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Coverage criteria policies

Etelcalcetide (Parsabiv™) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Etelcalcetide (Parsabiv) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

All requests for doses exceeding the FDA-approved regimen will not be covered.

Initial Authorizations:
  1. Patient must be at least 18 years old; and,
  2. Patient must have a diagnosis of second hyperparathyroidism (HPT) with chronic kidney disease (CKD) on hemodialysis meeting all of the following criteria:
    1. Patient must have intact parathyroid hormone (iPTH) level > 300 pg/mL
    2. Patient must be receiving hemodialysis 3 times weekly for at least 3 months; and,
  3. Patient’s corrected calcium level ≥ 7.5 mg/dL; and,
  4. Patient is on stable doses of active vitamin D analogs or calcium supplements or phosphate binders as documented in pharmacy fill history or other documentation indicating fill/refill history if patient is new to Medical Assistance and pharmacy claims data is not readily available; and,
  5. Patient has documented trial and failure of oral Sensipar therapy and Sensipar was discontinued for at least 7 days prior to starting Parsabiv; and,
  6. Prescriber must have a documented targeted treatment goal for the patient at baseline.

Initial approval will be for 6 months.

Reauthorizations:

  1. Patient must have >30% reduction from baseline in mean iPTH; or,
  2. Patient must meet targeted goal identified at baseline

Renewal approval will be for 12 months.

Quantity limit

15 mg three times per week.

Definitions

Parsabiv is a calcium-sensing receptor agonist indicated for:

  • 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.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS Codes

Codes

Description

J0606

Injection, etelcalcetide, 0.1 mg

NDC Codes

Codes

Description

55513074001

Parsabiv 2.5 MG/0.5ML SOLN

55513074010

Parsabiv 2.5 MG/0.5ML SOLN

55513074101

Parsabiv 5 MG/ML SOLN

55513074110

Parsabiv 5 MG/ML SOLN

55513074201

Parsabiv 10 MG/2ML SOLN

55513074210

Parsabiv 10 MG/2ML SOLN

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/parsabiv.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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