Xgeva Prior Authorization Criteria - Medicare Part D

Prior authorization criteria for approval

Xgeva will be approved when ALL of the following are met:

1. ONE of the following:

   1. The patient has a diagnosis of multiple myeloma AND BOTH of the following:

      1. The requested medication will be used for the prevention of skeletal-related events
         AND

      2. ONE of the following:

         1. The patient has a pretreatment or current calcium level that is NOT below the limits of the testing laboratory’s normal range
            OR
         2. The patient has a pretreatment or current calcium level that is below the limits of the testing laboratory’s normal range AND it will be corrected prior to use of the requested medication
            OR
         3. The prescriber has indicated that the patient is not at risk for hypocalcemia (not including risk associated with the requested medication)
            OR

   2. The patient has a diagnosis of prostate cancer AND ALL of the following:

      1. The requested medication will be used for the prevention of skeletal-related events
         AND

      2. The patient has bone metastases
         AND

      3. ONE of the following:

         1. The patient has a pretreatment or current calcium level that is NOT below the limits of the testing laboratory’s normal range
            OR
         2. The patient has a pretreatment or current calcium level that is below the limits of the testing laboratory’s normal range AND it will be corrected prior to use of the requested medication
            OR
         3. The prescriber has indicated that the patient is not at risk for hypocalcemia (not including risk associated with the requested medication)
            OR

   3. The patient has a solid tumor cancer diagnosis (e.g., thyroid, non-small cell lung, kidney cancer, or breast cancer) AND ALL of the following:

      1. The requested medication will be used for the prevention of skeletal-related events
         AND

      2. The patient has bone metastases
         AND

      3. ONE of the following:

         1. The patient has a pretreatment or current calcium level that is NOT below the limits of the testing laboratory’s normal range
            OR
         2. The patient has a pretreatment or current calcium level that is below the limits of the testing laboratory’s normal range AND it will be corrected prior to use of the requested medication
            OR
         3. The prescriber has indicated that the patient is not at risk for hypocalcemia (not including risk associated with the requested medication)
            OR

   4. The patient has a diagnosis of giant cell tumor of bone AND ONE of the following:

      1. The patient has a pretreatment or current calcium level that is NOT below the limits of the testing laboratory’s normal range
         OR
      2. The patient has a pretreatment or current calcium level that is below the limits of the testing laboratory’s normal range AND it will be corrected prior to use of the requested medication
         OR
      3. The prescriber has indicated that the patient is not at risk for hypocalcemia (not including risk associated with the requested medication)
         OR

   5. The patient has a diagnosis of hypercalcemia of malignancy
      AND

2. The patient will NOT be using the requested medication in combination with Prolia (denosumab)
   AND

3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

4. The requested dose is within FDA labeled dosing for the requested indication

Length of approval: 12 months