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Vadadustat (Vafseo; Medice) has been recommended for symptomatic anaemia in adults undergoing dialysis for chronic kidney disease (CKD) by the National Institute for Health and Care Excellence (NICE).
The draft guidance, published on 12 December 2024, said that patients would usually be offered iron, but in cases where iron is not sufficiently effective, erythropoiesis stimulating agents (ESAs) — which stimulate bone marrow to produce more red blood cells — can also be offered.
Vadadustat could be prescribed instead of ESAs because clinical trial evidence shows that it increases haemoglobin levels, the guidance said. Although vadadustat is no more effective than ESAs in raising haemoglobin levels, it tends to cost less than ESAs and, therefore, could be recommended.
Vadadustat is a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor, which acts by stimulating endogenous erythropoietin.
According to the draft guidance, anaemia is common in patients with CKD, which is because erythropoietin is produced by the kidneys in response to low oxygen levels, but production is reduced in people with kidney disease.
Unlike ESAs, vadadustat is taken orally, and the draft guidance says it could be suitable for people “who are unable to take ESAs because of needle phobia or people who are having peritoneal dialysis who are unable to self-inject ESAs”, as well as patients with ESA-resistant anaemia.
Isaac Tseng Chen, renal pharmacist at Oxford University Hospitals NHS Foundation Trust, said: “Roxadustat is licensed as the alternative to ESA for pre-dialysis patients in the UK, but uptake hasn’t been as high as expected. The reasons for this haven’t been extensively explored, but one key point being cost-neutral to ESA.
“Vadadustat is uniquely positioned as it has licensing for dialysis patients, so potentially has a role in managing ESA hyporesponsiveness due to a different mechanism of action.
“Having said that, we need longitudinal safety data to confirm there are no off-target effects (i.e. cardiovascular side effects) due to the specificity of HIF inhibition people are concerned about.
“Overall, [it has] potential utility in a very small prevalent haemodialysis cohort with ESA resistance. But I suspect the drug price and NICE commissioning pathway will play a key role in guiding clinicians’ prescribing practice,” he added.
Alison Railton, head of policy and external affairs at Kidney Research UK, said: “We welcome the decision from NICE to recommend vadadustat as part of a new approach to treating anaemia in people with CKD and receiving dialysis.
“Anaemia can be debilitating and seriously impact quality of life in people with kidney disease.”
The final guidance is due to be published on 22 January 2025.
