Jaehong Kim, Shanshan Wang, Moises Marin, Slaven Sikirica, Mariam Anderson, Jason Shafrin
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引用次数: 0
Abstract
Background: 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.
Objective: To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.
Methods: 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.
Results: 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.
Conclusions: 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.
背景：1型糖尿病（T1D）患者一生中发生共病慢性肾脏疾病（CKD）的风险大于50%。血糖控制可以减少糖尿病相关并发症，减缓慢性肾病的进展。与胰岛素单药治疗相比，在胰岛素治疗中加入sotagliflozin可使T1D患者的A1c降低0.46%。然而，T1D和CKD患者的长期经济价值仍然未知。目的：从美国付款人的角度评估sotagliflozin作为T1D和CKD患者胰岛素附加治疗的成本效益。方法：从美国付款人的角度，对诊断为T1D和合并CKD 3期的个体生成马尔可夫模型。临床和经济结果评估超过30年，包括阻止透析和移植的患者人数、生命年、质量调整生命年（QALY）收益、增量成本、增量成本-效果比（ICER）和净货币收益。通过普遍化，动态定价被纳入解释仿制药进入市场的经济影响。结果：索他列净联合治疗提高了生存率，预期寿命延长1.27年（索他列净组为13.08年，胰岛素单药组为11.81年）。在开始治疗后的前10年，每1000名患者透析和移植利用率分别下降3.06 （99.35 vs 102.41）和1.73 （30.59 vs 32.32）。每位患者的QALYs增加了0.63 (7.70 vs 7.07)，主要是由于终末期前肾脏疾病健康状态的延长(0.59；6.75 vs 6.16)。总成本增加了72,914美元（484,674美元对411,760美元），主要是因为药房成本增加了69,060美元（96,242美元对27,364美元）。ICER为每个QALY 115,677美元，该模型对药房成本最敏感。结论：Sotagliflozin是T1D和CKD患者胰岛素治疗的一种具有成本效益的辅助疗法，提供临床益处，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。
期刊介绍：
JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.
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