CurrentUnitedHealthcarePolicy CSIND0075.06

Parsabiv (Etelcalcetide) (for Indiana Only)

Defines UnitedHealthcare Indiana-specific medical coverage criteria for Parsabiv (etelcalcetide) for treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis, including initial and continuation authorization requirements.

Policy Summary

PayerUnitedHealthcare

PolicyParsabiv (Etelcalcetide) (for Indiana Only)

Policy CodePolicy CSIND0075.06

Change TypeAdded ICD-10 diagnosis codesarchived prior version

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization with documented diagnosis, dialysis status, prior trials/failures or contraindications to a phosphate binder, a vitamin D analog, and cinacalcet; ensure dosing per FDA labeling and prescriber is an endocrinologist or nephrologist.

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.

Archived previous policy version CSIND0075.05.

Initial + Continuation criteriadistinct authorization criterion groups

12 monthsmaximum initial authorization duration

12 monthsmaximum reauthorization duration

J0606HCPCS code listed for etelcalcetide

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Coverage Criteria for Parsabiv (etelcalcetide)

Initial Therapy

Covered when ALL of the following are met for Initial Therapy

Initial Therapy: Diagnosis of secondary hyperparathyroidism with chronic kidney disease

Initial Therapy: Patient is on dialysis

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

Prior therapies: History of failure, contraindication, or intolerance to one vitamin D analog (e.g., Calcitriol, Hectorol, Zemplar)

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

Concomitant therapy: Patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride)

Provider: 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

Continuation Therapy

Reauthorization (Continuation Therapy) is allowed when ALL of the following are met

Efficacy: Documentation of a reduction in serum calcium from baseline

Concomitant therapy: Patient is not receiving Parsabiv (etelcalcetide) in combination with Sensipar (cinacalcet hydrochloride)

Provider: 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 adult patients with parathyroid carcinoma or primary hyperparathyroidism, and it is not recommended for patients with chronic kidney disease who are not on hemodialysis. This limitation reflects the absence of clinical study data in these populations and is consistent with the product’s stated limitations of use.

Use of Parsabiv outside the FDA–approved indication is not supported. The FDA label indicates Parsabiv is approved only for secondary hyperparathyroidism in adult patients with CKD on hemodialysis, and clinical data are lacking for use in CKD patients who are not on hemodialysis or for treatment of primary hyperparathyroidism or parathyroid carcinoma; therefore these uses are not supported by the evidence cited in the labeling and are considered not medically necessary or limited.

For coverage and prior authorization purposes, requests for Parsabiv must align with the FDA indication (CKD on hemodialysis for secondary hyperparathyroidism). Requests seeking therapy for primary hyperparathyroidism, parathyroid carcinoma, or CKD without hemodialysis should be denied as they fall outside the supported indication and available studies.

Applicable Codes and Trial Endpoints

Applicable HCPCSHCPCS

J0606

Injection, etelcalcetide, 0.1 mg.

Applicable ICD-10 Diagnosis CodesICD-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 endpoints reported in trials

Primary trial primary endpointProportion of patients achieving >30% reduction in mean PTH from baseline during weeks 20–27

Secondary endpoint (placebo trials)Proportion of patients achieving mean PTH ≤300 pg/mL during treatment

Secondary/superiority endpoints (active comparator trial)Proportion of patients achieving >50% reduction in PTH concentrations

Reported trial result (etelcalcetide vs cinacalcet)52.4% of etelcalcetide patients achieved >50% reduction vs 40.2% with cinacalcet; etelcalcetide met noninferiority and superiority criteria for some endpoints

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization — Initial therapy

Prior authorization is required for initial Parsabiv (etelcalcetide) therapy. Initial authorization requires documented diagnosis of secondary hyperparathyroidism with chronic kidney disease and that the patient is on dialysis. The request must document prior trials, failures, contraindications, or intolerance to specified alternatives, and dosing must follow FDA labeling. Initial authorizations are limited to a maximum of 12 months.

Diagnosis: secondary hyperparathyroidism with chronic kidney disease
Patient must be on dialysis
Prescribed by or in consultation with an endocrinologist or nephrologist
Initial authorization duration: up to 12 months
Dosing per FDA‑approved labeling

Prior Authorization

Prior authorization — Continuation therapy

Reauthorization for Parsabiv (etelcalcetide) requires documentation of clinical benefit and ongoing appropriate use. Continuation requests must show biochemical response, adherence to dosing guidance, and that therapy is not being used concomitantly with cinacalcet (Sensipar). Reauthorizations are limited to a maximum of 12 months.

Background

Parsabiv (etelcalcetide) is a calcimimetic that activates the calcium-sensing receptor to reduce parathyroid hormone (PTH) secretion and is indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Clinical trials demonstrated larger reductions in PTH compared with placebo and comparable efficacy to oral cinacalcet in patients on hemodialysis, with common adverse events including hypocalcemia and gastrointestinal symptoms. The FDA label and policy limitations note that Parsabiv has not been studied—and therefore is not recommended—for parathyroid carcinoma, primary hyperparathyroidism, or CKD patients who are not on hemodialysis.

Key Definitions

Calcimimetic agent indicated for secondary hyperparathyroidism in adults with CKD on hemodialysis

DrugParsabiv (etelcalcetide)

ClassCalcimimetic agent — allosteric modulator of the calcium-sensing receptor (CaSR)

Indication (FDA)Secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis

MechanismBinds to CaSR and enhances activation by extracellular calcium to decrease PTH secretion

Chronic kidney disease stage 5 on dialysis (context for PTH‑lowering therapy recommendations)

TermCKD G5D

Definition