Clinical Policy: Etelcalcetide (Parsabiv)

Reference Number: CP.PHAR.379
Effective Date: 03.20.18
Last Review Date: 08.25
Line of Business: Commercial, HIM, Medicaid

[ Coding Implications ](Coding Implications)
[ Revision Log ](Revision Log)

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

Etelcalcetide (Parsabiv®) is a calcium-sensing receptor agonist which binds to the calcium-sensing receptor (CaSR) on chief cells of the parathyroid gland.

FDA Approved Indication(s)

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Limitation(s) of use:

Parsabiv has not been studied in adult patients with parathyroid carcinoma, primary HPT, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Policy/Criteria

II. Continued Therapy

A. Secondary Hyperparathyroidism (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy as evidenced by a decrease in iPTH;
3. Parsabiv is not prescribed concurrently with other calcimimetics (e.g., cinacalcet [Sensipar]);
4. If request is for a dose increase, new dose does not exceed either of the following (a and b):
   a. 15 mg three times per week;
   b. 3 mL three times per week.

Approval duration:

Medicaid/HIM – 12 months
Commercial – 6 months or to the member’s renewal date, whichever is longer

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

CaSR: calcium-sensing receptor
CKD: chronic kidney disease
HPT: hyperparathyroidism
iPTH: intact parathyroid hormone
PTH: parathyroid hormone

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): known hypersensitivity to etelcalcetide or any of its excipients
• Boxed warning(s): none reported

Appendix D: General Information

• Serum calcium levels should be measured 1 week after initiation of therapy or dosage adjustment, and every 4 weeks thereafter for maintenance. PTH should be measured 4 weeks after initiation of therapy or dose adjustment. In individuals with PTH levels below the target range, reduce the dose of Parsabiv or temporarily stop the therapy. Once PTH and serum calcium levels return to the target range, therapy will be initiated at a lower dose. Among individuals with a corrected serum calcium of at least 7.5 mg/dL but below target range and without symptoms of hypocalcemia, consider reducing the dose, temporarily stopping therapy, or adding on therapies to increase serum calcium. If therapy is stopped, reinitiate at a lower dose when PTH and serum calcium levels return to the target range. If the corrected serum calcium falls below 7.5 mg/dL, or if patient is experiencing symptomatic hypocalcaemia, stop the therapy and treat hypocalcaemia.
• Cinacalcet should be discontinued for at least 7 days prior to starting Parsabiv.
• If serum calcium falls below 7.5 mg/dL or if patient reports symptoms of hypocalcemia, therapy should be discontinued.

V. Dosage and Administration

VI. Product Availability

Solution in single-dose vials for injection: 2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.