccinated individuals (herd protection). Additional scenarios varying the number of doses, discount rate for effects and the number of serotypes in the vaccine were evaluated and can be analysed on the web. Our model projects a base-case incremental cost-effectiveness ratio (iCER) of epsilon 14,000 (95% uncertainty interval (UI): 9,800-20,200) per quality adjusted life year (QALY) or epsilon 15,600 (95% UI: 11,100-23,900) per life year gained (LYG). (C) 2007 Elsevier Ltd. All rights reserved.

This chapter addresses the increasing role of pharmacoinformatics in enhancing the pharmacoeconomics context of decision-making. Notably, the role of pharmacoeconomics—i.e. cost per QALY calculations—is growing rapidly for decisions on reimbursement of new drugs. These pharmacoeconomic analyses often involve complex mathematical computer models requiring specific informatics techniques such as probabilistic simulations, bootstrapping, and discrete-event approaches. Transparancy of these complex models is crucial for decision makers to accept the model and its results. The authors argue that Web technology, Web-based access to models, international transferability of analyses, and decision-support systems may help in this respect. In particular, to allow decision makers and researchers to directly interact with transferable economic models and adapt a model to their region, efficient solutions have to be found to disseminate technically complex models to decision makers and researchers outside of the original setting. One such solution is through the use of Web technology and other pharmacoinformatics’ techniques as explored in this chapter.

Background: Screening at hospital admission for carriage of methicillin-resistant Staphylococcus aureus (MRSA) has been proposed as a strategy to reduce nosocomial infections. The objective of this study was to determine the long-term costs and health benefits of selective and universal screening for MRSA at hospital admission, using both PCR-based and chromogenic media-based tests in various settings.Methodology/Principal Findings: A simulation model of MRSA transmission was used to determine costs and effects over 15 years from a US healthcare perspective. We compared admission screening together with isolation of identified carriers against a baseline policy without screening or isolation. Strategies included selective screening of high risk patients or universal admission screening, with PCR-based or chromogenic media-based tests, in medium (5%) or high nosocomial prevalence (15%) settings. The costs of screening and isolation per averted MRSA infection were lowest using selective chromogenic-based screening in high and medium prevalence settings, at $4,100 and $10,300, respectively. Replacing the chromogenic-based test with a PCR-based test costs $13,000 and $36,200 per additional infection averted, and subsequent extension to universal screening with PCR would cost $131,000 and $232,700 per additional infection averted, in high and medium prevalence settings respectively. Assuming $17,645 benefit per infection averted, the most cost-saving strategies in high and medium prevalence settings were selective screening with PCR and selective screening with chromogenic, respectively.Conclusions/ Significance: Admission screening costs $4,100-$21,200 per infection averted, depending on strategy and setting. Including financial benefits from averted infections, screening could well be cost saving.

This study aims to measure the direct and indirect costs of HIV/AIDS care and quality of life (QoL) of HIV-infected patients in Northern Italy. We conducted a prospective cohort study over 12 months, enrolling a sample of 121 patients with HIV infection from two cities in Northern Italy. Patients were surveyed at baseline and were followed-up at 6 and 12 months. To assess the relationship between costs and stage of disease, patients were categorized into three groups at baseline: "No HAART" (asymptomatic and never before on highly active antiretroviral therapy (HAART)), "Stable HAART" (HAART with mild HIV infection and no prior opportunistic infections) and "HAART failure" (primary HAART regimen was altered because of severe side effects or immunological failure). Direct medical costs were based on utilization of (day) hospital admissions, diagnostic procedures, laboratory tests, clinic visits, consultations and antiretroviral drug use. Indirect costs included production losses due to absence from work, reduced productivity at work and reduced unpaid labour participation. QoL was assessed by visual analogue scale. Parametric regression was used to estimate the expected value and the standard deviation of annual costs per patient. The expected value of total annual costs was is an element of 1818 and is an element of 9820 and is an element of 12,332, for groups "No HAART", "Stable HAART" and "HAART failure" respectively. We estimated annual expected earnings as is an element of 14,994 and is an element of 10,811 and is an element of 9820 for the same respective groups. The expected value of QoL on a scale of 0-1 in these same patient groups was 0.80, 0.78 and 0.64. We conclude that indirect costs contribute substantially to total costs and are comparable in magnitude to the direct costs excluding antiretroviral drugs. The costs of inpatient care in our cohort were almost negligible compared to total costs. Despite being in treatment, many patients were still gainfully employed and generated substantial expected annual earnings.

Background This study compares the costs and effects of a regimen with ritonavir-boosted tipranavir (TPV/r) to a physician-selected genotypically-defined standard-of-care comparator protease inhibitor regimen boosted with ritonavir (CPI/r) in HIV infected patients that were previously exposed to antiretroviral therapy in the Netherlands. Methods We compared the projected lifetime costs and effects of two theoretical groups of 1000 patients, one receiving a standard of care regimen with TPV/r as a component and the other receiving a standard of care regimen with CPI/r. A 3-stage Markov model was formulated to represent three different consecutive HAART regimens. The model uses 12 health states based on viral load and CD4+ count to simulate disease progression. The transition probabilities for the Markov model were derived from a United States cohort of treatment experienced HIV patients. Furthermore, the study design was based on 48-week data from the RESIST-2 clinical trial and local Dutch costing data. Cost and health effects were discounted at 4% and 1.5% respectively according to the Dutch guideline. The analysis was conducted from the Dutch healthcare perspective using 2006 unit cost prices. Results Our model projects an accumulated discounted cost to the Dutch healthcare system per patient receiving the TPV/r regimen of €167,200 compared to €145,400 for the CPI/r regimen. This results in an incremental cost of €21,800 per patient. The accumulated discounted effect is 7.43 life years or 6.31 quality adjusted life years (QALYs) per patient receiving TPV/r, compared to 6.91 life years or 5.80 QALYs per patient receiving CPI/r. This translates into an incremental effect of TPV/r over CPI/r of 0.52 life years gained (LYG) or 0.51 QALYs gained. The corresponding incremental cost effectiveness ratios (iCERs) are €41,600 per LYG and €42,500 per QALY. Conclusion We estimated the iCER for TPV/r compared to CPI/r at approximately €40,000 in treatment experienced HIV-1 infected patients in the Netherlands. This ratio may well be in range of what is acceptable and warrants reimbursement for new drug treatments in the Netherlands, in particular in therapeutic areas as end-stage oncology and HIV and other last-resort health-care interventions.