The costs and cost-effectiveness of different treatments are increasing concerns in healthcare. Vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), the first new agent approved for the treatment of metastatic non-small cell lung cancer (NSCLC) in more than a decade, was recently approved in the United States. In this report the terminology of cost-effectiveness analysis is reviewed and the findings from a comparative cost-effectiveness analysis of three regimens for NSCLC are discussed. The findings are from a randomized clinical trial of vinorelbine alone versus vinorelbine plus cisplatin versus vindesine plus cisplatin in 612 European patients with NSCLC (J Clin Oncol 12:360-367, 1994) and from cost data from the Medical College of Virginia. In this study the vinorelbine plus cisplatin regimen was the most effective, with a mean survival of 49.6 weeks. Using vinorelbine alone as the baseline, vinorelbine plus cisplatin added 56 days of life at an additional cost of $2,700, resulting in an incremental cost-effectiveness ratio of $17,700 per year of life gained. Similarly, vindesine plus cisplatin added 19 days of life at a cost of $1,150, or $22,100 per year of life gained. Compared with vindesine plus cisplatin, vinorelbine plus cisplatin added 37 days of life at a cost of $1,570, or $15,500 per year of life gained. The cost-effectiveness of the vinorelbine plus cisplatin regimen was within the accepted limits for medical interventions. If vinorelbine is preferred because of its more favorable toxicity profile, adding cisplatin to the treatment regimen substantially increases efficacy at an acceptable cost. The study demonstrated that, compared with other available medical interventions, chemotherapy for NSCLC has acceptable efficacy and cost effectiveness. Access to treatment should not be denied on the basis of clinical or economic grounds.