An economic cost analysis of oral ganciclovir prophylaxis for the prevention of CMV disease

Purpose. The study conducted an economic cost analysis of oral ganciclovir prophylaxis in preventing cytomegalovirus (CMV) disease for AIDS patients i n a randomized clinical trial setting. Methods. Data were generated from patient interviews, medical records, and case reports from a multi-center, randomized, double-blind, and placebo-con trolled pharmacoeconomic study appended to a clinical trial. The outcomes w ere measured in monthly cost per patient. Various cost functions were teste d in the context of sample-selection model (SSM) and two-part model (TPM), and were estimated using both the ordinary least squares (OLS) and the boun ded influence estimation (BIE) methods. Results. The use of informal caregiver services did not differ significantl y between patients in the treatment group and those in the placebo group. T he OLS estimates for the ganciclovir prophylaxis arm showed a reduced, but statistically insignificant use of formal care in both outpatient and inpat ient settings. The BIE results for the ganciclovir prophylaxis arm, in cont rast, showed a significant reduction of 27% in hospital cost among hospital users, and 44% among the total sample of AIDS patients. The monthly total cost function also identified a decreasing but insignificant trend due to t he treatment effect. Conclusions. At the methodological level, this study demonstrated the value of employing more rigorous econometric techniques in identifying subtle tr eatment effects on cost outcomes from clinical trial data in the economic a ssessment of medical technologies. At the empirical level, the study conclu ded that beyond its demonstrated efficacy of preventing CVM disease among A IDS patients, ganciclovir prophylaxis did not lead to additional health car e costs, other than the cost of the drug therapy.