Prolia® (denosumab) Non-Oncology

Covered: Prolia (denosumab) is covered only for FDA‑approved non‑oncology uses — treatment of postmenopausal osteoporosis, osteoporosis in men at high fracture risk, and glucocorticoid‑induced osteoporosis — and oncology or other off‑label uses are excluded. Key requirements: approval (up to 12 months; dosing 60 mg SC every 6 months) requires documented diagnostic criteria (osteoporotic/fragility fracture or T‑score ≤ −2.5, or T‑score −1.0 to −2.5 with high fracture risk), one of the prior‑therapy/clinical criteria (e.g., 12‑month oral bisphosphonate failure, significant intolerance or inability to take oral bisphosphonates, trial of IV bisphosphonate, prior fracture, or CrCl <30 mL/min), glucocorticoid users must be on ≥7.5 mg prednisone‑equivalent and expected ≥6 months, CrCl <30 mL/min patients require evaluation for mineral and bone disorder to reduce hypocalcemia risk, and reauthorization requires documented clinical benefit (stability, fewer vertebral fractures, or increased BMD).