Parsabiv™

Drug - Parsabiv™ (etelcalcetide) [Amgen]

February 2018

Therapeutic area - Hyperparathyroidism

Initial approval criteria

Patient must be at least 18 years old AND
Patient must have a diagnosis of second hyperparathyroidism (HPT) with chronic kidney disease (CKD) on hemodialysis meeting ALL of the following criteria:
- Patient must have intact parathyroid hormone (iPTH) level > 300 pg/mL
- Patient must be receiving hemodialysis 3 times weekly for at least 3 months AND
Patient’s corrected calcium level ≥ 7.5 mg/dL AND
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
Patient has documented trial and failure of oral Sensipar therapy AND Sensipar was discontinued for at least 7 days prior to starting Parsabiv AND
Prescriber must have a documented targeted treatment goal for the patient at baseline
Initial approval will be for 6 months

Renewal criteria

Patient must have >30% reduction from baseline in mean iPTH; OR
Patient must meet targeted goal identified at baseline
Renewal approval will be for 12 months

Quantity limits

15 mg three times per week

Billing for Parsabiv

Parsabiv must be billed as a medical claim.

Background

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.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411