Abstract
BACKGROUND: Limited-stage small-cell lung cancer (LS-SCLC) has suboptimal long-term survival despite standard chemoradiotherapy. Durvalumab, an anti-PD-L1 antibody, demonstrated survival benefits in the ADRIATIC Phase III trial, but its cost-effectiveness in China remains uncertain. This study evaluates the economic value of durvalumab as consolidation therapy for LS-SCLC post-chemoradiotherapy. METHODS: A Markov model was constructed using data from the ADRIATIC trial (NCT03703297), simulating three health states: progression-free survival (PFS), progressive disease (PD), and death state, transition probabilities were derived from trial outcomes. A 10-year horizon, 5.0% discount rate, and willingness-to-pay (WTP) thresholds (1-3×per capita gross domestic product (GDP): $12,569.82-$37,709.46/QALY) were applied. All costs were converted to unified currency using the average exchange rate of 1 USD = 7.11 CNY, based on exchange rates from 1 January 2024, to 31 October 2024. RESULTS: The study results demonstrated that while durvalumab provided clinical benefits by extending quality-adjusted life years (QALYs) by 0.44 compared to placebo (2.24 vs. 1.80), its high cost resulted in poor cost-effectiveness within China's healthcare system. The incremental cost reached $108,609.45, yielding an ICER of $245,591.59 per QALY, exceeding China's standard willingness-to-pay thresholds. Sensitivity analyses revealed drug pricing as the most influential factor, where a 30% price reduction could improve the ICER by 30.3%. The negative incremental net monetary benefit (-$107,394.34) further confirmed the economic challenges. These findings suggest that despite its clinical advantages, durvalumab's current pricing makes it economically unviable for routine use in China's LS-SCLC treatment without substantial cost reductions or alternative reimbursement strategies. CONCLUSION: Durvalumab improves survival in LS-SCLC but lacks cost-effectiveness under current pricing in China. Drug costs and health utilities are critical determinants. Policy measures, such as price negotiation, risk-sharing agreements, or subgroup targeting, may enhance affordability. Balancing clinical benefits with economic burden is essential for optimizing durvalumab's role in LS-SCLC management.