Sustainability of national health services and justice: the case of new DAAs for HCV in Italy

Background - Direct acting antivirals (DAAs) for hepatitis C virus (HCV) have quite changed the therapeutic routine in the last few years. Reported rates of sustained virological response (SVR), exceed 90% in all patients subgroups. Other, even more effective, DAAs combinations are being developed for use in the most difficult to treat and advanced patients, aiming for 100% of SVR in 100% of cases. The perspective is the eradication of HCV and reduction of main complications: liver cirrhosis and hepatocellular carcinoma. Aim and Methodology - Dealing with justice issues related to DAAs for HCV in Italy through the anlysis of available literature and documentation. Results - The ethical principle of beneficence/non maleficence is fulfilled for new DAAs. Otherwise, the principle of justice in a welfare context, like Italian National Health Service (NHS), generally requires “to give everyone his/her own" to feed citizens’ health needs. Anyway, in a setting of restricted access due to DAAs costs, availability and the wait for even better and universally applicable regimens is the crucial knot to deal with from justice perspective, also considering the need for a balance both of NHS expenditure and “inter nosological” fairness (e.g., oncology, neurology, etc.). So, the selection of patients for immediate treatment or deferral entails adherence to established and ethically accountable policies. In Italy, as well as in other countries, the early solution in 2015 was a stratification of patients for prioritization of treatment according a “needs-based” approach, which means allowing IFN-free DAAs treatment in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease, through ‘informed deferral’ policies aimed at saving a really informed consent. Another justice issue is the conflict between the patient’s “right to care” and NHS economic charge due to the prevalence of HCV+ patients ≥ 70 yy (nearly half of overall infected subjects). The question is: given limited resources, why paying DAAs therapy for HCV+ >70yy (with compensated liver disease, including cirrhosis) since life expectancy is similar to that of HCV- (except for decompensated cirrhosis)? Save for clinical benefit, this selection can be justifiable on condition that a punctual social/individual information be provided, also strengthening patient/public involvement. Moreover, a fair access to DAAs necessarily works through a continuous clinical/epidemiological follow-up aimed at preserving the primacy of patient’s clinical benefit in an overall sustainability, also paying attention to different impact of DAAs in different subgroups. Since the update of DAAs evidence, Italian Medicines Agency (AIFA) has identified in March 2017 the new priority reimbursement criteria for the treatment with the new DAAs. The goal is to treat all eligible patients preserving welfare justice and sustainability. Conclusion - Even if the price of new DAAs will be reduced through competition and patent expiration, the phenomenon of high drug costs will go on in the next decades and we need proper tools to face the problems of distributive justice that come with it, starting from a clear declaration of which justice approach is assumed, and consequently, collaboration among all stakeholders.