Denosumab Products (Prolia, Jubbonti, Stoboclo) Non-oncology

Denosumab (Prolia, Jubbonti, Stoboclo) is covered only for FDA‑approved non‑oncology indications—postmenopausal osteoporosis, osteoporosis in men, and glucocorticoid‑induced osteoporosis—and oncology uses are excluded. Approval requires documented diagnosis (osteoporotic/fragility fracture or T‑score ≤‑2.5 or low bone mass with high fracture risk), evidence of prior therapy or contraindication (typically a 12‑month oral bisphosphonate trial with inadequate efficacy, documented intolerance/inability to take oral bisphosphonates, prior IV bisphosphonate, or advanced CKD with MBD evaluation), glucocorticoid cases must show ≥7.5 mg prednisone‑equivalent use expected ≥6 months, dosing is 60 mg SC every 6 months, authorization is for 12 months, and reauthorization requires documented clinical benefit (stability, fewer vertebral fractures, or increased BMD).

"Treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or a..."