title: Cost-effectiveness of hepatitis B vaccination using HEPLISAV™ in selected adult populations compared to Engerix-B® vaccine.
abstract: OBJECTIVE
  HEPLISAV™ is an adult hepatitis B vaccine that requires fewer doses over a shorter period of time and elicits higher and earlier seroprotection compared to Engerix-B to reduce the risk of hepatitis B infection. The objective of this analysis was to evaluate the cost-effectiveness of vaccination with HEPLISAV vs. Engerix-B(®) to prevent hepatitis B infection in select populations.
  
  
  METHODS
  Markov models were developed for the following populations: diabetics, patients with chronic or end stage kidney disease, healthcare workers and international travelers to countries with high HBV infection prevalence. Hepatitis B disease progression was modeled using 11 health states: seroprotected, susceptible, acute infection, chronic infection, fulminant hepatic failure, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant, post-transplant care, and death. Seroprotection rates were obtained from two phase 3 clinical trials comparing HEPLISAV with Engerix-B and ranged across various populations from 89-96% for HEPLISAV and 62-81% for Engerix-B. Higher vaccination completion rates were assumed for HEPLISAV compared with Engerix-B given that fewer doses of HEPLISAV are required in a shorter period of time to achieve seroprotection for the evaluated populations. Each cycle length after the first year in the model was 1-year. All future costs and benefits were discounted at 3%. A lifetime analysis and a U.S. payer perspective were used.
  
  
  RESULTS
  HEPLISAV has a favorable cost-effectiveness profile with incremental cost effectiveness ratios <$25,000 across all populations studied. In the patients with chronic or end stage kidney disease, HEPLISAV was the dominant option and was cost-saving compared with Engerix-B. The cost of vaccine, regimen completion rates, and seroprotection rates were the sensitive variables in the models.
  
  
  CONCLUSIONS
  HEPLISAV is a cost-effective option to provide high rates of seroprotection and early seroprotection across a range of populations from health care workers to patients with chronic or end stage kidney disease.
authors.affiliation: Health Economics and Outcomes Research, PriceSpective, 2101 Rosecrans Ave, Suite 5280, El Segundo, CA 90245, United States. rkuan@pricespective.com
authors.forename: Renee Kim
authors.initials: RK
authors.lastname: Kuan
authors.forename: Robert
authors.initials: R
authors.lastname: Janssen
authors.forename: William
authors.initials: W
authors.lastname: Heyward
authors.forename: Sean
authors.initials: S
authors.lastname: Bennett
authors.forename: Robert
authors.initials: R
authors.lastname: Nordyke
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000191:economics / Q000821:virology; D006282:Health Personnel; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000191:economics / Q000821:virology; D008390:Markov Chains; D008875:Middle Aged; D018803:Models, Economic; D008962:Models, Theoretical; D011336:Probability; D051436:Renal Insufficiency, Chronic / Q000191:economics / Q000821:virology; D055815:Young Adult
chemical_list: C075654:Engerix-B; D017325:Hepatitis B Vaccines
keywords: ASR; Anti-HBs; Chronic kidney disease; Cost-effectiveness analysis; Diabetes; End-stage renal disease; FHF‘; HBV; HBsAg; HCC; Hepatitis B; ICER; International travelers; QALY; SPR; Vaccine; age-standardized rate; antibody to hepatitis B surface antigen; fulminant hepatic failure; hepatitis B surface antigen; hepatitis B virus; hepatocellular carcinoma; incremental cost-effectiveness ratio; quality adjusted life-year; seroprotection rate (anti-HBs ≥10 mIU/mL)