Cost-effectiveness and prognostic model of hepatic arterial infusion chemotherapy for hepatocellular carcinoma with high tumor burden and/or Vp4 tumor thrombus compared with sorafenib: a post-hoc analysis of the FOHAIC-1 trial

Abstract

Objectives: The phase III FOHAIC-1 trial revealed that hepatic arterial infusion of chemotherapy (HAIC) improved overall survival compared to sorafenib in the high-risk hepatocellular carcinoma (HCC). This study therefore set out to evaluate the cost-effectiveness and establish a prognostic clinico-radiological score of HAIC. Materials and methods: A total of 409 patients with high-risk HCC who received HAIC between 2014 and 2020 were included. A Markov model was applied in the cost-effectiveness analysis using data from the FOHAIC-1 trial. In prognosis analysis, a clinico-radiological score was developed using a Cox-regression model and subsequently confirmed in the internal validation and test cohorts. The area under the curve from receiver operator characteristic analysis was used to assess the performance of the clinico-radiological score. Results: HAIC resulted in an incremental cost-effectiveness ratio of $10190.41/quality-adjusted life years compared to sorafenib, which was lower than the willingness-to-pay threshold. Probabilistic sensitivity analysis predicted a ≥99.9% probability that the incremental cost-effectiveness ratio was below the willingness-to-pay. The Cox analysis identified five factors, namely extrahepatic metastasis (m), arterial enhancing type (a), tumor number (nu), albumin-bilirubin index (a), and involved lobe (l), which together comprise the clinico-radiological score (HAIC-manual). Patients were classified into three groups based on the number of factors present, with cutoffs at 2 and 4 factors. The stratified median overall survival for these groups were 21.6, 10.0, and 5.9 months, respectively (P<0.001). These findings were verified through internal validation and test cohorts with a significance level of P≤0.01. The time-dependent area under the curve from receiver operator characteristic for the ability of the HAIC-manual to predict survival in 1, 2, and 3 years were 0.71, 0.76, and 0.78, which significantly outperformed existing staging systems. Conclusion: HAIC is a promising and cost-effective strategy for patients with high-risk HCC. The clinico-radiological score may be a simple prognostic tool for predicting HAIC treatment.

Cost-Effectiveness Analysis of Hepatic Arterial Chemotherapy for Advanced Hepatocellular Carcinoma in China: A Comparative Analysis of HAIC-FO and Sorafenib

“…To assess cost-effectiveness, we calculated the incremental cost-effectiveness ratio (ICER), which reflects the additional cost per 1 quality-adjusted life years (QALY). In our primary analysis, a willingness-to-pay (WTP) threshold of $30,492/ QALY was applied using 3 times the GDP per capita [16]. A discount rate of 3% per annum was applied to adjust for inflation, consistent with the pharmacoeconomics guidelines [13].…”

“…Two other studies, based on the IMbrave150 trial, concluded that atezolizumab plus bevacizumab was not a cost-effective first-line option compared with sorafenib in patients with unresectable HCC [19,20]. Previously, Chen et al found HAIC-FO was a cost-effective strategy for patients with high-risk factors (the ICER of HAIC-FO was $10190.41/QALYs, compared with sorafenib) [16]. Consistently, our study showed the costeffectiveness of HAIC-FO vs that of sorafenib in advanced HCC.…”

“…A health state utility of 0.76 was presumed for the PFD state, and a utility of 0.68 was presumed for the PD state, in line with previously published literature [16]. Grade 1-2 minor toxicities were regarded as intrinsic to the cancer state and were APPROVED GALLEY PROOF excluded from the model.…”