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Cost-effectiveness of a 3-antigen versus single-antigen vaccine for the prevention of hepatitis B in adults in the United States
Affiliation:1. RTI Health Solutions, 3040 Cornwallis Rd., Durham, NC 27709, United States;2. VBI Vaccines Inc., 160 Second St., Floor 3, Cambridge, MA 02142, United States
Abstract:ObjectivesThe first 3-antigen hepatitis B vaccine was approved by the United States (US) Food and Drug Administration in November 2021 and was recommended by the Centers for Disease Control and Prevention in 2022. We estimated the cost-effectiveness of this 3-antigen vaccine (PreHevbrio™) relative to the single-antigen vaccine, Engerix-BTM, to prevent hepatitis B virus (HBV) infection among US adults.MethodsA cost-effectiveness model was developed using a combined decision-tree and Markov structure to follow 100,000 adults over their remaining lifetimes after vaccination with either the 3-antigen or single-antigen vaccine. Outcomes from societal and healthcare sector perspectives were calculated for adults aged 18–44, 45–64, and ≥65 years; adults with diabetes; and adults with obesity. Seroprotection rates were obtained from the phase 3, head-to-head PROTECT trial (NCT03393754). Incidence, vaccine costs, vaccine adherence rates, direct and indirect costs, utilities, transition probabilities, and mortality were obtained from published sources. Health outcomes and costs (2020 USD) were discounted 3% annually and reported by vaccine and population. One-way sensitivity and scenario analyses were conducted.ResultsIn the model, the 3-antigen vaccine led to fewer HBV infections, complications, and deaths compared with the single-antigen vaccine in all modeled populations due to higher rates and faster onset of seroprotection. Compared with the single-antigen vaccine, the 3-antigen vaccine had better health outcomes, more quality-adjusted life-years (QALYs), and lower costs in adults aged 18–64 years, adults with diabetes, and adults with obesity (dominant strategy). For adults aged ≥65 years, the 3-antigen vaccine was cost-effective compared with the single-antigen vaccine ($26,237/QALY gained) below common willingness-to-pay thresholds ($50,000-$100,000/QALY gained). In sensitivity analyses, results were sensitive to vaccine cost per dose, incidence, and age at vaccination.ConclusionThe recently approved 3-antigen vaccine is a cost-saving or cost-effective intervention for preventing HBV infection and addressing the long-standing burden of hepatitis B among US adults.
Keywords:Cost-effectiveness  Hepatitis B  HBV  Vaccine  3-antigen  Universal vaccination  ACIP"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0040"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Advisory Committee on Immunization Practices  anti-HBc"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0050"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  antibody to hepatitis"  },{"  #name"  :"  hsp"  ,"  $"  :{"  sp"  :"  0.25"  }},{"  #name"  :"  __text__"  ,"  _"  :"  B core antigen  anti-HBe"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0060"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  antibody to hepatitis"  },{"  #name"  :"  hsp"  ,"  $"  :{"  sp"  :"  0.25"  }},{"  #name"  :"  __text__"  ,"  _"  :"  B e antigen  anti-HBs"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0070"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  antibody to hepatitis B surface antigen  CHB"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0080"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  chronic hepatitis"  },{"  #name"  :"  hsp"  ,"  $"  :{"  sp"  :"  0.25"  }},{"  #name"  :"  __text__"  ,"  _"  :"  B virus infection  HBeAg−"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0090"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  hepatitis"  },{"  #name"  :"  hsp"  ,"  $"  :{"  sp"  :"  0.25"  }},{"  #name"  :"  __text__"  ,"  _"  :"  B e antigen negative  HBeAg+"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0100"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  hepatitis"  },{"  #name"  :"  hsp"  ,"  $"  :{"  sp"  :"  0.25"  }},{"  #name"  :"  __text__"  ,"  _"  :"  B e antigen positive  HBsAg"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0110"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  hepatitis B surface antigen  HBV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0120"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  hepatitis B virus  HCC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0130"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  hepatocellular carcinoma  ICER"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0140"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  incremental cost-effectiveness ratio  NA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0150"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  not applicable  NNV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0170"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  number needed to vaccinate  SPR"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0180"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  seroprotection rate
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