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Aim: To develop a framework for the clinical and health economic assessment for management of Clostridium difficile infection (CDI)., Methods: CDI has vast economic consequences emphasizing the need for innovative and cost effective solutions, which were aim of this study. A guidance model was developed for coverage decisions and guideline development in CDI. The model included pharmacotherapy with oral metronidazole or oral vancomycin, which is the mainstay for pharmacological treatment of CDI and is recommended by most treatment guidelines., Results: A design for a patient-based cost-effectiveness model was developed, which can be used to estimate the cost-effectiveness of current and future treatment strategies in CDI. Patient-based outcomes were extrapolated to the population by including factors like, e.g., person-to-person transmission, isolation precautions and closing and cleaning wards of hospitals., Conclusion: The proposed framework for a population-based CDI model may be used for clinical and health economic assessments of CDI guidelines and coverage decisions for emerging treatments for CDI.

Background and Objective: Chronic kidney disease (CKD) is a highly morbid disorder. The most severe form of CKD is end-stage renal disease (ESRD), in which the patient requires some form of renal replacement therapy to survive. The increasing incidence, prevalence, and costs of ESRD are major national healthcare concerns. The objective of this study was to determine the cost effectiveness of two innovative therapies, paricalcitol versus cinacalcet + calcitriol (oral) in patients with CKD stage 5 (CKD 5) in the healthcare setting in Italy in 2013., Methods: A Markov process model was developed employing data sources from the published literature, paricalcitol clinical trials, official Italian price/tariff lists, and national population statistics. The analysis is based on a comparison of treatment with paricalcitol versus cinacalcet + calcitriol (oral) in CKD 5. The perspective of the study was that of the payer [Italian National Health Service (INHS)]. The primary efficacy outcomes in the paricalcitol and cinacalcet + calcitriol (oral) clinical trials (reduction of secondary hyperparathyroidism, complications, and mortality) were extrapolated to effectiveness outcomes: number of life-years gained (LYG) and number of quality-adjusted life-years (QALYs). Clinical and economic outcomes were discounted at 3 %., Results: The base-case analysis is based on a 5-year time horizon. From the INHS perspective, the use of paricalcitol leads to a cost saving of €1,853 and an increase in LYG (0.136) and a gain in QALYs (0.089). Consequently, the use of paricalcitol is dominant over the use of combination cinacalcet + calcitriol (oral paricalcitol leads to cost savings and a higher effectiveness). Sensitivity analyses confirmed the robustness of the model., Conclusion: The results showed that the favorable clinical benefit of paricalcitol results in positive health economic benefits. This study suggests that the use of paricalcitol in patients with ESRD may be cost effective from the perspective of the INHS.

Rational: The objective of this paper is to describe the applications of health economic theory to medical nutrition., Background: The published literature provides evidence that medical nutrition, e.g. oral nutritional supplements, is an effective treatment for patients with disease related malnutrition. Malnutrition is associated with mortality risk and complication rates, including infections. Malnutrition is not a new problem and with an ageing population it continues to become a major public health concern as increasing age is associated with an increased risk of malnutrition., Findings: This overview shows that in the case RCTs are providing the clinical evidence, there is no methodological difference between a cost-effectiveness analysis for pharmaceutical or nutrition. However, in nutrition the evidence may not always come from RCT data, but will be more often based on observational data. Therefore the clinical evidence of nutrition in itself is not the issue, but the handling of clinical evidence from observational studies. As the link between the consumption of a food product and a resulting health status is often more difficult to establish than the effect of a drug treatment it requires the further development of adapted methodologies in order to correctly predict the impact of food-related health effects and health economic outcomes from a broader perspective., (© 2015 Nestec Ltd., Vevey/S. Karger AG, Basel.)

In the current socio-economic scenario characterized by a growing shortage of resources and progressive budget constraints, the need to better coordinate processes in health institutions appears as a relevant aspect to ensure the future sustainability of system. In this sense, Relational Coordination (RC) provides a valuable opportunity for the reconfiguration of clinical guidelines concerning isolated single-level considerations. In this research the RC model has been applied to explain best results in the process of diagnosing and offering clinical treatments for lung cancer. Lung cancer presents the higher rates of tumor's mortality worldwide. Through unstructured and informal interviews with clinicians at both levels (Primary/Specialist Care), a diagnosis of the situation in relation to joint management of lung cancer is provided. Solutions of continuity in terms of coordination are explained due to the observation of lack of effective knowledge transfer between the two levels. It is this disconnection which justifies the introduction of a modified model of RC for the study and implementation of transfer relations between the knowledge holders, in order to structure consolidated and cooperative evidence-based models that lead to a substantial shortening in the response times with a marked outcomes improvement. To our knowledge, the application of this model to a Public Health problem bringing together both levels of care, hasn't been made till now.

Economic evaluations for medical nutrition, such as oral nutritional supplements (ONS), are relatively uncommon compared with other health technologies, and represent an area that has not been reviewed so far. In this systematic review, economic evaluations of enteral medical nutrition in the management of disease-related malnutrition (DRM) were reviewed and qualified to estimate the economic value. Initially, 481 studies were found, of which 37 full-text articles were assessed for eligibility and were rated on their quality using the Quality of Health Economic Studies (QHES) instrument. The final review focused on the high QHES quality economic evaluation studies. As both the studied medical nutrition intervention and the form of the economic evaluation varied, a quantitative synthesis (meta-analysis) was not attempted but a critical analysis and comparison of the individual study results were performed. ONS was the most studied intervention, covering several patient populations and different health care settings. Outcomes included cost savings (n = 3), no significant extra costs per unit of clinical and/or functional improvement (n = 1), or significantly higher costs per unit of clinical and/or functional improvement but still cost-effective for the used threshold (n = 4). This review shows that the use of enteral medical nutrition in the management of DRM can be efficient from a health economic perspective., (Copyright © 2014 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Disease related malnutrition (under-nutrition caused by illness) is a worldwide problem in all health care settings with potentially serious consequences on a physical as well as a psycho-social level. In the European Union countries about 20 million patients are affected by disease related malnutrition, costing EU governments up to € 120 billion annually. The aim of this study is to calculate the total additional costs of disease related malnutrition in The Netherlands., Methods: A cost-of-illness analysis was used to calculate the additional total costs of disease related malnutrition in adults (>18 years of age) for The Netherlands in 2011 in the hospital, nursing- and residential home and home care setting, expressed as an absolute monetary value as well as a percentage of the total Dutch national health expenditure and as a percentage of the total costs of the studied health care sectors in The Netherlands., Results: The total additional costs of managing adult patients with disease related malnutrition were estimated to be € 1.9 billion in 2011 which equals 2.1% of the total Dutch national health expenditure and 4.9% of the total costs of the health care sectors analyzed in this study., Conclusions: The results of this study show that the additional costs of disease related malnutrition in adults in The Netherlands are considerable., (Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Objective: This study assessed the cost-effectiveness of escitalopram for the treatment of depression in the Netherlands from a societal perspective., Methods: A decision tree model was constructed using decision analytical techniques. Data sources included published literature, clinical trials, official price/tariff lists, national population statistics, and Delphi panel data. The comparators were venlafaxine XR and citalopram. The primary perspective of this health economic evaluation was that of the society in the Netherlands in 2010. The time horizon was 26 weeks. The effectiveness outcomes of the study were quality-adjusted life-years (QALYs)., Results: Escitalopram was associated with a cost savings per patient of €263 versus venlafaxine XR and €1992 versus citalopram over a period of 26 weeks from a societal perspective. Escitalopram was also associated with a gains QALYs: 0.0062 versus venlafaxine XR and 0.0166 versus citalopram. Escitalopram was dominant over both venlafaxine XR and citalopram., Conclusion: Based on the findings from this cost-effectiveness analysis, the favorable clinical benefit of escitalopram resulted in a positive health economic benefit in the Netherlands., (Copyright © 2012. Published by EM Inc USA.)

Background: Lung cancer is the leading cause of cancer deaths worldwide (1.38 million cancer deaths, 18.2% of the total) and of cancer morbidity (1.61 million new cases, 12.7% of all new cancers). Currently only three second-line non-small-cell lung cancer (NSCLC) pharmacotherapies are licensed in the European Union: the chemotherapies pemetrexed and docetaxel and the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib. These therapy alternatives have shown a comparable efficacy (survival benefit). In the past, cost comparisons showed that erlotinib was less costly compared to docetaxel, which in turn is cheaper than pemetrexed. Nowadays erlotinib (and docetaxel) are still less expensive than pemetrexed; but docetaxel lost patent protection (basic compound patent) at the end of 2010, so docetaxel drug costs have decreased rapidly and the question remains whether erlotinib is still the least costly therapy alternative in second-line NSCLC., Material and Methods: Italy was selected for base case analysis to compare the total therapy costs, estimated by combining country-specific drug costs, administration costs, and adverse event costs of erlotinib and generic docetaxel in second-line NSCLC therapy. Sensitivity analyses on central input parameters have been performed., Results: The total costs of treating one patient with erlotinib therapy of €5121 are lower than the docetaxel costs of €6699 for the Italian health care setting. Although the drug costs of erlotinib are higher than generic docetaxel (incremental €3770): the costs of intravenous chemotherapy administration (incremental -€4510), and the costs of adverse event therapy (incremental -€837) lead to higher total therapy costs for docetaxel compared to the epidermal growth factor receptor tyrosine kinase inhibitor therapy erlotinib., Conclusion: The cost comparison findings for Italy show that erlotinib is still the less costly therapy alternative in second-line NSCLC. These results were robust to changes of central input parameters and robust to further potential price decreases for docetaxel.

Objective: This analysis compared the cost-effectiveness of interferon beta-1a (IFNbeta-1a) 44 microg SC with that of other available first-line treatments for relapsing-remitting multiple sclerosis (RRMS) from the German societal perspective in 2008., Methods: A decision-analytic model was used to estimate the cost-effectiveness of IFNbeta-1a 44 microg SC given 3 times weekly compared with that of IFNbeta-la 30 microg IM given once weekly, IFNbeta-1b 8 mIU given every other day, and glatiramer acetate 20 mg SC given once daily. Data sources included the published literature, clinical trials, German price/tariff lists, and national population statistics. The time horizon of the model was 4 years, which was the maximum duration of follow-up in published clinical trials., Results: The cost-effectiveness (cost per relapse avoided) of IFNbeta-la 44 microg SC compared with no active treatment was euro51,250, which compared favorably with that of IFNbeta-la 30 microg IM (euro133,770), glatiramer acetate (euro71,416), and IFNbeta-1b (euro54,475). When the cost of disease progression was excluded, the cost per relapse avoided remained favorable for IFNbeta-1a 44 microg SC (euro54,292) compared with the other options (euro143,186, euro72,809, and euro56,816, respectively). Indirect comparison of each available treatment option with the next best alternative indicated that the incremental cost-effectiveness of IFNbeta-la 44 microg SC (euro23,449) was consistent with accepted thresholds. Sensitivity analyses in which the discount rate, frequency of relapse and disease progression, costs of relapse and disease progression, and adherence were varied did not affect the relative outcomes., Conclusion: In this analysis from the German societal perspective, IFNbeta-la 44 microg SC had favorable overall cost-effectiveness versus no active treatment compared with other available disease-modifying drugs for the treatment of RRMS.

Objectives: To assess the cost effectiveness of palivizumab for prevention of severe respiratory syncytial virus (RSV) disease in high-risk infants in Spain, incorporating country-specific observational hospitalisation data., Methods: An existing decision tree model, designed using data from a large international clinical trial of palivizumab versus no prophylaxis, was updated to include Spanish observational hospitalisation data. The analysis was performed for preterm children born at or before 32 weeks gestational age, who are at high risk of developing severe RSV disease requiring hospitalisation. Data sources included published literature, official price/tariff lists and national population statistics. The primary perspective of the study was that of the Spanish National Health Service in 2006., Results: The base-case analysis included the direct medical costs associated with palivizumab prophylaxis and hospital care for RSV infections. Use of palivizumab produces an undiscounted incremental cost-effectiveness ratio (ICER) of euro6,142 per quality-adjusted life-year (QALY), and a discounted ICER of euro12,814/QALY., Conclusion: Palivizumab provides a cost-effective method of prophylaxis against severe RSV disease requiring hospitalisation among preterm infants in Spain.

A previous publication in this journal showed that the pricing matrix model (PMM) allows an assessment of the pricing potential of a new innovative product. When the PMM is going to be used for the determination of a drug price for a new drug in the strategic product planning process, it is important that this methodology is reliable. In the initial paper the PMM only yielded an expected price for the new antidepressant without generating an estimate of the probability that the new drug would indeed be listed at this expected price. In this manuscript we present various methodologies to deal with uncertainty in the PMM. We introduce the concept of price acceptability curves. The conclusion of this paper is that the incorporation of uncertainty into the PMM will lead to a more accurate assessment of the pricing potential of a new drug.

Objective: To determine the cost-effectiveness of thromboprophylaxis with enoxaparin versus no thromboprophlaxis in patients with acute medical illness in Italy from the NHS perspective., Methods: Markov process analysis techniques were used to model the health economic outcomes. Clinical data were derived mainly from the MEDENOX trial, while health care utilization was derived from Delphi panels., Results: An analysis over the MEDENOX trial period shows that the cost per event avoided is [symbol: see text] 2450.99, while the cost per life saved is [symbol: see text] 8395.89. The lifetime model, which assumes no higher risk for recurrence of VTE and mortality in asymptomatic patients, shows that the use of enoxaparin leads a cost per event avoided of [symbol: see text] 2243.20, and cost per life year gained of [symbol: see text] 605.38. The lifetime model, which assumes a higher risk for recurrence of VTE in asymptomatic patients, shows that enoxaparin is dominant over no thromboprophylaxis., Conclusion: The results showed that the favourable clinical benefit of enoxaparin as thromboprophylaxis in patients with acute medical illness, which was observed in the MEDENOX trial, results in a positive health economic benefit on the short-term and long-term in the health care setting of Italy.