CurrentmhnPolicy CP.PHAR.379

Etelcalcetide (Parsabiv) clinical coverage

Defines medical necessity criteria, dosing, and authorization requirements for etelcalcetide (Parsabiv) for treatment of secondary hyperparathyroidism in adults with CKD on hemodialysis for members of Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyEtelcalcetide (Parsabiv) clinical coverage

Policy CodePolicy CP.PHAR.379

Change TypeNo material change

Effective Date03.20.18

Next Review Date

Key ActionSubmit documentation (chart notes, labs) showing member meets all approval criteria, including age ≥18, hemodialysis status, elevated iPTH, and prior trial of generic cinacalcet plus a vitamin D analog unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

hemodialysisrequired dialysis modality

15 mg TIWmax permitted dose

6 moinitial approval duration

12 morenewal duration (Medicaid/HIM)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Etelcalcetide (Parsabiv)

Initial Therapy

Covered when ALL of the following are met

Initial approval - Secondary HPT: 1. Diagnosis of secondary hyperparathyroidism (HPT) associated with chronic kidney disease (CKD).

Prescriber: 2. Prescribed by or in consultation with a nephrologist or endocrinologist.

Age: 3. Patient age is ≥ 18 years.age >=18

Dialysis status: 4. Member is on hemodialysis.

Evidence of elevated iPTH

(a): Lab results over the previous 3–6 months show a trending increase in intact PTH (iPTH).
(b): Current labs (within the last 30 days) show iPTH above the normal range.

Step therapy failure

(a): Trial and inadequate response or intolerance to generic cinacalcet (Sensipar).
(b): Trial and inadequate response or intolerance to one vitamin D analog (see Appendix B).

Calcimimetic exclusion: 7. Etelcalcetide (Parsabiv) is not prescribed concurrently with other calcimimetics (e.g., cinacalcet [Sensipar]).

Serum calcium: 8. At the time of request, serum calcium is not below the lower limit of normal.

Dose limits

(a): 15 mg three times per week.
(b): 3 mL three times per week.

Continuation Therapy

Covered for continuation when ALL of the following are met

Continuation eligibility

(a): Currently receiving etelcalcetide via the plan benefit or previously met initial approval criteria.
(b): Member is receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

Clinical response: 2. Member is responding positively to therapy as evidenced by a decrease in intact PTH (iPTH).response = decrease in iPTH

Calcimimetic exclusion:

Coverage is NOT authorized for use of etelcalcetide (Parsabiv) in the following situations: primary hyperparathyroidism, parathyroid carcinoma, or patients with chronic kidney disease who are not on hemodialysis. The manufacturer’s labeling states Parsabiv has not been studied in these populations and is not recommended for use in them.

In addition, uses that are not FDA‑approved and are not specifically addressed in this policy are considered not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see related off‑label policies).

Coding listed in this policy is provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers must follow current professional coding guidance and plan billing rules when submitting claims.

Non‑FDA approved indications that are not specifically addressed by this policy are considered not authorized unless the provider supplies adequate clinical documentation demonstrating efficacy and safety per the applicable off‑label use policy (see related policies for commercial, HIM, and Medicaid).

Coding and Monitoring

HCPCS CodesHCPCS

J0606

Injection, etelcalcetide, 0.1 mg

Serum calcium monitoring (inv-07)

TimingMeasure serum calcium 1 week after initiation or dosage adjustment, then every 4 weeks thereafter for maintenance.

Action on low calciumIf corrected serum calcium falls below 7.5 mg/dL or patient has symptomatic hypocalcemia, stop therapy and treat hypocalcemia.

ReinitiationIf therapy is stopped for low calcium, reinitiate at a lower dose once PTH and serum calcium return to target range.

PTH monitoring (inv-08)

TimingMeasure PTH 4 weeks after initiation of therapy or after a dose adjustment.

Dose adjustment guidanceIn individuals with PTH below target range, reduce dose or temporarily stop therapy; reinitiate at a lower dose once PTH returns to target.

Provider Requirements, Prior Authorization, and Step Therapy

Documentation Required

Required Documentation to Support Prior Authorization

Provider must submit documentation such as office chart notes, lab results, or other clinical information to support that the member has met all approval criteria. Failure to submit required documentation or use for non‑FDA indications may result in denial.

Required documentation must include recent iPTH labs and trend data when relevant, documentation of hemodialysis status, specialty prescriber or consult notes, and records of prior therapies and doses.

Prior Authorization

Prior Authorization Clinical Requirements

Prior authorization is required for Parsabiv (etelcalcetide) for secondary hyperparathyroidism associated with CKD in adults on hemodialysis. Providers must document failure of required step therapy agents at maximally indicated doses unless contraindicated or not tolerated.

Diagnosis: secondary hyperparathyroidism associated with CKD

Background

Etelcalcetide is a calcium‑sensing receptor (CaSR) agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on hemodialysis. Therapy is intended to reduce elevated intact parathyroid hormone (iPTH) levels in this population.

Dosing is administered intravenously at the end of hemodialysis sessions; initial dosing and subsequent adjustments should follow the prescribing information and monitoring guidance. Serum calcium should be measured 1 week after initiation or dosage adjustment and then every 4 weeks, and intact PTH should be reassessed 4 weeks after initiation or dose change to guide therapy and avoid hypocalcemia.

Definitions and References

CaSR definition (inv-18)

TermCaSR stands for calcium-sensing receptor.

RoleCaSR mediates calcium homeostasis and is the pharmacologic target of etelcalcetide (Parsabiv).

ContextListed in Appendix A: abbreviation/acronym key for this policy.

CKD definition (inv-19)

TermCKD stands for chronic kidney disease.

Context in policyCKD is the underlying condition associated with secondary hyperparathyroidism addressed by this policy.

Source

Policy Summary

Payermhn

PolicyEtelcalcetide (Parsabiv) clinical coverage

Policy CodePolicy CP.PHAR.379

Change TypeNo material change

Effective Date03.20.18

Next Review Date

SourceLink

On This Page

3. Etelcalcetide (Parsabiv) is not prescribed concurrently with other calcimimetics (e.g., cinacalcet [Sensipar]).

Dose limits on renewal or increase

(a): 15 mg three times per week.
(b): 3 mL three times per week.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Monitoring purposeUsed to assess response to etelcalcetide and guide dose modifications to avoid hypocalcemia and oversuppression of PTH.

Prescriber: nephrologist or endocrinologist (or consultation documented)

Hemodialysis: member must be on hemodialysis

iPTH: trending increase over 3–6 months or current iPTH above normal within 30 days

Step therapy: failure of generic cinacalcet and one vitamin D analog (see Appendix B for dosing)

Concurrent therapy: Parsabiv must not be prescribed concurrently with other calcimimetics (e.g., cinacalcet)

Step Therapy

Step Therapy Requirements

Step therapy requires trial and failure of generic cinacalcet (Sensipar) and one vitamin D analog at up to maximally indicated doses per Appendix B, unless clinically significant adverse effects occur or agents are contraindicated.

Generic cinacalcet dosing reference: start 30 mg PO QD and titrate up to a maximum of 300 mg/day per Appendix B
Vitamin D analog examples and dosing in Appendix B (e.g., calcitriol, doxercalciferol)

Step Therapy

Step Therapy Bypass (Illinois)

Per Illinois HB 5395, as of 01/01/2026 the IL HIM line of business is exempt from the step therapy requirements — providers should request the IL HIM bypass when applicable. This policy addition was approved by P&T on 08/25.

IL HIM step therapy bypass effective 01/01/2026 per IL HB 5395
P&T Approval Date for step therapy bypass: 08.25

Billing Rule

Coding and Administrative Clarifications

Administrative and coding notes: inclusion of HCPCS code J0606 (injection, etelcalcetide, 0.1 mg) is informational and does not guarantee coverage. Providers should reference current coding guidance prior to claim submission. Recent administrative updates clarified redirection to generic cinacalcet and added Commercial line of business approval duration.

HCPCS: J0606 — Injection, etelcalcetide, 0.1 mg (informational)
3Q2025 updates: clarified redirection to generic cinacalcet; added Commercial LOB and approval duration to 6 months or member renewal date; added IL HIM step therapy bypass

Listed in Appendix A: abbreviation/acronym key for this policy.

HPT definition (inv-20)

TermHPT stands for hyperparathyroidism.

Type addressedPolicy addresses secondary HPT associated with CKD in adults on hemodialysis.

Appendix listingIncluded in Appendix A: abbreviation/acronym key.

Parsabiv Prescribing Information (inv-21)

TitleParsabiv Prescribing Information — KAI Pharmaceuticals, Inc.; January 2025.

AvailabilityAvailable at: www.parsabiv.com (accessed April 14, 2025).

Use in policyCited as the manufacturer’s prescribing information and reference for dosing and safety guidance.