ESRD 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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image of nephrologist
image of nephrologist

FEEL CONFIDENT IN YOUR ACCESS TO PARSABIV® FOR
CLINICALLY APPROPRIATE PATIENTS WHO NEED IT.

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

Understanding ESRD reimbursement to enhance planning for patient care

Transitional Drug Add-on Payment Adjustment (TDAPA) was established by CMS to make and keep qualifying new drugs and biologicals accessible to CMS beneficiaries3

According to CMS, “The intent of TDAPA is to facilitate beneficiary access to certain qualifying new injectables or IV products, allowing payments for these drugs and biologicals while the necessary utilization data is collected.”4

TDAPA process

CMS reimburses all TDAPA products for what the patient uses while the necessary utilization data is collected.4

The data then will be used to incorporate the costs of these qualifying drugs into the ESRD PPS bundle.4

*Data period from Q3 2018 to Q4 2019.

When a therapy is added to the ESRD PPS bundle, its valuation is based on utilization under TDAPA5

Average Parsabiv® utilization of

~6.3%

of dialysis sessions in Q3 2018-Q4 20192

That's roughly 6 patients out of 100
That's roughly 6 patients out of 100

That’s roughly 6 patients out of 100

$10.09†

Amount added to the bundle for calcimimetics, including Parsabiv®, in 20211

The addition means providers receive the same $10.09 calcimimetics reimbursement, whether patients are taking Parsabiv® or not1

The additional reimbursement for Parsabiv® (etelcalcetide) based on the Q3 2018-Q4 2019 national average of ~6.3% of dialysis treatments6 supports continued access to Parsabiv®.

supports patient access to Parsabiv®.

Reflects a $9.93 calcimimetic valuation plus a market basket increase of 1.6%.

CMS = Center for Medicare and Medicaid Services; ESRD = End-Stage Renal Disease; PPS = Prospective Payment System.

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Reimbursement for Parsabiv®, and other dialysis costs, is adjusted annually by a market basket increase to the ESRD bundle rate.1

Periodic rebasing of the ESRD market basket occurs to reflect a more up-to-date cost structure7

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Parsabiv® Reimbursement Chart Showing Periodic Rebasing of the ESRD Market Basket from 2011 to 2022
Parsabiv® Reimbursement Chart Showing Periodic Rebasing of the ESRD Market Basket from 2011 to 2022

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®. Based on utilization at ~6.3% of dialysis sessions during the evaluation period, the $10.09 added to the ESRD bundle is designed to cover Parsabiv® for clinically appropriate patients. This amount is expected to grow annually with the bundle base rate increase.

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

SUPPORT AND SERVICES

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We know every patient has unique needs. And we're here to provide financial support information and resources, regardless of their current financial situation or type of insurance they have.

For financial support information and other resources for your patient, contact Amgen SupportPlus at (866) 264-2778 Monday through Friday, 9:00 am to 8:00 pm ET.

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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.  CMS. 42 CFR Part 413. Medicare program; ESRD PPS, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and ESRD QIP. Final rule.  2.  Data on file, Amgen; [Parsabiv and Cinacalcet Usage, 2020].  3.  CMS. Implementation of the TDAPA. Transmittal R1999OTN. cms.gov/Regulationsand-Guidance/ Guidance/Transmittals/2018Downloads/R1999OTN.pdf. Accessed July 1, 2024.  4.  CMS.gov website. ESRD PPS TDAPA. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/ESRD-Transitional-Drug. Accessed July 1, 2024.  5.  CMS.gov website. ESRD PPS Transitional Drug Add-on Payment Adjustment. https://www.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/ESRD-Transitional-Drug.html. Accessed June 24, 2024.  6.  CMS. 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 ESRD QIP. Final rule.  7.  CMS.gov. Fact Sheet. CY19 ESRD/DME NPRM (CMS-1691-F) and DMEPOS competitive bidding program temporary gap period announcement; 2018.  8.  DHHS. CMS. MLN Matters. 2011.  9.  CMS.gov. Fact Sheet. CMS finalizes policies and payment rates for ESRD PPS for CY2014.  10.  CMS. 42 CFR Parts 412, 413, and 512. Medicare program; ESRD PPS, payment for renal dialysis services furnished to individuals with acute kidney injury, ESRD QIP, and ESRD treatment choices model. Final rule.  11.  Medicare program; ESRD PPS, payment for renal dialysis services furnished to individuals with acute kidney injury, ESRD QIP, and ESRD treatment choices model; 42 CFR Parts 413 and 512. (2023).