Efficacy, Safety, and Economic Evaluation of Originator Versus Generic Moxifloxacin Hydrochloride Injection in the Treatment of Community-Acquired Pneumonia Under China's National Centralized Drug Procurement Policy: A Retrospective Study.

PURPOSE: To investigate the efficacy, safety and economic outcomes of moxifloxacin hydrochloride injection in the treatment of community-acquired pneumonia (CAP) under the centralized volume-based procurement policy, and to provide a basis for its rational clinical application. METHODS: Inpatients with CAP who received moxifloxacin hydrochloride injection as initial therapy across 4 tertiary hospitals from January 2019 to March 2024 were retrospectively enrolled and divided into the originator group (Group A) and the NCDP-selected generic group (Group B) based on the drug source. Inverse probability of treatment weighting (IPTW) was applied to balance baseline confounding factors. Efficacy was evaluated by comparing primary and secondary outcomes such as the clinical efficacy and microbial clearance rates; for missing data regarding efficacy outcomes, complete-case analysis and baseline observation carried forward (BOCF) were adopted for sensitivity testing. Concurrently, exploratory subgroup analyses based on different treatment regimens and the concurrent-use period were conducted to evaluate the stability of moxifloxacin's efficacy and control for potential temporal confounding. Safety was assessed based on the incidence of total and specific adverse reactions. Economic evaluation utilized a cost-consequences analysis (CCA), and the robustness of the conclusions was assessed through sensitivity analyses (including a generalized linear model and bootstrap resampling). FINDINGS: Group A and Group B included 414 and 455 patients, respectively. After balancing via IPTW, there were no statistical differences in baseline characteristics between the 2 groups. In terms of efficacy, there were no statistical differences between the 2 groups in the primary and secondary outcomes (P > 0.05). The sensitivity analysis for missing data supported the robustness of the main analysis results. Furthermore, exploratory subgroup analyses showed no statistical differences in efficacy among the treatment regimen subgroups, suggesting that the effect of moxifloxacin is relatively stable. Additionally, the subgroup analysis based on the concurrent-use period indicated that the comparative effectiveness was not significantly affected by calendar time. In terms of safety, no statistically significant differences were observed in the incidence of total and specific adverse reactions between the 2 groups (P > 0.05). Economically, with no statistically significant difference observed clinically, the base-case CCA and sensitivity analyses showed significantly lower average total medical costs in the NCDP-selected group. IMPLICATIONS: Under the centralized procurement policy, the NCDP-selected generic moxifloxacin showed clinical efficacy and safety not significantly different from those of the originator, while being associated with lower total medical costs. These findings require further validation in large‑sample studies.