Abstract: TH-PO0976
Reductions in Etelcalcetide Use After Withdrawal of the Transitional Drug Add-On Payment Adjustment
Session Information
- Diversity and Equity in Kidney Health
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diversity and Equity in Kidney Health
- 900 Diversity and Equity in Kidney Health
Authors
- Caldwell, Jillian, Stanford University School of Medicine, Stanford, California, United States
- Chertow, Glenn M., Stanford University School of Medicine, Stanford, California, United States
- Cheng, Xingxing S., Stanford University School of Medicine, Stanford, California, United States
- Lin, Eugene, University of Southern California Keck School of Medicine, Los Angeles, California, United States
Background
Etelcalcetide, an intravenous calcimimetic, was approved by the FDA in 2017 for management of secondary hyperparathyroidism in patients receiving dialysis. In response, the Centers for Medicare & Medicaid Services (CMS) transitioned calcimimetic reimbursement from Part D to Part B through the Transitional Drug Add-on Payment Adjustment (TDAPA), which provided add-on fee-for-service payments from 2018 to 2020. After TDAPA ended, payment for etelcalcetide was folded into the dialysis bundled rate. Although etelcalcetide use declined post-TDAPA, it is unclear whether the extent of reductions differed by patient characteristics.
Methods
We analyzed claims from adult Medicare Fee-for-Service beneficiaries undergoing dialysis between January 1, 2019 and December 31, 2021 using the US Renal Data System. We estimated the probability of receiving etelcalcetide in each quarter using linear probability models with person- and time-fixed effects. Univariate interaction models tested whether changes post-TDAPA varied by patient and facility characteristics.
Results
Among 402,766 patients and 2,743,400 patient-quarters, 57% were male, 42% white, 35% Black, 4% Asian, 3% other race, and 15% Hispanic, with a median age of 66 years [25%, 75% range 55–74]. Following the end of TDAPA, etelcalcetide use declined by 3.4 percentage points [95% CI, –3.5 to –3.3]. Larger declines were observed among women, Black patients, patients under age 45, with vintage >5 years, those treated with in-center hemodialysis, dialyzing at for-profit facilities, and/or receiving full low-income subsidies. Patients in the Northeast experienced more pronounced reductions than patients in the Midwest, South, or West.
Conclusion
Following TDAPA, etelcalcetide prescriptions declined, particularly among clinically and socially vulnerable subgroups. Monitoring of payment reforms should ensure that unintended consequences do not jeopardize equitable access to medications.
Funding
- NIDDK Support