SENSIPAR (cinacalcet)

SENSIPAR (cinacalcet)

SELF ADMINISTRATION - Oral

Indications for Prior Authorization: 

• Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis

  •   Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis

• Hypercalcemia in adult patients with Parathyroid Carcinoma (PC)   

• Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy

Patients must meet the following criteria for the indication(s) above:

Secondary Hyperparathyroidism due to CKD

• Patient is 18 years of age or older, AND

• Patient has a diagnosis of secondary hyperparathyroidism due to chronic kidney disease as confirmed by chart note documentation, AND

• Prescribed by or in consultation with a specialist (e.g. oncologist, nephrologist, or endocrinologist), AND

• Patient is currently on dialysis, AND

• Current lab results show iPTH and serum calcium level is above the normal range, AND

• Patient has tried and failed a Vitamin D analog (e.g. Calcitriol, Hectorol®, Zemplar®), AND

• Patient has tried and failed a phosphate binder (e.g., PhosLo®, Fosrenol®, Renvela®, Renagel®) unless contraindicated

Parathyroid Carcinoma

• Patient is 18 years of age or older, AND

• Patient has a diagnosis of Hypercalcemia Parathyroid Carcinoma as confirmed by chart note documentation, AND

• Prescribed by or in consultation with a specialist (e.g. oncologist, nephrologist, or endocrinologist), AND

• Patient has a serum calcium level of ≥ 12.5 mg/dL prior to initiation of therapy

Primary Hyperparathyroidism

• Patient is 18 years of age or older, AND

• Patient has a diagnosis of Primary Hyperparathyroidism as confirmed by chart note documentation, AND

• Prescribed by or in consultation with a specialist (e.g. oncologist, nephrologist, or endocrinologist), AND

• Patient is not a candidate for parathyroidectomy, AND

• Patient has a serum calcium level of ≥ 12.5 mg/dL prior to initiation of therapy

Contraindications to treatment:

• Sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range

Reauthorization Criteria:

• Patient has one of the following:
  • Patient has secondary HPT and has a decrease in iPTH level, OR
  • Patient has PC or primary HPT and has a decrease in serum calcium levels

Dosing:

• Secondary Hyperparathyroidism (HPT):
  • Initial: 30mg once daily
  • Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels
• Parathyroid Carcinoma (PC) and Primary Hyperparathyroidism (HPT):
  • Initial: 30 mg twice daily
  • Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels
• Once the maintenance dose has been established, monitor serum calcium approximately monthly for patients with secondary HPT and every 2 months for patients with PC or primary HPT

Approval: 

• Initial: 6 months
• Renewal: 1 year