Interventions of Interest:
- roxadustat (AstraZeneca and FibroGen, Inc.)
Anemia is common in patients with CKD and generally becomes more prevalent with decreasing hemoglobin (Hb) levels as CKD progresses from dialysis-independent CKD (DI-CKD) to dialysis-dependent CKD (DD-CKD). Risk factors for CKD include genetic or sociodemographic predisposition, or the presence of diseases that can initiate and worsen kidney disease, such as diabetes and hypertension.
Nearly all patients with DD-CKD, and many patients with advanced stages of DI-CKD, are treated for anemia with erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron if needed. ESAs may be injected in an infusion center, clinic or at home or infused during dialysis and so different regimens may be chosen based on the need for dialysis and/or IV iron, and where dialysis is performed.
The independent appraisal committee determined the evidence is not adequate to demonstrate that roxadustat provides a net health benefit over erythropoiesis-stimulating agents (ESAs); until greater net benefit is proven, value-based pricing would suggest that roxadustat be priced at most at parity with ESAs.
At the policy roundtable, experts emphasized the need for researchers to continue to gather comparative data across more ethnically and racially diverse patient subgroups.
“Roxadustat represents an oral alternative for patients living with anemia from CKD, and as such, it may offer important advantages for those not receiving in-center hemodialysis. However, given prior concerns around cardiovascular risks when ESAs are used to correct anemia, as well as the high baseline risk of cardiovascular events in people with CKD, the effect of roxadustat on cardiovascular events and all-cause mortality is of particular concern. The drug maker has conducted multiple trials examining this issue, but although these trials ended several years ago, the company has not yet made public a number of analyses that we feel are necessary to answer several key questions. This leaves large uncertainties about the balance of risks and benefits of roxadustat, and the votes of the CTAF panel confirmed these concerns.”