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® (etelcalcetide) 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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Reimbursement

Parsabiv® is reimbursed as part of the ESRD bundle in 20211

Medicare Fee-for-Service

The Transitional Drug Add-on Payment Adjustment (TDAPA) was established to make innovative therapies accessible to CMS beneficiaries.2

Parsabiv® was available as an add-on payment under TDAPA in 2020.2

Reimbursement changes support your clinical decisions to use Parsabiv®

The bundle addition reflects the average national calcimimetic utilization* under TDAPA.

Your actual reimbursement will be affected by geography, wages, patient average case mix, volume, and other adjustments.

National Parsabiv® utilization contributed to 83%, or $8.39,† of the calcimimetic valuation.‡

ESRD = end-stage renal disease; CMS = Centers for Medicare & Medicaid Service; PPS = prospective payment system.
*CMS final rule is based on Q3 2018 through Q4 2019 total US calcimimetic utilization. †After 1.6% market basket increase. ‡CMS final rule is based on Q3 2018 through Q4 2019 total US calcimimetic utilization and Q4 2020 ASP+0. Data used to calculate the Parsabiv® (etelcalcetide) cost per treatment: (Parsabiv® milligrams × Q4 2020 ASP + cinacalcet milligrams × Q4 2020 ASP) = total valuation of calcimimetics ÷ total number of dialysis treatments. The information provided in this material is of a general nature and for informational purposes only. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. The information provided here should in no way be considered a guarantee of coverage or reimbursement for any product or service. ASP = average sales price.

Parsabiv® can fit within your facility operations

Providers will receive the same amount of additional Parsabiv® reimbursement for every Medicare FFS patient, whether they are taking Parsabiv® or not

Avoids specialty pharmacy hassles and costs

There are no changes to billing workflow that would require additional staff training/time. Parsabiv® will simply be reimbursed as part of the bundle

FFS = fee-for-service.

Medicare Advantage

  • While they are not required to adopt the bundle payment methodology, they are responsible for covering calcimimetics for clinically appropriate patients. Amgen believes it would be appropriate for Medicare Advantage Organizations to adopt a payment methodology similar to the CMS 2021 bundle addition to account for the cost of calcimimetics not previously covered in Part B

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. Contact your contracted payer or parent organization to determine how Parsabiv® will be covered under your specific contract terms; contract amendments may be necessary.

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

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DOSING & MONITORING

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

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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.

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. CMS TDAPA Transmittal R1999OTN 2018. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R1999OTN.pdf. Accessed January 7, 2021.