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)