Denosumab (CPB 0804, reviewed 2026-06-08)
Summary
Aetna's commercial medical policy sets coverage criteria for Prolia and its biosimilars and for Xgeva and its biosimilars, and precertification is required for these products in applicable plan designs. Prolia and its biosimilars are considered medically necessary for postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer, bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer, and inhibiting progression of bone erosion in rheumatoid arthritis. Xgeva and its biosimilars are considered medically necessary for multiple myeloma, bone metastases from a solid tumor, giant cell tumor of bone, hypercalcemia of malignancy refractory to intravenous bisphosphonate therapy, and second-line therapy for osteopenia or osteoporosis in systemic mastocytosis. All other indications are considered experimental, investigational, or unproven, and combination therapy of denosumab with intravenous bisphosphonates is also considered experimental, investigational, or unproven.
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