Michela Meregaglia

Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme

Introduction In January 2013 a novel type of multicomponent protein-based vaccine against group B meningococcal disease was licensed by the European Medicines Agency. With the widespread use of the meningococcal serogroup C conjugate vaccines, serogroup B remains now the major cause of bacterial meningitis and septicaemia in young children in Europe. The aim of this study is to investigate the health and the economic outcomes of MenB vaccine introduction into the Italian routine mass vaccination programme. Methods The present work is structured in two main parts. Firstly, we assess the epidemiological burden of group B meningococcal disease using official hospitalisation and notification data from two of the most populated Italian regions (Lombardia and Piemonte) during a 6-year study period (2007-2012). Secondly, we evaluate the cost-effectiveness of the immunisation programme in Italy from the public health payer perspective under base case parameters assumptions and performing a comprehensive sensitivity analysis to assess the robustness and the uncertainty of our model results. Results MenB serotype is responsible for 59% of the 341 cases of Invasive Meningococcal Disease in Lombardia and Piemonte. Incidence rate for MenB infection is estimated to be 0.21/100,000/y resulting at the highest level in children ≤4 years of age. Although the new MenB vaccine can potentially prevent about one third of the disease cases in the Italian population, model results show this strategy is unlikely to be cost-effective (ICER value over €350,000/QALY) with a vaccine that prevents disease only. These results are robust under most of the sensitivity scenarios except when allowing for lower discount rates. Discussion The introduction of the novel vaccine into the routine immunisation schedule needs to be carefully evaluated. The new MenB vaccine has the potential to reduce the disease burden at the population level. However, from the Italian Health Service perspective, the immunisation programme is unlikely to be cost-effective at the current incidence levels and vaccine price.

Mud-bath therapy in addition to usual care in bilateral knee osteoarthritis: Economic evaluation alongside a randomized controlled trial.

To perform a cost‐effectiveness analysis of mud‐bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA).

A comparison of EuroQol 5-Dimension health-related utilities using Italian, UK, and US preference weights in a patient sample.

Weights associated with the EuroQol 5-Dimension 3-Level (EQ-5D-3L) instrument represent preferences for health states elicited from general population’s samples. Weights have not been calculated for every country; however, empirical research shows that cross-country differences exist. This empirical study aims at investigating the impact of recently developed Italian weights in comparison with UK and US scores on health-related utility calculation using a sample of patients with Crohn’s disease. The study is based on a survey on health-related quality of life in patients (n=552) affected by active Crohn’s disease conducted in Italy from 2012 to 2013. Utilities computed through the Italian algorithm (mean: 0.76; SD: 0.20; median: 0.81) are generally higher than US (mean: 0.69; SD: 0.22; median: 0.77) and UK (mean: 0.57; SD: 0.32; median: 0.69) utilities, except for extremely severe health states where US values outweigh the Italian ones. UK preference weights generate the highest number of negative results. All the three value distributions are left-skewed due to very low scores associated with the most serious health states (ie, three or four levels equal to 3). As expected, despite the tariff set considered, more severe disease (Harvey Bradshaw Index >16) reduces the mean conditional EQ-5D-3L index (P<0.0001). Kendall’s rank correlation between EQ Visual Analog Scale score and EQ-5D-3L index is positive (P<0.0001), even though patients tend to value their health-related quality of life more when responding to EQ-5D-3L questions than on EQ Visual Analog Scale. Regardless of the tariff set considered, ordinary least-square results highlight that more severe disease (Harvey Bradshaw Index >16) reduces the mean conditional EQ-5D-3L index (P<0.0001). Results reveal remarkable differences among the three national tariff sets and especially when severe health states occur, suggesting the need for country-specific preference weights when evaluating utilities, which can be problematic since they have not been calculated for every country yet.

Hospital Burden and Gastrointestinal Surgery in Inflammatory Bowel Disease Patients in Italy: A Retrospective Observational Study

BACKGROUNDS AND AIMS Despite recent advances in medical therapies for inflammatory bowel disease [IBD], little is known about their impact on inpatient management. Our objectives were to explore hospitalisation and surgery trends for all IBD patients in Italy at three time points over 7 years. METHODS National hospital discharge records were retrospectively reviewed for all admissions with a Crohns disease [CD, 555*] or ulcerative colitis [UC, 556*] diagnosis in 2005, 2008, and 2011. Quantitative variables [mean, standard deviation] and categorical variables [frequencies] were described; comparison among admission-years was made by analysis of variance and chi-square tests. A multivariate logistic regression analysis was performed to identify predictors of surgery risk regarding demographics, inpatient management, and clinical features; p-values ≤ 0.05 were considered statistically significant. RESULTS Overall, 109657 hospitalisations occurred over the 3 years, with a decreasing trend observed in UC admissions. Mean age was higher in UC [50.1±19.7] than in CD [43.2±21.9]. The number of paediatric admissions rose from 3637 to 4372 between 2005 and 2011. An increasing proportion of CD [from 12.4% to 14.6%] and UC [from 5.8% to 8.0%] admissions reported a digestive system-related, surgical diagnosis-related group in the same period; overall, gastrointestinal surgical admissions increased from 3299 to 3964. In regression analysis, male gender, age, admission year, northern university hospital, disease localisation, and cancer as independent factors significantly affected the likelihood of surgery. CONCLUSIONS Despite a reduction in total IBD hospitalisations, surgical and paediatric admissions rose over time. Further study is needed to clarify benefits associated with new drugs in terms of inpatient management.

Critical review of economic evaluation studies of interventions promoting low-fat diets

Various national and local policies encouraging healthy eating have recently been proposed. The present review aims to summarize and critically assess nutrition-economic evaluation studies of direct (e.g., diet counseling) and indirect (e.g., food labeling) interventions aimed at improving dietary habits. A systematic literature review was performed by searching 5 databases (PubMed, Ovid Medline, EconLit, Agricola, and Embase) using a combination of diet-related (fat, diet, intake, nutrition) and economics-related (cost-effectiveness, cost-benefit, cost-utility, health economics, economic evaluation) key words. The search yielded 36 studies that varied in target population, study design, economic evaluation method, and health/economic outcome. In general, all provide limited experimental evidence and adopt the framework of economic evaluations in healthcare. Certain important aspects were not well considered: 1) the non-health-related effects of nutrition interventions on well-being; 2) the private nature of food expenditures; 3) the distributional effects on food expenditures across socioeconomic groups; and 4) the general economic implications (e.g., agrofoods, import/export) of such interventions. Overall, the methodology for the economic evaluation of nutrition interventions requires substantial improvement.

Impatto economico dell’utilizzo di carbossimaltosio ferrico in pazienti con anemia da carenza di ferro nelle regioni italiane

L’anemia da carenza di ferro rappresenta la forma di anemia riscontrata piu comunemente nella pratica clinica. L’assunzione di ferro per via endovenosa si e dimostrata sicura ed efficace e in grado di riportare rapidamente i pazienti a livelli normali di emoglobina. A partire dalla rilevazione dell’utilizzo delle risorse sanitarie in cinque ospedali italiani, si e stimata la dimensione economica, a livello ospedaliero e dei sistemi sanitari regionali, nella gestione dei pazienti con anemia da carenza di ferro in Italia considerando diversi scenari di utilizzo di carbossimaltosio ferrico (FCM) e ferro gluconato (FG). Per la valorizzazione delle risorse sono state utilizzate le tariffe di rimborso delle prestazioni nella prospettiva dei sistemi sanitari regionali, mentre per la prospettiva ospedaliera si e fatto riferimento alla funzione di costo legata ai diversi fattori produttivi. Nell’ipotesi di sostituzione completa di FCM rispetto a FG, il risparmio massimo ottenibile per il Sistema Sanitario Italiano sarebbe di circa 34 milioni di euro. Nella prospettiva ospedaliera, con una singola infusione di 1.000 mg di FCM, che all’ospedale costa 131,24 €, e possibile ottenere un risparmio del 75% rispetto a 16 infusioni di FG da 62,5 mg ciascuna e del 50% rispetto a 8 infusioni di due fiale di FG ciascuna (125 mg). In conclusione, FCM si puo ritenere un’opzione cost-saving, sia dal punto di vista dei sistemi sanitari regionali sia dal punto di vista ospedaliero, se confrontata con la formulazione attualmente piu utilizzata in Italia per il trattamento dei pazienti con anemia da carenza di ferro.

The short-term economic burden of gestational diabetes mellitus in Italy

BackgroundThe incidence of Gestational Diabetes Mellitus (GDM) is rising in all developed countries. This study aimed at assessing the short-term economic burden of GDM from the Italian healthcare system perspective.MethodsA model was built over the last pregnancy trimester (i.e., from the 28th gestational week until childbirth included). The National Hospital Discharge Database (2014) was accessed to estimate delivery outcome probabilities and inpatient costs in GDM and normal pregnancies (i.e., euglycemia). International Classification of Disease-9th Revision-Clinical Modification (ICD9-CM) diagnostic codes and Diagnosis-Related Group (DRG) codes were used to identify GDM cases and different types of delivery (i.e., vaginal or cesarean) within the database. Neonatal outcomes probabilities were estimated from the literature and included macrosomia, hypoglycemia, hyperbilirubinemia, shoulder dystocia, respiratory distress, and brachial plexus injury. Additional data sources such as regional documents, official price and tariff lists, national statistics and expert opinion were used to populate the model. The average cost per case was calculated at national level to estimate the annual economic burden of GDM. One-way sensitivity analyses and Monte Carlo simulations were performed to quantify the uncertainty around base case results.ResultsThe amount of pregnancies complicated by GDM in Italy was assessed at 54,783 in 2014 using a prevalence rate of 10.9%. The antenatal outpatient cost per case was estimated at €43.7 in normal pregnancies compared to €370.6 in GDM patients, which is equivalent to a weighted sum of insulin- (14%; €1034.6) and diet- (86%; €262.5) treated women’s costs. Inpatient delivery costs were assessed at €1601.6 and €1150.3 for euglycemic women and their infants, and at €1835.0 and €1407.7 for GDM women and their infants, respectively. Thus, the overall cost per case difference between GDM and normal pregnancies was equal to €817.8 (+ 29.2%), resulting in an economic burden of about €44.8 million in 2014 at national level. Probabilistic sensitivity analysis yielded a cost per case difference ranging between €464.9 and €1164.8 in 80% of simulations.ConclusionsThe economic burden of GDM in Italy is substantial even accounting for short-term medical costs only. Future research also addressing long-term consequences from a broader societal perspective is recommended.