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1.
Artículo en Inglés | MEDLINE | ID: mdl-33158223

RESUMEN

Decision makers are used to consider Out-of-Pocket Expenditure (OOPE) within a health technology assessment framework in order to account for an indicator relying on the level of fairness and on the quality of care of a health system. In this paper, we provide estimates on the determinants of OOPE in Italy by using data coming from an observational cross-sectional study that enrolled a sample of 2526 patients suffering from inflammatory bowel diseases. We explore the association between OOPE and: (1) geographical location; (2) income effects; (3) performances in delivering healthcare. A regression model was used. Individuals' age were in the range of 18-88 (mean 44 ± 14.55). Forty-six percent were females, 54% were married and 19% held a bachelor degree. Ninety-six percent of respondents declared an OOPE >0 whose mean value was €960 ± €950. Individuals belonging to low-income and low-performance regions were more likely to declare an OOPE >0 (99%). Regression findings suggest that increases in OOPE could be considered as a response from patients aiming to compensate for lacks and inefficiencies in the public healthcare offers. Policymakers should consider increases in OOPE in patients with Inflammatory Bowel Diseases (IBDs) as an indicator of poor quality of care and poor fairness.

2.
Artículo en Inglés | MEDLINE | ID: mdl-33114587

RESUMEN

Aim: In this article, we aim to present a tool for the early assessment of medical technologies. This evaluation system was designed and implemented by the National Centre for HTA and the National Centre for Innovative Technologies of the Istituto Superiore di Sanita, Italy, in order to respond to an institutional commitment within the "Health Technologies Assessment Team" that was established to face the huge demand for the evaluation of Health Technologies during the pandemic event caused by COVID-19, with a smart and easy-to-use framework. Methods: Horizon scanning was conducted through a brief assessment carried out according to the multicriteria decision analysis methodology. Each HTA domain was attributed a score according to a pros/cons and opportunities/threats system, derived from evidence in the literature. Scores were weighted according to different perspectives. Scores were presented in a Cartesian graph showing the positioning according to the potential value and the perceived risk associated with the technology. Results: Two case studies regarding the early assessment were reported, concerning two specific technologies: an individual protection device and a contact tracking system.


Asunto(s)
Infecciones por Coronavirus , Técnicas de Apoyo para la Decisión , Pandemias , Neumonía Viral , Evaluación de la Tecnología Biomédica , Betacoronavirus , Humanos , Italia , Riesgo
3.
Int J Technol Assess Health Care ; 36(2): 133-138, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32052725

RESUMEN

OBJECTIVES: When assessing the economic value of vaccines, decision makers should adopt a full societal perspective. One approach for estimation of the fiscal impact of a disease is to use the human capital method to determine productivity losses. The aim of this study was to test an analytical framework developed for the estimation of the fiscal impacts of vaccination programs for influenza (FLU), pneumococcus (PC), and herpes zoster (HZ), in Italy. METHODS: We tested the framework in a two-stage analysis. First, we estimated the fiscal impact of the disease, second we performed a cost-benefit analysis of the individual benefits of vaccination against the cost of the vaccine. To estimate the fiscal impact of the diseases, the human capital approach was used. Epidemiological data were extrapolated from the literature. A Monte Carlo simulation enabled exploration of the uncertainty in the model variables. RESULTS: For FLU, assuming 2.1 million people infected, the total expected impact was EUR 999,371,520; the estimated fiscal impact was EUR 159,563,520. For PC, assuming 90,000 people infected, the total impact was EUR 148,055,040 and the estimated fiscal impact was EUR 23,639,040. For HZ, assuming 6,400 people infected, the total impact was EUR 4,777,200, with EUR 630,000 resulting from a decrease in fiscal taxation. CONCLUSIONS: In conclusion, our work shows how traditional methods aimed at estimating the cost of illness from a social perspective can be improved by additionally considering the fiscal impact, which accounts for the decrease in fiscal revenues due to illness.

4.
Pharmacoeconomics ; 38(5): 473-484, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32107743

RESUMEN

BACKGROUND: All health economics reviews on chronic and episodic migraine published to date underline the heterogeneity of results. Currently, the need for the generalizability of economic evaluations across different jurisdictions is considered a key issue to avoid unnecessary overlaps and to minimize the time to reimbursement decisions. OBJECTIVE: The aim of this study was to review the economic evaluations on the prophylaxis and treatments for migraine published in the previous 10 years (since 2009) and to perform a critical assessment of their generalizability. METHODS: We searched PubMed, EMBASE, and EconLit databases. Articles underwent a three-stage selection process. To assess the level of generalizability, we used the checklist implemented by Augustovski et al. Studies were classified as: (1) generalizable; (2) transferable; and (3) context specific. RESULTS: In total, 227 articles were identified after running the search string and 11 studies were included in our review. Overall, none of the studies was judged as generalizable and three were judged transferable according to the established criteria. CONCLUSIONS: Our review suggests that no evidence on the economic value of either acute or prophylactic treatments against migraine is generalizable to different jurisdictions. However, the majority of studies reporting results about prophylactic treatments were found to be transferable.

5.
J Med Screen ; 27(4): 186-193, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31948342

RESUMEN

OBJECTIVES: To estimate the cost-effectiveness of the public colorectal cancer screening program in the Abruzzo region, Italy. METHODS: Cost-effectiveness was analysed using a two-armed Markov model comparing: (1) Abruzzo screening program based on biennial faecal immunochemical occult blood testing, with colonoscopy as second level test for individuals with positive results, with (2) Treatment of symptomatic patients according to the stage of the neoplasm. Transition probabilities were adjusted for accuracy of tests and incidence of colorectal cancer. Diagnosis-related groups' charges and field collected data were used to estimate costs. Costs and benefits were discounted by 3.5%. Monte Carlo simulation confirmed the robustness of the model results. RESULTS: Assuming a compliance rate of 64.7%, the incremental cost-effectiveness ratio for the current colorectal screening program was €433.06/quality adjusted life year gained, considerably lower than conventional thresholds (around €30,000). CONCLUSION: Early detection and intervention programs help to avoid a large number of highly debilitating and expensive cancer treatments. These results show that the screening program currently implemented in Abruzzo should be considered as a good investment in health.

6.
Health Policy ; 122(10): 1078-1084, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-30227975

RESUMEN

This paper reports the results of an empirical analysis exploring the impact of new professions (eg a physician associate) and new professional roles on patient experiences of and satisfaction with care. A sub set of data from a patient survey conducted as part of the MUNROS programme of work was used. The overall survey aim was to describe and quantify the use of new professionals and new roles for established health care professionals other than medical doctors, in primary and secondary care sectors in three care pathways in nine European countries Ordered logit models were used to investigate the association between: (1) patient satisfaction with the last visit; (2) with their care provider; (3) with the information provided and a set of covariates explaining the involvement of new professional roles in three clinical pathways: type 2 diabetes, heart disease and breast cancer. For patients with breast cancer, high levels of satisfaction are associated with the involvement of new professions/professional roles in the provision of conditions specific education and monitoring. For patients with heart disease, the involvement of new professions/professional roles is likely to have a negative impact on satisfaction. For patients with Type 2 diabetes results are ambivalent. Patients belonging to countries experiencing innovative models of healthcare delivery and with high levels of involvement of new professions/professional roles are generally more satisfied. In conclusion, the introduction of new professions does not affect patient satisfaction negatively, therefore introducing new health professional roles is a pursuable strategy from a patient satisfaction perspective, at least for breast cancer and type 2 diabetes.


Asunto(s)
Neoplasias de la Mama/terapia , Enfermedad Coronaria/terapia , Diabetes Mellitus Tipo 2/terapia , Personal de Salud , Educación del Paciente como Asunto/organización & administración , Satisfacción del Paciente/estadística & datos numéricos , Adulto , Vías Clínicas , Prestación de Atención de Salud/organización & administración , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios
7.
Value Health ; 21(7): 783-791, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-30005750

RESUMEN

OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection. METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanità). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted. RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of €40,000/QALY gained. CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.


Asunto(s)
Antivirales/economía , Antivirales/uso terapéutico , Costos de los Medicamentos , Hepacivirus/efectos de los fármacos , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/economía , Cirrosis Hepática/tratamiento farmacológico , Cirrosis Hepática/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/efectos adversos , Presupuestos , Simulación por Computador , Análisis Costo-Beneficio , Quimioterapia Combinada , Femenino , Hepacivirus/patogenicidad , Hepatitis C Crónica/diagnóstico , Hepatitis C Crónica/epidemiología , Humanos , Italia/epidemiología , Cirrosis Hepática/diagnóstico , Cirrosis Hepática/epidemiología , Masculino , Cadenas de Markov , Persona de Mediana Edad , Modelos Económicos , Método de Montecarlo , Análisis Multivariante , Años de Vida Ajustados por Calidad de Vida , Sistema de Registros , Factores de Tiempo , Resultado del Tratamiento , Incertidumbre , Adulto Joven
8.
Appl Health Econ Health Policy ; 16(5): 711-722, 2018 10.
Artículo en Inglés | MEDLINE | ID: mdl-30039348

RESUMEN

BACKGROUND: Chronic Hepatitis C virus (cHCV) is a major health issue worldwide. New effective direct-acting anti-viral (DAA) drugs such as the combination sofosbuvir/velpatasvir, represent an important turning point, given the high sustained virologic response (SVR) rates associated with their use. OBJECTIVES: To estimate the cost and effects of two different treatment strategies based on sofosbuvir/velpatasvir. Strategy 1: treating all patients, including those in the early stages of fibrosis; Strategy 2: reserving treatments for patients at more advanced stages of disease (≥ F3). The analysis compares the incremental cost-effectiveness ratio (ICER) of Strategy 1 versus Strategy 2 in a cohort of HCV-infected patients and a cohort of hepatitis C virus (HCV)-human immunodeficiency virus (HIV) patients. METHODS: A Markov model simulating the natural history of the disease was built considering a 60-year time horizon and two cohorts of 1000 patients aged ≥ 35 years. Disease morbidity was classified according to the METAVIR classification. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses (PSA). RESULTS: In both cohorts, Strategy 1 results in higher resource consumption and a greater number of quality-adjusted life-years (QALYs) compared with Strategy 2. The ICERs for the cohort of HCV patients and the cohort of co-infected HCV/HIV patients ranged between €15,555-74,804/QALY and €10,708-55,138/QALY, respectively, depending on the assumed cost of the treatment. In the PSA, the ICER distribution remained below the threshold of €30,000/QALY in 96 and 97% of the scenarios in the cohorts of HCV and HCV/HIV patients, respectively. CONCLUSIONS: Extending the treatment of HCV to patients at an early stage of HCV infection is estimated to be cost effective from the perspective of the Italian Healthcare System.


Asunto(s)
Antivirales/economía , Carbamatos/economía , Hepatitis C Crónica/economía , Compuestos Heterocíclicos de 4 o más Anillos/economía , Sofosbuvir/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/administración & dosificación , Antivirales/uso terapéutico , Carbamatos/administración & dosificación , Carbamatos/uso terapéutico , Análisis Costo-Beneficio , Costos de los Medicamentos/estadística & datos numéricos , Quimioterapia Combinada , Femenino , Costos de la Atención en Salud/estadística & datos numéricos , Hepatitis C Crónica/tratamiento farmacológico , Compuestos Heterocíclicos de 4 o más Anillos/administración & dosificación , Compuestos Heterocíclicos de 4 o más Anillos/uso terapéutico , Humanos , Italia , Masculino , Cadenas de Markov , Persona de Mediana Edad , Aceptación de la Atención de Salud/estadística & datos numéricos , Años de Vida Ajustados por Calidad de Vida , Sofosbuvir/administración & dosificación , Sofosbuvir/uso terapéutico , Adulto Joven
9.
J Crohns Colitis ; 12(9): 1079-1088, 2018 08 29.
Artículo en Inglés | MEDLINE | ID: mdl-29860436

RESUMEN

BACKGROUND AND AIMS: Empirical dose intensification and therapeutic drug monitoring [TDM] of infliximab [IFX] trough levels [ITLs] and antibody to infliximab [ATI] assays are recognized approaches for managing loss of response [LoR] in patients with inflammatory bowel disease [IBD]. The aim of the study was to compare these two interventions in a clinical setting, in terms of effectiveness and cost savings. METHODS: Consecutive IBD patients experiencing LoR were clinically managed according to a TDM algorithm. A historical group of empirically treated patients, for whom sera for ITLs and ATI assays had been collected, served as the control group. Clinical outcomes 12 weeks after the therapeutic interventions were compared between the two groups. A cost-minimization analysis was performed to compare the economic impact of these two approaches. RESULTS: Ninety-six patients were enrolled prospectively and compared with 52 controls. The two cohorts were similar in characteristics and in the distribution of TDM results. In the prospective cohort, however, we observed less IFX dose escalations compared with in the controls [45% versus 71%, p = 0.003]. Also, more patients were switched to a different anti-TNFα in the prospective cohort than in the control cohort [25% versus 4%, p = 0.001]. The percentages of patients achieving a clinical response at 12 weeks were 52% and 54% for the prospective and control groups, respectively. By cost analysis, we estimated a savings of 15% if the TDM algorithm was applied. CONCLUSIONS: In our population, applying a TDM algorithm for LoR to IFX resulted in less dose escalations, without loss of efficacy, compared with empirical adjustment. In addition, the TDM approach was cost-effective.


Asunto(s)
Monitoreo de Drogas/economía , Fármacos Gastrointestinales/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/uso terapéutico , Adolescente , Algoritmos , Niño , Estudios de Cohortes , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Resultado del Tratamiento
10.
Lancet ; 391(10138): 2417-2429, 2018 06 16.
Artículo en Inglés | MEDLINE | ID: mdl-29861076

RESUMEN

BACKGROUND: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. METHODS: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials.gov, number NCT01288794. FINDINGS: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events. INTERPRETATION: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. FUNDING: Italian Medicine Agency.


Asunto(s)
Albúminas/uso terapéutico , Ascitis/terapia , Cirrosis Hepática/tratamiento farmacológico , Anciano , Ascitis/etiología , Diuréticos/administración & dosificación , Diuréticos/efectos adversos , Quimioterapia Combinada , Femenino , Furosemida/administración & dosificación , Furosemida/efectos adversos , Humanos , Hiperpotasemia/inducido químicamente , Hiponatremia/inducido químicamente , Estimación de Kaplan-Meier , Cirrosis Hepática/complicaciones , Cirrosis Hepática/fisiopatología , Masculino , Persona de Mediana Edad , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Paracentesis , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Tasa de Supervivencia , Factores de Tiempo
11.
J Med Econ ; 21(9): 902-911, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-29882711

RESUMEN

BACKGROUND: Stroke has a significant disease burden in terms of acute and long-term disability in Italy and throughout the world. Endovascular treatments for the management of a stroke event have been coupled in the past years with the possibility to mechanically remove the occlusion by means of specially designed thrombectomy devices, and their exclusive use showed levels of effectiveness in line with those of the existing pharmacological treatments. OBJECTIVE: To assess the cost-effectiveness of mechanical thrombectomy (MT) with the Solitaire Revascularization Device (stent retriever) for the treatment of acute ischemic stroke (AIS) in patients with large vessel occlusions (LVOs), comparing MT plus intravenous tissue plasminogen activation (MT plus IV t-PA) vs IV t-PA alone, in Italy. METHODS: A Markov model was used to simulate costs and benefits of MT plus IV t-PA and IV t-PA alone over a 5-year time horizon and considering the perspective of the Italian National Health Service (NHS). Results are reported in terms of Incremental Cost Effectiveness Ratio (ICER). Deterministic and probabilistic sensitivity analyses are carried out in order to test the robustness of the results. RESULTS: Total costs of MT plus IV t-PA and IV t-PA alone are equal to €31,798 and €34,855, respectively. The MT allows incremental QALYs for 0.77, determining a dominant ICER. The utilities associated to the mRS health states are the parameters with the highest impact on the results. Multiway sensitivity analyses determined a 90% probability of dominance. CONCLUSIONS: MT plus IV t-PA for AIS patients with LVO is cost-effective from year 1 through year 3, and cost-saving from year 4 onward in the Italian context, achieving better results, both in terms of efficacy and in terms of resource consumption.


Asunto(s)
Fibrinolíticos/economía , Accidente Cerebrovascular/terapia , Trombectomía/economía , Activador de Tejido Plasminógeno/economía , Terapia Combinada , Análisis Costo-Beneficio , Fibrinolíticos/uso terapéutico , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Servicios de Salud/economía , Servicios de Salud/estadística & datos numéricos , Humanos , Italia , Modelos Econométricos , Años de Vida Ajustados por Calidad de Vida , Factores de Riesgo , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Activador de Tejido Plasminógeno/uso terapéutico
12.
Hepatology ; 66(6): 1814-1825, 2017 12.
Artículo en Inglés | MEDLINE | ID: mdl-28741307

RESUMEN

We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. CONCLUSION: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).


Asunto(s)
Antivirales/economía , Política de Salud/economía , Hepatitis C/tratamiento farmacológico , Modelos Económicos , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Análisis Costo-Beneficio , Hepatitis C/economía , Humanos , Persona de Mediana Edad , Adulto Joven
13.
Aging Clin Exp Res ; 29(1): 75-79, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-28160252

RESUMEN

In a global context of population aging, gaining better knowledge of the mechanisms leading to loss of autonomy has become a major objective, notably with the aim of implementing effective preventive health policies. The concept of frailty, originally introduced in gerontology and geriatrics as a precursor state to functional dependency, appears as a useful tool in this specific context. The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) project will provide a unique opportunity to explore health economics issues associated with frailty. In terms of health economics, the loss of autonomy approach retained here focuses on the economic and social causes and consequences of the onset of frailty in older adults, and examines the challenges not only in terms of health system efficiency but also in terms of social protection.


Asunto(s)
Prestación de Atención de Salud/economía , Anciano Frágil , Trastornos de la Destreza Motora/prevención & control , Servicios Preventivos de Salud/economía , Sarcopenia/economía , Anciano , Anciano de 80 o más Años , Europa (Continente) , Humanos , Factores de Riesgo , Sarcopenia/prevención & control
14.
Ig Sanita Pubbl ; 73(5): 453-471, 2017.
Artículo en Italiano | MEDLINE | ID: mdl-29433132

RESUMEN

INTRODUCTION: Decision-making in healthcare should rely on evidence-based approaches able to make possible a transparent and robust assessment of all the aspects related to health technologies. One of the assessment elements is represented by the efficiency that is the specific objective of economic evaluations and also of Health Technology Assessment (HTA). The collection and synthesis of evidence is the first indispensable step in order to foster a proper convey of scientific knowledge to the decision-makers. This work, carried out within a broader project on the transfer of evidence from the scientific to the decision making world, is aimed to release an overview of economic evaluations and HTA on vaccines conducted in Italy. The project was carried out within the activities of the ISPOR Italy-Rome Chapter. METHODS: A systematic review of Italian economic evaluations and HTA performed on vaccines and published up to May 2015 was carried out. PubMed, Scopus and the NIHR HTA databases were queried and a hand-search was performed on key journals in the field (Global & Regional Health Technology Assessment; PharmacoEconomics Italian Research Articles; Giornale italiano di HTA; Politiche Sanitarie; HTA Focus - Pills of Clinical Governance; Pillole di Farmacoeconomia; Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione; IJPH; Quaderni dell'IJPH). Studies were considered eligible if showing the results of a full economic evaluations and if performed in Italy. RESULTS: The literature search yielded 10 HTA reports and 33 economic evaluations. Among the latter, 20 (60,6%) were cost-effectiveness analyses. Ten studies (23,3%) assessed the vaccination against S. pneumoniae figuring out that it is cost-effectiveness and even costsaving in cases of newborns and subjects at risk. Nine studies (20,9%) addressed influenza vaccination and demonstrated its dominance on non-vaccination in the elderly. Eight studies (18,6%) evaluated the HPV vaccines concluding that they are cost-effective. Five studies (11,6%) devoted to anti-rotavirus vaccination showing its dominance on non-vaccination, in particular from the society perspective. Vaccination against pertussis, hepatitis B, chicken pox, measles, rubella, mumps were eventually shown cost-saving. The vaccine against Neisseria meningitidis was considered potentially cost-effective. CONCLUSION: The Italian scientific evidence on efficiency of vaccination is broad and allows concluding that vaccinations are value for money interventions.


Asunto(s)
Análisis Costo-Beneficio , Evaluación de la Tecnología Biomédica , Vacunación/economía , Humanos , Italia , Vacunas
15.
Int J Technol Assess Health Care ; 32(4): 233-240, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-27624398

RESUMEN

OBJECTIVES: Herpes zoster (HZ) is characterized by a painful skin rash. Its main complication is postherpetic neuralgia (PHN), pain persisting or occurring after the rash onset. HZ treatment aims to reduce acute pain, impede the onset complications, and disease progression. The aim of this study was to assess the cost-effectiveness of HZ vaccination compared with no vaccination strategy, within the Italian context. METHODS: The natural history of HZ and PHN was mapped through a Markov model with lifetime horizon. A population of patients aged between 60 and 79 years was hypothesized. Third party payer (Italian National Health Service, I-NHS) and societal perspectives were adopted. Data were derived from literature. RESULTS AND CONCLUSIONS: The incremental cost-effectiveness ratio of the vaccination equaled EUR 11,943 per quality-adjusted life-year (QALY) under the I-NHS perspective and EUR 11,248 per QALY under the societal perspective. Considering a cost-effectiveness threshold of EUR 30,000/QALY, the multi-way sensitivity analysis showed that vaccination is cost-effective regardless of the perspective adopted, in 99 percent of simulations.


Asunto(s)
Vacuna contra el Herpes Zóster/administración & dosificación , Vacuna contra el Herpes Zóster/economía , Herpes Zóster/prevención & control , Neuralgia Posherpética/prevención & control , Factores de Edad , Anciano , Costo de Enfermedad , Análisis Costo-Beneficio , Herpes Zóster/economía , Humanos , Reembolso de Seguro de Salud/economía , Italia , Cadenas de Markov , Persona de Mediana Edad , Modelos Econométricos , Neuralgia Posherpética/economía , Años de Vida Ajustados por Calidad de Vida , Medicina Estatal
16.
Blood Transfus ; 14(4): 287-386, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27403740

RESUMEN

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.


Asunto(s)
Seguridad de la Sangre/métodos , Transfusión Sanguínea , Plasma/microbiología , Plasma/virología , Animales , Bacterias/aislamiento & purificación , Transfusión Sanguínea/métodos , Desinfección/métodos , Humanos , Reacción a la Transfusión , Virus/aislamiento & purificación
17.
Blood Transfus ; 14(4): 277-286, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27136429

RESUMEN

BACKGROUND: Only a few studies have compared solvent/detergent plasma (SD-plasma) to standard fresh-frozen plasma (FFP) in terms of efficacy and safety. MATERIALS AND METHODS: A systematic review was performed in order to develop a consensus document on the use of SD-plasma. Moreover, a pharmacoeconomic study was performed in order to assess whether the use of SD-plasma can be cost-effective with respect to the use of FFP. A multidisciplinary panel used the systematic review and the GRADE methodology to develop evidence-based recommendations on this topic. RESULTS: Based on moderate to very low quality evidence, the panel developed the following consensus statements: (i) the panel suggested that SD-plasma is safer than FFP; (ii) the panel could not express for or against a greater efficacy of SD-plasma as compared to FFP; (iii) the panel suggested that in patients undergoing liver transplantation SD-plasma can be preferred over FFP; (iv) the panel suggested that SD-plasma can be preferred over FFP in patients with thrombotic thrombocytopenic purpura undergoing plasma-exchange procedures; (v) the panel could not recommend for or against preferring SD-plasma over FFP in critical care patients; and (vi) the panel suggested that the use of SD-plasma can be cost-effective with respect to the use of FFP. DISCUSSION: Data from additional randomised studies are needed to establish more definitive guidelines on the use of SD-plasma.

18.
Minerva Med ; 107(1): 1-13, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26999384

RESUMEN

BACKGROUND: The aim of this analysis is to evaluate the costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in nine different Italian hospitals, defined as the cumulative cost of drugs, consumable materials and time required for anesthesiologists, surgeons and nurses to administer each analgesic technique. METHODS: Nine Italian hospitals have been involved in this study through the administration of a questionnaire aimed to acquire information about the Italian clinical practice in terms of analgesia. This study uses activity-based costing (ABC) analysis to identify, measure and give value to the resources required to provide the therapeutic treatment used in Italy to manage the postoperative pain patients face after surgery. A deterministic sensitivity analysis (DSA) has been performed to identify the cost determinants mainly affecting the final cost of each treatment analyzed. Costs have been reclassified according to three surgical macro-areas (abdominal, orthopedic and thoracic) with the aim to recognize the cost associated not only to the analgesic technique adopted but also to the type of surgery the patient faced before undergoing the analgesic pathway. RESULTS: Fifteen different analgesic techniques have been identified for the treatment of moderate to severe pain in patients who underwent a major abdominal, orthopedic or thoracic surgery. The cheapest treatment actually employed is the oral administration "around the clock" (€ 8.23), whilst the most expensive is continuous peripheral nerve block (€ 223.46). The intravenous patient-controlled analgesia costs € 277.63. In terms of resources absorbed, the non-continuous administration via bolus is the gold standard in terms of cost-related to the drugs used (€ 1.28), and when administered pro re nata it also absorbs the lowest amount of consumables (€0.58€) compared to all other therapies requiring a delivery device. The oral analgesic administration pro re nata is associated to the lowest cost in terms of health professionals involved (€ 6.25), whilst intravenous PCA is the most expensive one (€ 245.66), requiring a massive monitoring on the part of physicians and nurses. CONCLUSIONS: The analysis successfully collected information about costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in all the nine different Italian hospitals. The interview showed high heterogeneity in the treatment of moderate to severe pain after major abdominal, orthopedic and thoracic surgeries among responding anesthesiologists, with 15 different analgesic modalities reported. The majority of the analgesic techniques considered in the analysis is not recommended by any guideline and their application in real life can be one of the reasons for the high incidence of uncontrolled pain, which is still reported in the postoperative period. Health care costs have become more and more important, although the choice of the best analgesic treatment should be a compromise between efficacy and economic considerations.


Asunto(s)
Analgesia Controlada por el Paciente/economía , Analgésicos/administración & dosificación , Analgésicos/economía , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/economía , Administración Intravenosa , Administración Oral , Anestésicos Locales/administración & dosificación , Anestésicos Locales/economía , Análisis Costo-Beneficio , Encuestas de Atención de la Salud , Humanos , Inyecciones Intralesiones , Italia , Manejo del Dolor/métodos , Dimensión del Dolor , Encuestas y Cuestionarios , Resultado del Tratamiento
19.
Int J Med Robot ; 12(4): 613-619, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26748491

RESUMEN

INTRODUCTION: The aim of this study was to identify, quantify and evaluate the use of robotic materials and operating theatre times in Telelap ALF-X robotic hysterectomy. MATERIALS AND METHODS: Cost analysis was performed on 81 patients who underwent a Telelap ALF-X robotic hysterectomy. Data were collected during a phase II study trial conducted at the University Hospital A. Gemelli, Catholic University, Rome. According to micro-costing technique, surgical team costs, materials and operating theatre usage were recorded during each surgical intervention. Cost data were provided by the hospital's accounting office. Probabilistic sensitivity analysis was carried out in order to test the robustness of the results by assuming an Inv-norm random variable. RESULTS: The base case analysis showed a cost/patient of €3391.82. The new robotic device requires a low consumption of robotic materials. Sensitivity analysis showed that the most sensitive cost driver was use of the operating theatre. CONCLUSION: This study shows that Telelap ALF-X robotic hysterectomy is feasible and safe and could offer specific advantages in terms of cost. Copyright © 2016 John Wiley & Sons, Ltd.


Asunto(s)
Neoplasias Endometriales/cirugía , Histerectomía/métodos , Tempo Operativo , Procedimientos Quirúrgicos Robotizados/métodos , Algoritmos , Costos y Análisis de Costo , Neoplasias Endometriales/economía , Femenino , Humanos , Histerectomía/economía , Histerectomía/instrumentación , Quirófanos , Dimensión del Dolor , Probabilidad , Procedimientos Quirúrgicos Robotizados/economía , Procedimientos Quirúrgicos Robotizados/instrumentación , Resultado del Tratamiento
20.
Clinicoecon Outcomes Res ; 7: 575-81, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26635482

RESUMEN

BACKGROUND: Agency is a pervasive feature of the health care market, with doctors acting as agents for both patients and the health care system. In a context of scarce resources, doctors are required to take opportunity cost into account when prescribing treatments, while cost containment policies cannot overlook their active role in determining health care resource allocation. This paper addresses this issue, investigating the effects of cost containment measures in the market of biosimilar drugs that represent a viable and cost-saving strategy for the reduction of health care expenditure. The analysis focuses on a particular region in Italy, where several timely policies to incentivize biosimilar prescribing were launched. METHODS: Drugs were identified by the anatomical therapeutic chemical classification system. Information about biosimilar drugs and their originator biological products was extracted from the IMS Health regional database. Drug consumption was expressed in terms of counting units, while expenditure was evaluated in Euro (€). The market penetration of biosimilars was analyzed by year and quarterly. RESULTS: In the Campania region of Italy, the effects of cost containment policies, launched between 2009 and 2013, showed the prescription of biosimilars strongly increasing in 2010 until prescribing levels reached and exceeded the market share of the reference biological products in 2012. After a slight reduction, a plateau was observed at the beginning of 2013. At the same time, the use of the originator products had been decreasing until the first quarter of 2011. However, after a 1-year plateau, this trend was reversed, with a new increase in the consumption of the originators observed. CONCLUSION: Results show that the cost containment policies, applied to cut health expenditure "to cure and not to care", did not produce the cultural change necessary to make these policies effective in the long run. Therefore, top-down policies for cost containment are not successful; rather, a bottom-up approach based on consensus among professionals should become the preferred option.

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