Cinacalcet will be approved when the following is met:
- The patient has ONE of the following:
- A diagnosis of hypercalcemia due to parathyroid carcinoma
OR - A diagnosis of primary hyperparathyroidism (HPT) AND BOTH of the following:
- The patient has a pretreatment serum calcium level that is above the testing laboratory’s upper limit of normal
AND - The patient is unable to undergo parathyroidectomy
OR
- The patient has a pretreatment serum calcium level that is above the testing laboratory’s upper limit of normal
- Another indication that is FDA approved or supported in CMS approved compendia for the requested medication not otherwise excluded from Part D [i.e., secondary hyperparathyroidism due to end-stage renal disease (ESRD) on dialysis]
- A diagnosis of hypercalcemia due to parathyroid carcinoma
NOTE: The use of cinacalcet for the diagnosis of secondary hyperparathyroidism (HPT) due to endstage renal disease (ESRD) on dialysis is not a Medicare Part D eligible indication but is coverable under Medicare Part B from the covered uses.
Length of approval: 12 months
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