Kim Jaehong, Wang Shanshan, Marin Moises, Sikirica Slaven, Anderson Mariam, Shafrin Jason
FTI Consulting, Center for Healthcare Economics and Policy, Los Angeles, CA.
FTI Consulting, Center for Healthcare Economics and Policy, Washington, DC.
J Manag Care Spec Pharm. 2025 Jul;31(7):641-650. doi: 10.18553/jmcp.2025.31.7.641.
Patients with type 1 diabetes (T1D) have a greater than 50% lifetime risk of developing comorbid chronic kidney disease (CKD). Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46% compared with insulin monotherapy in patients with T1D. However, the long-term economic value for patients with both T1D and CKD remains unknown.
To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.
A Markov model was generated for individuals diagnosed with both T1D and comorbid CKD stage 3 from a US payer's perspective. Clinical and economic outcomes were assessed over 30 years and included number of patients prevented from dialysis and transplantation, life-years, quality-adjusted life-year (QALY) gains, incremental costs, incremental cost-effectiveness ratio (ICER), and net monetary benefit. Dynamic pricing, through genericization, was incorporated to account for the economic impacts of market entry by generics.
Sotagliflozin add-on therapy improved survival, extending life expectancy by 1.27 years (13.08 with sotagliflozin vs 11.81 with insulin monotherapy). During the first 10 years after treatment initiation, dialysis and transplant utilization decreased by 3.06 (99.35 vs 102.41) and 1.73 (30.59 vs 32.32) per 1,000 patients, respectively. QALYs per patient increased by 0.63 (7.70 vs 7.07), largely driven by prolonged time in pre-end-stage renal disease health states (0.59; 6.75 vs 6.16). Total costs rose by $72,914 ($484,674 vs $411,760), primarily because of pharmacy costs increasing by $69,060 ($96,242 vs $27,364). The ICER was $115,677 per QALY and the model was most sensitive to pharmacy costs.
Sotagliflozin is a cost-effective adjunct to insulin therapy for T1D and CKD patients, providing clinical benefits and falling below the $150,000/QALY willingness-to-pay threshold in 59% of probabilistic sensitivity analysis simulations.
1型糖尿病（T1D）患者一生中发生合并慢性肾脏病（CKD）的风险超过50%。血糖控制可减少糖尿病相关并发症并减缓CKD进展。在T1D患者中，与胰岛素单药治疗相比，在胰岛素治疗基础上加用索格列净可使糖化血红蛋白（A1c）降低0.46%。然而，T1D和CKD患者的长期经济价值仍不明确。
从美国医保支付方的角度评估索格列净作为T1D和CKD患者胰岛素治疗附加药物的成本效益。
从美国医保支付方的角度为诊断为T1D且合并CKD 3期的个体建立马尔可夫模型。对30年的临床和经济结果进行评估，包括避免透析和移植的患者数量、生命年、质量调整生命年（QALY）增益、增量成本、增量成本效益比（ICER）和净货币效益。纳入动态定价（通过仿制药替代）以考虑仿制药进入市场的经济影响。
索格列净附加治疗改善了生存率，预期寿命延长了1.27年（索格列净治疗组为13.08年，胰岛素单药治疗组为11.81年）。在开始治疗后的前10年，每1000例患者的透析和移植使用率分别下降了3.06（99.35对102.41）和1.73（30.59对32.32）。每位患者的QALY增加了0.63（7.70对7.07），这主要是由于终末期肾病前期健康状态的时间延长所致（0.59；6.75对6.16）。总成本增加了72,914美元（484,674美元对411,760美元），主要原因是药房成本增加了69,060美元（96,242美元对27,364美元）。ICER为每QALY 115,677美元，该模型对药房成本最为敏感。
索格列净是T1D和CKD患者胰岛素治疗的一种具有成本效益的辅助药物，具有临床益处，并且在59%的概率敏感性分析模拟中低于150,000美元/QALY的支付意愿阈值。
