Kidney Week

Abstract: FR-PO0609

Cost Analysis of Hospitalizations for Vadadustat vs. Darbepoetin Alfa Based on the Phase 3 INNO2VATE Trials

Session Information

• Anemia: Global Burden, Disease Interactions, and Emerging Therapeutic Paradigms
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• 200 Anemia and Iron Metabolism

Authors

• Winkelmayer, Wolfgang C., Baylor College of Medicine, Houston, Texas, United States

Wolfgang C. Winkelmayer, MD, ScD, MPH, FASN

• Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Wenli Luo, MD, PhD

• Burke, Steven K., Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Steven K. Burke, MD

• Foote, Bryce Stephen, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Bryce Stephen Foote, PharmD

• Minga, Todd Eric, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States

Todd Eric Minga, MD

• Benjumea, Darrin W., Genesis Research Group LLC, Hoboken, New Jersey, United States

Darrin W. Benjumea, MPH

• Cinfio, Frank, Genesis Research Group LLC, Hoboken, New Jersey, United States

Frank Cinfio

• Szende, Agota, Genesis Research Group UK Limited, London, England, United Kingdom

Agota Szende, PhD

Background

Vadadustat (VADA) is approved in the US for CKD-related anemia in adults on dialysis for ≥ 3 months. INNO₂VATE phase 3 trials compared VADA to darbepoetin alfa (DA) in patients with anemia who had dialysis-dependent CKD (DD-CKD). In prespecified safety analyses, 50.6% patients in VADA and 53.9% in DA had a serious treatment emergent adverse event (STEAE) that led to a hospitalization.

The objective of this study is to quantify hospitalization and cost differences between patients randomized to VADA and DA in the INNO₂VATE trials in the on-study and on-treatment (OT) populations.

Methods

A cost-comparison model leveraged pooled INNO₂VATE data (VADA N=1947, DA N=1955) to estimate the cost offsets associated with STEAE profiles of VADA versus DA treatment. Trial inputs were STEAE per arm and mean length of stay (LOS) per event by STEAE System Organ Class (SOC). The costing methods used a combination of STEAE-specific average inpatient costs per day from Medicare data for STEAE hospitalizations occurring in >20 patients and a more generic US Renal Data System average per patient hospitalization costs per day in rarer STEAEs; all adjusted to 2025 US dollars.

Results

Annual hospitalization rate was 1.02 events per patient per year (PPPY) on VADA vs 1.10 on DA (p=0.02 by Zero-inflated negative binomial model). Mean LOS was 8.7 (SD 9.8) days on VADA vs 9.5 (SD 12.8) on DA (p<0.001 by Zero-Truncated Poisson model). Estimated PPPY hospitalization cost was $30,171 (VADA) vs $36,355 (DA), a $6,184 offset (17.0%). Largest named-SOC drivers were cardiac disorders ($3,749 PPPY; 43.7% offset), infections ($2,083.26; 19.0%), and respiratory ($936; 33.3%). Extrapolated to the total US VADA eligible population (n=502,101), VADA was associated with ~42,700 fewer hospitalizations per year and a national cost offset of ~$3.10 billion.

The OT analysis yielded directionally consistent results: hospitalization rate 1.06 PPPY (VADA) vs 1.14 (DA); mean LOS 8.3 vs 9.3 days; and PPPY costs of $33,732 vs $38,897, a $5,165 offset (13.3%). US-level annual cost offset was ~$2.59 billion.

Conclusion

Treatment of DD-CKD anemia with VADA was associated with less hospitalizations, shorter LOS, and lower annual per-patient cost compared with DA in both on study and OT populations. Applied at the US national level, these per-patient savings translate to substantial annual cost reductions.

Funding

• Commercial Support – Akebia Therapeutics, Inc.