Value-based price corridor for bepirovirsen in chronic hepatitis B: an early health technology assessment in a...

We conducted an early health technology assessment (eHTA) of bepirovirsen, an investigational finite-course therapy for chronic hepatitis B. In China, low-cost generic nucleos(t)ide analogues (NAs) create a demanding comparator environment. The value-based price of a potential functional-cure strategy therefore depends on local comparator prices, threshold selection, cure durability, safety, monitoring requirements, and cured-state utility assumptions.

A lifetime Markov model simulated bepirovirsen 300 mg/week for 24 weeks plus background NAs against comparator-specific standard-of-care options. Chinese cost inputs were valued in 2024 renminbi (RMB) and converted to US dollars using the 2024 annual average exchange rate of 7.1957 RMB per US dollar. The base case used a China-context cost-effectiveness threshold (CET) of $13,500 per quality-adjusted life-year (QALY), approximating China's 2024 gross domestic product (GDP) per capita after currency conversion, and compared it with higher threshold scenarios. Because reliable long-term relapse rates were unavailable, a 48-week maintained-response scenario set bepirovirsen efficacy to 9.0%, corresponding to the B-Clear primary-outcome rate among participants receiving background NA therapy.

Bepirovirsen yielded 0.41-0.82 incremental QALYs across standard-of-care comparators. Compared with entecavir (ETV), the base case generated 0.82 additional QALYs, incurred an incremental total cost of $10,833.72 per patient at the value-based price, and avoided 906 hepatocellular carcinoma (HCC) cases per 10,000 patients. Under the $13,500/QALY threshold, the value-based price per dose ranged from $92.92 to $367.44 across comparators. In the 48-week maintained-response scenario, the value-based price per dose was $70.29 versus ETV and ranged from $28.62 to $294.24 across comparators. The societal-perspective scenario increased the value-based price per dose to $426.41. Model-cohort expected value of perfect information (EVPI) was $0.46 million at the base-case threshold.

Bepirovirsen's value-based price is conditional on comparator prices, CET selection, durability of hepatitis B surface antigen (HBsAg) seroclearance, safety, monitoring needs, and cured-state utility assumptions. These eHTA results are hypothesis-generating and should be interpreted within the limits of phase II-derived efficacy inputs, uncertain relapse pathways, and adverse-event and monitoring costs that cannot yet be estimated reliably.