CurrentUnitedHealthcarePolicy CS2025D0075J

Parsabiv (Etelcalcetide) — Medical Benefit Drug Policy (coverage criteria)

Medical benefit drug policy governing coverage criteria for Parsabiv (etelcalcetide) for adult patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis; applies to UnitedHealthcare Community Plan except where state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyParsabiv (Etelcalcetide) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0075J

Change TypeAdded diagnosis codes

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation that the patient has secondary hyperparathyroidism, is on dialysis, and has required prior therapy trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

Added list of applicable ICD-10 diagnosis codes including E21.1, N18.1, N18.2, N18.30, N18.31, N18.32, N18.4, N18.5, N18.9, and N25.81.

12 monthsmaximum initial approval duration

12 monthsmaximum reauthorization duration

J0606HCPCS

Adults on hemodialysisFDA-indicated population

Coverage Criteria for Parsabiv (etelcalcetide)

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Initial Therapy

Covered when ALL of the following are met:

Diagnosis of secondary hyperparathyroidism with chronic kidney disease

Dialysis requirement: Patient is on dialysis

Prior therapy requirements (all)

Phosphate binder trial: History of failure, contraindication, or intolerance to one phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel, etc.)
Vitamin D analog trial: History of failure, contraindication, or intolerance to one vitamin D analog (e.g., calcitriol, Hectorol, Zemplar, etc.)
Cinacalcet failure or intolerance: History of failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride)

No combination with cinacalcet: Patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride)

Specialist prescriber: Prescribed by, or in consultation with, an endocrinologist or nephrologist

FDA dosing: Dosing is in accordance with the United States Food and Drug Administration approved labeling

Authorization duration: Initial authorization will be for no longer than 12 months

Continuation Therapy

Reauthorization covered when ALL of the following are met:

Response documentation: Documentation of a reduction in serum calcium from baseline

No combination with cinacalcet: Patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride)

Specialist prescriber: Prescribed by, or in consultation with, an endocrinologist or nephrologist

FDA dosing: Dosing is in accordance with the United States Food and Drug Administration approved labeling

Authorization duration:

Parsabiv (etelcalcetide) is not recommended for use in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or in patients with chronic kidney disease who are not on hemodialysis. These populations were not studied and are outside the FDA‑labeled indications for etelcalcetide.

Use of Parsabiv in populations that were not studied — specifically adults with parathyroid carcinoma, primary hyperparathyroidism, or CKD patients who are not receiving hemodialysis — is outside the recommended use and therefore may be considered not medically necessary.

Coding and Clinical Endpoints

Applicable HCPCS/CPT CodesHCPCS

J0606

Injection, etelcalcetide, 0.1 mg

Applicable Diagnosis Codes (ICD-10)ICD-10

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

PTH reduction endpoints used in trials — primary and secondary endpoints

Primary endpoint (trials by Block et al)Proportion of patients achieving >30% reduction in mean pre-dialysis PTH from baseline during weeks 20–27

Secondary endpoint (Block et al., parallel trials)Proportion of patients reaching mean PTH ≤ 300 pg/mL

Secondary/sensitivity endpoints (active-control trial vs cinacalcet)Proportion achieving >50% reduction in PTH (also assessed >30% reduction)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must document the clinical diagnosis, that the patient is on dialysis, and prior therapy trials (phosphate binder, vitamin D analog, and cinacalcet) when requesting coverage for Parsabiv (etelcalcetide). Initial authorization is limited to 12 months.

Affected drug: Parsabiv (etelcalcetide) — J0606
Initial authorization: up to 12 months
Prescriber: must be prescribed by or in consultation with an endocrinologist or nephrologist
Dosing: must follow FDA-approved labeling

Step Therapy

Step Therapy Requirements

Step therapy requires documented failure, contraindication, or intolerance to agents in specified classes prior to approval of Parsabiv.

Documented failure, contraindication, or intolerance to at least one phosphate binder (examples: PhosLo, Fosrenol, Renvela, Renagel)
Documented failure, contraindication, or intolerance to at least one vitamin D analog (examples: calcitriol, Hectorol, Zemplar)
Documented failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride)

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request to demonstrate that coverage criteria are met.

Clinical diagnosis of secondary hyperparathyroidism with chronic kidney disease (include relevant ICD-10 code[s])
Documentation that the patient is on dialysis
Records showing trials of and reasons for failure/contraindication/intolerance to: one phosphate binder, one vitamin D analog, and cinacalcet (Sensipar)
Baseline and follow-up laboratory results including serum calcium (corrected) demonstrating response for continuation requests
Medication history including dates, dosages, and reason for discontinuation of prior therapies
Prescriber specialty (endocrinologist or nephrologist) or documentation of consultation
Planned dose per FDA-approved labeling

Denial Risk

Triggers for Denial / Noncoverage

Requests may be denied if required criteria or documentation are missing or if clinical prerequisites are not met.

Denial trigger: patient is not on dialysis
Denial trigger: missing documentation of prior trials of a phosphate binder, a vitamin D analog, or cinacalcet
Denial trigger: concurrent use of Parsabiv and Sensipar (cinacalcet hydrochloride)
Denial trigger: prescriber is not an endocrinologist or nephrologist and no consultation is documented
Denial trigger: dosing not consistent with FDA-approved labeling

Definitions

Definition — Secondary hyperparathyroidism (CKD-related)

DefinitionSecondary hyperparathyroidism (CKD-related): elevated parathyroid hormone due to chronic kidney disease (renal origin)

FDA-indicated populationAdult patients with chronic kidney disease on hemodialysis (Parsabiv indication)

Pathophysiology summaryEtelcalcetide activates the calcium-sensing receptor on parathyroid cells to decrease PTH secretion

HCPCS code definition — J0606

HCPCS codeJ0606 = Injection, etelcalcetide, 0.1 mg

Usage noteListed for reference in Applicable Codes section of the policy

Coding systemHCPCS (Healthcare Common Procedure Coding System)

OpenPayer

Parsabiv (Etelcalcetide) — Medical Benefit Drug Policy (coverage criteria)

Coverage Criteria for Parsabiv (etelcalcetide)

Coding and Clinical Endpoints

Provider Actions and Requirements

Background

Definitions

Revision History