Silvio Capizzi

Economic value of influenza vaccination.

Influenza epidemics are responsible for high mortality and morbidity rates in particular among elderly and high risk groups. This review is aimed at assessing the economic value of vaccination in these groups. A search of full economic evaluations of influenza vaccination in comparison with no interventions was performed on PubMed from January 1990 to May 2011. Only economic evaluations dealing with elderly and high risk groups were considered. The quality of selected articles was assessed through Drummond’s checklist. Sixteen cost-effectiveness analyses and four cost-benefit analyses were included: overall, the quality of studies was fairly good. The vaccination was demonstrated to be cost-effective or cost-saving in almost all studies, independently by the perspective and the type of analysis. Influenza vaccination is a worthwhile intervention from the pharmacoeconomic view-point, anyway a standardization of methods should be desirable in order to guarantee the comparability and transferability of results.

Health Technology Assessment of Belimumab: A New Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus

Objective. Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy. Methods. SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed. Results. Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2–5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial. Conclusions. The assessment supports the use of belimumab into the SLE treatment paradigm in Italy.

Does clinical governance influence the appropriateness of hospital stay

BackgroundClinical Governance provides a framework for assessing and improving clinical quality through a single coherent program. Organizational appropriateness is aimed at achieving the best health outcomes and the most appropriate use of resources. The goal of the present study is to verify the likely relationship between Clinical Governance and appropriateness of hospital stay.MethodsA cross-sectional study was conducted in 2012 in an Italian Teaching Hospital. The OPTIGOV© (Optimizing Health Care Governance) methodology was used to quantify the level of implementation of Clinical Governance globally and in its main dimensions. Organizational appropriateness was measured retrospectively using the Italian version of the Appropriateness Evaluation Protocol to analyze a random sample of medical records for each clinical unit.Pearson-correlation and multiple linear regression were used to test the relationship between the percentage of inappropriate days of hospital stay and the Clinical Governance implementation levels.Results47 Units were assessed. The percentage of inappropriate days of hospital stay showed an inverse correlation with almost all the main Clinical Governance dimensions. Adjusted multiple regression analysis resulted in a significant association between the percentage of inappropriate days and the overall Clinical Governance score (β = −0.28; p < 0.001; R-squared = 0.8). EBM and Clinical Audit represented the Clinical Governance dimensions which had the strongest association with organizational appropriateness.ConclusionsThis study suggests that the evaluation of both Clinical Governance and organizational appropriateness through standardized and repeatable tools, such as OPTIGOV© and AEP, is a key strategy for healthcare quality. The relationship between the two underlines the central role of Clinical Governance, and especially of EBM and Clinical Audit, in determining a rational improvement of appropriateness levels.

The Prevention of Postmenopausal Osteoporotic Fractures: Results of the Health Technology Assessment of a New Antiosteoporotic Drug

Objective. The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women. Method. Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation. Results. In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance. Conclusion. Denosumab could add value in the prevention of osteoporotic fractures.

Knowledge, opinions and attitudes of Italian mothers towards HPV vaccination and Pap test.

Aim This study evaluated the knowledge and attitudes of Italian mothers – whose daughters had been vaccinated in 2012 – towards primary (anti-HPV vaccination) and secondary (Pap test screening) cervical cancer prevention, as well as sources of information and mother-daughter communication on health issues. Methods The survey – part of a multicenter study carried out in 4 Italian cities (Ferrara, Rome, Cassino and Palermo) – was conducted through self-administered questionnaires. The first univariate analysis evaluated differences between mothers of under-18s and over-18s relative to knowledge and attitudes on HPV vaccination and Pap test. The second univariate analysis evaluated differences between the 2 groups of mothers and possible geographical variations regarding the sources of information on HPV and Pap test. Results The sample proved knowledgeable about the correlation between HPV and cervical cancer (>85%) but less aware of other HPV-related diseases. HPV vaccination should be administered before first sexual intercourse according to mothers of over-18s, and to 14- to 17-year-olds according to mothers of under-18s. Up to 88% of mothers of under-18s and 80% of mothers of over-18s declared that the vaccine should be given free of charge. More mothers of under-18s consulted a general practitioner (GP) or gynecologist before deciding to vaccinate their daughters. Mothers of under-18s received information on HPV vaccination mainly from GPs and gynecologists, while mothers of over-18s were informed through TV and books/journals. Over 80% of the sample declared satisfaction with the information received from their gynecologist during the Pap test. Conclusions The findings provide useful information for the development of effective public health interventions that may help improve acceptance of HPV vaccination among mothers.

Global Burden and Health Trends of Non-Communicable Diseases

Non-communicable diseases (NCD) are the biggest global killers today. More than 60 % of all deaths are caused by NCDs and nearly 80 % of these deaths occur in low- and middle-income countries, where the highest proportion of deaths under the age of 60 from NCDs occur. A large percentage of NCDs are preventable through the reduction of main behavioural (tobacco, alcohol, unhealthy diet, physical inactivity) and metabolic risk factors (raised cholesterol, raised blood pressure, overweight and obesity) .

Economic Issues Related to Tobacco Smoking

The aim of this chapter is to give an overview on the economic aspects related to tobacco smoking, including production and supply of tobacco products.

Can Clinical Governance tools improve the appropriateness in hospital stay

Data on all somatic specialist hospital admissions in Finland, both public and private, in 1998-2010 were obtained from the Hospital Discharge Register. The register data were limited to patients aged 25-85 years. Patients’ disposable family income each year was individually linked to each admission from the Employment Statistics and adjusted for family size. Main disease categories were formed using DRG classification. Agestandardised admission costs and cost per bed day were calculated per 100 000 person years for men and women separately and deflated for 2010. Time trends were analysed using concentration index. Results Hospital admission costs reduced with increasing income. The differences between the extreme quintiles widened from 1998 to 2010. In 1998, men in the lowest income group had on average EUR 552 (12%) higher admission costs than men in the highest, while in 2010, the difference was EUR 1187 (24%). The corresponding figures for women were EUR 444 (12%) and EUR 814 (18%). A similar pattern was found in main DRG disease categories and number of bed days. A reverse pattern was found in costs per bed day. In 1998, the highest income group among men had EUR 104 (21%), and in 2010, EUR 222 (28%) higher costs per bed day than the lowest. The results were similar for women. The differences between income groups were prominent in disease categories involving surgery, while less evident in non-surgical disease categories such as diseases of the nervous and respiratory system. Discussion One of the main reasons for the differences in hospital costs between income groups is likely to be the observed differences in length of stay. The shorter length of stay among highincome earners may originate from their overall better health. The higher costs per bed day among high-income patients may originate from differential morbidity profiles or inequality in the use of more costly health care technology. Key messages An inverse stepwise gradient was found between income groups as reported by earlier research. However, according to our results this is likely to be due to longer length of stay. High-income groups were found to have higher costs per ded day, which may be due to use of more costly health care technology.

Clinical epidemiology of IgE-mediated cutaneous and oculo-conjunctival allergic diseases.

Background : IgE-mediated allergic disease may clinically manifest itself with either a single symptom or a multisymptomatic disease involving different organs. In this work we investigated whether gender and age of the patients and reactivity to specific allergens are related to different clinical presentations of IgE-mediated allergic disease, considering in particular eye-conjunctival and cutaneous symptoms, alone or in combination. Methods : Epidemiological and clinical data related to patients of the Local Health Unit of Torino and Alessandria were collected. Measuring of specific Immunoglobulin E (IgE) was carried out by using allergenic extracts and by the employment of the chemiluminescence method. Clinical outcomes were the presence of eye-conjunctival, cutaneous (with also other symptom), and only cutaneous symptoms. The covariates under study were the type of allergen (mite, epithelium, poaceae, food, trees and grasses), number and localisation of the allergic reactions, gender, age over 30 years. For each clinical outcome, a logistic regression analysis was performed. Statistical significance was set at p < 0.05. Results : 844 patients with allergic problems (clinical manifestations of allergic disease) entered the study. We found that exposure to epithelium [OR=3,61; IC 95% (2,17; 6,00)], poaceae [OR=2,24; IC 95% (1,46; 3,42)], grasses [OR=2,06; IC 95% (1.35; 3,14)] and age over 30 years [OR=2,05; IC 95% (1,35; 3,13)] are risk factors for the development of eye-conjunctival symptoms. With regard to cutaneous allergic reactions, exposure to mite [OR=1,49; IC 95% (1,07; 2,08)], food [OR=4,16; IC 95% (3,01; 5,75)] and multidistrict symptoms [OR=3,63; IC 95% (2,54; 5,20)] should be risk factors. Instead, considering only cutaneous reactions, possible risk factor is the exposure to food [OR=3,58; IC 95% (2,54; 5,03)]. The exposure to trees is associated with a reduction of the likelihood to have cutaneous [OR=0,45; IC 95% (0,26; 0,76)] and only cutaneous reactions [OR=0,24; IC 95% (0,11; 0,53)]. For only cutaneous symptoms, a reduction in probability is present for the exposure to the grasses [OR=0,60; IC 95% (0,38; 0,94)] too. Conclusions : The study highlighted significant associations between subgroups of allergens and specific symptoms. As a consequence, in the presence of cutaneous symptoms, IgE tests could be restricted to mite and food, and to epithelium, poaceae and grasses in the presence of oculo-conjunctival symptoms.