OBJECTIVES: While curative breakthrough therapies for hepatitis C have been recently developed, treatments for chronic hepatitis B (CHB) have progressed slower. We examined the potential health impact and cost-effectiveness of a hypothetical curative CHB immunotherapy compared to current standard of care (SOC) treatment.

METHODS: We developed a lifetime Markov cohort simulation model from a US healthcare sector perspective. CHB patients started in an inactive state where their viral load would be low enough to be eligible for immunotherapy. The SOC cohort received oral anti-viral treatments, tenofovir or entecavir. Patients cycled through a simulated disease progression, which included seroclearance, seroconversion, HBeAg+, HBeAG-, cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant, and death. We used a discount rate of 3%, yearly cycles, half-cycle corrections, and costs adjusted to 2019 US dollars. Clinical, utility, and cost inputs were obtained from published literature. We assumed a cost of $84,000 for the hypothetical immunotherapy drug. We ran one-way sensitivity and probabilistic analyses. We also ran scenario analyses based on the immunotherapy and how it would be used in practice (delayed start, add-on, loss of effectiveness).

RESULTS: In the base case, the immunotherapy arm resulted in 20.60 life-years compared to 20.04 for SOC. This translated to 13.99 and 13.18 quality-adjusted life-years, respectively, for immunotherapy and SOC. Average costs totaled $95,875 and $96,849, respectively, for immunotherapy and SOC, indicating immunotherapy as the dominant strategy. Based on one-way sensitivity analysis, the ICER is most sensitive to the cost of immunotherapy. Nearly half of the probabilistic simulation results suggest this immunotherapy would be cost saving, while 54% indicate it to be more effective and more costly than SOC.

CONCLUSIONS: Our study suggests that a therapy for CHB, which performs like the hypothetical one we modelled, is expected to be cost-effective if not cost saving.