Madrigal Pharmaceuticals, Inc, West Conshohocken, PA, USA.
Medicus Economics, LLC., Boston, MA, USA.
J Comp Eff Res. 2024 Dec;13(12):e240096. doi: 10.57264/cer-2024-0096. Epub 2024 Nov 22.
Non-alcoholic steatohepatitis (NASH), or metabolic dysfunction-associated steatohepatitis (MASH), is a severe form of non-alcoholic fatty liver disease (NAFLD) or metabolic dysfunction-associated liver disease (MASLD), that may progress to advanced liver disease. Costs associated with progression are not well characterized. This study sought to quantify costs and healthcare resource utilization (HRU) associated with NASH progression. Patients were included if diagnosed with NASH (ICD-10: K75.81) in 100% Medicare claims data (2015-2021) who were ≥66 years at index (diagnosis), continuously enrolled in Parts A, B and D for ≥12 months prior to and 6 months following index (unless death) and who had no evidence of other causes of liver disease. Patient-time was categorized into five severity states: non-cirrhotic NASH, compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver transplant (LT). Annualized HRU and costs were calculated during the study periods overall and stratified by occurrence and timing of progression. In 14,806 unique patients (n = 12,990 non-cirrhotic NASH; 1899 CC; 997 DCC; 209 HCC; 140 LT), mean age and follow-up were 72.2 and 2.8 years, respectively. Average annualized costs increased from baseline following diagnosis, generally scaling with severity: $16,231 to $27,044; $25,122 to $57,705; $40,613 to $181,036; $36,549 to $165,121 and $35,626 to $108,918 in NASH; CC; DCC; HCC; and LT; respectively. Non-cirrhotic NASH and CC patients with progression had higher follow-up spending (1.6x for NASH; 1.7x for CC) than non-progressors (both p < 0.001), 2.8 and 6.1-times higher odds of an inpatient stay and 2.6 and 3.6-times higher odds to be in the top 20% of spenders, respectively, relative to non-progressors (both p < 0.001). Patients progressing within a year had costs 1.4, 1.6, 1.7 and 2.2-times more than year 2, 3, 4 and 5 progressors' costs, respectively, for non-cirrhotic NASH and 1.3, 1.8, 2.0 and 2.2-times more than year 2, 3, 4 and 5 progressors' costs, respectively, for CC. NASH progression is associated with high costs that increase in more severe disease states. Slower progression is associated with lower costs, suggesting a potential benefit of therapies that may delay or prevent progression.
非酒精性脂肪性肝炎（NASH）或代谢相关脂肪性肝病（MASH），是一种严重的非酒精性脂肪性肝病（NAFLD）或代谢相关肝疾病（MASLD），可能会进展为晚期肝病。与进展相关的成本尚未得到很好的描述。本研究旨在量化 NASH 进展相关的成本和医疗资源利用（HRU）。
如果在 100%的医疗保险索赔数据（2015-2021 年）中诊断为 NASH（ICD-10：K75.81）的患者在索引（诊断）时≥66 岁，并且在索引前至少 12 个月和索引后 6 个月内连续参加 A、B 和 D 部分（除非死亡），且没有其他原因导致肝脏疾病的证据，则纳入患者。患者时间分为五个严重程度状态：非肝硬化性 NASH、代偿性肝硬化（CC）、失代偿性肝硬化（DCC）、肝细胞癌（HCC）和肝移植（LT）。在整个研究期间和根据进展的发生和时间分层，计算了年度 HRU 和成本。
在 14806 名独特的患者（n=12990 例非肝硬化性 NASH；1899 例 CC；997 例 DCC；209 例 HCC；140 例 LT）中，平均年龄和随访时间分别为 72.2 岁和 2.8 年。自诊断后，基线后的平均年度成本增加，通常随严重程度而增加：NASH 为 16231 美元至 27044 美元；CC 为 25122 美元至 57705 美元；DCC 为 40613 美元至 181036 美元；HCC 为 36549 美元至 165121 美元；LT 为 35626 美元至 108918 美元。NASH、CC 和 DCC 患者进展后，随访费用更高（NASH 为 1.6 倍；CC 为 1.7 倍），而非进展者（均 P <0.001），住院的可能性分别高 2.8 倍和 6.1 倍，花费前 20%的可能性分别高 2.6 倍和 3.6 倍，而非进展者（均 P <0.001）。非肝硬化性 NASH 和 CC 患者在一年内进展的患者的费用分别比第 2 年、第 3 年、第 4 年和第 5 年进展的患者高出 1.4 倍、1.6 倍、1.7 倍和 2.2 倍，比第 2 年、第 3 年、第 4 年和第 5 年进展的患者高出 1.3 倍、1.8 倍、2.0 倍和 2.2 倍，CC 患者的费用分别高出 1.4 倍、1.6 倍、1.7 倍和 2.2 倍。NASH 进展与较高的成本相关，在更严重的疾病状态下成本增加。进展较慢与成本较低相关，这表明可能会延迟或预防进展的疗法具有潜在益处。
