CurrentColorado Rocky Mountain Health PlansPolicy CSOH2026D0075.D

Parsabiv (etelcalcetide) — Coverage Criteria for Secondary Hyperparathyroidism in CKD on Hemodialysis

Defines medical necessity criteria, prior authorization requirements, and coding for etelcalcetide (Parsabiv) for adult patients with secondary hyperparathyroidism and chronic kidney disease on hemodialysis in Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyParsabiv (etelcalcetide) — Coverage Criteria for Secondary Hyperparathyroidism in CKD on Hemodialysis

Policy CodePolicy CSOH2026D0075.D

Change TypeClarified references (non‑material)

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for J0606 with documentation of dialysis status, prior therapy failures, and required specialist consultation.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information.

Up to 12 moauthorization duration

J0606HCPCS

E21.1, N25.81Primary diagnoses

Ohiogeographic applicability

Coverage and Medical Necessity Criteria

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Initial Therapy

Covered when ALL of the following are met for Initial Therapy:

Initial Therapy criteria: Diagnosis of secondary hyperparathyroidism with chronic kidney disease; patient is on dialysis; history of failure, contraindication, or intolerance to one phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel); history of failure, contraindication, or intolerance to one vitamin D analog (e.g., calcitriol, Hectorol, Zemplar); history of failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride); patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride); prescribed by or in consultation with an endocrinologist or nephrologist; dosing in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no longer than 12 months

All listed conditions must be met.

Continuation Therapy

Reauthorization criteria — Covered when ALL of the following are met for Continuation Therapy:

Continuation Therapy criteria: Documentation of a reduction in serum calcium from baseline; patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride); prescribed by or in consultation with an endocrinologist or nephrologist; dosing in accordance with the United States Food and Drug Administration approved labeling; reauthorization will be for no longer than 12 months

All listed conditions must be met for reauthorization.

Use of Parsabiv is not recommended in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or chronic kidney disease who are not on hemodialysis, as these populations were not studied.

Per policy medical necessity criteria, concomitant use of Parsabiv (etelcalcetide) with cinacalcet (Sensipar) is not permitted and such combination therapy would not meet medical necessity for both initiation and reauthorization.

Coding and Diagnosis References

Applicable HCPCSHCPCSCovered

J0606

Injection, etelcalcetide, 0.1 mg

Diagnosis Codes referencedICD-10

E21.1	Secondary hyperparathyroidism, not elsewhere classified
N25.81	Secondary hyperparathyroidism of renal origin
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

PTH eligibility threshold in trial — inv-07

PTH eligibility threshold (trial)> 500 pg/mL

Trial populationPatients receiving hemodialysis with serum PTH > 500 pg/mL

Treatment duration in trial26 weeks (etelcalcetide administered after each hemodialysis session)

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Parsabiv (J0606). Initial authorization may be approved for up to 12 months when all medical necessity criteria are met. Reauthorization may be approved for up to 12 months when continuation criteria are satisfied.

J0606 - Parsabiv (etelcalcetide)

Step Therapy

Step Therapy Requirements

Step therapy prerequisites apply. Requests must document failure, contraindication, or intolerance to the specified prior therapies (at least one phosphate binder, one vitamin D analog, and prior failure/contraindication/intolerance to or inability to tolerate cinacalcet when specified in clinical criteria).

Documentation Required

Required Documentation

Provider documentation must include the diagnosis of secondary hyperparathyroidism with chronic kidney disease, confirmation that the patient is on dialysis, and a clear prior therapy history demonstrating failure, contraindication, or intolerance to the required prior agents (phosphate binder, vitamin D analog, and prior cinacalcet therapy or reason for not using cinacalcet).

Documented diagnosis: secondary hyperparathyroidism with chronic kidney disease
Dialysis status: must state patient is on dialysis
Prior therapy history: failure, contraindication, or intolerance to required prior agents

Denial Risk

Denial Risk for Incomplete Requests

Requests missing required documentation (diagnosis, dialysis status, or prior therapy failure/contraindication/intolerance) are at risk for denial. Ensure all supporting clinical notes, medication trials, dosing information, and specialist consultation (endocrinologist or nephrologist) are included to avoid administrative denial.

Absence of documented dialysis status may result in denial
Absence of documentation demonstrating failure/contraindication/intolerance to prior therapies may result in denial

Background

Etelcalcetide (Parsabiv) is a calcimimetic that allosterically activates the calcium-sensing receptor (CaSR) to reduce parathyroid hormone (PTH) secretion. It is indicated for secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis and has demonstrated greater PTH reductions versus placebo and comparable efficacy to oral cinacalcet in phase 3 trials, with safety considerations including hypocalcemia and gastrointestinal complaints.

Definitions and Clinical Concepts

Secondary hyperparathyroidism (of renal origin) — inv-13

DefinitionElevated parathyroid hormone (PTH) in patients with chronic kidney disease (CKD) related to altered mineral metabolism (secondary hyperparathyroidism of renal origin).

Mechanism relevant to treatmentCalcimimetics (e.g., etelcalcetide) allosterically activate the calcium-sensing receptor (CaSR) on parathyroid cells to decrease PTH secretion.

Indication for etelcalcetideParsabiv (etelcalcetide) is indicated for secondary hyperparathyroidism in adult patients with CKD on hemodialysis.

Treatment alternativesOther options include oral cinacalcet, vitamin D analogs, phosphate binders, and parathyroidectomy for refractory cases.