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Get the Facts About Reimbursement for a Secondary Hyperparathyroidism Treatment Option

Program Information
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Program Information

Get the Facts About Reimbursement for a Secondary Hyperparathyroidism Treatment Option
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What does the updated Centers for Medicare and Medicaid Services End-Stage Renal Disease Prospective Payment System mean for your dialysis care team? 

  • Overview

    The 2021 updates to the Centers for Medicare and Medicaid Services End-Stage Renal Disease Prospective Payment System affect everyone who works on a dialysis care team. Joining Dr. John Russell to explain what those changes are and what they mean for dialysis care teams are nephrologist Dr. Kevin Griffiths and renal dietitians Ms. Linda Roberto and Ms. Colleen Guffee. 

    This promotional, non-CME program is intended for US Health Care Professionals. Kevin Griffiths, MD, MPH, FASN, Colleen Guffee, MS, RD, LD, and Linda Roberto, MA, RD, LDN were paid a fee by Amgen for their participation in the program.

                                                                                                                                          USA-416-80969

  • 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.

  • IMPORTANT SAFETY INFORMATION

    Contraindication: Parsabiv® 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%).

    Please click here to see accompanying Parsabiv® full prescribing information.

    Visit ParsabivHCP.com for more 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. CMS. Implementation of the Transitional Drug Add on Payment Adjustment. Transmittal R1999OTN. https://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/2018Downloads/R1999OTN.pdf. Accessed March 11, 2021.
    3. CMS. 42 CFR Part 413 CMS-1732-F. 2020.
    4. DHHS. CMS. MLN Matters. 2011.
    5. DHHS. CMS. MLN Matters. 2012.
    6. CMS finalizes policies and payment rates for end-stage renal disease prospective payment system for CY2014.
    7. CMS updates to policies and payment rates for end-stage renal disease facilities for CY2016 and changes to the ESRD QIP; 2015.
    8. CMS updates to policies and payment rates for end-stage renal disease prospective payment system (CMS 1651-F); 2016.
    9. CY19 ESRD DME NPRM (CMS-1691-F) and DMEPOS competitive bidding program temporary gap period announcement; 2018.
    10. Data on file, Amgen; [Parsabiv and Cinacalcet Usage, 2020].

Programs 8/1/21