Gallegos-Orozco Juan F, O'Leary Jacqueline G, Reddy Kapuluru Gautham, Bindra Jas, Chopra Ishveen, Niewoehner John, Huang Xingyue
University of Utah, Salt Lake City, UT, USA.
University of Texas, Southwestern, Dallas, TX, USA.
Clinicoecon Outcomes Res. 2025 Aug 29;17:615-625. doi: 10.2147/CEOR.S530832. eCollection 2025.
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.
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.
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.
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.
特利加压素是美国食品药品监督管理局批准的唯一用于治疗肾功能迅速减退的肝肾综合征 - 急性肾损伤（HRS - AKI）成人患者的药物。特利加压素治疗，尤其是在诊断时血清肌酐（SCr）较低的患者中，可改善治疗效果。尽管有证据表明在较低的SCr阈值下治疗HRS - AKI可能改善临床结局，但早期干预策略对医疗资源利用（HCRU）和医疗成本的影响仍未量化。本基于模型的分析从美国医院的角度进行，以预测成人早期HRS - AKI诊断和特利加压素治疗的临床和经济影响。
一个决策分析模型比较了两种基于SCr水平的方案，并预测了两种方案的结果。对于当前临床实践，患者分布基于CONFIRM试验（SCr <3 mg/dL：45%，≥3至<5 mg/dL：55%）。对于早期诊断和治疗，分布基于HRS病历审查研究（<3 mg/dL：85%，≥3至<5 mg/dL：15%）。对于标签上规定的人群（SCr <5 mg/dL且急性慢性肝功能衰竭0 - 2级），特利加压素使HRS逆转率在SCr <3 mg/dL时为52.2%，在SCr≥3至<5 mg/dL时为33.3%。假设HRS年发病率为50,000。
基于模型预测，与当前实践相比，特利加压素早期诊断和治疗额外实现了3040例HRS逆转，从而减少了住院天数和重症监护病房天数。早期干预使住院期间需要肾脏替代治疗的患者减少960例，90天无移植存活患者增加1200例。预计早期干预可为每位患者节省11,504美元，全国每年总共节省4.602亿美元。
基于使用临床试验数据的模型预测，与当前临床实践相比，特利加压素早期诊断和治疗HRS可能改善临床结局，减少HCRU并节省成本。
