The economic sustainability of Advanced Therapy Medicinal Products and a parallelism between the Swedish and the Italian National Health Systems: a Financial Model Applied to the Italian and Swedish N

Abstract: In this thesis the economic sustainability of Advanced Therapy Medicinal Products (ATMPs), a class of innovative drugs composed of somatic cell therapies, gene therapeutics and tissue engineered products, is investigated. These drugs cure rare and often mortal diseases (which are currently cured with palliative or only partially working care), with a one-shot treatment. However, giving their expensiveness (average price ranging around 500,000 with peaks of over 2,000,000), a problem of overall sustainability for the public health systems arises - especially considering the expected increase in the potentially targetable population, due to the expected rising of both available ATMPs and targetable population of currently available ATMPs (as demonstrated through an empirical regression analysis). When going through the literature review phase, an in-depth analysis of the Italian and Swedish National Health Systems is conducted and many parallelisms are found between the two national organs, not only with reference to the functioning of these public systems, but specifically to the adoption and the attitude towards ATMPs. it is noticed how, due to the very innovative roots of this field (the first ATMP currently in use was authorised in March 2015), the available material is extremely limited, especially when considering the economic side. For this reason, after an in-depth analysis of the available literature and of the history and functioning of the Italian and Swedish National Health Systems, a new payment scheme is proposed, based on the accountability of ATMPs as intangible assets, also given their evident multiannual economical validity. This innovative payment scheme is applied to the Italian and Swedish National Health Systems case through empirical financial predictive models, based on the comparison of costs due to treating patients with traditional therapies compared with the costs of curing them through ATMPs, throughout the years; in addition, the GDP effect of cured people, gaining in terms of quality of life, is taken into account. The main result obtained is that ATMPs would be sustainable in the long run for the Italian and Swedish National Health Systems only if this new proposed payment scheme is applied. Based on the outcomes of the applied financial model and given the importance of ATMPs on people standards of living, it is advised to partially amend the current Italian and Swedish regulations to make possible the accountability of ATMPs into intangible assets, with the final goal of making them economically sustainable for the two analysed National Health Systems.