n payment adjustment (TDAPA) to an increased bundled payment, with $10.09 per session added for all hemodialysis patients to cover the expense for calcimimetics, whether or not patients are administered etelcalcetide. We leveraged this natural experiment to investigate the impact of this policy change. Methods: This analysis included 713 US in-center hemodialysis patients enrolled in the United States Dialysis Outcomes and Practice Patterns Study (US-DOPPS) who discontinued etelcalcetide during the TDAPA transition period (December 2020 – April 2021). Within a self-matched longitudinal design, within-patient changes in mean PTH, calcium, and phosphorus were assessed in the six months pre- vs. post- etelcalcetide discontinuation, using linear regression adjusted for potential confounders. Results: Etelcalcetide use in US-DOPPS decreased 58%, from 12% to 5% from July 2020 to July 2021; 73% of etelcalcetide discontinuers switched to cinacalcet within six months. Comparing the six months pre- vs. post- etelcalcetide discontinuation, mean PTH levels increased by 107 (95% CI: 80, 133) pg/mL, and the prevalence of PTH >600 pg/mL increased by 15% (95% CI: 11%, 19%), from 28% to 43% overall, and increased from 26% to 49% among Black patients. Mean serum calcium and phosphorus levels increased by 0.42 and 0.16 mg/dL, respectively. Conclusion: Etelcalcetide use decreased substantially after TDAPA ended in January 2021, with most patients switching to cinacalcet. The subsequent increase in PTH levels was swift and sustained, and especially pronounced among Black patients, raising concerns about disparities and potential downstream impact on clinical outcomes. Despite the spirit of the policy change, the flat per-treatment increased payment may have inadvertently created a financial incentive to restrict patient access to a more effective therapy, and potentially stifle drug innovation. Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology...

中文翻译：

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将拟钙剂纳入 ESRD 束：TDAPA 指定结束后依替卡塞肽利用和 PTH 控制的变化


n 付款调整 （TDAPA） 到增加的捆绑付款，为所有血液透析患者每次增加 10.09 美元，以支付拟钙药的费用，无论患者是否服用依替卡肽。我们利用这个自然实验来调查这项政策变更的影响。方法： 该分析包括 713 名参加美国透析结果和实践模式研究 （US-DOPPS） 的美国中心血液透析患者，他们在 TDAPA 过渡期（2020 年 12 月至 2021 年 4 月）停用依替卡肽。在自我匹配的纵向设计中，使用针对潜在混杂因素进行调整的线性回归，评估了依特卡肽停药前后 6 个月内患者体内平均 PTH 、钙和磷的变化。结果：从 2020 年 7 月到 2021 年 7 月，US-DOPPS 中依替卡塞肽的使用量下降了 58%，从 12% 下降到 5%;73% 的依替卡肽停药剂在 6 个月内改用西那卡塞。比较依替卡肽停药前后 6 个月，平均 PTH 水平增加了 107 （95% CI： 80， 133） pg/mL，PTH >600 pg/mL 的患病率增加了 15% （95% CI： 11%， 19%），总体从 28% 增加到 43%，黑人患者从 26% 增加到 49%。平均血清钙和磷水平分别增加 0.42 和 0.16 mg/dL。结论：2021 年 1 月 TDAPA 结束后，依特卡塞肽的使用大幅减少，大多数患者改用西那卡塞。随后 PTH 水平的快速和持续增加，在黑人患者中尤其明显，这引发了对差异和对临床结果的潜在下游影响的担忧。 尽管政策变化的精神，但每次治疗的固定增加付款可能无意中产生了一种经济激励，限制患者获得更有效的治疗，并可能扼杀药物创新。版权所有 © 2024 作者。由 Wolters Kluwer Health， Inc. 代表美国肾脏病学会出版...