Abstract

Novel oral hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHi) offer a more convenient therapeutic option over erythropoiesis-stimulating agents (ESAs), which are administered intravenously for the treatment of renal anemia (RA). However, HIF-PHi could result in increased expenditures in an environment of tightening healthcare budgets for US insurers and dialysis centers. This research explores how payers and physicians interact and how reimbursement decisions impact the prescribing and uptake of RA therapies in chronic kidney disease-nondialysis (CKD-ND) and dialysis patients. In February 2016, 100 US nephrologists were surveyed regarding their current and expected prescribing of ESAs, IV iron and future prescribing of HIF-PHi for treating RA. 30 managed care organization pharmacy directors/medical directors were also surveyed. 59% of physicians report pressure from their dialysis units regarding RA treatment. Payers employ a wide range of measures to control access to premium-priced ESAs. 33%-48% of payers quoted prior authorization (PA) as the main control across ESAs. However, PA can be overcome as payers want to ensure that drugs are used according to the FDA label and are prescribed by specialists. 32% of nephrologists reported they would prescribe HIF-PHi over ESAs in CKD-ND due to its less invasive route of administration. Assuming availability, nephrologists expect HIF-PHi to capture approximately 38% of their RA patients. The main market access challenge HIF-PHi will face is likely an anticipated high price compared with ESAs—and thus unfavorable tiering. However, 67% of payers indicate they would place HIF-PHi on tier 1 if priced at a 20% discount to ESAs. Opportunity exists for HIF-PHi, partly due to the intravenous administration of ESAs and increased scrutiny of costs at dialysis centers. Although nephrologists expect to decrease their ESA use following the launch of HIF-PHi, these agents will need to convincingly demonstrate cost-effectiveness to secure optimum reimbursement status.

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