Effective Date:

1.     This policy will apply to all services performed on or after the above revision date which will become the new effective date.

2.     For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Prolia and Xgeva both require prior authorization.

2)    Prolia and Xgeva are considered specialty medications.

3)    Prolia is used to treat osteoporosis in men and post-menopausal women at high risk for fracture, for treatment of bone loss in women with breast cancer, and in men with non-metastatic prostate cancer.

4)    Xgeva is used for the prevention of skeletal-related events in patients with bone metastases from solid tumors (including prostate cancer), in the treatment of giant cell tumor of bone, and hypercalcemia of malignancy.

Prolia is considered medically necessary for patients who meet the following criteria:

1)    Diagnosis of osteoporosis in men and post-menopausal women at high risk for fracture*  (M80.011A-M80.88XS, M81.0, M81.8) and trial/failure or intolerance to at least two (2) bisphosphonates (oral or injectable)

                                                             OR

2)    Diagnosis of bone loss in women with breast cancer (C50.011-C50.929)

OR

3)    Diagnosis of non-metastatic prostate cancer in males (for metastatic prostate cancer, see Xgeva criteria below) (C61)

*High risk for fracture defined as:

1) A QFracture calculated 10 year osteoporotic fracture risk of 9% or greater, or a calculated 10 year osteoporotic hip fracture risk of 2% or greater. (See http://www.qfracture.org) or

2) A WHO FRAX® calculated risk of 9% or greater (see http://www.shef.ac.uk/FRAX/tool.jsp) or

3) Prolonged use of high doses of corticosteroids (doses> 7mg/day of prednisone or the equivalent for more than 3 months or

4) Prolonged bed rest – exceeding 90 days of non-weight bearing

5) Starvation: a prolonged period with BMI below 17

The occurrence of pathologic fractures without other apparent cause

6) The occurrence of multiple fractures with minimal trauma such as compression fractures documented by x-ray

Xgeva is considered medically necessary for patients who meet the following criteria:

1)    For use in patients for the prevention of skeletal-related events with bone metastases (C40.00-C41.9) from solid tumors, including prostate cancer.

2)    For treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity (D48.0)

3)    For the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy.

Codes Used In This BI:

J0897           Denosumab injection

1)    Prolia Product Information.  Amgen.  September 2010

2)    Clinical Pharmacology Online. “Denosumab”, retrieved May 2017.

3)    Xgeva Product Information.  Amgen.  June 2013.

Addendum:

1.     Effective 05/01/2017:  Updated to include Prolia approved for men with osteoporosis and Xgeva approved for hypercalcemia of malignancy refractory to bisphosphonate therapy.

2.     Effective 07/01/2017: Updated to include trial/failure or intolerance to at least two (2) bisphosphonates (oral or injectable) for approval of Prolia to treat osteoporosis.