Management of patients with Bacilli Calmette-Guerin-refractory carcinoma in situ of the urinary bladder: Cost implications of a clinical trial for valrubicin

Objective: This study was undertaken to identify the expected first- and se cond-year clinical costs associated with intravesical valrubicin therapy, u sing a decision analytic model, for patients with Bacilli Calmette-Guerin ( BCG)-refractory carcinoma in situ (CIS) of the urinary bladder. Background: Cancer of the urinary bladder is the fourth most common maligna ncy in men and the sixth most common noncutaneous carcinoma overall. One hi stopathologic stage of bladder cancer is CIS, for which BCG intravesical im munotherapy is the first-line therapy. Radical cystectomy has been recommen ded for patients with CIS who do not respond to or become refractory to the rapy with BCG. Surgery, however, may not be appropriate for all patients, e specially those who are ineligible for the lengthy procedure because of adv anced age or comorbidities and those who prefer alternative nonsurgical man agement. For these groups, intravesical valrubicin therapy is a plausible a lternative. Methods: Models were developed and populated with data from 1 open-label st udy of 90 patients, information from the medical literature, and input from clinical experts. The analysis was conducted from the payor perspective fo r direct costs only. Results: Our data indicate that first- and second-year expected costs for v alrubicin therapy are $19,912 and $23,496, respectively. Expected cost for radical cystectomy was also evaluated, since some patients may have no othe r option if drug therapy fails. Conclusion: Our cost-consequence analysis and clinical data provide decisio n-makers with tools to aid in global budgetary projections of fractional an d total expected health care costs associated with the management of BCG-re fractory CIS of the urinary bladder.