cinacalcet — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of hypercalcemia due to parathyroid carcinoma OR
• B. The patient has a diagnosis of primary hyperparathyroidism (HPT) AND BOTH of the following:
• 1. Pretreatment serum calcium level above the laboratory’s upper limit of normal AND
• 2. Patient unable to undergo parathyroidectomy OR
• C. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) AND ALL of the following:
• 1. Patient is on dialysis AND
• 2. Pretreatment or current intact PTH (iPTH) level > 300 pg/mL AND
• 3. ONE of the following regarding phosphate binder therapy:
• A. Tried and had inadequate response to a phosphate binder [e.g., calcium acetate, calcium carbonate, Renvela (sevelamer carbonate), Fosrenol (lanthanum carbonate), Renagel (sevelamer hydrochloride)] OR
• B. Intolerance or hypersensitivity to phosphate binder therapy OR
• C. FDA labeled contraindication to all phosphate binder agents AND
• 4. ONE of the following regarding vitamin D analog therapy:
• A. Tried and had inadequate response to a vitamin D analog [e.g., calcitriol, Hectorol (doxecalciferol), Rayaldee (calcifediol), Zemplar (paricalcitol)] OR
• B. Intolerance or hypersensitivity to vitamin D analog therapy OR
• C. FDA labeled contraindication to all vitamin D analog agents OR
• D. The patient has another FDA-approved indication for the requested agent OR
• E. The patient has another indication that is supported in compendia for the requested agent
• AND the patient’s age is within FDA labeling or is supported for the requested indication
• AND if the request is for a brand agent with a generic equivalent (Sensipar/cinacalcet) then ONE of the following:
• A. Intolerance or hypersensitivity to generic not expected with brand OR
• B. FDA labeled contraindication to generic not expected with brand OR
• C. Clinical support for brand use over generic
• AND the patient will NOT be using in combination with another calcium-sensing receptor agonist [e.g., Parsabiv (etelcalcetide)]
• AND the patient has no FDA labeled contraindications

Reauthorization criteria

• 1. Patient previously approved for the requested agent through plan prior authorization process AND
• 2. ONE of the following:
• A. Diagnosis of hypercalcemia due to parathyroid carcinoma OR
• B. BOTH of the following:
• 1. Diagnosis of primary hyperparathyroidism (HPT) AND
• 2. Serum calcium level evaluated to confirm appropriateness of current dose OR
• C. Diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) AND BOTH of the following:
• 1. Patient is on dialysis AND
• 2. Intact PTH (iPTH) level evaluated to confirm appropriateness of current dose OR
• D. Another FDA approved indication OR
• E. Another indication supported in compendia for the requested agent
• AND if the request is for brand agent with a generic equivalent (Sensipar/cinacalcet) then ONE of the following:
• A. Intolerance or hypersensitivity to generic not expected with brand OR
• B. FDA labeled contraindication to generic not expected with brand OR
• C. Clinical support for brand agent over generic
• AND patient has had clinical benefit with the requested agent
• AND not used in combination with another calcium-sensing receptor agonist [e.g., Parsabiv (etelcalcetide)]
• AND no FDA labeled contraindications

Approval duration

12 months