CurrentUnitedHealthcarePolicy 2025D0075I

Parsabiv (etelcalcetide) coverage for secondary hyperparathyroidism in CKD

Defines medical necessity and authorization requirements for Parsabiv (etelcalcetide) for patients with secondary hyperparathyroidism related to chronic kidney disease receiving dialysis under UnitedHealthcare Community Plan in NC.

Policy Summary

PayerUnitedHealthcare

PolicyParsabiv (etelcalcetide) coverage for secondary hyperparathyroidism in CKD

Policy CodePolicy 2025D0075I

Change TypeAdded applicable ICD-10 diagnosis codestemplate update

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization demonstrating the patient is on dialysis, meets prior therapy requirements, and is not receiving Parsabiv with cinacalcet.

SourceLink

POLICY UPDATE CHANGES

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.

Added Benefit Considerations to the policy template.

12 monthsmaximum initial or reauthorization duration

on dialysismember clinical status required

no cinacalcetconcomitant therapy exclusion

endo/nephprescriber specialty

Coverage and Medical Necessity Criteria

Initial Therapy / Medical Necessity

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

Initial therapy main criteria: Diagnosis of secondary hyperparathyroidism with chronic kidney disease; patient is on dialysis; patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride); prescribed by or in consultation with an endocrinologist or nephrologist; dosing is in accordance with FDA‑approved labeling; initial authorization will be for no longer than 12 months.

Prior therapy requirements for medical necessity: History of failure, contraindication, or intolerance to one phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel); AND history of failure, contraindication, or intolerance to one vitamin D analog (e.g., calcitriol, Hectorol, Zemplar); AND history of failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride).

These prior therapy requirements are additional required elements for initial medical necessity.

Continuation Therapy

Continuation Therapy - Reauthorization requires ALL of the following:

Policy Summary

PayerUnitedHealthcare

PolicyParsabiv (etelcalcetide) coverage for secondary hyperparathyroidism in CKD

Policy CodePolicy 2025D0075I

Change TypeAdded applicable ICD-10 diagnosis codestemplate update

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization demonstrating the patient is on dialysis, meets prior therapy requirements, and is not receiving Parsabiv with cinacalcet.

SourceLink

On This Page

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Continuation 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 is in accordance with FDA‑approved labeling; reauthorization will be for no longer than 12 months.

Use of Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride) is explicitly excluded. Requests where Parsabiv is being prescribed together with cinacalcet will not meet coverage criteria and are subject to denial.

Requests for Parsabiv are not medically necessary when the patient is not receiving dialysis. For initial therapy, coverage also requires documentation of prior therapy failure, contraindication, or intolerance to one phosphate binder (for example, PhosLo, Fosrenol, Renvela, Renagel), one vitamin D analog (for example, calcitriol, Hectorol, Zemplar), and failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride). If these prior therapy requirements are not met, the request should be considered not medically necessary.

Applicable Codes

Applicable ICD-10 diagnosis codesICD-10

E21.1	Hyperparathyroidism, primary
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

Prescriber and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are limited to 12 months and must meet diagnostic, dialysis status, prescriber specialty, and dosing requirements per FDA labeling.

Initial authorization duration: <= 12 months
Prescriber: endocrinologist or nephrologist (or consultation)
Dosing: per FDA-approved labeling

Documentation Required

Required Documentation for Authorization

Reauthorization is subject to documented clinical benefit and continued eligibility. Continuation/reauthorization is limited to 12 months and requires documentation of reduction in serum calcium from baseline, ongoing dialysis status, appropriate prescriber specialty, and dosing per labeling.

Reauthorization duration: <= 12 months
Required clinical response: documented reduction in serum calcium from baseline
Ongoing criteria: patient remains on dialysis

Step Therapy

Step Therapy / Prior Therapies Required

Prior to approval, members must have failed, had a contraindication to, or been intolerant of required prior therapies: at least one phosphate binder, at least one vitamin D analog, and prior failure/intolerance/contraindication to Sensipar (cinacalcet) or failure of maximum tolerated dosage.

Required prior therapies: 1 phosphate binder
Required prior therapies: 1 vitamin D analog
Required prior therapy: failure/intolerance/contraindication to Sensipar (cinacalcet) or failure of maximum tolerated dose

Denial Risk

Triggers for Denial

Denial may occur if the member is not on dialysis, if Parsabiv is prescribed in combination with Sensipar (cinacalcet), if required prior therapies are not documented as failed/contraindicated/intolerant, if prescriber specialty or dosing per labeling is not documented, or if continuation criteria (e.g., reduction in serum calcium) are not met.

Not on dialysis — not eligible
Combination with cinacalcet (Sensipar) — denial trigger
Missing documentation of prior therapy failures or contraindications — denial trigger
Prescriber not an endocrinologist/nephrologist or lacking consultation — denial trigger
Dosing not consistent with FDA labeling — denial trigger
For continuation: no documented reduction in serum calcium from baseline — denial trigger

Background

Parsabiv (etelcalcetide) is a calcimimetic that binds to and allosterically modulates the calcium-sensing receptor (CaSR) on parathyroid cells, resulting in decreased parathyroid hormone (PTH) secretion. It is indicated for the treatment of secondary hyperparathyroidism in patients receiving hemodialysis and was studied in clinical trials demonstrating reductions in PTH compared with placebo and comparative biochemical results versus cinacalcet. Adverse effects reported with treatment include an increased risk of hypocalcemia and gastrointestinal events.

Definitions and Drug Mechanism

Parsabiv (etelcalcetide) — mechanism (calcimimetic)

Drug classCalcimimetic agent

Molecular targetCalcium-sensing receptor (CaSR) on parathyroid chief cells

Mechanism of actionAllosterically modulates the CaSR; etelcalcetide binds to the CaSR and enhances activation by extracellular calcium, leading to decreased parathyroid hormone (PTH) secretion

Clinical indication (policy context)Treatment of secondary hyperparathyroidism in patients receiving hemodialysis

Key pharmacologic effectReduction of PTH secretion via CaSR activation