Parsabiv (etelcalcetide) — Medical Benefit Drug Policy
Defines medical necessity criteria, coding, and authorization requirements for Parsabiv (etelcalcetide) for treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis for UnitedHealthcare members in North Carolina.
Added list of applicable ICD-10 diagnosis codes: E21.1, N18.1, N18.2, N18.30, N18.31, N18.32, N18.4, N18.5, N18.9, and N25.81.
Coverage and Medical Necessity Criteria
Initial Therapy
Covered when ALL of the following are met:
Continuation Therapy
Reauthorization is allowed when ALL of the following are met:
Parsabiv has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or in patients with chronic kidney disease who are not on hemodialysis. Use in these populations is therefore not recommended.
Initiation of Parsabiv requires that the member meet all initial-therapy criteria, including documentation of failure, contraindication, or intolerance to one phosphate binder, one vitamin D analog, and to cinacalcet (Sensipar). Initiation when these prior-treatment requirements are not met does not satisfy coverage criteria. Similarly, Parsabiv should not be started if the patient is receiving concurrent cinacalcet; the policy requires that the patient is not receiving Parsabiv in combination with cinacalcet. Prescribing must be by, or in consultation with, an endocrinologist or nephrologist, dosing must follow the FDA label, and initial authorizations are limited to a maximum of 12 months.
Applicable Codes
| J0606 | Injection, etelcalcetide, 0.1 mg |
| E21.1 | Secondary hyperparathyroidism, not elsewhere classified |
| N18.1 | Chronic kidney disease, stage 1 |
| N18.2 | Chronic kidney disease, stage 2 (mild) |
| N18.30 | Chronic kidney disease, stage 3 unspecified |
| N18.31 | Chronic kidney disease, stage 3a |
| N18.32 | Chronic kidney disease, stage 3b |
| N18.4 | Chronic kidney disease, stage 4 (severe) |
| N18.5 | Chronic kidney disease, stage 5 |
| N18.9 | Chronic kidney disease, unspecified |
| N25.81 | Secondary hyperparathyroidism of renal origin |
Prior Authorization, Documentation, and Step Therapy
Prior Authorization Required
Prior authorization is required. Requests must include documentation of the diagnosis of secondary hyperparathyroidism with chronic kidney disease and evidence that the patient is on dialysis. Include documentation of prior treatment failures, contraindications, or intolerances as specified below.
- Diagnosis: secondary hyperparathyroidism with chronic kidney disease (CKD).
- Dialysis status: documentation that patient is on dialysis.
- Prior therapy: history of failure, contraindication, or intolerance to at least one phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel, etc.).
- Prior therapy: history of failure, contraindication, or intolerance to at least one vitamin D analog (e.g., calcitriol, Hectorol, Zemplar, etc.).
- Prior therapy: history of failure at maximum tolerated dose, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride).
- Treatment limitations: patient must not be receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride).
- Prescriber: prescribed by, or in consultation with, an endocrinologist or nephrologist.
- Dosing: must be in accordance with FDA-approved labeling.
- Authorization duration: initial authorization up to 12 months; reauthorization up to 12 months with documentation of reduction in serum calcium from baseline.
Step Therapy Prerequisites
Initial therapy requires documented prior failure, contraindication, or intolerance to specified agents before Parsabiv will be approved.
- Failure/contraindication/intolerance to at least one phosphate binder.
- Failure/contraindication/intolerance to at least one vitamin D analog.
- Failure at maximum tolerated dose, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride).
Required Documentation
Documentation must be submitted with the prior authorization request to support medical necessity. Incomplete documentation may lead to delay or denial.
- Clinical diagnosis confirming secondary hyperparathyroidism with CKD.
- Evidence the patient is on dialysis (e.g., dialysis records, clinic notes).
- Detailed history of prior treatments showing failure, contraindication, or intolerance for the required phosphate binder and vitamin D analog.
- Documentation of prior failure, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride).
- If requesting continuation, documentation of a reduction in serum calcium from baseline must be provided.
- Prescriber specialty documentation (endocrinologist or nephrologist) or documentation of consultation.
Triggers for Denial
Requests may be denied if required criteria or documentation are not met.
- Patient is not on dialysis.
- Missing documentation of diagnosis, dialysis status, or prior therapy failures/contraindications/intolerances.
- Concurrent use of Parsabiv (etelcalcetide) with Sensipar (cinacalcet hydrochloride).
- Prescriber is not an endocrinologist or nephrologist and no consultation is documented.
- Dosing not consistent with FDA-approved labeling.
Indication and Limitations
Clinical Background
Parsabiv (etelcalcetide) is a calcium‑sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease who are on hemodialysis. Clinical trial data demonstrate reductions in parathyroid hormone compared with placebo, but use is associated with risks such as hypocalcemia and other adverse events; dosing should follow the FDA‑approved labeling.
Policy History / Revision Information
Added applicable ICD-10 diagnosis codes: E21.1, N18.1, N18.2, N18.30, N18.31, N18.32, N18.4, N18.5, N18.9, and N25.81 to the policy.
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.