Reimbursement | Parsabiv® (etelcalcetide)

Indication and Limitations of Use:

  • Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Read More
  • Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Close
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FEEL CONFIDENT IN YOUR ACCESS TO PARSABIV® FOR
CLINICALLY APPROPRIATE PATIENTS WHO NEED IT.

The additional money added to the ESRD bundle for calcimimetics is designed to cover the ~6% of sHPT patients who need Parsabiv®, as well as other calcimimetics.1,2,*

Access to Parsabiv® is supported for clinically appropriate patients

Parsabiv® is reimbursed as part of the ESRD bundle for Medicare Fee-for-Service (FFS) beneficiaries1

Most patients are not prescribed Parsabiv®. The bundle valuation reflects utilization in ~6.3% of dialysis treatments2,*

Due to the calcimimetic addition, in 2021 the bundle base rate increased by $10.09—the largest increase ever—to cover the cost of calcimimetics, including Parsabiv®. The bundle addition payment is provided for all Medicare ESRD patients, whether they are taking a calcimimetic or not1

Providers are responsible for outcomes regardless of reimbursement. You can continue to prescribe Parsabiv® for clinically appropriate patients

The bundle addition reflects the average national calcimimetic utilization* under the Transitional Drug Add-on Payment Adjustment (TDAPA).1

*Data period from Q3 2018 to Q4 2019.

ESRD = end-stage renal disease.

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Reimbursement for Parsabiv®, and other dialysis costs, is adjusted annually by a market basket increase to the ESRD bundle rate.

Frequently asked questions

How are different organizations being impacted now that Parsabiv® reimbursement has been added to the bundle?

Now that Parsabiv® is reimbursed as part of the ESRD bundle, some organizations are limiting access. Dialysis organizations can think about reimbursement across all dialysis patients since the additional amount for calcimimetics is there for every single dialysis session, not just for dialysis sessions for patients prescribed Parsabiv®. The $10.09 added to the ESRD bundle for calcimimetics is designed to cover the ~6% of sHPT patients who needed Parsabiv®, as well as other calcimimetics.

How does being in the bundle impact patient out-of-pocket costs?

The portion of the bundle not covered by Medicare will increase by the same percentage that the bundle increases to account for the costs of calcimimetics. This will likely impact those patients who don’t have a secondary payer source. This Medicare policy is not specific to calcimimetics.

What can I do to get Parsabiv® for patients who really need it?

Talk with your medical director about the patients for whom Parsabiv® is the best fit, and make sure they and your care team understand Parsabiv® reimbursement. You can also reach out to your Parsabiv® representative on how to help start a conversation with your medical director for them to understand the reimbursement dynamics of Parsabiv®.

Contact your Parsabiv® account manager for more information about reimbursement and how we can support you and your care team.

Other payers

Medicare Advantage (MA)

MA plans receive capitated payments to provide all Medicare‐covered services to pay enrollees, and they are responsible for covering calcimimetics for clinically appropriate patients. Coverage and reimbursement will vary based on an individual organization’s payer contracts. Reach out to your contracted payer or parent organization to determine how Parsabiv® will be covered. Getting coverage for Parsabiv® may require amending your dialysis organization’s payer contracts. Work with your contracting group to make the case for coverage for clinically appropriate patients when contracts are being negotiated.

Medicaid

Medicaid coverage varies by state. Check with your State Medicaid Office to understand coverage and requirements specific to your state.

Commercial

Commercial coverage and reimbursement will vary. Verify payment details once you have identified clinically appropriate patients. Reach out to your contracted payer or parent organization to determine how Parsabiv® will be covered under your specific contract terms; contract amendments may be necessary. Work with your contracting group to make the case for coverage for clinically appropriate patients when contracts are being negotiated.

Contact Amgen Assist® at
1-800-272-9376 Monday
through Friday, 9:00 am to
8:00 pm ET, for reimbursement
support information.

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EFFICACY

See how Parsabiv® performed
in clinical trials and its use in real-world outcomes

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DOSING & MONITORING

Switching from oral
cinacalcet to Parsabiv® (etelcalcetide)
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REAL-WORLD EVIDENCE

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hundreds of real-world treatment experiences

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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due

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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to Parsabiv®. Closely monitor corrected serum calcium and QT interval in patients at risk on Parsabiv®.

Significant reductions in corrected serum calcium may lower the threshold for seizures. Patients with a history of seizure disorder may be at increased risk for seizures if they develop hypocalcemia due to Parsabiv®. Monitor corrected serum calcium in patients with seizure disorders on Parsabiv®.

Concurrent administration of Parsabiv® with another oral calcimimetic could result in severe, life-threatening hypocalcemia. Patients switching from cinacalcet to Parsabiv® should discontinue cinacalcet for at least 7 days prior to initiating Parsabiv®. Closely monitor corrected serum calcium in patients receiving Parsabiv® and concomitant therapies known to lower serum calcium.

Measure corrected serum calcium prior to initiation of Parsabiv®. Do not initiate in patients if the corrected serum calcium is less than the lower limit of normal. Monitor corrected serum calcium within 1 week after initiation or dose adjustment and every 4 weeks during treatment with Parsabiv®. Measure PTH 4 weeks after initiation or dose adjustment of Parsabiv®. Once the maintenance dose has been established, measure PTH per clinical practice.

Worsening Heart Failure: In Parsabiv® clinical studies, cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported. Closely monitor patients treated with Parsabiv® for worsening signs and symptoms of heart failure.

Upper Gastrointestinal Bleeding: In clinical studies, 2 patients treated with Parsabiv® in 1253 patient years of exposure had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding in these patients is unknown and there were too few cases to determine whether these cases were related to Parsabiv®.

Patients with risk factors for upper GI bleeding, such as known gastritis, esophagitis, ulcers or severe vomiting, may be at increased risk for GI bleeding with Parsabiv®. Monitor patients for worsening of common Parsabiv® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Parsabiv® therapy.

Adynamic Bone: Adynamic bone may develop if PTH levels are chronically suppressed.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Parsabiv® to placebo, the most common adverse reactions were blood calcium decreased (64% vs. 10%), muscle spasms (12% vs. 7%), diarrhea (11% vs. 9%), nausea (11% vs. 6%), vomiting (9% vs. 5%), headache (8% vs. 6%), hypocalcemia (7% vs. 0.2%), and paresthesia (6% vs. 1%).

Indication

Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Limitations of Use: Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Limitations of Use:

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

Please see Parsabiv® (etelcalcetide) full Prescribing Information.

References: 1. Centers for Medicare & Medicaid Services. 42 CFR Part 413. Medicare program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. Final rule. 2. Data on file, Amgen; [Parsabiv and Cinacalcet Usage, 2020].