BACKGROUND

1. Cost-Effectiveness Analysis of Point-of-Care versus Standard of Care Tests for Hepatitis B in Asian and Pacific Islanders in San Diego County Lillian Nguyen, BS1, Binh Tran, PharmD2, John Fontanesi, PhD3, Robert Gish, MD4  1Skaggs School of Pharmacy, UCSD, La Jolla, USA; 2Asian Pacific Health Foundation, San Diego, USA; 3Center for Management Science in Health, UCSD, San Diego, USA; 4Robert G. Gish Consultants LLC, La Jolla, USA RESULTS BACKGROUND Table 1: Subject Demographics at Community and Clinic Settings • A total of 834 patients were screened for the presence of HBsAg , anti-HBc, and anti-HBs via standard venipuncture and on-site POC tests at both community and clinic settings between October 2012 and September 2013. • At the community settings, a total of 621 patients were screened comprising of 59% females and 41% males averaging 56 years of age. The majority of the patients were Asian (n= 572, 92%). • At the clinic settings, a total of 213 patients were screened comprising of 67% females and 32% males averaging 53 years of age. The majority of the patients were Asian (n= 130, 61%). • Sensitivity analysis established the outcomes were most sensitive to personnel costs and SOC and POC test costs. • The direct cost to screen a patient via SOC testing in the community setting was $19.64 compared to $25.29 in the clinic setting; while POC testing in the community setting was $12.48 compared to $15.93 in the clinic setting. • An estimated 350 million people are living with chronic hepatitis B worldwide with 2 million people living in the United States1. • Hepatitis B has the biggest impact on Asian and Pacific Islanders (APIs), affecting 1 in 12;and APIs account for more than 50% of Americans living with chronic hepatitis B2. • Approximately 15% to 25 % of APIs develop serious liver damage and liver cancerresulting in the incidence of hepatitis B related liver cancer being the highest and leading cause of cancer deaths in this population2. • Despites these high rates, as many as 2 in 3 Asian Americans are unaware of their infection2. • Traditional standard of care (SOC) testing is expensive and requires time to run the tests leading to delay in patient notification, referrals, and treatment with associated losses to follow up and resulting in higher rates of liver cirrhosis, liver cancer, liver transplant, and death3. • On-site rapid point-of-care (POC) testing for hepatitis B can overcome SOC testing’s challenges and be used as an inexpensive first-line screening. Table 2: Cost of Hepatitis B Screening in Community and Clinic Settings4 OBJECTIVES • To assess the cost-effectiveness of POC testing over SOC testing for hepatitis B in community and clinic settings in Asian and Pacific Islanders living in San Diego County. • To identify the preferred setting for POC testing model. METHODS • Subjects were recruited by the Asian Pacific Health Foundation in San Diego focusing on areas with strong representation of Asian Americans. • Subjects were screened for the presence of HBsAg, anti-HBc, and anti-HBs via standard venipuncture and on-site POC test using the NanoSign kits provided by Bioland. • Inclusion criteria: subjects’ written consent, ≥ 18 years old and capable of giving consent, and able to provide blood samples for screening purposes. • Exclusion: Subjects who lack decision-making capacity and unable to give consent and have a known diagnosis of a bleeding disorder. • Study data was collected and managed using the REDCap (Research Electronic Data Capture) program hosted at UCSD. • Operational analysis was done to record the time required by each personnel to perform a particular activity in the screening process of one patient and to produce process maps and work breakdown structures. • In addition to operational analysis, hourly wages from the United States Bureau of Labor Statistics (USBLS) 4 were used to assess the direct incremental costs. • A non-parametric cost-effectiveness analysis was done to compare POC and SOC tests for hepatitis B in the community and clinic settings. Figure 1: Process Map for SOC and POC Testing at Community Setting Figure 2: Process Map for SOC and POC Testing at Clinic Setting CONCLUSIONS REFERENCES • Chu, D., Yang, J.D., Lok, A.S., et al. Hepatitis B Screening and Vaccination Practices in Asian American Primary Care. Gut Liver. 2013; 4:450-457. • Viral Hepatitis Populations. Centers for Disease Control and Prevention. 2012. http://www.cdc.gov/hepatitis/Populations/api.htm • Shivkumar, S., Peeling, R., Jafari, Y., Joseph, L., Pai, N.P. Rapid point-of-care first-line screening tests for hepatitis B infection: a meta-analysis of diagnostic accuracy (1980-2010). Am J Gastroenterol. 2012; 9:1306-1313. • U.S. Bureau of Labor Statistics. USBLS. http://www.bls.gov/home.htm • POC testing for hepatitis B was more cost effective than SOC testing at both settings. However, the referred setting for POC testing for hepatitis B was in the community. • Our study can be used to build Markov model of the relative costs and benefits, as well as local conditions, of SOC and POC testing for hepatitis B. • Future research will be able to determine reduction in healthcare costs with the following caveats. Demonstration of the value of POC tests for hepatitis B could lead to FDA approval for commercial use and expansion of screening and vaccination efforts along with improved linkage to care for those living with chronic hepatitis B. ACKNOWLEDGEMENTS The authors would like to thank all the patients and their families for their participation; the study team: Julio Gutierrez, Natali Cazarez, Michael Ross, David Rodriguez, John Swing, Ken Saragosa, David Wyles; staffs of the UC San Diego Anti-Viral Research Center (AVRC) and Asian Pacific Health Foundation; and UCSD pharmacy student volunteers.