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Abstract: TH-PO149

Calcimimetic Reimbursement Changes in 2021: Impact of Etelcalcetide Discontinuation on Parathyroid Hormone (PTH) Levels in US Hemodialysis Patients

Session Information

Category: Bone and Mineral Metabolism

  • 502 Bone and Mineral Metabolism: Clinical

Authors

  • Karaboyas, Angelo, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Zhao, Junhui, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Ma, Junjie, Amgen, Thousand Oaks, California, United States
  • Moore, Carol, Amgen, Thousand Oaks, California, United States
  • Saleem, Najma, Amgen, Thousand Oaks, California, United States
  • Martin, Kevin J., Saint Louis University School of Medicine, Saint Louis, Missouri, United States
  • Sprague, Stuart M., NorthShore University HealthSystem, Evanston, Illinois, United States
  • Pisoni, Ronald L., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
Background

Calcimimetics, including etelcalcetide and cinacalcet, are often prescribed to hemodialysis (HD) patients to prevent complications of elevated parathyroid hormone (PTH) levels. In January 2021, US 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 patients to cover the expense for calcimimetics, whether patients are taking etelcalcetide or not. The impact on calcimimetic prescription practices and mineral and bone disorder (MBD) markers is unknown.

Methods

Data from 23,359 US in-center HD patients were extracted from the prospective Dialysis Outcomes and Practice Patterns Study (DOPPS). Within-patient changes in PTH and other MBD markers in the 6 months before (pre) vs. 6 months after (post) etelcalcetide discontinuation were compared using linear regression among patients who discontinued etelcalcetide between December 2020 to April 2021 – when discontinuation was more likely driven by policy change than patient indication.

Results

From July 2020 to July 2021, etelcalcetide use decreased from 12% to 5% . Among 713 patients who discontinued etelcalcetide between December 2020 and April 2021, the prevalence of PTH >600 pg/mL increased from 28% to 43% overall and from 32% to 50% among Black patients. Mean serum calcium and phosphorus levels increased by 0.42 and 0.16 mg/dL, respectively. Adjusted model results were consistent (Figure).

Conclusion

In the US HD setting, etelcalcetide use decreased substantially following the end of TDAPA designation in January 2021 in spite of the increased bundle payment. We observed a swift and sustained impact on PTH levels, especially among Black patients, raising concerns about disparities and potential downstream impact on clinical outcomes.

Funding

  • Commercial Support – This manuscript was directly supported by Amgen. Global support for the ongoing DOPPS Programs is provided without restriction on publications by a variety of funders. For details see https://www.dopps.org/AboutUs/Support.aspx. As of May 5, 2023, the DOPPS program is supported by Amgen Inc. (since 1996, founding sponsor); Akebia Therapeutics, Inc.; Astellas Pharma Inc.; Bard Peripheral Vascular, Inc.; Baxter Healthcare Corp; Bayer AG & Bayer Yakuhin, Ltd; Cara Therapeutics, Inc.; Chugai Pharmaceutical Co., LTD; GlaxoSmithKline LLC; Japanese Society for Peritoneal Dialysis; JMS Co., Ltd; Kidney Foundation Japan; Kissei Pharmaceutical Co., Ltd; Kyowa Kirin Co., Ltd. (since 1999 for Japan DOPPS); Merck Sharp & Dohme Corp; Nikkiso Co., Ltd.; ONO Pharmaceutical Co., Ltd; Terumo Corporation; Torii Pharmaceutical Co., Ltd; CSL-Vifor, Ltd.