title: Budget impact analysis of sofosbuvir-based regimens for the treatment of HIV/HCV-coinfected patients in northern Italy: a multicenter regional simulation.
abstract: OBJECTIVE
  Chronic hepatitis C virus (HCV) is a leading cause of hospitalization and death in populations coinfected with human immunodeficiency virus (HIV). Sofosbuvir (SOF) is a pan-genotypic drug that should be combined with other agents as an oral treatment for HCV. We performed a 5-year horizon budget impact analysis of SOF-based regimens for the management of HIV/HCV-coinfected patients.
  
  
  METHODS
  A multicenter, prospective evaluation was conducted, involving four Italian Infectious Diseases Departments (Galliera, San Martino, Sanremo, and La Spezia). All 1,005 genotype-coinfected patients (30% cirrhotics) under observation were considered (patients in all disease-stages were considered: chronic hepatitis C, cirrhosis, transplant, hepatocellular carcinoma). Disease stage costs per patient were collected; the expected disease progression in the absence of treatment and sustained virological response (SVR) success rate for SOF-based regimens were calculated based on the literature and expert opinion. Drug prices were based on what the National Health Service paid for them. The comparison of "no treatment" disease progression costs versus the economic impact of SOF-based regimens was investigated.
  
  
  RESULTS
  Over the following 5 years, the disease progression scenario resulted in direct costs of approximately €54 million. Assuming an SVR success rate of 90%, average SOF-based regimens cost up to €50,000 per person, resulting in a final cost of more than €56 million, so this option is not economically viable. At the average price of €12,000, SOF-based regimens, expense was €17 million, saving 68%. At this price level, the economic resources invested in treating mild to moderate fibrosis stage patients would be equal to the amount of direct costs of disease management in this stage, resulting in a valid return of investment in the short-term.
  
  
  CONCLUSIONS
  Given the high rates of SVR, in the Italian Healthcare System, SOF-based regimens, price is a determinant and a predictor of the overall cost for the Hepatitis C patient's management. At the average price per therapy of €12,000 over the next 5 years, SOF-based regimens are becoming highly sustainable.
authors.affiliation: Infectious Diseases Unit EO, Ospedali Galliera, Genoa, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cenderello
authors.affiliation: Infectious Diseases Unit, ASL-5 Spezzina, La Spezia, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Artioli
authors.affiliation: Infectious Diseases Unit, A San Martino, IST, Genoa University, Genoa, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Viscoli
authors.affiliation: IT Unit, Ospedali Galliera, Genoa, Italy.
authors.forename: Ambra
authors.initials: A
authors.lastname: Pasa
authors.affiliation: Department of Informatics, Bioengineering, Robotics and System Engineering (DIBRIS), University of Genoa, Genova, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Giacomini
authors.affiliation: Department of Informatics, Bioengineering, Robotics and System Engineering (DIBRIS), University of Genoa, Genova, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Giannini
authors.affiliation: Infectious Diseases Unit, ASL-1 Imperiese, Sanremo, Imperia, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Dentone
authors.affiliation: Infectious Diseases Unit, A San Martino, IST, Genoa University, Genoa, Italy.
authors.forename: Laura Ambra
authors.initials: LA
authors.lastname: Nicolini
authors.affiliation: Infectious Diseases Unit EO, Ospedali Galliera, Genoa, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cassola
authors.affiliation: Infectious Diseases Unit, A San Martino, IST, Genoa University, Genoa, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Di Biagio
keywords: HCV treatment; HIV; HIV/HCV coinfection; budget impact; cirrhosis; sofosbuvir