CurrentUnitedHealthcarePolicy CSINDO075.06

Parsabiv (Etelcalcetide) (for Indiana Only)

UnitedHealthcare Medical Benefit Drug Policy for Parsabiv (etelcalcetide) applicable only to Indiana members. Defines initial and continuation medical necessity criteria, prescribing and dosing constraints, and applicable diagnosis and procedure codes.

Policy Summary

PayerUnitedHealthcare

PolicyParsabiv (Etelcalcetide) (for Indiana Only)

Policy CodePolicy CSINDO075.06

Change TypeCodes added

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, dialysis status, prior phosphate binder and cinacalcet failure/contraindication/intolerance, FDA-aligned dosing, and prescriber specialty (endocrinologist or nephrologist); initial and reauthorizations limited to 12 months.

POLICY UPDATE CHANGES

Applicable ICD-10 diagnosis codes were added: E21.1, N18.1, N18.2, N18.30, N18.31, N18.32, N18.4, N18.5, N18.9, and N25.81.

10Applicable ICD-10 codes listed

12 moInitial Authorization Max

12 moReauthorization Max

Coverage Summary & Stance

Coverage stance: covered_with_criteria. Scope: UnitedHealthcare Medical Benefit Drug Policy for Parsabiv (etelcalcetide) applicable to Indiana members only. Subject: Parsabiv (etelcalcetide) for secondary hyperparathyroidism in CKD on dialysis (Indiana only). Policy number: CSINDO075.06. Status: CURRENT. Effective date: 2025-05-01.

Initial Therapy — Medical Necessity Criteria

Initial Therapy - Medical Necessity

Parsabiv (etelcalcetide) is medically necessary when ALL of the following are met:

ALL of the following

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, etc.)
AND additional requirements
- 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)
- Dosing is in accordance with the United States Food and Drug Administration approved labeling
- Prescribed by or in consultation with an endocrinologist or nephrologist
- Initial authorization will be for no longer than 12 months<= 12 months

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Initial Therapy - Medical Necessity

Continuation Therapy — Reauthorization Criteria

Continuation Therapy - Reauthorization Criteria

Parsabiv (etelcalcetide) will be reauthorized when ALL of the following are met:

ALL of the following

Documentation of a reduction in serum calcium from baseline
Patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride)
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Prescribed by or in consultation with an endocrinologist or nephrologist
Reauthorization will be for no longer than 12 months<= 12 months

Applicable Codes

HCPCS / Drug CodeHCPCSCovered

Jxxxx

Injection, etelcalcetide, 0.1 mg (exact HCPCS code not specified)

Applicable ICD-10 Diagnosis Codes (reference list added 2025-05-01)ICD-10Covered

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

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for initial therapy

Initial authorization limited to no longer than 12 months and requires documentation of diagnosis, dialysis status, prior phosphate binder trial failure/contraindication/intolerance, prior cinacalcet failure/contraindication/intolerance, FDA-aligned dosing, and prescriber specialty (endocrinologist or nephrologist).

Documentation required: diagnosis of secondary hyperparathyroidism and CKD
Documentation required: patient on dialysis
Documentation required: prior phosphate binder trial failure, contraindication, or intolerance
Documentation required: prior cinacalcet (Sensipar) failure, contraindication, or intolerance
Dosing must align with FDA-approved labeling
Prescriber must be an endocrinologist or nephrologist (or consultation documented)
Initial authorization maximum duration: 12 months

Prior Authorization

Reauthorization requirements

Reauthorization requires documentation of a reduction in serum calcium from baseline, continued absence of concurrent cinacalcet use, FDA-aligned dosing, and prescriber specialty; reauthorization limited to no longer than 12 months.

Documentation required: reduction in serum calcium from baseline
Patient must not be receiving Parsabiv in combination with Sensipar (cinacalcet)
Dosing must align with FDA-approved labeling
Prescribed by or in consultation with an endocrinologist or nephrologist
Reauthorization maximum duration: 12 months

Documentation Required

Prescriber specialty documentation

Must be prescribed by or in consultation with an endocrinologist or nephrologist; documentation of consultation required if not prescribed by these specialists.

If not prescribed by an endocrinologist or nephrologist, include documentation of specialist consultation

Denial Risk

Do not combine with cinacalcet

Patient must not be receiving Parsabiv in combination with Sensipar (cinacalcet hydrochloride); concurrent use is a denial risk.

Concurrent use with cinacalcet (Sensipar) is a denial risk

Documentation Required

Dosing adherence

Dosing must be in accordance with FDA-approved labeling; provider must document dose and schedule consistent with labeling.

Document dose and administration schedule consistent with United States FDA-approved labeling

Clinical Evidence Summary

Evidence: Phase 3 placebo-controlled trials demonstrated etelcalcetide produced significantly greater reductions in PTH versus placebo, increasing the proportion of patients achieving >30% PTH reductions and higher rates of the secondary endpoint (PTH ≤ 300 pg/mL). In an active-comparator phase 3 trial versus cinacalcet, etelcalcetide was noninferior for the primary endpoint (>30% PTH reduction) and met superiority criteria, with a higher proportion of patients achieving >50% PTH reduction (52.4% vs 40.2%). Common adverse events included hypocalcemia (decreased blood calcium) and gastrointestinal effects such as nausea and vomiting; muscle spasms were also reported.

Background & Definitions

Parsabiv (etelcalcetide) is an intravenous calcimimetic that allosterically modulates the calcium-sensing receptor (CaSR), enhancing receptor activation by extracellular calcium to decrease parathyroid hormone (PTH) secretion. It is indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Adverse events include hypocalcemia (decreased blood calcium) and gastrointestinal effects such as nausea and vomiting; muscle spasms have also been reported.

Parsabiv: Brand name for etelcalcetide, an intravenous calcimimetic used to treat secondary hyperparathyroidism in adults with CKD on hemodialysis.