most switching to cinacalcet.These findings have US policy implications not only for etelcalcetide and parathyroid hormone but also for future development of innovative therapies in dialysis. Background Calcimimetics, including intravenous etelcalcetide and oral cinacalcet, are often prescribed to hemodialysis patients to prevent complications of elevated parathyroid hormone (PTH) levels. In January 2021, US dialysis reimbursement policy switched from the transitional drug add-on 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 effect 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 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 6 months before versus after etelcalcetide discontinuation, using linear regression adjusted for potential confounders. Results Etelcalcetide use in the United States Dialysis Outcomes and Practice Patterns Study decreased by 58%, from 12% to 5% from July 2020 to 2021; 73% of etelcalcetide discontinuers switched to cinacalcet within 6 months. Comparing the 6 months before versus after etelcalcetide discontinuation, the mean PTH levels increased by 107 (95% CI; 80 to 133) pg/ml, and the prevalence of PTH >600 pg/ml increased by 15% (95% CI; 11% to 19%), from 28% to 43% overall, and increased from 26% to 49% among Black patients. The mean serum calcium and phosphorus levels increased by 0.42 and 0.16 mg/dl, respectively. Conclusions 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 effects 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....

中文翻译：

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将拟钙药纳入终末期肾病集束：过渡药物附加付款调整指定结束后依特卡西肽利用和甲状旁腺激素控制的变化


大多数人改用西那卡塞。这些发现不仅对依特钙肽和甲状旁腺激素具有美国政策影响，而且对透析创新疗法的未来发展也有影响。背景 拟钙药，包括静脉注射依特卡肽和口服西那卡塞，通常用于血液透析患者，以预防甲状旁腺激素 （PTH） 水平升高的并发症。2021 年 1 月，美国透析报销政策从过渡性药物附加付款调整 （TDAPA） 转变为增加捆绑付款，为所有血液透析患者每次增加 10.09 美元，以支付拟钙剂的费用，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化的影响。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。在自匹配纵向设计中，使用针对潜在混杂因素调整的线性回归，评估依特卡肽停药前后 6 个月内患者内平均 PTH 、钙和磷的变化。结果 美国透析结果和实践模式研究 Etelcalcetide 的使用从 2020 年 7 月到 2021 年下降了 58%，从 12% 下降到 5%;73% 的依特卡肽停药剂在 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 pg/ml（95% CI;80 至 133）pg/ml，PTH >600 pg/ml 的患病率增加了 15%（95% CI;11% 至 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了 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，在黑人患者中尤为明显，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，以限制患者获得更有效的治疗，并可能扼杀药物创新。