“On the basis of the incremental 1-year costs for the medical care of a patient with a pulmonary embolus or deep-vein thrombosis, an estimated $250,000 or so in medical care costs would be averted, resulting in a net cost of fondaparinux treatment of about $2.88 million, or about $1,900 per treated patient, without any lives saved.”
No clinical trial phases assess this information. Likewise, decisions regarding Medicare reimbursement do not “consider the cost or cost-effectiveness of the agent itself or of the strategy into which it is incorporated,” wrote Dr. Goldman and Dr. Ginsberg.
“We recommend that the Food and Drug Administration give serious thought to mandating phase 3.5 trials to document the costs, the effects on quality of life, and the cost-effectiveness of new interventions so as to reach a consensus regarding their worthiness.”
DR. GOLDMAN is executive vice president of Health and Biomedical Sciences and dean of the Faculties of Health Sciences and Medicine at Columbia University, New York. DR. GINSBERG is professor of hematology and thromboembolism at McMaster University, Hamilton, Ont. They reported that they have no financial conflicts.