OBJECTIVES

Chronic HDV infection affects on average 34 Swedes per year and is considered the most severe form of viral hepatitis leading to disease progression and death for 60-80% of patients. In anticipation of reimbursement of HEPCLUDEX® (bulevirtid) as the first and only treatment for chronic HDV, this study aimed to assess Incremental Cost-Effectiveness vs. Best Supportive Care (BSC) to support patient access to treatment in Sweden.

METHODS :

A simulation model was developed to characterize the efficiency of HEPCLUDEX® by calculating its Incremental Cost-Utility Ratio (ICUR) compared to the current practices in a lifetime horizon. Other criteria documented by the model were Compensated Cirrhosis (CC), Decompensated Cirrhosis (DC), Hepatocellular Carcinoma (HCC), Liver Transplant (LT), the percentage of living patients and the percentage of Liver-Related Death (LRD) at the end of the simulation.

RESULTS :

HDV patients treated with BSC had an average discounted survival of 14.5 year. Patients spent an average 0.9 years with a decompensated liver disease and 1.1 years with HCC. Accounting for health-related quality of life, this corresponded to 11.05 QALYs. In contrast, HEPCLUDEX® was able to limit disease progression and development of complications, with an improved survival of 16.03 years (+10%). Patients remained longer without cirrhosis, liver decompensation, HCC, and LT. This led to further improvements in terms of quality of life adjusted survival: 12.51 QALYs (+13%) at an extra cost of 1 357 055 SEK over a lifetime horizon, determining an ICER of 926 414 SEK/QALY.

CONCLUSIONS :

HEPCLUDEX® may be considered Cost Effective for an orphan drug in a Swedish setting using a direct healthcare perspective.