Social value of gender-neutral HPV vaccination in Italy

Over the last decade, the main theme underlying my research in Health Economics has been to estimate how the Value for Money of breakthrough pharmaceutical innovation evolves with the availability of new clinical information. In 2008, Prof. H. Zur Hausen received the Nobel Prize for discovering the cancerogenic role of HPV that he initially discovered in 1976. Following that, in 1989, Prof. Ian Frazer discovered the HPV vaccine that later in 2006 became available globally. After the introduction of the vaccine, the clinical information concerning the HPV changed considerably. At the time of its introduction, the HPV vaccine was mostly used for the prevention of cervical cancer in women. A few years later, the role of HPV as causative agent of gender-neutral cancers was proved, namely anal, oral and head and neck cancers. In 2015, a new version of the vaccine was introduced, active on a larger number of HPV strains causing malignancies. The five publications included for examination describe the historical contribution of my research to the assessment of the economic value to the payor (National Health System) of the HPV immunisation following the availability of new clinical information. The setting is constant: the Italian population covered by the NHS. The analytical approach varies according to the availability of new inputs informing the economic models, aimed to demonstrate the match between economic assessment and the availability of new clinical evidence about the HPV immunization. First, an original Markov model [1] demonstrated that vaccinating adolescent girls against HPV would be beneficial and cost-effective as a public health programme in Italy. To provide inputs to the model relevant to Italy, both terms of the economic assessment were drawn from original NHS data that were used in two publications. Specifically, a standardized time trade-off (TTO) methodology was used [2] to quantify the utility loss in health states affected by HPV- induced pathologies in Italy. On the other hand, an innovative Bound Optimisation Model [3] was developed to determine whether the allocation of resources was efficient for the prevention of HPV induced diseases ex-ante. The outcomes of the cost-effective analyses [1,2,3] were included in the pricing dossier leading to the initial reimbursement of HPV vaccine in Italy. Furthermore, the BEST II study [4] evaluated the cost-effectiveness of universal vaccination compared with selective vaccination of 12-year-old girls and the economic impact of immunization on various HPV-induced diseases. In this paper, a dynamic Bayesian Markov model was developed to investigate the transmission of HPV virus in cohorts of females and males. As a result, genderneutral HPV vaccination was found to be a cost-effective alternative when compared with either cervical cancer screening or female-only vaccination. Based on this new evidence, the Italian Government was the first among the G8 Countries to extend the HPV national immunisation programme to 12-year- old boys (2017). Finally, a systematic review of the extant literature [5] showed that the inclusion of additional HPV types in the non-violent (active on nine strains of the virus) vaccine offers a significant potential to expand protection against HPV infection. The study was included in the pricing dossier for the reimbursement of the 9- valent HPV vaccine as a replacement of the currently available quadrivalent formulation My main contribution to research has been the use of triangulation to augment the internal validity of the outcomes. Triangulation has benefited investigators, methods and data collection. In addition to my contributions to the development of the overarching research plan, I also directly contributed to the research output of each published paper submitted for examination. My contributions reflect the expected research skills to be demonstrated upon conferment of a Doctoral Degree: - Review of the literature (Papers 1, 4, 5) - Formulation of research question (Papers 1, 2, 3, 4, 5) - Choice of methods (Papers 1, 2, 3, 5) - Data collection (Papers 1, 3, 5) - Data analysis (Papers 2, 3, 5) - Analysis of limitations of the research (Papers 1, 2, 3, 4, 5) - Conclusions and recommendations (Papers 1, 2, 3, 4, 5

PMS31 Economic Evaluation of Adalimumab Versus Other Biologic Treatments for Moderate to Severe Psoriatic Arthritis in Italy

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Economic burden of diverticular disease : an observational analysis based on real world data from an Italian region

INTRODUCTION: Diverticular disease (DD), a herniation of the colonic mucosa through the muscle layer, covers a wide variety of conditions associated with the presence of diverticula in the colon. The most serious form is an acute episode of diverticulitis, which can lead to hospitalization and surgery with various types of consequences. The main aim of this study is to evaluate the economic burden of hospitalizations arising from acute episodes of diverticulitis using data from the administrative databases used in the Marche region in Italy and, as a secondary objective of this real-world data analysis, to study patient outcome variables following initial hospitalization for diverticulitis. METHOD: A deterministic linkage was performed at individual user level between the different administrative sources of the Marche region through anonymous ID number for a period of analysis between 1 January, 2008 and 31 December, 2014. We enrolled all patients with at least one hospitalization for "diverticulitis of the colon without mention of haemorrhage" (ICD-9-CM code 562.11) or "diverticulitis of the colon with haemorrhage" (ICD-9-CM code 562.13) as primary or secondary diagnosis. For each patient we assessed the cost of hospitalization, of medicines and of specialist services considering a time-scale of one year or cohort analysis 365days after first admission. RESULTS: The total number of residents in the Marche region who had at least one hospitalization for diverticulitis in the period 2008-2014 was 2987 (427 patients a year, corresponding to about 35 patients per 100,000 adult residents); the total number of admissions was 3453 (just over 490 a year). The direct healthcare costs incurred by the Marche region for episodes of diverticulitis in 2008-2014 amounted to approximately €11.4 million (€1.6 million a year), of which €10.9 million (95.5%) for the hospitalizations, € 246,000 (2.1%) for pharmaceutical treatment and €270,000 (2.4%) for specialist outpatient services. The average annual cost per patient was €3826, of which €3653 was for hospitalization, while pharmaceutical expenditure and specialist services accounted for €83 and €90, respectively. The cohort of patients undergoing a first admission for diverticulitis between 2010 and 2013 was made up of 1729 people (54.4% women, mean age 68.9 years), of whom 1500 (86.8%) did not undergo surgery while in hospital. Hospital mortality, recorded only for the over-65 age class, averaged 1.2%; for patients not receiving surgery during the initial hospitalization it was 0.5%, reaching 5.2% in patients undergoing surgery. The percentage of patients with one or more readmissions for diverticulitis within a year of the first was on average 7.8% and in 48% of cases this resulted in surgery. CONCLUSIONS: Our study is the first analysis in Italy to use real-world data to measure the financial impact of diverticular disease. Assuming that the diagnostic and therapeutic behaviour identified in the Marche region could be representative of the situation nationwide, the estimated annual number of hospitalizations in Italy for acute episodes of diverticulitis is 19,000. The total amount of economic resources needed to treat patients suffering from acute episodes of diverticulitis is estimated at €63.5 million a year

Towards the eradication of HPV infection through universal specific vaccination

Background: The Human Papillomavirus (HPV) is generally recognized to be the direct cause of cervical cancer. The development of effective anti-HPV vaccines, included in the portfolio of recommended vaccinations for any given community, led to the consolidation in many countries of immunization programs to prevent HPV-related cervical cancers. In recent years, increasing evidence in epidemiology and molecular biology have supported the oncogenic role of HPV in the development of other neoplasm including condylomas and penile, anal, vulvar, vaginal, and oro-pharyngeal cancers. Men play a key role in the paradigm of HPV infection: both as patients and as part of the mechanisms of transmission. Data show they are affected almost as often as women. Moreover, no screening procedures for HPV-related disease prevention are applied in men, who fail to undergo routine medical testing by any medical specialist at all. They also do not benefit from government prevention strategies. Discussion. A panel of experts convened to focus on scientific, medical, and economic studies, and on the achievements from health organizations' intervention programs on the matter. One of the goals was to discuss on the critical issues emerging from the ongoing global implementation of HPV vaccination. A second goal was to identify contributions which could overcome the barriers that impede or delay effective vaccination programs whose purpose is to eradicate the HPV infection both in women and men. Summary. The reviewed studies on the natural history of HPV infection and related diseases in women and men, the increasing experience of HPV vaccination in women, the analysis of clinical effectiveness vs economic efficacy of HPV vaccination, are even more supportive of the economic sustainability of vaccination programs both in women and men. Those achievements address increasing and needed attention to the issue of social equity in healthcare for both genders

A Macroeconomic analysis of institutional assets and their impact in modelling pharmaceutical market in Italy

Rationale Since its institution in 1978, the National Health Service in Italy has undergone two major reforms: the first one occurred in 1992/1993 and the second one in 1999/2000. The reform process has seen the increase of the degree of decentralization and the shift in the financial responsibility for health expenditures - from the central level of government to the local level of government -). The legislative measures implemented according to the health care reforms have modified the initial scenario, leading pharmaceutical firms to adapt their strategies to the arising challenges. Objectives The aim of this study is that of analysing how the Italian pharmaceutical market has been evolving across the last decades. The strategy selection process for pharmaceutical firms, in order to adapt to changes, might depend on some structural "exogenous" factors, such as regulatory issues, concentration in the market, etc., likely to influence firms' performances. Methodology In this paper, a sample of Italian pharmaceutical firms, representing the 75% of total sales, has been observed from 1978 on, when the National Health System was set out in Italy. Estimations have been carried out through a Fully Modified-LS (Phillips-Hansen) regression, given the presence of unit roots for the variables that have been employed. Moreover, structural changes occurred in the years immediately following the reforms in the health sector have been tested. Among variables included in the analysis there are level of revenues, dummies related to institutional change, health, R&S and pharmaceutical expenditure. Results Results of this paper explain trends in pharmaceutical industry in Italy from the institution of National Health Service till 2005: first of all, structural changes have been observed few years after the main reform of 1992/93; a minor impact on firms' revenues has been observed after the reform of 1999. Even if there has been an increase in number of products and level of R&S expenditure, the latter is still influenced by the high level of regulation and pricing policies. Qualified employment in the pharmaceutical sector do exert a positive impact on firms' revenues as well as mergers and acquisitions that, along time, have led to a more concentrated market. It still needs to be clarified the sustainability of the whole system in the next years, because of the aging population and the consequent increase in health expenditure demand. A positive impact of the openned towards foreigna markets is signalled by the value of the export/import ratio. Conclusions Strategies and performances of pharmaceutical firms have to be analysed looking at macro variables instead of micro and behavioural factors only. Institutional assets do have a role in determining variations in their economic results