Early Diagnosis and Timely Terlipressin in Hepatorenal Syndrome Improves Projected Outcomes and Lowers Cost.

Introduction: Terlipressin is the only Food and Drug Administration-approved medication for adults with hepatorenal syndrome-acute kidney injury (HRS-AKI) with rapid reduction in kidney function. Treatment with terlipressin, particularly in patients with lower serum creatinine (SCr) at diagnosis, improves outcomes. Despite evidence suggesting that treating HRS-AKI at lower SCr thresholds may improve clinical outcomes, the impact on healthcare resource utilization (HCRU) and medical costs of an earlier intervention strategy remains unquantified. This model-based analysis was conducted from a United States hospital perspective to project the clinical and economic impact of early HRS-AKI diagnosis and treatment with terlipressin among adults. Methods: A decision-analytic model compared two SCr level-based scenarios and projected the outcomes for both scenarios. For current clinical practice, patient distribution was based on the CONFIRM trial (SCr <3 mg/dL: 45% and ≥3 to <5 mg/dL: 55%). For early diagnosis and treatment, distribution was based on the HRS medical chart review study (<3 mg/dL: 85% and ≥3 to <5 mg/dL: 15%). Terlipressin HRS reversal rate for the on-label population (SCr <5 mg/dL and acute-on-chronic liver failure grade 0-2) was 52.2% for SCr <3 mg/dL and 33.3% for SCr ≥3 to <5 mg/dL. An annual HRS incidence of 50,000 was assumed. Results: Based on the modeled projections, early diagnosis and treatment with terlipressin versus current practice yielded an additional 3040 HRS reversals and consequently led to a reduction in hospital days and intensive care unit days. Early intervention resulted in 960 fewer patients requiring renal replacement therapy during hospitalization and 1200 more patients with 90-day transplant-free survival. Early intervention is projected to save $11,504 per patient, with total national savings of $460.2 million annually. Conclusion: Based on the modeled projections using data from clinical trial, earlier HRS diagnosis and treatment with terlipressin may improve clinical outcomes, reduce HCRU, and save costs versus current clinical practice.