Fewer patients on hemodialysis used etelcalcetide after ESRD payment bundle change
Key takeaways:
- Etelcalcetide use decreased 58% after the transitional drug add-on payment adjustment ended.
- Mean parathyroid hormone levels increased by 107 pg/mL after etelcalcetide discontinuation.
Fewer patients on in-center hemodialysis used etelcalcetide after the transitional drug add-on payment adjustment ended in January 2021, according to an analysis.
As a result of the policy change, many patients switched to cinacalcet, researchers found.
The End-Stage Renal Disease Prospective Payment System bundle has since increased by $10.09 per dialysis session for all patients to cover the expense for calcimimetics, Angelo Karaboyas, PhD, of Arbor Research Collaborative for Health in Ann Arbor, Michigan, and colleagues wrote in the study. As a result, “some dialysis providers may have shifted to alternative strategies to lower [parathyroid hormone] PTH levels, including from etelcalcetide to cinacalcet or active vitamin D, and/or from daily to off-label thrice weekly cinacalcet. This natural real-world experiment provided the opportunity to evaluate the impact on etelcalcetide utilization and [secondary hyperparathyroidism] SHPT control.”
Researchers analyzed data from the United States Dialysis Outcomes and Practice Patterns Study to identify 713 U.S. patients on in-center hemodialysis who stopped using etelcalcetide during the December 2020 to April 2021 policy transition period.
Researchers assessed changes in mean PTH, calcium and phosphorus in the 6 months before vs. after etelcalcetide discontinuation.
Etelcalcetide use among the cohort decreased 58% (from 12% to 5%) between July 2020 and 2021, according to the results. In all, 73% of etelcalcetide users switched to cinacalcet.
Mean parathyroid hormone levels increased by 107 pg/mL (HR = 95%; CI, 80 pg/mL-133 pg/mL) pre- vs. post-stoppage, data showed. The rate of PTH levels greater than 600 pg/mL increased from 28% to 43% (HR = 95%; CI, 11%-19%), with levels in Black patients increasing from 26% to 49%. In addition, researchers found 0.42 mg/dL and 0.16 mg/dL mean serum calcium and phosphorus levels, respectively.
PTH level increases were “swift and sustained,” Karaboyas and colleagues wrote, “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.”
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