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Prolia Prior Authorization Criteria – Medicare Part D

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Medicare Drug Policy
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Version Date: January 1, 2025
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Prior Authorization Criteria for Approval

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

  1. ONE of the following:

    1. The patient’s sex is male or the patient is postmenopausal with a diagnosis of osteoporosis AND BOTH of the following:

      1. The patient’s diagnosis was confirmed by ONE of the following:

        1. A fragility fracture in the hip or spine OR

        2. A T-score of -2.5 or lower OR

        3. A T-score of -1.0 to -2.5 AND ONE of the following:

          1. A fragility fracture of the proximal humerus, pelvis, or distal forearm OR
          2. a FRAX 10-year probability for major osteoporotic fracture of 20% or greater OR
          3. a FRAX 10-year probability of hip fracture of 3% or greater AND

      2. ONE of the following:

        1. The patient is at a very high fracture risk as defined by ONE of the following:

          1. Patient had a recent fracture (within the past 12 months) OR
          2. Patient had fractures while on FDA approved osteoporosis therapy OR
          3. Patient has had multiple fractures OR
          4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
          5. Patient has a very low T-score (less than -3.0) OR
          6. Patient is at high risk for falls or has a history of injurious falls OR
          7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR

        2. ONE of the following:

          1. The patient’s medication history includes use of a bisphosphonate OR
          2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to a bisphosphonate OR

    2. The patient is requesting the medication for osteopenia (osteoporosis prophylaxis) AND ALL of the following:

      1. ONE of the following:

        1. The patient’s sex is male and the patient is at least 50 years of age OR
        2. The patient is postmenopausal Updated: 01/01/2025 AND

      2. The patient has a T-score between -1.0 to -2.50 AND

      3. The patient has ONE of the following:

        1. A fragility fracture of the proximal humerus, pelvis, or distal forearm OR
        2. 10-year probability of a hip fracture 3% and greater per FRAX OR
        3. 10-year probability of a major OP-related fracture 20% and greater per FRAX AND

      4. ONE of the following:

        1. The patient’s medication history includes use of a bisphosphonate OR
        2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to a bisphosphonate OR

    3. The patient’s sex is female with a diagnosis of breast cancer who is receiving aromatase inhibitor therapy AND ONE of the following:

      1. The patient’s medication history includes use of a bisphosphonate OR
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to a bisphosphonate OR

    4. The patient’s sex is male with a diagnosis of prostate cancer receiving androgen deprivation therapy (ADT) AND ONE of the following:

      1. The patient’s medication history includes use of a bisphosphonate OR
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to a bisphosphonate OR

    5. The patient has a diagnosis of glucocorticoid-induced osteoporosis AND ALL of the following:

      1. The patient is either initiating or continuing systemic glucocorticoids in a daily dose equivalent to 7.5 mg or greater of prednisone AND

      2. The patient is expected to remain on glucocorticoids for at least 6 months AND

      3. The patient’s diagnosis was confirmed by ONE of the following:

        1. A fragility fracture in the hip or spine OR

        2. A T-score of -2.5 or lower OR

        3. A T-score of -1.0 to -2.5 AND ONE of the following:

          1. A fragility fracture of the proximal humerus, pelvis, or distal forearm OR
          2. A FRAX 10-year probability for major osteoporotic fracture of 20% or greater OR
          3. A FRAX 10-year probability of hip fracture of 3% or greater AND

      4. ONE of the following:

        1. The patient is at a very high fracture risk as defined by ONE of the following:

          1. Patient had a recent fracture (within the past 12 months) OR
          2. Patient had fractures while on FDA approved osteoporosis therapy OR
          3. Patient has had multiple fractures Updated: 01/01/2025 OR
          4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
          5. Patient has a very low T-score (less than -3.0) OR
          6. Patient is at high risk for falls or has a history of injurious falls OR
          7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR

        2. ONE of the following:

          1. The patient’s medication history includes use of a bisphosphonate OR
          2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to a bisphosphonate AND

  2. ONE of the following:

    1. The patient has a pretreatment or current calcium level that is NOT below the lower limit of the testing laboratory’s normal range OR
    2. The patient has a pretreatment or current calcium level that is below the lower limit 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) AND

  3. The patient will NOT be using the requested medication in combination with a bisphosphonate, another form of denosumab (e.g., Xgeva), romosozumab-aggg (Evenity), or parathyroid hormone analog [e.g., abloparatide (Tymlos), teriparatide (Forteo)] for the requested indication AND

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

  5. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Length of approval: 12 months

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