Effects of US Reimbursement Policy Change for Calcimimetics

Angelo Karaboyas, PhD, and colleagues investigated the effects of a US reimbursement policy change that moved calcimimetic drugs from the transitional drug add-on payment adjustment (TDAPA) to an increased bundled payment.

Calcimimetics, including IV etelcalcetide and oral cinacalcet, are often used by patients undergoing hemodialysis to help prevent complications from elevated parathyroid hormone (PTH) levels. The policy change, which went into effect in January 2021, added $10.09 per hemodialysis session to cover the expense of calcimimetics, regardless of whether patients also receive etelcalcetide.

The study included 713 patients enrolled in the United States Dialysis Outcomes and Practice Patterns Study who received in-center hemodialysis and discontinued etelcalcetide during the TDAPA transition period from December 2020 to April 2021. The researchers used a self-matched longitudinal design and linear regression adjusted for confounders to examine changes in mean PTH, calcium, and phosphorus levels within patients in the 6 months before and after etelcalcetide discontinuation.

Among patients in the United States Dialysis Outcomes and Practice Patterns Study, etelcalcetide use declined by 58%, from 12% to 5% from July 2020 to 2021. Of those who discontinued etelcalcetide, 73% switched to cinacalcet within 6 months.

Mean PTH levels increased by 107 pg/mL (95% CI, 80-133) when the 6 months before discontinuation were compared with the 6 months after discontinuation. Also, the prevalence of PTH .600 pg/mL increased by 15% (95% CI, 11%-19%), from 28% to 43% overall; the prevalence increased from 26% to 49% among Black patients. Mean serum calcium levels increased by 0.42 mg/dL, and mean phosphorus levels increased by 0.16 mg/dL.

In summary, the study revealed that the use of etelcalcetide substantially decreased after the reimbursement policy change, and most patients switched to cinacalcet. Subsequently, PTH levels increased quickly, and the increase was sustained. This increase was especially noticeable among Black patients, suggesting potential disparities and effects on clinical outcomes.

The authors noted that, “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.”

Source: Clinical Journal of the American Society of Nephrology