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Clinicians should follow the principle of shared decision making to ensure that the values of patients with diverse needs and perspectives on risks and benefits of different treatments are at the heart of all treatment decisions
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Clinicians should have decision support tools and invest the time needed for shared decision making given the uncertainty and potential variability in patients’ values about an oral treatment option for anemia in chronic kidney disease
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Given the level of uncertainty about the benefits vs. harms and the long-term effect of using roxadustat compared with ESAs, we strongly suggest a mandate for a registry or other rapid and comprehensive postmarketing assessment
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The manufacturer and researchers should avoid focusing primarily on hemoglobin levels and the need for transfusion. Future research should expand outcomes measured to include patient-relevant outcomes, such as quality of life, functional status, fatigue, overall cardiovascular events, and mortality, in addition to the need for transfusion
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Researchers should conduct real-world comparative studies of roxadustat vs. ESAs that evaluate a broad set of patient subgroups, including ethnic and racially diverse populations and those who are hyporesponsive to ESAs
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Given the mechanism of action for roxadustat, patients were excluded from clinical trials if they had acute coronary syndrome, acute stroke, acute seizure, or thrombotic event within the last 12 weeks. Until further data are gathered, clinicians should consider delaying treatment with roxadustat for patients with this clinical scenario
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Given that the evidence is not adequate to distinguish clinical benefit and that there are more data and years of clinical experience with ESAs, some payers may wish to consider stepping through ESAs if they are substantially lower priced than roxadustat before obtaining coverage for a more expensive option
