Background

Secondary hyperparathyroidism (sHPT) is a common and clinically meaningful complication of chronic kidney disease (CKD), particularly among individuals receiving long‑term hemodialysis. As kidney function declines, impaired phosphate excretion and reduced synthesis of active vitamin D (calcitriol) disrupt normal mineral homeostasis. These disturbances lead to hypocalcemia, hyperphosphatemia, and decreased vitamin D activity, all of which stimulate the parathyroid glands and drive persistent elevations in parathyroid hormone (PTH). Chronic PTH elevation contributes to the broader syndrome known as CKD‑mineral and bone disorder (CKD‑MBD), which includes abnormalities in bone turnover, mineralization, linear growth, and vascular or soft‑tissue calcification. Clinically, uncontrolled sHPT is associated with fracture risk, bone pain, cardiovascular morbidity, hospitalization, and reduced quality of life in dialysis populations.

Parsabiv™ (etelcalcetide) is an intravenous calcimimetic agent designed to directly activate the calcium‑sensing receptor (CaSR) on parathyroid cells, thereby reducing PTH secretion. Administered thrice weekly at the end of hemodialysis sessions, Parsabiv provides a clinic‑controlled, non‑oral treatment option that can improve adherence and reduce pill burden. The medication is FDA‑approved for the treatment of secondary hyperparathyroidism in adults with CKD who require maintenance hemodialysis.

Clinical trials have demonstrated that Parsabiv produces significant and sustained reductions in PTH, as well as improvements in serum phosphorus and the calcium‑phosphate product (Ca×P). These biochemical improvements are important targets in CKD‑MBD management and may help mitigate long‑term complications related to vascular calcification and bone disease.

Common adverse effects of etelcalcetide include hypocalcemia, muscle spasms, nausea, and diarrhea, with hypocalcemia being the most clinically relevant and requiring regular monitoring. Because the drug is administered intravenously by dialysis staff, clinicians can more reliably titrate therapy, ensure adherence, and monitor for adverse events.

Parsabiv is a particularly valuable option for patients who:

• Have difficulty achieving adequate biochemical control with oral calcimimetics (e.g., cinacalcet)
• Experience gastrointestinal intolerance or nonadherence to daily oral medication
• Require a more predictable, dialysis‑center–based approach to therapy
• Have persistent elevations in PTH despite optimized vitamin D analog therapy and phosphate management

Overall, Parsabiv represents an important addition to the therapeutic landscape for managing sHPT in hemodialysis patients, offering effective biochemical control with a mode of administration that can enhance treatment consistency and reduce the complexity of medication regimens.

Description 
Parsabiv is a calcium-sensing receptor agonist indicated for:

• Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.¹

Policy  
Parsabiv (etelcalcetide) is considered MEDICALLY NECESSARY when ALL of the following are met:

1. The patient has a diagnosis of secondary hyperparathyroidism (sHPT) with chronic kidney disease (CKD) AND
2. The patient is currently receiving maintenance  hemodialysis AND
3. The patient’s  corrected serum calcium level is  ≥ 8.4 mg/dL prior to initiating therapy AND
4. The patient has a pre-treatment or current intact PTH (iPTH) level ≥ 300 pg/mL AND
5. The patient does not have any one of the following contraindicating conditions:
   • Parathyroid carcinoma, OR
   • Primary hyperparathyroidism AND
6. At least ONE of the following must be documented:
   • The patient’s medication history includes previous use of a prerequisite agent (Sensipar [cinacalcet] and had an inadequate response to treatment (inadequate reduction in IPTH) OR
   • The patient has documented intolerance, FDA-labeled contraindication, or developed hypocalcemia from treatment with cinacalcet or other conventional therapies.

Any other use of Parsabiv (etelcalcetide) is investigational and/or unproven and therefore is considered NOT MEDICALLY NECESSARY. 

Dosage Forms and Strengths  

• Injection: 2.5 mg/0.5 mL solution in a single-dose vial
• Injection: 5 mg/mL solution in a single-dose vial 
• Injection: 10 mg/2 mL solution in a single-dose vial

Dosage and Administration

• Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, dose increase, or re-initiation of therapy
• The recommended starting dose of Parsabiv (etelcalcetide) is 5 mg, administered by intravenous bolus injection three times per week at the end of each hemodialysis session.The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The dose range is 2.5 to 15 mg three times per week.
• The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every four weeks.
• Measure serum calcium within one week after initiation or dose adjustment and every four weeks for maintenance.
• Measure PTH after four weeks from initiation or dose adjustment.
• Decrease or temporarily discontinue PARSABIV in individuals with PTH levels below the target range. 
• Consider decreasing or temporarily discontinuing PARSABIV or use concomitant therapies to increase corrected serum calcium in patients with a corrected serum calcium below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia.  
• Stop PARSABIV and treat hypocalcemia if the corrected serum calcium falls below 7.5 mg/dL or patients report symptoms of hypocalcemia. 
• Do not mix or dilute prior to administration.  
• Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of the hemodialysis treatment during rinse back or intravenously after rinse back.  

Evidence Summary

Randomized clinical trials demonstrate that etelcalcetide significantly reduces intact parathyroid hormone (iPTH) compared with cinacalcet in adults on hemodialysis with secondary hyperparathyroidism, with 68.2 % achieving ≥ 30% PTH reduction over 27 weeks.  Additional trials—including the DUET study and subsequent real‑world observational cohorts—show consistent biochemical response, durable PTH suppression, and improved tolerability in patients transitioning from oral calcimimetics.  These findings support the continued use of Parsabiv as an effective, guideline‑concordant therapy for secondary hyperparathyroidism in the hemodialysis population.

Reference 

1. Parsabiv prescribing information--------. Amgen. April 2017
2. Amgen Inc. (2025). Parsabiv (etelcalcetide) injection: Prescribing information. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/parsabiv/parsabiv_pi.pdf
3. Block GA, Bushinsky DA, Cheng S, et al. “Effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: A randomized clinical trial.” JAMA. 2017;317(2):156–164.
4. Itano Y, Kato S, Tsuboi M, et al. “A prospective, randomized clinical trial of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism (the DUET Trial).” Kidney Int Rep. 2020;5(12):2168‑2177.
5. Amood A, Al Omari AJB, Fouda T, et al. “Efficacy and safety of using etelcalcetide for controlling secondary hyperparathyroidism in hemodialysis patients.” BMJ Open Quality. 2025;14(Suppl 2):A4.
6. Moreno Guzmán F, Esteve Simó V, et al. “Etelcalcetide in hemodialysis: Better SHPT control and gastrointestinal tolerance in clinical practice.” AUN. 2023.

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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