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.

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.

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coverage

Coverage

Coverage and reimbursement support

PERMANENT J-CODE:
 J0606*

Parsabiv® is reimbursed as an add-on payment adjustment to the bundle for Medicare patients

Medicare

With the February 2017 FDA approval of Parsabiv®, calcimimetics are no longer oral-only and are not reflected in the current ESRD PPS bundle base rate.24

  • Because Parsabiv® is not reflected in the ESRD PPS base rate, it is paid for with a transitional drug add-on payment effective for a minimum of 2 years24
  • The payment is 1of 5 adjustors to the ESRD PPS bundle base rate that is in place for dialysis treatment (see below)25
Parsabiv®’s 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.24

Medicare Advantage

  • 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, 8:00 am to 8:00 pm ET for coverage and reimbursement support information

Important Safety Information

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

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Data on file, Amgen; [Summary of Clinical Efficacy; 2015]. 3. Goodman WG. Calcium and phosphorus metabolism in patients who have chronic kidney disease. Med Clin North Am. 2005;89:631-647. 4. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 5. Wesseling-Perry K, Harkins GC, Wang HJ, et al. The calcemic response to continuous parathyroid hormone (PTH)(1-34) infusion in end-stage kidney disease varies according to bone turnover: a potential role for PTH(7-84). J Clin Endocrinol Metab. 2010;95:2772-2780. 6. Komaba H, Shiizaki K, Fukagawa M. Pharmacotherapy and interventional treatments for secondary hyperparathyroidism: current therapy and future challenges. Expert Opin Biol Ther. 2010;10:1729-1742. 7. Goodman WG, Quarles LD. Vitamin D, calcimimetics, and phosphate-binders. In: Brenner BM, Levine SA, eds. Brenner & Rector’s The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:1904-1927. 8. Alexander ST, Hunter T, Walter S, et al. Critical cysteine residues in both the calcium-sensing receptor and the allosteric activator AMG 416 underlie the mechanism of action. Mol Pharmacol. 2015;88:853-865. 9. Sensipar® (cinacalcet) prescribing information, Amgen. 10. Data on file, Amgen; [Report R20130052; 2014]. 11. Chen P, Olsson Gisleskog P, Perez-Ruixo JJ, et al. Population pharmacokinetics and pharmacodynamics of the calcimimetic etelcalcetide in chronic kidney disease and secondary hyperparathyroidism receiving hemodialysis. CPT Pharmacometrics Syst Pharmacol. 2016;5:484-494. 12. Ma JN, Owens M, Gustafsson M, et al. Characterization of highly efficacious allosteric agonists of the human calcium-sensing receptor. J Pharmacol Exp Ther. 2011;337:275-284. 13. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2017;7:1–59. 14. Data on file, Amgen; [Clinical Study Report 20120229; 2014]. 15. Data on file, Amgen; [Clinical Study Report 20120230; 2014]. 16. Block GA, Bushinsky DA, Cunningham J, et al. Effect of etelcalcetide vs placebo on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: two randomized clinical trials. JAMA. 2017;317:146-155. 17. Data on file, Amgen; [Integrated Summary of Safety; 2015]. 18. Data on file, Amgen; [Average Weekly Dose Vitamin D; 2017]. 19. Data on file, Amgen; [Combined Phase 3 Lab Values Multiple Imputation Approach; 2017]. 20. Data on file, Amgen; [Combined Phase 3 Lab Values Over Time; 2016]. 21. Data on file, Amgen; [Clinical Study Report 20120231; 2015]. 22. Data on file, Amgen; [Integrated Summary of Efficacy; 2015]. 23. Data on file, Amgen; [Summary of Clinical Safety; 2015]. 24. 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/2017-Transmittals-Items/R1889OTN.html. Accessed September 11, 2017. 25. Centers for Medicare & Medicaid Services. CMS Proposed Updates to Policies and Payment Rates for End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (CMS 1674-P), June 29, 2017. 26. Centers for Medicare & Medicaid Services. CMS Manual System; Pub 100-20 Implementation of the Transitional Drug Add-On Payment Adjustment. Transmittal 1999, January 10, 2018. 27. CMS.gov website. End Stage Renal Disease (ESRD) Prospective Payment System (PPS). https://www.cms.gov/medicare/medicare-fee-for-service-payment/ESRDpayment/index.html?redirect=/esrdpayment. Accessed May 22, 2018. 28. Centers for Medicare & Medicaid Services. CMS Updates to Policies and Payment Rates for End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (CMS 1674-F), October 27, 2017.