Denosumab Products (Prolia, Jubbonti, Stoboclo, Conexxence, Bildyos, Ospomyv) Non-oncology

Denosumab products (Prolia, Jubbonti, Stoboclo, Conexxence, Bildyos, Ospomyv) are covered only for FDA‑approved non‑oncology indications — postmenopausal osteoporosis at high fracture risk, to increase bone mass in men at high risk, and glucocorticoid‑induced osteoporosis for patients on ≥7.5 mg prednisone‑equivalent expected ≥6 months — dosed 60 mg SC every 6 months with 12‑month authorization; use outside these indications is not covered. Initial approval requires diagnostic evidence (osteoporotic/fragility fracture or qualifying T‑score/low bone mass with high fracture risk) plus prior 12‑month oral bisphosphonate trial with documented failure/intolerance or inability to use bisphosphonates (or prior IV bisphosphonate), CrCL <30 mL/min patients require MBD evaluation to mitigate hypocalcemia, and reauthorization requires documented stability, reduced vertebral fractures, or increased BMD.

"Treatment of postmenopausal women with osteoporosis at high risk for fracture"