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 a Transitional Drug Add-on Payment Adjustment (TDAPA) through 2020

Medicare Fee-for-Service

With the February 2017 FDA approval of Parsabiv® (etelcalcetide), calcimimetics are no longer oral-only and are not reflected in the current ESRD PPS bundle base rate.1

  • Because Parsabiv® is not reflected in the ESRD PPS base rate, it is paid for with a transitional drug add-on payment effective through at least 2020
  • The payment is 1 of 5 adjustors to the ESRD PPS bundle base rate that is in place for dialysis treatment (see below)2
*The Parsabiv® (etelcalcetide) add-on payment adjustment is based on the ASP methodology.

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.

Why did the Centers for Medicare and Medicaid Services (CMS) establish the add-on payment?

The ESRD PPS bundled payment system did not include any mechanism to pay for new, innovative drugs and biologics. Therefore, in 2015, CMS created the transitional drug add-on payment for qualifying drugs and biologics whose costs were not included in the bundled payment rate.1

ESRD = end-stage renal disease; PPS = prospective payment system.

Medicare Advantage

  • While they are not required to adopt the add-on payment methodology, they are responsible for covering calcimimetics for clinically appropriate patients. Amgen believes it would be appropriate for Medicare Advantage Organizations to adopt an add-on payment methodology similar to TDAPA to account for the cost of calcimimetics not previously covered in Part B2
  • Medicare Advantage coverage and reimbursement will vary based on an individual organization’s payer contracts. Verify payment details for clinically appropriate patients before initiating therapy

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; it is best to verify payment details prior to initiating clinically appropriate patients

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 (CMS). Implementation of the Transitional Drug Add-On Payment Adjustment. Transmittal R1889OTN. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018-Transmittals-Items/R1999OTN.html. Accessed November 4, 2019. 2. Centers for Medicare & Medicaid Services. 42 CFR Parts 405, 410, 413, and 414. Medicare program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, etc. www.federalregister.gov/document/2019/08/06/2019-16369/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis. Accessed July 31, 2019.