{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T02:50:38Z","timestamp":1788922238597,"version":"build-2803163510"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T00:00:00Z","timestamp":1728345600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000042","name":"Amgen Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000042","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2025,2]]},"abstract":"\n Key Points<\/jats:title>\n \n \n \n After incorporation into the bundle in 2021, etelcalcetide use decreased substantially, reflecting financial incentives to restrict access.<\/jats:p>\n <\/jats:list-item>\n \n Etelcalcetide discontinuers had a swift and sustained increase in parathyroid hormone and loss of secondary hyperparathyroidism control, despite most switching to cinacalcet.<\/jats:p>\n <\/jats:list-item>\n \n These findings have US policy implications not only for etelcalcetide and parathyroid hormone but also for future development of innovative therapies in dialysis.<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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\u2013April 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.2215\/cjn.0000000583","type":"journal-article","created":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T15:00:12Z","timestamp":1728399612000},"page":"218-228","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":6,"title":["Incorporation of Calcimimetics into End-Stage Kidney Disease Bundle"],"prefix":"10.2215","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8846-5360","authenticated-orcid":false,"given":"Angelo","family":"Karaboyas","sequence":"first","affiliation":[{"name":"Arbor Research Collaborative for Health, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junhui","family":"Zhao","sequence":"additional","affiliation":[{"name":"Arbor Research Collaborative for Health, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6249-876X","authenticated-orcid":false,"given":"Junjie","family":"Ma","sequence":"additional","affiliation":[{"name":"Amgen, Inc., Thousand Oaks, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Moore","sequence":"additional","affiliation":[{"name":"Amgen, Inc., Thousand Oaks, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najma","family":"Saleem","sequence":"additional","affiliation":[{"name":"Amgen, Inc., Thousand Oaks, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4907-1255","authenticated-orcid":false,"given":"Kevin J.","family":"Martin","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Saint Louis University School of Medicine, St. Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3330-0179","authenticated-orcid":false,"given":"Stuart M.","family":"Sprague","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Hypertension NorthShore University Health System, Evanston, Illinois"},{"name":"University of Chicago Pritzker School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Smerdon","sequence":"additional","affiliation":[{"name":"Arbor Research Collaborative for Health, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0255-6710","authenticated-orcid":false,"given":"Roberto","family":"Pecoits-Filho","sequence":"additional","affiliation":[{"name":"Arbor Research Collaborative for Health, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald L","family":"Pisoni","sequence":"additional","affiliation":[{"name":"Arbor Research Collaborative for Health, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,10,8]]},"reference":[{"issue":"1","key":"B1-20260423","doi-asserted-by":"crossref","first-page":"98","DOI":"10.2215\/CJN.12941213","article-title":"Recent changes in therapeutic approaches and association with outcomes among patients with secondary hyperparathyroidism on chronic hemodialysis: the DOPPS study","volume":"10","author":"Tentori","year":"2015","journal-title":"Clin J Am Soc Nephrol."},{"issue":"6","key":"B2-20260423","doi-asserted-by":"crossref","first-page":"1938","DOI":"10.1093\/ndt\/gfq304","article-title":"Calcium, phosphorus, PTH and death rates in a large sample of dialysis patients from Latin America. 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Payment Adjustment Designation"],"short-title":[],"issued":{"date-parts":[[2024,10,8]]},"references-count":21,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.2215\/cjn.0000000583","relation":{},"ISSN":["1555-9041","1555-905X"],"issn-type":[{"value":"1555-9041","type":"print"},{"value":"1555-905X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,8]]},"assertion":[{"value":"2024-03-20","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-02","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}