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Abstract: Off-label prescribing is particularly common in oncology. While it brings abundant benefits to cancer treatment, decisions on off-label prescribing should be made with caution, due to insufficient supporting data, weak safety monitoring system, and increased health care burden. Currently, reimbursement decisions for off-label oncology are based on recommendations from four drug compendia, each of which combines data from clinical trials and/or observational studies and expert opinions. Further enhancements are expected in terms of transparency and consistency of compendia’s methods of data synthesis. While the existing FDA regulations prohibit direct-to-prescriber promotion, with the exception of publication on off-label drug use, considerable leeway may be given to late-stage cancer patients. Clinical Trials for oncology off-label indication should focus on late stage cancer patients beyond first-line therapy and patient sample should have equal representations from academic and community settings. Off-label oncology clinical trials should also provide full information on conflict of interest. Given the high stakes involved in oncology treatment, future policies should strike a balance between innovation and clinical, economic, and humanistic consequences. Keywords: Off-label drug use, cancer, health policy, FDA, healthcare reimbursement.Download Full Article |
