Sensipar – NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Sensipar® (cinacalcet)

FDA Approved Use

• For the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. 
• For the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma (PC) 
• For the treatment of 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.

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient does NOT have hypocalcemia, as treatment is contraindicated if serum calcium is less than the lower limit of the normal range, AND 
3. If the request is for brand Sensipar,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic cinacalcet (medical record documentation required); AND 
4. ONE of the following:
   1. The patient has a diagnosis of hypercalcemia due to parathyroid carcinoma (medical record documentation required); OR 
   2. The patient has a diagnosis of primary hyperparathyroidism (HPT) (medical record documentation required) and BOTH of the following:
      1. The patient currently has or had pretreatment severe hypercalcemia, defined as serum calcium >12.5 mg/dL; AND 
      2. The patient is unable to undergo parathyroidectomy; OR 
   3. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) (medical record documentation required) and ALL of the following:
      1. The patient is on dialysis; AND 
      2. The patient has a pretreatment or current intact PTH (iPTH) level >300 pg/mL; AND 
      3. The patient has tried and failed or had an inadequate response to a prerequisite agent [Fosrenol®1 (lanthanum carbonate), Renvela®1 (sevelamer carbonate), Renagel®1 (sevelamer hydrochloride), calcium acetate or calcium carbonate]; OR
         1. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a prerequisite agent [Fosrenol (lanthanum carbonate), Renvela (sevelamer carbonate), Renagel (sevelamer hydrochloride), calcium acetate or calcium carbonate]; AND
5. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Ketteler M, Block GA, Evenepoel P, et al. Executive summary of the 2017 KDIGO Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Guideline Update: what's changed and why it matters. Kidney Int 2017; 92:26.

Policy Implementation/Update Information

October 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. Added medical record documentation required for diagnosis. Added the patient is 18 years of age and the prescribed dose and quantity are appropriate based on intended use and FDA labeling.
March 2022: Criteria update: Annual criteria review. No changes to policy.
April 2019: Reviewed criteria against current guidelines
March 2019: Added generic cinacalcet to restricted category
January 2016: Original utilization management criteria issued.