ModifiedMolina HealthcarePolicy C17883-A

Parsabiv (etelcalcetide) Coverage for Secondary Hyperparathyroidism

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Coverage of intravenous Parsabiv for adults with secondary hyperparathyroidism associated with chronic kidney disease who receive hemodialysis, including authorization criteria, documentation, dosing, administration, and prescriber requirements.

Policy Summary

PayerMolina Healthcare

PolicyParsabiv (etelcalcetide) Coverage for Secondary Hyperparathyroidism

Policy CodePolicy C17883-A

Change TypeModified

Effective DateOctober 9, 2025

Next Review DateJuly 1, 2026

Key ActionDocument failure, contraindication, or serious side effects to a phosphate binder, vitamin D analog, and cinacalcet before requesting initial coverage.

SourceLink

POLICY UPDATE CHANGES

The Q3 2025 revision identified notable updates to continuation-of-therapy duration and contraindications, exclusions, and discontinuation requirements.

The Q3 2025 revision identified updates to the drug class, FDA-approved uses, required medical information, continuation of therapy, available dosage forms, and contraindications, exclusions, and discontinuation sections.

Adult CKD on hemodialysisCovered population

12 monthsAuthorization duration

<7.5 mg/dL

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ModifiedMolina HealthcarePolicy C17883-A

Parsabiv (etelcalcetide) Coverage for Secondary Hyperparathyroidism

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Policy Summary

PayerMolina Healthcare

PolicyParsabiv (etelcalcetide) Coverage for Secondary Hyperparathyroidism

Policy CodePolicy C17883-A

Change TypeModified

Effective DateOctober 9, 2025

Next Review DateJuly 1, 2026

Key ActionDocument failure, contraindication, or serious side effects to a phosphate binder, vitamin D analog, and cinacalcet before requesting initial coverage.

SourceLink

POLICY UPDATE CHANGES

The Q3 2025 revision identified notable updates to continuation-of-therapy duration and contraindications, exclusions, and discontinuation requirements.

Adult CKD on hemodialysisCovered population

12 monthsAuthorization duration

<7.5 mg/dL

Calcium discontinuation threshold

>300 pg/mLiPTH coverage threshold

15 mg 3x weeklyMaximum dose

Coverage Criteria

Initial Therapy

Covered when ALL of the following initial-therapy criteria are met:

ALL of the following

Documented diagnosis of secondary hyperparathyroidism associated with chronic kidney disease (CKD).
Member is currently receiving regular hemodialysis treatments.
Documented laboratory results show an increase in intact parathyroid hormone (iPTH) levels over the previous 3–6 months, or current iPTH is greater than 300 pg/mL.
Documentation required.
Corrected serum calcium is greater than or equal to 8.4 mg/dL without symptoms of hypocalcemia.≥ 8.4 mg/dL
Corrected serum calcium must be at or above 8.4 mg/dL before initiation, dose increase, or re-initiation.
Documented failure, contraindication, or serious side effects to one phosphate binder, such as PhosLo, Fosrenol, Renvela, or Renagel.
Documented trial and failure, contraindication, or serious side effects to one vitamin D analog up to maximally indicated doses, such as calcitriol, Hectorol, or Zemplar.
Calcitriol or synthetic vitamin D analogs should be avoided, administered at a low dose, or discontinued if serum phosphate exceeds 5.5 mg/dL or serum calcium exceeds 10.2 mg/dL, unless a clearly reversible cause is identified.
Documented trial and failure of the maximum tolerated dosage, serious side effects, or contraindication to cinacalcet hydrochloride.
Parsabiv will not be used in combination with cinacalcet hydrochloride.

Continuation Therapy

Continuation of therapy is covered when ALL applicable criteria are met:

ALL of the following

ONE of the following adherence circumstances
- Prescriber attestation confirms adherence to therapy at least 85% of the time, verified by the prescriber or the member’s medication fill history.≥ 85% adherence
- Adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.
No evidence of drug toxicity or intolerable adverse effects.
Documentation of symptomatic improvement or disease stabilization compared with baseline, evidenced by a decrease in iPTH from baseline.

FDA-Label Limitations and Off-Label Use

Coverage follows the FDA-approved indication. No compendial approved off-label uses are identified; uses outside the covered indication are subject to Molina’s OffLabel policy.

ALL of the following

Use is for secondary hyperparathyroidism in an adult patient with CKD who is receiving hemodialysis.
Use is not for parathyroid carcinoma, primary hyperparathyroidism, or CKD in a patient who is not receiving hemodialysis.
No compendial approved off-label use is identified.

FDA-Approved Use

The FDA-approved use is covered when ALL of the following apply:

ALL of the following

The patient is an adult with chronic kidney disease (CKD).
The patient has secondary hyperparathyroidism.
The patient is receiving hemodialysis.

Initiation, Titration, and Monitoring

Initiation, titration, and monitoring must follow the prescribing information and the requirements below:

ALL of the following

For members changing from cinacalcet to Parsabiv, cinacalcet is discontinued for at least 7 days before starting Parsabiv.≥ 7 days
For members changing from cinacalcet, Parsabiv is initiated at a starting dose of 5 mg.
Corrected serum calcium is at or above the lower limit of normal before Parsabiv initiation.
For initial therapy, corrected serum calcium must be at least 8.4 mg/dL before initiation, dose increase, or re-initiation.
The maintenance dose is individualized and titrated based on PTH and corrected serum calcium response.

Parsabiv has not been studied in adults with parathyroid carcinoma, primary hyperparathyroidism, or CKD who are not receiving hemodialysis and is not recommended for use in these populations.

Parsabiv will not be used in combination with cinacalcet hydrochloride.

Coverage is not provided for Parsabiv used for parathyroid carcinoma, primary hyperparathyroidism, or CKD without hemodialysis.

Parsabiv is contraindicated in members with hypersensitivity to etelcalcetide or any component of its excipients.

Do not use Parsabiv in combination with cinacalcet.

Parsabiv is not recommended when breastfeeding.

All other uses of Parsabiv are considered experimental or investigational and follow Molina’s OffLabel policy.

Coding, Dosing, and Clinical Thresholds

HCPCS CodeHCPCS

J0606

Injection, etelcalcetide, 0.1 mg

Intact parathyroid hormone

Current iPTH thresholdGreater than 300 pg/mL

Alternative documentationAn increase in intact parathyroid hormone (iPTH) levels over the previous 3-6 months

DocumentationDocumented laboratory results are required

Corrected serum calcium before treatment

Minimum corrected serum calciumGreater than or equal to 8.4 mg/dL

Symptom requirementMember must not have symptoms of hypocalcemia

Applies before

Provider Requirements and Authorization Rules

Prior Authorization

Specialist Prescriber Requirement

Parsabiv must be prescribed by, or used in consultation with, a nephrologist or endocrinologist.

Billing Rule

Adult Members Only

Coverage is restricted to adult members who are 18 years of age or older.

Billing Rule

Approved Place of Administration

Administration must occur under the pharmacy or medical benefit in a facility-based, non-inpatient hospital setting.

Clinical Background

Parsabiv (etelcalcetide) is an intravenous calcimimetic agent indicated for secondary hyperparathyroidism in adults with chronic kidney disease who are receiving hemodialysis. The policy's covered clinical role includes management with monitoring of intact parathyroid hormone and corrected serum calcium, together with consideration of prior treatment with phosphate binders, vitamin D analogs, and cinacalcet.

Definitions

Corrected serum calcium

CalculationCorrected serum calcium = measured total calcium + 0.8 × (4.0 − serum albumin)

Measured componentMeasured total calcium

Albumin adjustment0.8 × (4.0 − serum albumin)

CKD Stage 5

StageChronic kidney disease stage 5

PopulationAdult members receiving hemodialysis

Clinical contextTarget goals apply to adult CKD members on hemodialysis

Policy Summary

PayerMolina Healthcare

PolicyParsabiv (etelcalcetide) Coverage for Secondary Hyperparathyroidism

Policy CodePolicy C17883-A

Change TypeModified

Effective DateOctober 9, 2025

Next Review DateJuly 1, 2026

Key ActionDocument failure, contraindication, or serious side effects to a phosphate binder, vitamin D analog, and cinacalcet before requesting initial coverage.

SourceLink

On This Page

Prescriber is monitoring corrected serum calcium levels.

If corrected calcium is below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia, consider decreasing or temporarily discontinuing Parsabiv or using concomitant therapies to increase corrected serum calcium. Stop Parsabiv and treat hypocalcemia if corrected calcium falls below 7.5 mg/dL or symptoms of hypocalcemia occur.

The dose may be increased by 2.5–5 mg no more frequently than every 4 weeks.Every ≥ 4 weeks

Serum calcium is measured 1 week after initiation or dosage adjustment and every 4 weeks thereafter for maintenance.1 week, then every 4 weeks

PTH is measured 4 weeks after initiation or dose adjustment.4 weeks

If PTH is below the target range, reduce the Parsabiv dose or temporarily stop therapy. Reinitiate at a lower dose when PTH and serum calcium return to the target range.

If corrected serum calcium is at least 7.5 mg/dL but below the target range and the patient has no symptoms of hypocalcemia, consider reducing the dose, temporarily stopping therapy, or adding therapy to increase serum calcium.≥ 7.5 mg/dL and below target

If corrected serum calcium falls below 7.5 mg/dL or the patient experiences symptomatic hypocalcemia, discontinue Parsabiv and treat the hypocalcemia.< 7.5 mg/dL or symptomatic hypocalcemia

Initiation, dose increase, or re-initiation

Corrected serum calcium during continuation

Below normal rangeIf corrected calcium is below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia, consider decreasing or temporarily discontinuing Parsabiv or using concomitant therapies to increase corrected serum calcium

Safety thresholdCorrected serum calcium must remain at or above 7.5 mg/dL when the member is asymptomatic

Action below threshold or with symptomsStop Parsabiv and treat hypocalcemia if corrected serum calcium falls below 7.5 mg/dL or symptoms occur

Parsabiv starting dose

Starting dose5 mg

FrequencyThree times per week

Administration timingAt the end of hemodialysis treatment

Parsabiv maintenance dose

Permitted maintenance dose2.5-15 mg

FrequencyThree times per week

Maximum quantity limit15 mg three times per week

Continuation adherence

Minimum adherenceAt least 85% of the time

VerificationVerified by the prescriber or the member's medication fill history

Permitted interruption exceptionAdherence below 85% is permitted when surgery or treatment of an infection required temporary discontinuation

Corrected serum calcium — CKD stage 5

Target corrected serum calcium8.4 to 9.5 mg/dL

Equivalent range2.1 to 2.37 mmol/L

PopulationAdult CKD stage 5 members on hemodialysis

Serum phosphorus — CKD stage 5

Target serum phosphorus3.5 to 5.5 mg/dL

Guideline contextTarget goal for adult CKD members on hemodialysis

CKD classificationCKD stage 5

Serum calcium-phosphorus product — CKD stage 5

Maximum calcium-phosphorus productLess than 55 mg²/dL²

PopulationAdult CKD stage 5 members on hemodialysis

Guideline sourceKDOQI 2003 target goal

Intact PTH — CKD stage 5

Target intact PTH150 to 300 pg/mL

PopulationAdult CKD stage 5 members on hemodialysis

Guideline sourceKDOQI 2003 target goal

Corrected calcium safety threshold

Discontinuation thresholdStop Parsabiv if corrected serum calcium falls below 7.5 mg/dL

Hypocalcemia treatmentTreat hypocalcemia when corrected serum calcium is below 7.5 mg/dL

Symptomatic triggerStop therapy and treat hypocalcemia if the member reports symptoms of hypocalcemia, regardless of the calcium level stated in the continuation guidance

Billing Rule

Route of Administration

Parsabiv must be administered by intravenous injection.

Prior Authorization

Authorization Duration

Authorization is granted for 12 months initially and for 12 months for continuation of therapy.

Initial authorization: 12 months
Continuation authorization: 12 months

Prior Authorization

Covered FDA-Approved Indication

Coverage applies to Parsabiv for secondary hyperparathyroidism in adult patients with chronic kidney disease who are receiving hemodialysis.

Covered indication: secondary hyperparathyroidism associated with CKD
Member must be receiving hemodialysis

Step Therapy

Phosphate Binder and Vitamin D Analog Prerequisite

The member must have documented failure, contraindication, or serious side effects to one phosphate binder and a documented trial and failure, contraindication, or serious side effects to one vitamin D analog at maximally indicated doses.

Phosphate binder examples include PhosLo, Fosrenol, Renvela, and Renagel.
Vitamin D analog examples include calcitriol, Hectorol, and Zemplar.
Vitamin D analog use should account for elevated serum phosphate or calcium and any clearly reversible cause.

Step Therapy

Cinacalcet Prerequisite and Noncombination

The member must have a documented trial and failure of the maximum tolerated cinacalcet dose, serious side effects, or a contraindication. Parsabiv must not be used concurrently with cinacalcet.

Document the cinacalcet trial, failure, intolerance, or contraindication.
Concurrent cinacalcet and Parsabiv use is prohibited.

Step Therapy

Transition From Cinacalcet

When transitioning from cinacalcet, discontinue cinacalcet for at least 7 days before starting Parsabiv and initiate Parsabiv at 5 mg.

Confirm the 7-day discontinuation interval.
Confirm corrected serum calcium is at or above the lower limit of normal before initiation.

Documentation Required

Medical Records and Rationale

Submit medical records and the clinical rationale needed to establish medical necessity, non-investigational use, and benefit eligibility. Molina may request additional documentation, including patient records, test results, and ordering or performing provider credentials.

Additional information may be required on a case-by-case basis.
For member-specific dosing, submit the applicable weight, body surface area, or other measurement.
Insufficient or inappropriate documentation may result in denial or other action.

Documentation Required

Initial Clinical Documentation

With the initial request, document the diagnosis of secondary hyperparathyroidism associated with CKD, current regular hemodialysis, qualifying iPTH results, corrected serum calcium, and required prerequisite treatment history.

Document increased iPTH over the prior 3–6 months or current iPTH greater than 300 pg/mL.
Document corrected serum calcium of at least 8.4 mg/dL without symptoms of hypocalcemia before initiation, dose increase, or re-initiation.
Include phosphate binder, vitamin D analog, and cinacalcet treatment documentation or applicable exceptions.

Documentation Required

Specialist Consultation Notes

If Parsabiv is prescribed in consultation, submit the nephrologist's or endocrinologist's consultation notes with the initial request and each reauthorization request.

Consultation documentation is required for both initial authorization and reauthorization.

Documentation Required

Continuation Documentation

For continuation authorization, document adherence of at least 85% as verified by the prescriber or medication fill history, or explain lower adherence caused by surgery or infection. Also document no intolerable adverse effects, clinical response or disease stabilization, and continued monitoring.

Document symptomatic improvement or disease stabilization compared with baseline, including a decrease in iPTH.
Document ongoing eligibility and prescriber monitoring of corrected serum calcium.

Documentation Required

Covered Indication and Clinical Status

Documentation must establish secondary hyperparathyroidism in an adult member with CKD who is receiving hemodialysis, along with qualifying iPTH and corrected calcium values.

Member must be 18 years of age or older.
Document increased iPTH over the prior 3–6 months or current iPTH greater than 300 pg/mL.
Corrected serum calcium must be at least 8.4 mg/dL without symptoms of hypocalcemia before initiation, dose increase, or re-initiation.

Documentation Required

Laboratory Monitoring and Safety

Monitor corrected serum calcium and PTH during treatment and document dose adjustments and safety management. Measure calcium 1 week after initiation or dose adjustment and every 4 weeks thereafter; measure PTH 4 weeks after initiation or dose adjustment.

Titrate the maintenance dose based on PTH and corrected calcium response, increasing by 2.5–5 mg no more frequently than every 4 weeks.
Document dose reduction or temporary interruption when PTH is below target or calcium is below the target range.
Document treatment of hypocalcemia and any safety-related discontinuation.

Denial Risk

Insufficient Supporting Documentation

Molina may deny the request or reimbursement when submitted records do not establish medical necessity, support expected outcomes, demonstrate non-investigational use, or otherwise support the requested service within the member's benefits.

Additional records may be requested during coverage determination or review.
Documentation that is incomplete, inappropriate, or inconsistent with the request creates denial risk.

Denial Risk

Diagnosis or Population Outside Policy

Coverage may be denied when the diagnosis, dialysis status, or member population falls outside the policy criteria.

Noncovered populations include members with primary hyperparathyroidism, parathyroid carcinoma, or CKD who are not receiving hemodialysis.
Coverage is limited to adults with secondary hyperparathyroidism associated with CKD.

Denial Risk

Criteria or Step-Therapy Failure

Coverage may be denied when required step therapy, laboratory results, or program requirements are not documented or are not met.

Required prerequisites include phosphate binder, vitamin D analog, and cinacalcet treatment history or applicable exceptions.
Required laboratory criteria include qualifying iPTH and corrected serum calcium results.
Parsabiv must not be used concurrently with cinacalcet.

Denial Risk

Quantity Limit Exceeded

Requests exceeding the maximum quantity limit may be denied.

Starting dose: 5 mg three times weekly at the end of hemodialysis.
Maintenance dose: 2.5–15 mg three times weekly.
Maximum quantity: 15 mg three times weekly.

Denial Risk

Use Outside Covered Indication

Use outside the covered FDA-approved indication is not covered under this policy and is considered experimental or investigational, subject to Molina's applicable OffLabel policy.

Covered use is limited to secondary hyperparathyroidism in adults with CKD receiving hemodialysis.
Requests for other uses may be denied as noncovered or investigational.

Denial Risk

Contraindicated or Unstudied Populations

Parsabiv is contraindicated in members with hypersensitivity to etelcalcetide or any excipient, and is not recommended for certain unstudied populations or conditions.

Do not use in members with hypersensitivity to etelcalcetide or its excipients.
Not studied or recommended for parathyroid carcinoma, primary hyperparathyroidism, or CKD without hemodialysis.

Denial Risk

Concurrent Cinacalcet Use

Parsabiv must not be used in combination with cinacalcet. Cinacalcet must be discontinued for at least 7 days before Parsabiv is started.

Document the transition interval when changing therapies.
Start Parsabiv at 5 mg after the required discontinuation period.

Denial Risk

Hypocalcemia

Stop Parsabiv and treat hypocalcemia if corrected serum calcium falls below 7.5 mg/dL or the member reports symptoms of hypocalcemia.

For corrected calcium at least 7.5 mg/dL but below the lower limit of normal without symptoms, consider dose reduction, temporary discontinuation, or concomitant therapy to increase calcium.
Reinitiate at a lower dose only after PTH and corrected calcium return to the target range.