Factors associated with renewal outcomes for anti-cancer drugs in China's national reimbursement drug list negotiation: a retrospective observational study.

BACKGROUND: Price negotiation improves access to innovative anti-cancer drugs in China but pressures healthcare funds. Renewal negotiation balances cost and access, with success defined as entering a new two-year agreement after initial term. This study analyzes renewal factors from innovation and price adjustment dimensions. RESEARCH DESIGN AND METHODS: We analyzed 104 anti-cancer drugs (2017-2023) using a multivariate logistic regression model with five prespecified variables from two policy-relevant dimensions (innovation and price adjustment). Adopting Bootstrap validation (1000 resamples) to assess overfitting and estimation stability. Stratified analyses were performed by innovation category. RESULTS: Sixty-eight drugs were renewed. With five variables, EPV was 13.6. Exclusivity and priority review status were positively associated with renewal success from the innovation dimension. Indication expansion showed positive but non-significant association. Initial price reduction and first price reduction showed positive association from the price adjustment dimension. Bootstrap-corrected AUC was 0.856. Stratified analyses showed 52.9% of First-in-class (FIC) drugs renewed without price reduction or indication expansion, whereas non-FIC drugs required these measures. CONCLUSIONS: Exclusivity, priority review status, and price reduction measures are positively associated with renewal success. Stratified analyses suggest that FIC drugs may receive greater policy tolerance, whereas non-FIC drugs appear to require price reductions or indication expansion.