title: Economic Analysis and Budget Impact of Tenofovir and Entecavir in the First-Line Treatment of Hepatitis B Virus in Italy.
abstract: BACKGROUND
  Chronic hepatitis B is a common, progressive disease, particularly when viral replication is detected. Oral antivirals can suppress viral replication and prevent or delay the development of cirrhosis and liver-related complications. The treatments of chronic hepatitis B cannot totally cure the disease but can prevent its progression to hepatocellular carcinoma, decreasing the levels of both morbidity and mortality. To date, there are several therapies indicated by the international guidelines as first-line treatments for the management of hepatitis B; two of the most effective are those based on either tenofovir or entecavir.
  
  
  OBJECTIVE
  The aim of this study is to evaluate the cost-effectiveness of tenofovir and entecavir in the treatment of naïve patients with chronic hepatitis B. The two treatments are compared with the "no treatment" and to one another.
  
  
  METHODS
  The cost-effectiveness analysis was conducted using a Markov model; patients entered one of the following health states: chronic hepatitis, cirrhosis (compensated or decompensated), hepatocellular carcinoma, liver transplantation or death. The analysis was carried out from the perspective of the Italian National Health Service by considering a life-time horizon with cycles lasting 1 year and with costs and QALYs (quality-adjusted life years) discounted at a rate of 3.5%. The results of the model were analysed in terms of incremental cost-effectiveness ratio (ICER).
  
  
  RESULTS
  ICERs for tenofovir and entecavir emerging from the comparison versus "no treatment" were equal to €10,274.73 and €16,300.44 per QALY gained, respectively, on the life-time horizon. Tenofovir was dominant in the direct comparison with entecavir, indicating more QALYs and a lower consumption of resources. The Monte Carlo simulation demonstrated that in 97% (tenofovir) and in 85% (entecavir) of the scenarios performed, the cost per QALY fell below the threshold of €30,000/QALY. The budget impact analysis showed savings for tenofovir amounting to 33% compared to entecavir in the first year on treatment and to 31% in following years.
  
  
  CONCLUSIONS
  Entecavir and tenofovir are recommended for the treatment of patients with chronic Hepatitis B in the Italian Health System. In particular, tenofovir appeared to be the more cost-effective drug for the management of chronic hepatitis B virus (HBV) infections. These results could help decision makers and clinicians to address their decision when choosing a first-line treatment for the management of people affected by chronic HBV.
authors.affiliation: Catholic University of Sacred Heart, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Ruggeri
authors.affiliation: Catholic University of Sacred Heart, Rome, Italy. michelebasile@icloud.com.
authors.forename: M
authors.identifier: http://orcid.org/0000-0002-1098-2648
authors.initials: M
authors.lastname: Basile
authors.affiliation: Catholic University of Sacred Heart, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Coretti
authors.affiliation: "Nicolò Cusano" University, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Drago
authors.affiliation: Catholic University of Sacred Heart, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Cicchetti
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D006147:Guanine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D017048:Health Care Costs / Q000706:statistics & numerical data; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008390:Markov Chains; D019057:Quality-Adjusted Life Years; D000068698:Tenofovir / Q000191:economics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir