A one health framework to estimate the cost of antimicrobial resistance.

OBJECTIVES/PURPOSE: The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ON€) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized analyses for quantifying the full economic burden attributable to AMR at the global level. METHODS: GAP-ON€ (funded under the JPIAMR 8th call (Virtual Research Institute) is composed of 19 international networks and institutions active in the field of AMR. For this project, the Network operated by means of Delphi rounds, teleconferences and face-to-face meetings. The resulting costing framework takes a bottom-up approach to incorporate all relevant costs imposed by an AMR bacterial microbe in a patient, in an animal, or in the environment up through to the societal level. RESULTS: The framework itemizes the epidemiological data as well as the direct and indirect cost components needed to build a realistic cost picture for AMR. While the framework lists a large number of relevant pathogens for which this framework could be used to explore the costs, the framework is sufficiently generic to facilitate the costing of other resistant pathogens, including those of other aetiologies. CONCLUSION: In order to conduct cost-effectiveness analyses to choose amongst different AMR-related interventions at local level, the costing of AMR should be done according to local epidemiological priorities and local health service norms. Yet the use of a common framework across settings allows for the results of such studies to contribute to cumulative estimates that can serve as the basis of broader policy decisions at the international level such as how to steer R&D funding and how to prioritize AMR amongst other issues. Indeed, it is only by building a realistic cost picture that we can make informed decisions on how best to tackle major health threats.

Economic Evaluation of Dulaglutide vs Traditional Therapies: Implications of the Outcomes of the Rewind Study.

BACKGROUND: Diabetes represents a relevant public health problem worldwide due to its growing prevalence and socioeconomic burden, principally due to the development of macrovascular and microvascular complications as well as to the continuous launch of new and even more expensive drugs. The aim of our study is to evaluate the economic impact of dulaglutide, a weekly GLP-1 receptor agonist, on the treatment of diabetic patients as an alternative to both high dose sulphonylureas and insulin basalization at the failure of oral therapies alone. We carried out a cost-effectiveness analysis developed considering the economic implications of recent clinical studies regarding cardiovascular risk drug effects and especially of REWIND studies outcomes, focusing on the impact of weight changes on HRQoL. MATERIAL AND METHOD: In our analysis, we have applied the cost-utility technique to the above reported clinical outcomes and compared the global costs of dulaglutide versus sulfonylurea or basal insulin, all in add-on with metformin. We have chosen gliclazide, as a sulfonylurea and Abasaglar®, the less expensive among basal insulin analogues. Abasaglar was titrated to 20 IU, corresponding to the mean dosage used in the treatment of type II diabetic patients. The model aims to estimate total direct costs related to the above-reported treatments and find out the real gap in costs between dulaglutide, the apparently cheaper gliclazide and basal insulin glargine (IGlargine) based on the Italian National Healthcare System (INHS). RESULTS: The total cost of dulaglutide has resulted in €859.66 higher than gliclazide (€1,579.73 vs €720.07) and basal insulin, although less significantly, reporting a difference of €396.54 (€1,579.73 vs 1,183.19). Except for the purchase cost, dulaglutide has reported reduced costs compared to insulin IGlargine and gliclazide. Dulaglutide showed lower self-monitoring blood glucose and hypoglycaemia costs, a significant reduction in costs related to cardiovascular complications, as well as savings in costs in other drugs. Dulaglutide can be considered a cost-effective antidiabetic therapy, due to the positive impact on the quality of life induced by weight reduction, despite the higher annual cost per patient, mainly influenced by drug purchase cost. DISCUSSION AND CONCLUSION: In this cost-utility analysis, dulaglutide has shown to be a cost-effective treatment option from the Italian healthcare system perspective as add-on therapy to metformin in patients with inadequately controlled type 2 diabetes mellitus. Study findings can provide stakeholders valuable evidence to support the adoption of this cost-effective second- or third-line therapy compared to gliclazide or basal insulin glargine. Dulaglutide cost-effectiveness has been particularly evident in the comparison with basal insulin glargine, indicating that, in patients who have treatment indication, this therapy may be preferred to basalization avoiding related complications and costs.

Budget impact model of secukinumab for the treatment of moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis in Italy: a cross-indication initiative.

OBJECTIVE: Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes the proinflammatory cytokine IL-17A, has been approved in Europe in 2015 for the treatment of adult patients with moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This analysis assessed the budget impact of introduction of secukinumab to the Italian market for all three indications from the perspective of the Italian National Health Service. MATERIALS AND METHODS: A cross-indication budget impact model was developed and included biologic-treated adult patients diagnosed with psoriasis, PsA, and AS. The analyses were conducted over a 3-year time horizon and included direct costs (drug therapy costs, administration costs, diseases-related costs, and adverse events costs). Model input parameters (epidemiology, market share projections, resource use, and costs) were obtained from the published literature and other Italian sources. The robustness of the results was tested via one-way sensitivity analyses: secukinumab cost, secukinumab market share, intravenous administration costs, and adverse events costs were varied by ±10%. RESULTS: The total patient population for secukinumab over the 3-year timeframe was projected to be 6,648 in the first year, increasing to 12,001 in the third year, for all three indications combined (psoriasis, PsA, and AS). Compared to a scenario without secukinumab in the market, the introduction of secukinumab in the market for the treatment of psoriasis, PsA, and AS showed a cumulative 3-year incremental budget impact of -5%, corresponding to savings of €66.1 million and per patient savings of about €1,855. The majority of the cost savings came from the adoption of secukinumab in AS (58%), followed by PsA (29%) and psoriasis (13%). Sensitivity analyses confirmed the robustness of the results. CONCLUSION: Results from this cross-indication budget impact model show that secukinumab is a cost-saving option for the treatment of PsA, AS, and psoriasis patients in Italy.

The preventive effect on respiratory tract infections of Oscillococcinum®. A cost-effectiveness analysis.

BACKGROUND: Anas barbariae hepatis et cordis extractum 200K (Oscillococcinum®) is used to treat and prevent seasonal colds and airway inflammatory affections, improve symptom control, and reduce the frequency of respiratory tract infection (RTI) episodes. The objective of this controlled observational study is to investigate, from the Italian National Health Service (NHS) point of view, the role of Anas barbariae hepatis et cordis extractum 200K in preventing RTIs and estimate the annual average cost per patient due to visits and medicines in a real-world setting, investigating whether this method of treatment can bring savings for the NHS. METHODS: Data from a single center from 2002 to 2011 were used. The analysis examined 455 patients who suffered from respiratory diseases. Of the total number of patients, 246 were treated with Anas barbariae hepatis et cordis extractum 200K while 209 were not treated (Control group). All the data concerning RTI episodes, pharmacological treatments, and pneumological visits were extracted from the database. RESULTS: It was found that, regardless of the diagnosis, the frequency of RTI episodes was always lower in patients treated with Anas barbariae hepatis et cordis extractum 200K; the difference between the numbers of events occurring was statistically significant in every class of patients (p<0.001). The costs that the NHS had to incur were significantly lower in the classes of patients treated (p<0.001). DISCUSSION: The results indicate that Anas barbariae hepatis et cordis extractum 200K has a preventive effect on the onset of RTI episodes. The analysis shows that treating patients with Anas barbariae hepatis et cordis extractum 200K lowers costs for the NHS; this is primarily due to the fact that the medication causes fewer episodes of RTI to develop. This study suggests that the treatment with Anas barbariae hepatis et cordis extractum 200K could be helpful in preventing RTIs and improving the health status of patients who suffer from respiratory diseases, and it could lead to savings to the Italian NHS.

Economic burden of Clostridium difficile in five hospitals of the Florence health care system in Italy.

INTRODUCTION: Despite the awareness about the increasing rates of Clostridium difficile infection (CDI) and the economic burden arising from its management (prolonged hospitalization, laboratory tests, visits, surgical treatment, environmental sanitation), few studies are available in Italy on the economic costs directly attributable to the CDI. The Florence health care system has designed a study with the aim of describing the costs attributable to the CDI and defines the incremental economic burden associated with the management of this complication. METHODS: We conducted a retrospective study in five hospitals of the Florence health care system. The enrolled population included all patients who were hospitalized during the year 2013 with a diagnosis of CDI. Of the 187 total cases reported in 2013, 69 patients were enrolled, for whom the main cause of hospitalization was directly attributable to CDI. RESULTS: We enrolled 69 patients (19 males and 50 females), with a mean age of 82.16 years (minimum 46 to maximum 98). The total number of hospitalization days observed was 886 (12.8 per patient on average). The data from this study show that the mean total incremental cost for a patient with CDI was €3,270.52 per year. The hospital stay length is the most significant cost parameter, having the largest influence on the overall costs, with an impact of 87% on the total cost. The results confirm the costs for the management of CDI in five hospitals of the Florence health care system are in line with data from the international literature. CONCLUSION: The economic impact of CDI is most evident in the extension of the duration of hospitalization and emergency recurrences requiring new therapeutic options with the need to develop and implement new diagnostic and therapeutic algorithms in clinical practice.

Cost-effectiveness analysis of antiretroviral therapy in a cohort of HIV-infected patients starting first-line highly active antiretroviral therapy during 6 years of observation.

OBJECTIVES: Costs may play a role in deciding how and when to start highly active antiretroviral therapy (HAART) in a naïve patient. The aim of the present study was to assess the cost- effectiveness of treatment with HAART in a large clinical cohort of naïve adults to determine the potential role of single-tablet regimens in the management of patients with human immunodeficiency virus (HIV). An incremental cost-effectiveness ratio analysis was performed, including a quality-adjusted life year approach. RESULTS: In total, 741 patients (females comprising 25.5%) were retrospectively included. The mean age was 39 years, the mean CD4 cell count was 266 cells/µL, and the mean viral load was 192,821 copies/mL. The most commonly used backbone was tenofovir + emtricitabine (77.6%); zidovudine + lamivudine was used in 10%, lamivudine + abacavir in 3%, and other nucleoside reverse transcriptase inhibitor (NRTI) or NRTI-free regimens in 9.4% of patients. NNRTIs were used in 52.8% of cases, boosted protease inhibitors in 44.1%, and unboosted protease inhibitors and integrase inhibitors in 0.7% and 2.4%, respectively. Starting therapy at CD4 >500 cells/µL and CD4 351-500 cells/µL rather than at <201 cells/µL was the more cost-effective approach. The same consideration was not true comparing current indications with the possibility to start HAART at any CD4 value (eg, >500 cells per µL); in this case, the incremental cost-effectiveness ratio value was €199,130 per quality-adjusted life year gained, a higher value than the one suggested in guidelines. The single-tablet regimen (STR) invariably dominated any other therapeutic approach. Sensitivity analysis was performed, and starting right away with an STR was cost-effective even when compared with therapeutic strategies contemplating STR as simplification. CONCLUSION: By integrating clinical data with economic variables, our study offers an estimate of the cost-effectiveness of the various first-line treatment strategies for patients infected with HIV and provides significant evidence to be used in future prospective pharmacoeconomic evaluations.

Economic and outcomes consequences of TachoSil®: a systematic review.

BACKGROUND: TachoSil(®) is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient. This review systematically analyses the international scientific literature relating to the use of TachoSil in hemostasis and as a surgical sealant, from the point of view of its economic impact. METHODS: We carried out a systematic review of the PubMed literature up to November 2013. Based on the selection criteria, papers were grouped according to the following outcomes: reduction of time to hemostasis; decrease in length of hospital stay; and decrease in postoperative complications. RESULTS: Twenty-four scientific papers were screened, 13 (54%) of which were randomized controlled trials and included a total of 2,116 patients, 1,055 of whom were treated with TachoSil. In the clinical studies carried out in patients undergoing hepatic, cardiac, or renal surgery, the time to hemostasis obtained with TachoSil was lower (1-4 minutes) than the time measured with other techniques and hemostatic drugs, with statistically significant differences. Moreover, in 13 of 15 studies, TachoSil showed a statistically significant reduction in postoperative complications in comparison with the standard surgical procedure. The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01-3.58 days versus standard techniques, with a statistically significant difference in favor of TachoSil in eight of 15 studies. CONCLUSION: This analysis shows that TachoSil has a role as a supportive treatment in surgery to improve hemostasis and promote tissue sealing when standard techniques are insufficient, with a consequent decrease in postoperative complications and hospital costs.

Syringeless power injector versus dual-syringe power injector: economic evaluation of user performance, the impact on contrast enhanced computed tomography (CECT) workflow exams, and hospital costs.

OBJECTIVE: The utilization of diagnostic imaging has substantially increased over the past decade in Europe and North America and continues to grow worldwide. The purpose of this study was to develop an economic evaluation of a syringeless power injector (PI) versus a dual-syringe PI for contrast enhanced computed tomography (CECT) in a hospital setting. MATERIALS AND METHODS: Patients (n=2379) were enrolled at the Legnano Hospital between November 2012 and January 2013. They had been referred to the hospital for a CECT analysis and were randomized into two groups. The first group was examined with a 256-MDCT (MultiDetector Computed Tomography) scanner using a syringeless power injector, while the other group was examined with a 64-MDCT scanner using a dual-syringe. Data on the operators' time required in the patient analysis steps as well as on the quantity of consumable materials used were collected. The radiologic technologists' satisfaction with the use of the PIs was rated on a 10-point scale. A budget impact analysis and sensitivity analysis were performed under the base-case scenario. RESULTS: A total of 1,040 patients were examined using the syringeless system, and 1,339 with the dual-syringe system; the CECT examination quality was comparable for both PI systems. Equipment preparation time and releasing time per examination for syringeless PIs versus dual-syringe PIs were 100±30 versus 180±30 seconds and 90±30 and 140±20 seconds, respectively. On average, 10±3 mL of contrast media (CM) wastage per examination was observed with the dual-syringe PI and 0±1 mL with the syringeless PI. Technologists had higher satisfaction with the syringeless PI than with the dual-syringe system (8.8 versus 8.0). The syringeless PI allows a saving of about €6.18 per patient, both due to the lower cost of the devices and to the better performance of the syringeless system. The univariate sensitivity analysis carried out on the base-case results within the standard deviation range confirmed the saving generated by using the syringeless device, with saving values between €5.40 and €6.20 per patient. CONCLUSION: The syringeless PI was found to be more user-friendly and efficient, minimizing contrast wastage and providing similar contrast enhancement quality compared to the dual-syringe injector, with comparable CECT examination quality.