ObjectiveTo evaluate the efficacy and cost-effectiveness of thymalfasin (Tα1) as an adjuvant therapy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after surgery.MethodsPatients with HBV-related HCC who underwent hepatectomy from February 2007 to December 2015 in West China Hospital of Sichuan University, Chengdu Military General Hospital, or the Third Affiliated Hospital of Sun Yat-sen University were retrospectively collected and divided into the Tα1 group and the observation group. Log-rank test and Kaplan-Meier curve were used to assess the overall survival, recurrence-free survival, and safety of patients. A Markov model was used to calculate the quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) of the Tα1 group compared with the observation group. Cost data was from the hospital information system of the three hospitals. Utility scores mainly came from published data. Sensitivity analyses were applied to explore the impact of essential variables.ResultsA total of 208 patients with HCC after liver resection were enrolled, among them 48 received Tα1 treatment (the Tα1 group) and 160 were only followed up (the observation group). There was no significant difference between the two groups in the baseline characteristics. The median overall survival of the Tα1 group and the observation group was 102.0 months [95% confidence interval (CI) (74.8, 129.2) months] and 81.6 months [95%CI (65.7, 97.6) months], respectively, and the difference was statisitically significant (P=0.047); the median recurrence-free survival was 66.7 months [95%CI (17.3, 116.1) months] and 37.4 months [95%CI (28.7, 46.2) months], respectively, and the difference was statistically significant (P=0.044). There were no grade Ⅲ-Ⅳ adverse events and no treatment-related death occurred. The ICER of Tα1 group was ¥108 050.02/QALY, which was less than the willingness to pay (¥177 785.25/QALY).ConclusionsTα1, as an adjuvant therapy for HBV-related HCC patients, can improve the prognosis of the patients, and the cost is within the acceptable level in our country, so this strategy is likely to be a cost-effective option compared with the observation group.