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Roxadustat for treating anaemia in chronic kidney disease

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1 Recommendations

1.1 Roxadustat is not recommended, within its marketing authorisation, for treating symptomatic anaemia associated with chronic kidney disease in adults.

1.2 This recommendation is not intended to affect treatment with roxadustat that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatment for symptomatic anaemia associated with chronic kidney disease includes erythropoiesis stimulating agents (ESAs). Roxadustat is an alternative to ESAs.

A clinical trial comparing roxadustat with darbepoetin alfa (an ESA) shows that roxadustat works as well as darbepoetin alfa. However, the clinical-effectiveness estimates for roxadustat combined results from this trial and trials comparing roxadustat with placebo. This way of estimating the clinical effectiveness of roxadustat compared with ESAs is inappropriate and means the cost-effectiveness estimates are uncertain. These estimates are also likely to be higher than what NICE normally considers acceptable. So, roxadustat is not recommended.