title: Prioritization of high-cost new drugs for HCV: making sustainability ethical.
abstract: Hepatitis C virus (HCV) infection is a major health problem worldwide. Chronic HCV infection may in the long run cause cirrhosis, hepatic decompensation and hepatocellular carcinoma, with an ultimate disease burden of at least 350,000 deaths per year worldwide. The new generation of highly effective direct acting antivirals (DAA) to treat HCV infection brings major promises to infected patients in terms of exceedingly high rates of sustained virological response (SVR) but also of tolerability, allowing even the sickest patients to be treated. Even in the face of the excellent safety and efficacy and wide theoretical applicability of these regimens, their introduction is currently facing cost and access issues denying their use to many patients in need. Health systems in all countries are facing a huge problem of distributive justice, since while they should guarantee individual rights, among which the right to health in its broader sense, therefore not limited to healing, but extended to quality of life, they must also grant equal access to the healthcare resources and keep the distribution system sustainable. In the face of a disease with a relatively unpredictable course, where many but not of all chronically infected will eventually die of liver disease, selective allocation of this costly resource is debatable. In most countries the favorite solution has been a stratification of patients for prioritization of treatment, which means allowing Interferon-free DAA treatment only in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease. In this report, we will perform an ethical assessment addressing the issues linked to access to new therapies, prioritization and eligibility criteria, analyzing the meaning of the term "distributive justice" and the different approaches that can guide us (individualistic libertarianism, social utilitarianism and egalitarianism) on this specific matter. Even if over time the price of new DAA will be reduced through competition and eventual patent expiration, the phenomenon of high drug costs will go on in the next decades and we need adequate tools to face the problems of distributive justice that come with it.
authors.affiliation: Institute of Bioethics and Medical Humanities, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy. dario.sacchini@gmail.com.
authors.forename: L
authors.initials: L
authors.lastname: Craxì
authors.forename: D
authors.initials: D
authors.lastname: Sacchini
authors.forename: P
authors.initials: P
authors.lastname: Refolo
authors.forename: R
authors.initials: R
authors.lastname: Minacori
authors.forename: V
authors.initials: V
authors.lastname: Daloiso
authors.forename: G
authors.initials: G
authors.lastname: Ricci
authors.forename: R
authors.initials: R
authors.lastname: Bruno
authors.forename: C
authors.initials: C
authors.lastname: Cammà
authors.forename: A
authors.initials: A
authors.lastname: Cicchetti
authors.forename: A
authors.initials: A
authors.lastname: Gasbarrini
authors.forename: A G
authors.initials: AG
authors.lastname: Spagnolo
mesh_terms: D000818:Animals; D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000191:economics; D016527:Drug Costs / Q000941:ethics*; D004359:Drug Therapy, Combination; D006292:Health Priorities / Q000191:economics* / Q000941:ethics*; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy* / Q000191:economics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy; D006801:Humans; D016898:Interferon-alpha / Q000191:economics / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000188:drug therapy / Q000191:economics; D011788:Quality of Life
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha