Vaccinating Italian infants with a new multicomponent vaccine (Bexsero®) against meningococcal B disease: A cost-effectiveness analysis.

The European Medicines Agency has approved a multicomponent serogroup B meningococcal vaccine (Bexsero®) for use in individuals of 2 months of age and older. A cost-effectiveness analysis (CEA) from the societal and Italian National Health Service perspectives was performed in order to evaluate the impact of vaccinating Italian infants less than 1 y of age with Bexsero®, as opposed to non-vaccination. The analysis was carried out by means of Excel Version 2011 and the TreeAge Pro® software Version 2012. Two basal scenarios that differed in terms of disease incidence (official and estimated data to correct for underreporting) were considered. In the basal scenarios, we considered a primary vaccination cycle with 4 doses (at 2, 4, 6 and 12 months of age) and 1 booster dose at the age of 11 y, the societal perspective and no cost for death. Sensitivity analyses were carried out in which crucial variables were changed over probable ranges. In Italy, on the basis of official data on disease incidence, vaccination with Bexsero® could prevent 82.97 cases and 5.61 deaths in each birth cohort, while these figures proved to be three times higher on considering the estimated incidence. The results of the CEA showed that the Incremental Cost Effectiveness Ratio (ICER) per QALY was €109,762 in the basal scenario if official data on disease incidence are considered and €26,599 if estimated data are considered. The tornado diagram indicated that the most influential factor on ICER was the incidence of disease. The probability of sequelae, the cost of the vaccine and vaccine effectiveness also had an impact. Our results suggest that vaccinating infants in Italy with Bexsero® has the ability to significantly reduce meningococcal disease and, if the probable underestimation of disease incidence is considered, routine vaccination is advisable.

Costs and quality of life in patients with myelodysplastic syndromes.

Myelodysplastic syndromes (MDS) encompass a range of myeloid neoplasms characterised by a defect in haematopoietic stem cell maturation, resulting in peripheral cytopenias. As a major consequence, most MDS patients become anaemic, so as to require red blood cell transfusions. To investigate the costs and the impact on quality of life (QOL) of MDS-separately in transfusion-independent (TI) and -dependent (TD) patients-a literature search was conducted. From Medline and Embase, 742 studies were identified, of which 17 were considered eligible. Total medical costs per patient/year range from $ 9,840 to $ 19,811 for the TI condition and from $ 29,608 to $ 51,066 in the TD condition, more than doubling when moving from the former condition to the latter. With regard to QOL, in the transition from TI to TD, QOL could be reduced by half depending on the studies. The TD condition negatively impacts on costs and the QOL of patients with MDS. Therapeutic strategies that reduce transfusion dependence may lead to broad benefits for patients and the community.

Abatacept or infliximab for patients with rheumatoid arthritis and inadequate response to methotrexate: an Italian trial-based and real-life cost-consequence analysis.

OBJECTIVES: In the 1-year, double-blind, placebo-controlled ATTEST trial, efficacy of abatacept or infliximab versus placebo was reported in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). The current study estimated trial-based and real-life costs of abatacept and infliximab for achieving pre-defined remission or low disease activity state (LDAS). METHODS: Quantity of drug, serious adverse event (SAE) rates and time (months) in remission or LDAS were taken from ATTEST for the trial-based calculation to derive a cost per remitting/LDAS patient and a cost per patient-month in remission/LDAS. Trial-based and real-life scenarios were performed. RESULTS: The annual trial-based costs per remitting/LDAS patient were €70.238/€37.208 for abatacept and €85.565/€46.602 for infliximab. In the first 6 months of the ATTEST trial, costs per patient-month in remission/LDAS were higher for abatacept (€11.024 and €6.018, respectively), relative to infliximab (€8.347 and €4.174, respectively). Over the full 12-month trial period cost per month in remission/LDAS estimates were only slightly in favour of infliximab (€6.959/€3.625) relative to abatacept (€7.297/€3.909). Assuming extension of treatment under real life conditions the cost per month in remission/LDAS turned substantially in favour of abatacept (€5.321/€2.819), as compared to infliximab (€7.189/€3.916). The higher initiation cost for abatacept to achieve remission/LDAS would be offset after a total 14.6 and 16.1 months of treatment, respectively, if treatment extended beyond 6 months under real-life conditions. These results proved to be robust when it was assumed that the (i) sharing of vials across patients completely averted infliximab wastage, (ii) AE risks were similar and (iii) onset of response was slower for abatacept. CONCLUSIONS: Our findings suggest a lower cost-consequence for abatacept during real-life treatment.

Cost of cystic fibrosis: analysis of treatment costs in a specialized center in northern Italy.

INTRODUCTION: Advances in cystic fibrosis (CF) therapy have resulted in improved survival and increasing treatment burden and costs. The economic impact of current treatment strategies for CF is poorly defined. METHODS: The authors prospectively assessed direct medical costs (including hospitalizations, outpatient interventions, drugs, devices, dietetic products) in 165 consecutive CF patients (aged 5-39 years) seen between March and July 2009. RESULTS: The mean annual cost/patient increased with age and lung disease severity from yy4,164 in children aged ≤5 years to yy30,123 in patients aged >5 years with severe lung disease (forced expiratory volume in 1 second [FEV1] <40% of predicted). The increase in costs involved all items, with a progressive increase in cost attributed to hospitalizations. CONCLUSION: Treatment of CF is associated with relevant cost for the Italian National Healthcare Service. Costs of illness tend to increase progressively with age, suggesting that increasing economic resources should be allocated to the treatment of CF, given the increasing number of patients surviving into adulthood.

Economic evaluation of levosimendan versus dobutamine for the treatment of acute heart failure in Italy.

INTRODUCTION: Inodilators are the first-choice class of drugs for the treatment of acute heart failure (AHF). Levosimendan is a relatively recent inodilatory agent, presenting superior outcomes in comparison with traditional inotropes. METHODS: An economic evaluation of levosimendan for the treatment of AHF in Italy was performed. In a retrospective study conducted on patients with AHF admitted to a teaching hospital in Rome, two groups were derived from an observational registry: 147 patients treated with levosimendan and 145 treated with dobutamine. Follow-up was at 1 year after treatment. In the reference study looked at in this paper, treatment with levosimendan reduced mean length of stay (LOS) by 1.5 days (P<0.05). Reduction in the rehospitalization rate was 6.7% (P<0.05). Mortality rate at 1 month was reduced by 4.8% (P<0.05). RESULTS: Based on the reference study, a cost analysis from the hospital perspective was carried out. The incremental cost of treatment with levosimendan (€697) was equivalent to the incremental savings (€694), the latter being obtained from the reduction in LOS (€508) and rehospitalization rate (€186). CONCLUSION: Despite the limitations of this study, and even neglecting all nonmonetary health gains as additional outcomes, levosimendan appears to be a competitive alternative compared with dobutamine for the treatment of AHF in the Italian hospital setting.

The cost of unresectable stage III or stage IV melanoma in Italy.

BACKGROUND: In recent decades, melanoma incidence has been increasing in European countries; in 2006, there were approximately 60,000 cases leading to 13,000 deaths. Within Europe there is some geographical variation in the incidence of melanoma, with the highest rates reported in Scandinavia (15 cases per 100,000 inhabitants per year) and the lowest in the Mediterranean countries (5 to 7 cases per 100,000 inhabitants per year). METHODS: The present article is based on the information collected in the MELODY study (MELanoma treatment patterns and Outcomes among patients with unresectable stage III or stage IV Disease: a retrospective longitudinal survey).In that study, the medical charts of patients were reviewed to document current treatment patterns and to analyse information on patients, disease characteristics and healthcare resource utilization related to the treatment of advanced melanoma regarding patients who presented with a diagnosis of malignant melanoma (stage I to IV) at participating sites between 01 July, 2005 and 30 June, 2006. RESULTS: Summarizing, though the length of the follow-up period varies among sample patients, an amount of the yearly cost per patient can be estimated, dividing the average per patient total cost (€ 5.040) by the average follow-up duration (17.5 months) and reporting to one year; on these grounds, unresectable stage III or stage IV melanoma in Italy would cost € 3,456 per patient per year.

Cost analysis: treatment of chemotherapy-induced anemia with erythropoiesis-stimulating agents in five European countries.

OBJECTIVE: Cost-analysis comparing darbepoetin-alfa (DARB), epoetin-alfa (EPO-A), and epoetin-beta (EPO-B) for treatment of chemotherapy-induced anemia in Belgium concluded that costs for DARB-treated patients were significantly lower than costs for EPO-A- or EPO-B-treated patients. The objective of the present study was to extend the Belgian analysis to Austria, France, Italy, Portugal, and Spain, estimating differences in costs between erythropoiesis-stimulating agents (ESAs) in each country. METHODS: Differences in epidemiology and treatment patterns between countries were adjusted using data from Eurostat, national cancer registries, IMS sales data, and reimbursement and treatment guidelines. Belgian unit costs were replaced with country-specific costs. Costs were analyzed using a mixed-effects model stratifying for propensity score quintiles. RESULTS: All populations were comparable to the Belgian population in terms of age, gender, ESA, and blood transfusions use. After adjusting for country-specific chemotherapy use and cancer incidence, total management costs per patient (Euro, 2010) were 19-26% (France, Spain) lower with DARB compared with EPO-A (p < 0.0001) and 20-36% (Portugal, Austria) compared with EPO-B (p < 0.01). Anemia-related costs with DARB were between 12% (Portugal; p = 0.0235) and 38% (Italy; p < 0.0001) lower compared with EPO-A (p < 0.01; all remaining countries), and between 13% (Austria; p = 0.064) and 19% (Portugal; p = 0.0028) lower compared with EPO-B (p < 0.05; all remaining countries except Italy; p = 0.0935). LIMITATIONS: Not all differences could be accounted for by a lack of country-specific data; however, the potential under- and over-estimation of costs should be similar for all three ESAs. CONCLUSIONS: These findings are in line with the Belgian analysis. In all countries, total and anemia-related costs were lowest in patients receiving DARB vs EPO-A or EPO-B. This study demonstrates the feasibility of adapting real-life country-specific data to other settings, adjusting for differences in patients' characteristics and treatment strategies. These findings should be valuable in healthcare decision-making in oncology patients treated in each of the countries studied.

Varicella vaccination in Italy : an economic evaluation of different scenarios.

AIM: To determine the economic impact (cost-benefit analysis) of childhood varicella vaccination, with the Oka/Merck varicella zoster virus vaccine live (Varivax) in Italy. METHODS: This analysis is based on an epidemiological model of varicella zoster virus (VZV) dynamics adapted to the Italian situation. Cost data (Euro, 2002 values) were collected through a literature review. Several vaccination scenarios were analysed: (i) routine vaccination programme for children aged 1-2 years with different levels of vaccination coverage (90%, 70% and 45%) without any catch-up programme; (ii) routine vaccination programme for children aged 1-2 years with different levels of vaccination coverage (90%, 70% and 45%) completed by a catch-up programme for 6-year-old children over the first 5 years of vaccine marketing; and (iii) routine vaccination programme for children aged 1-2 years with different levels of vaccination coverage (90%, 70% and 45%) completed by a catch-up programme during the first year of vaccine marketing for children aged 2-11 years. PERSPECTIVES: A societal perspective, including both direct and indirect costs, and a health-system perspective, limited to costs supported by Italian Health Authorities, were considered. RESULTS: A routine vaccination programme has a clearly positive impact on chickenpox morbidity. Respectively, 68% and 57% of chickenpox-related hospitalisations and deaths could be prevented with a 90% coverage rate. With vaccination costs being more than offset by a reduction in chickenpox treatment costs in the base case, such a programme could also induce savings from both a societal and a health-system perspective (40% and 12% savings, respectively for a 90% coverage rate). A lower coverage rate reduces cost savings, but there is still a 9% decrease in overall societal costs for a 45% coverage rate. Although the reduction in total societal costs was robust to the sensitivity analyses performed, a slight uncertainty remains regarding cost reduction from a health-system perspective. However, in this latter perspective, even in the worst-case scenario of the sensitivity analysis, routine vaccination programmes may be cost effective, the worst-case scenario for cost parameters leading to cost per life-year gained of Euro2853. Catch-up programmes combined with routine vaccination should lead to further cost reductions from a societal perspective: 15% for a massive catch-up during the first year of vaccine marketing compared with toddlers' vaccination alone, and 11% for a catch-up focused on 6-year-old children for a period of 5 years. However, the impact of catch-up programmes on the costs from an Italian health-system perspective remains close to zero (+/-1%). CONCLUSION: This model suggests, with its underlying assumptions and data, that routine ZVZ vaccination may be cost saving from both a societal and a health system perspective in the base case. In the worst-case scenario of the sensitivity analysis, vaccination remains cost effective.

Spending on pharmaceuticals in Italy: macro constraints with local autonomy.

Italy has a national health service (SSN) that is moving toward decentralization and empowerment of local health enterprises (LHEs)-the arms of the regions for delivering health services. Drug policy and spending decisions are both influenced by central government and local authorities. At the "macro" level, the government holds the power to decide the amount of drug expenditure, currently at 13% of total SSN expenditure; the pricing policy, price negotiation, reference price, and price cuts; criteria for reimbursement, inclusion in the positive list, and restrictive notes; and the copayments and exemptions. So far, the government concern has been predominantly on cost containment, and its approach in selecting drugs for reimbursement has been cost minimization. Italy has no centralized office for health technology assessment and this hinders the search for an efficient use of drugs. At the "micro" level, however, the LHEs are showing a great vitality in fostering a better use of drugs by general practitioners. One of the tools employed is local voluntary agreements between LHEs and general practitioners (GPs) that may be supported by economic incentives, in cash or in kind. In 2000 there were 61 agreements in place, 31% of total LHEs, which concerned the respect of drug expenditure ceilings and the local development and implementation of clinical guidelines (47% of LHEs). A traditional and widespread tool for controlling drug expenditure is providing GPs with regular reports on their drug prescriptions (59% of LHEs). Monitoring, moral suasion, and clinical guidelines are the main incentives for efficiency at local level, but focus on health outcomes is limited. The cost-containment mentality still prevails and the use of drug budget for purchasing better health is at its very early stage.

The costs of type 2 diabetes mellitus in Italy: a CODE-2 sub-study.

AIM: To estimate the direct, indirect, and intangible costs associated with type 2 diabetes mellitus in Italy in 1998. To evaluate the economic impact of diabetic complications, and to investigate drug treatment patterns and associated costs in patients with type 2 diabetes. METHODS: The Italian arm of an international study (COsts of Diabetes in Europe--Type 2 [CODE-2], a descriptive, cross-sectional survey) was set up to collect information retrospectively by means of questionnaires from a sample of 1263 patients. Resource use was measured in monetary terms using a set of costs and tariffs. Intangible costs were estimated using the EuroQol questionnaire. RESULTS: The average yearly cost for medical resources for a patient with type 2 diabetes was 2991 Euro, whereas the estimated cost for the whole population with type 2 diabetes was about 5170 million Euro. This corresponds to 6.65% of the total healthcare expenditure (public and private) in Italy. Of direct costs, 29% was spent for the treatment of diabetes and 39% for the treatment of diabetic complications; while the remaining 32% was spent for healthcare not related to diabetes. Quality of life score in patients with type 2 diabetes (EuroQoL overall average score) was 0.68. CONCLUSIONS: Type 2 diabetes has a high cost to society. The major cost component is due to the care of diabetic complications, not to the treatment of the illness itself; in particular, drug costs represent a relatively small proportion of such treatment cost.