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[In reference to "Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”]
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Varenicline treatment for smoking cessation in high risk patients: a budget impact analysis
Full text linkINTRODUCTION: The promotion of smoking cessation is a worldwide Public Health priority.OBJECTIVE: To estimate the budget impact on the Italian National Health Service (NHS) of the access to reimbursement of varenicline for the treatment of high risk patients with bronchopulmonary, diabetic and cardiovascular diseases.METHODS: A closed-group Markov model was developed in order to compare the costs incurred by the NHS to promote smoking cessation with cessation-related savings, using an alternative scenario in which aids to cessation are not reimbursed by the NHS. The analysis was conducted over a 5-year time horizon, in the perspective of the Italian NHS. Efficacy was expressed in terms of smoke abstinence for at least one year, and data was derived from clinical trials; the savings associated with smoking cessation were derived from cost-of-illness studies.RESULTS: The results show how costs would concentrate in the first year: they are estimated at € 200.6 million, of which € 162.4 million for drug therapy and € 38.2 million for counseling. Average annual savings over the first five years are estimated at € 77.7 million, with a cumulative net impact at 5 years of € -188.0 million (cost-saving). The analysis appears to be robust: sensitivity analyses show that the covering of initial costs occurs in any case between the third and fourth year, and that the treatment remains cost-saving at 5 years.CONCLUSIONS: The financial impact on the Italian NHS of the reimbursement of varenicline for the treatment of high risk smoking population would be a sustainable healthcare policy, resulting in cost savings starting from the fourth year
Equilibrium between resources and expenditure of health sector of Social Security Fund: a case study of Iran
Full text linkIn Iran, Social Security is the most important institution of social insurance fund, currently insuring more than a half of country population, and it has a significant role in fulfilling short-term and long-term commitments. Therefore investigation of the balance of resources and expenditure of health sector of the fund can be a scientific process of the funding the future and can pave the way to provide necessary revisions in this sector. Analyzing equilibrium between resources and expenditure of health sector of Social Security Fund in the past years, the present study offers recommendations for improving it in terms of parametric and structural dimensions. The methodology includes documentary library methods and statistical part is descriptive using Excel. Findings indicated that, regarding the present lack of balance of resources and expenditure of health sector, keeping on with the present conditions can lead to many crises. As a result, to escape from the present conditions of the funds where lack of balance of resources and expenditure exists, carrying out parametric and management-structural revisions seems necessary
A cost-effectiveness analysis of E/C/F/TAF vs three boosted regimens in the Italian context
Full text linkBACKGROUND: Highly Active Antiretroviral Therapy (HAART) has transformed HIV into a lifelong condition. Following the chronicity of the disease, and significant increase in lifespan – the prevalence of comorbidities increased in HIV+ subjects that are exposed both to a higher risk of developing cardiovascular disease, renal disease, osteopenia/osteoporosis and diabetes, and to the risk of developing them early. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (E/C/F/TAF), a complete, Single-Tablet antiretroviral Regimen (STR) that combines the effectiveness and tolerability of integrase inhibitors with an innovative backbone was recently introduced in Italy. Compared to Tenofovir Disoproxil Fumarate (TDF), TAF reaches the sites of action more efficiently, reducing tenofovir plasma concentration to more than 90% and the risk of off-target effects.OBJECTIVE: A patient-level micro-simulation model was adapted to the Italian context to evaluate E/C/F/TAF cost-effectiveness vs three boosted regimens for HIV+ patients treatment.METHODS: A Markov micro-simulation model was adapted to the Italian context for the evaluation of the cost-effectiveness in patients with HIV. The total cost per patient accounts for drug therapies and the management of adverse events and comorbidities. The quality-adjusted life expectancy (in QALYs) is calculated by weighing the years of life lived by the utility weights. A 70-year time horizon was adopted to simulate a lifetime analysis; shorter time horizons were considered in the sensitivity analyses. 3.5% discount rate was applied both for costs and future benefits. The rate of virologic suppression at 48 weeks with E/C/F/TAF is 92.3%; for the other treatments such proportion is calculated by applying to the reference rate the relative risks, as calculated in a recent network meta-analysis (NMA). Alternative treatments considered in this analysis are three boosted regimens commonly used in Italy: tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat in STR; tenofovir disoproxil fumarate/emtricitabine + darunavir/ritonavir; tenofovir disoproxil fumarate/emtricitabine + atazanavir/ritonavir.RESULTS: E/C/F/TAF improves survival and quality of life (20.17 LY and 14.89 QALY), with the lowest total cost (€ 280,528), thus resulting dominant over three comparators considered as starting therapy. The sensitivity analysis confirms the results of the base case: at a willingness-to-pay threshold of € 30,000 per QALY, the E/C/F/TAF strategy is the most cost-effective, with a 90% probability and it is the most cost-effective even with a threshold of € 10,000 per QALY, with a 50% probability.CONCLUSION: E/C/F/TAF can be a sustainable alternative to currently available treatments, combining the advantage of the STR to lower risks of kidney and bone damage than observed in regimens based on TDF
Nurse staffing e responsabilità professionale: quando l’organizzazione è il vero imputato
No full text[Nurse staffing and professional responsibility: when the organization is the real accused] The continuous perception of organizational failure, in terms of human resources adequacy, often generates professional and ethical upsets in health professional workers. Moreover, the perception of insecurity for their own actions, with particular regard to clinical-care needs of assisted people, is ever present.The international literature thoroughly examines the safety limits of the organizations, by giving clear guidance on policy and organizational decisions to pursue.Clinical case report dramatically confirms what the literature describe
[Acute exacerbations in Chronic Obstructive Pulmonary Disease (COPD)]
Full text linkChronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) are important events in the natural history of this condition because they negatively impact health status, rate of hospitalization, disease progression, and mortality.Viral and/or bacterial infections are the main cause of exacerbations. The treatments include systemic corticosteroids, bronchodilators, anticholinergics and/or short- or long-acting β2-agonists, and antibiotics in case of bacterial infections. In some cases, oxygen-therapy is indicated.This article focuses on several aspects of AECOPD, including epidemiology, diagnostic approach, i.e. investigations and management of AECOPD
Evaluation of the cost saving potential of introducing Benepali® and Flixabi® on the European and Italian markets
Full text linkINTRODUCTION: Biosimilar products play an important role in improving the access to biological medicines for an increased number of patients and enhancing the financial sustainability of the health systems.AIM: To assess the cost saving potential associated with the introduction of two biosimilars (Benepali® and Flixabi®) vs. their respective reference biological products on the European and Italian markets.METHODS: A budget impact model was developed to estimate the cost saving of the hypothetical introduction of Benepali® and Flixabi® vs. Enbrel® and Remicade®, respectively, in three European countries. The analysis was conducted from the payer perspective, over a 3-year period. In addition, the same model was used to assess the impact of Benepali® vs. Enbrel® in three Italian regions over a 2-year period. The model compares the costs associated with the current treatment patterns, used to manage patients with all the conditions which Benepali® and Flixabi® are authorized for, with that of a hypothetical treatment pattern in which biosimilar products have been introduced. Only direct costs associated with the drug acquisition were considered. The model was constructed using published country- or region-specific data, where available. Annual drug acquisition costs were calculated using the dosing information from SPCs and country-/region-specific price lists.RESULTS: The introduction of Benepali® and Flixabi® in the biologic therapeutic setting of three European countries resulted in substantial cost savings across the entire scenario, with different penetration over a 3-year period. Similarly, over a 2-year horizon, the introduction of Benepali® in the biologic therapeutic setting of three Italian regions resulted in significant cost savings. In all cases, the greater savings were observed in the scenario where the biosimilars’ penetration was higher.CONCLUSIONS: The introduction of Benepali® and Flixabi® has a substantial cost saving potential for the Italian and European health systems, and the budget impact is sensitive to the uptake rates of the biosimilars market
[Tecfidera® (delayed-release dimethylfumarate) in the treatment of relapsing-remitting multiple sclerosis]
No full textThe present health technology assessment (HTA) evaluates the clinical and economic profile of delayed-release dimethylfumarate (DMF, also known as gastro-resistant DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy. Chapter 1 briefly introduces the condition (multiple sclerosis and, more specifically, the relapsing-remitting form) and provides an overall description of the main therapeutic options for physicians, in terms of clinical evidence, regulatory status in Europe and approval status and reimbursement (refunding) criteria in Italy. In the next sections (Chapters 2-5), key-topics regarding RRMS are analysed: epidemiology, clinical burden, quality of life/social impact and the economic implications for healthcare services, patients and society. In Chapter 6, the clinical evidence supporting the use of DMF in RRMS is summarized. Data from phase III randomized clinical trials (DEFINE, CONFIRM), plus the pooled post-hoc analysis of the two studies, were evaluated to assess the level of clinical benefit provided by DMF. Finally, in Chapter 7, a review of the health economic evidence assessing DMF is performed, with a specific focus on Italy. Overall, the methodological quality of registration studies, together with the robustness and consistency of the study results, support the conclusion that DMF is an effective and safe treatment for RRMS. The economic assessment of DMF in Italy, based on cost-effectiveness and budget impact analyses (adopting clinical input data from a mixed treatment comparison and economic input data relative to the Italian healthcare setting), confirm that DMF is a cost-effective and economically sustainable treatment for the Italian National Healthcare Service. These findings are in line with the results of most international publications and the assessments from well-recognized HTA agencies (e.g. NICE/SMC). In summary, both the clinical and economic evidence analyzed in this HTA substantiate DMF as an important therapeutic option for the treatment of RRMS
Rapid Response Systems: how to interpret levels of evidence
Full text linkBACKGROUND AND AIM: The Rapid Response System (RRS) has been introduced to prevent cardiac arrest, unplanned admissions to the intensive care unit, and death in hospitalized patients. Despite the constant and widespread presence of this system in worldwide hospitals, it remains debated whether its use improves patient outcomes. The aim of this narrative review is to describe the available evidence supporting the effectiveness of RRSs and to discuss the controversies on the lack of level 1 evidence studies.METHODS: The literature search covers the period from 1 January 2000 to 31 March 2016.RESULTS: Studies with different research designs, observational, quasi-experimental with non-randomized control group and experimental, and aggregate data of meta-analyses indicate a statistically significant reduction of in-hospital cardiac arrests and hospital mortality associated with the deployment of RRSs.CONCLUSIONS: A RRS is a complex intervention in a complex system, such as a hospital. This complexity does not allow considering experimental trials only as the most appropriate methodology to answer at research objectives. Furthermore, the benefits of a RRS depend greatly on its proper use. Accumulating evidence suggests the importance to investigate barriers and facilitators that can affect the integration, within a hospital, of this complex intervention