Cost-effectiveness of gemifloxacin: results from the GLOBE study.

The cost-effectiveness of treatment with oral gemifloxacin versus oral clarithromycin for acute exacerbations of chronic bronchitis (AECB) was evaluated. Economic outcomes were assessed for the Gemifloxacin Long-term Outcomes in Bronchitis Exacerbations study. This prospective double-blind, controlled, health outcomes study compared health, economic, and clinical outcomes after randomized treatment with either oral gemifloxacin or oral clarithromycin for AECB. Base case analysis was performed from the third-party payer's perspective and considered the costs of respiratory tract infection-related medical care. Analysis from the societal perspective also included costs of lost productivity. Treatment effectiveness was measured as the proportion of patients without recurrence requiring antimicrobial treatment following resolution of the initial AECB. Data sources included the outcomes study itself and standard U.S. cost sources. Compared with clarithromycin, gemifloxacin treatment resulted in significantly more patients without AECB recurrence requiring antimicrobial treatment after 26 weeks (73.8% versus 63.8%, p = 0.024). Fewer patients receiving gemifloxacin were hospitalized (5 of 214 patients versus 14 of 224 patients, p = 0.059), and they had less time off from usual activities (8.3 days versus 10.1 days). The mean direct cost per patient receiving gemifloxacin was $127 less than with clarithromycin ($247 versus $374, respectively); mean total costs (direct plus indirect) per patient were $329 less for patients receiving gemifloxacin ($1413 versus $1742). Gemifloxacin dominated clarithromycin in cost-effectiveness analysis. Bootstrap analysis indicated that the probability of gemifloxacin being both cost saving and more effective than clarithromycin is 88% from a payer's perspective and 84% from the societal perspective. Gemifloxacin was more cost-effective, improving AECB outcomes and producing substantial cost offsets compared with clarithromycin.