Reimbursement for dialysis patients on AstraZeneca’s/FibroGen’s roxadustat needs to be untangled such that it can be billed separately and be accompanied by hikes in eventual payment bundles, as reported by Manasi Vaidya, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company.

Vaidya comments: “Clarity on how the US Centers of Medicare and Medicaid (CMS) will cover this new class of drugs with transitional payments before folding them into a reimbursement bundle is currently missing.

“Once incorporated into a payment bundle, after potentially being eligible for transitional payments, the CMS has not stated that the bundle reimbursement rate will be adjusted. Thus, roxadustat’s use by dialysis centers will be challenging, given the expected higher price than currently available anemia treatments.

“Since dialysis units operate on a tight budget, incorporating a new drug at a higher price without corresponding reimbursement hike in the payment bundle would be challenging.”

Roxadustat is a HIF prolyl hydroxylase inhibitor (PHI), and is the first of its drug class to be under FDA review for treating anemia associated with chronic kidney disease. An FDA approval decision is expected on or before its PDUFA date in December. Other HIF PHIs expected to follow roxadustat in terms of approval are Akebia Therapeutics’ vadadustat and GlaxoSmithKline’s daprodustat.