Currentsierra health and lifePolicy 2026D0075J

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

Policy governs medical benefit coverage and authorization requirements for Parsabiv (etelcalcetide) for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2026D0075J

Change TypeOperational and reference updates

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization demonstrating patient is on hemodialysis, not receiving concomitant cinacalcet, and prescribed by or in consultation with a nephrologist or endocrinologist.

SourceLink

POLICY UPDATE CHANGES

Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans.

Updated References section to reflect the most current information and archived previous policy version 2025D0075I.

J0606HCPCS code listed for etelcalcetide

2Key randomized trials cited

≤12 moInitial authorization duration

≤12 moReauthorization duration

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Coverage Criteria for Parsabiv (etelcalcetide)

inv-01: Initial Therapy / Medical Necessity

Covered when ALL of the following are met:

Initial Therapy Criteria: Diagnosis of secondary hyperparathyroidism with chronic kidney disease

Dialysis Status: Patient is on dialysis

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

Prescriber: Prescribed by or in consultation with an endocrinologist or nephrologist

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

inv-02: Medical Necessity — Prior Medication Requirements

For medical necessity when prior medications tried, ALL of the following are required:

Diagnosis of secondary hyperparathyroidism with chronic kidney disease

Dialysis Status: Patient is on dialysis

Phosphate Binder Trial: History of failure, contraindication, or intolerance to one phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel)

Vitamin D Analog Trial: History of failure, contraindication, or intolerance to one vitamin D analog (e.g., calcitriol, Hectorol, Zemplar)

Cinacalcet Trial: History of failure of maximum tolerated dosage, adverse reaction, or contraindication to Sensipar (cinacalcet hydrochloride)

inv-03: Reauthorization Criteria

Reauthorization is allowed when ALL of the following are met:

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

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

Prescriber: Prescribed by or in consultation with an endocrinologist or nephrologist

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

Authorization Duration: Reauthorization will be for no longer than 12 months

Parsabiv (etelcalcetide) is not recommended for use in the following adult populations: those with parathyroid carcinoma, those with primary hyperparathyroidism, and patients with chronic kidney disease who are not on hemodialysis. The FDA states Parsabiv has not been studied in these populations and therefore use in these groups is not supported by the available evidence.

Use of Parsabiv (etelcalcetide) in patients who are not on dialysis does not meet coverage criteria. Concurrent use of Parsabiv with Sensipar (cinacalcet hydrochloride) is also excluded; when switching from cinacalcet to Parsabiv, cinacalcet should be discontinued for at least 7 days prior to initiation and Parsabiv should be started per FDA dosing (initiate at 5 mg with corrected serum calcium at or above the lower limit of normal). Additionally, requests lacking the required prior medication history — specifically documentation of failure, contraindication, or intolerance to one phosphate binder, one vitamin D analog, and failure or contraindication to maximum tolerated cinacalcet dose — will not meet medical necessity requirements.

Billing and Diagnosis Codes

Procedure (HCPCS) codesHCPCSCovered

J0606

Injection, etelcalcetide, 0.1 mg.

Diagnosis (ICD-10) codesICD-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 reduction endpoints

Primary efficacy endpoint>30% reduction in mean PTH from baseline during weeks 20-27

Secondary efficacy endpointProportion of patients achieving mean PTH ≤ 300 pg/mL

Trial duration supporting endpointsEfficacy assessed over 26 weeks with measurements during weeks 20–27

Evidence sourceTwo parallel phase 3 randomized trials in patients receiving hemodialysis

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must document a diagnosis of secondary hyperparathyroidism with chronic kidney disease and that the patient is on dialysis. Initial authorizations are limited to 12 months; reauthorizations are limited to 12 months. Prescriber must be an endocrinologist or nephrologist or the request must include consultation with one. Dosing must follow FDA‑approved labeling.

Initial authorization: ≤ 12 months
Reauthorization: ≤ 12 months
Prescriber: endocrinologist or nephrologist (or consult)
Patient must be on dialysis
Dosing per FDA labeling

Step Therapy

Step Therapy / Prior Medication Requirements

Step therapy requirements must be met prior to medical necessity for Parsabiv. Document history of failure, contraindication, or intolerance to one phosphate binder and one vitamin D analog, and history of failure, adverse reaction, or contraindication to maximum tolerated dosage of Sensipar (cinacalcet) unless contraindicated or not tolerated.

Key Definitions

Secondary hyperparathyroidism (CKD-related)

DefinitionSecondary hyperparathyroidism (CKD-related): elevated parathyroid hormone levels associated with chronic kidney disease, particularly in patients on dialysis.

PathophysiologyResult of disturbed calcium-sensing and mineral metabolism in CKD leading to increased PTH secretion; etelcalcetide (a calcimimetic) activates the CaSR to decrease PTH.

Typical severity/contextCommonly seen in patients receiving hemodialysis with moderate to severe elevations in PTH (studies enrolled patients with PTH >500 pg/mL).

Clinical relevance for policyPolicy applies to adults with CKD on hemodialysis with secondary hyperparathyroidism; efficacy endpoints from trials guide authorization criteria.

Clinical Background

Etelcalcetide (Parsabiv) is a calcimimetic that acts on the calcium-sensing receptor to reduce parathyroid hormone (PTH) secretion. It is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Key prescribing considerations include adherence to US FDA dosing and the requirement that patients be receiving hemodialysis; the agent has not been studied in patients with parathyroid carcinoma, primary hyperparathyroidism, or CKD patients not on hemodialysis.

Policy Revision History

2026-04-01Operational updateLatest

Content transferred to a shared policy template and an Application section was added to specify applicability to UnitedHealthcare Commercial and Individual Exchange benefit plans.

2026-04-01Reference update

References section updated to reflect the most current information.

2026-04-01Archival