| Coverage Policy Manual | |
| Policy #: | 2017025 |
| Category: | Pharmacy |
| Initiated: | July 2017 |
| Last Review: | December 2023 |
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| Etelcalcetide | |
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| Description: |
Etelcalcetide is a calcium-sensing receptor agonist that binds to the calcium-sensing receptor (CaSR) enhancing activation of the receptor by extracellular calcium on parathyroid chief cells which decreases PTH secretion. This drug is specifically indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of etelcalcetide in the treatment of hyperparathyroidism or any other condition does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered.
For members with benefits without primary coverage criteria, the use of etelcalcetide in the treatment of hyperparathyroidism or any other condition is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Two parallel randomized trials compared etelcalcetide with placebo in 1023 hemodialysis patients with hyperparathyroidism (mean baseline PTH of approximately 840 pg/mLAn) (Block, 2017a). The primary endpoint of both studies was the proportion of patients achieving greater than 30 percent reduction from baseline in PTH during the Efficacy Assessment Phase (EAP), defined as weeks 20 through 27. Secondary endpoints included the proportion of patients with PTH less than or equal to 300 pg/mL during the EAP; and percent reductions in PTH, albumin-adjusted calcium (cCa), phosphate (P) and cCa x P during the EAP. The two studies demonstrated: a) greater than 30 percent reduction from baseline in PTH during the EAP: 77% versus 11% in Study 1, and 79% versus 11% in Study 2 and b) PTH levels of 300 pg/mL or less during the EAP: 52% versus 6% in Study 1, and 56% versus 5% in Study 2. Etelcalcetide was more effective than placebo in reducing PTH (with 74 to 75 percent of patients achieving >30 percent reduction in PTH versus 8.3 to 9.6 percent in placebo) by 27 weeks. However etelcalcetide-treated patients had more side effects compared with placebo (hypocalcemia, muscle spasms, nausea and vomiting).
Another randomized trial compared IV etelcalcetide versus oral placebo (n = 340) and oral cinacalcet versus IV placebo (n = 343) among hemodialysis patients with hyperparathyroidism (block, 2017b). Etelcalcetide was superior to cinacalcet in reducing PTH by greater than 30 percent (68.2 in etelcalcetide groups versus 57.7 percent in cinacalcet group). In addition, treatment with etelcalcetide led to greater reductions in fibroblast growth factor 23 (FGF23) compared with cinacalcet.
Hypocalcemia was more common in the etelcalcetide group and required interventions to increase serum calcium concentrations (such as raising the dialysate calcium concentrations and prescribing calcium-containing phosphate binders, oral calcium supplements, calcitriol, and active vitamin D analogs). Etelcalcetide administration led to prolongation of corrected QT intervals in many patients. Interventions that increase serum calcium concentrations could lead to positive calcium balance and worse cardiovascular outcomes; prolongation of corrected QT intervals caused by etelcalcetide could increase the risk of sudden death. Longer-term studies are needed to evaluate the effects of etelcalcetide on cardiovascular events and mortality.
2018 Update
A literature search conducted through December 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Block GA, Bushinsky DA, Cheng S, et al.(2017) Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA 2017; 317:156. Block GA, Bushinsky DA, Cunningham J, et al.(2017) Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA 2017; 317:146. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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