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

Denosumab (Prolia, Jubbonti, Stoboclo, Conexxence) is covered only for non‑oncology FDA‑approved indications — postmenopausal osteoporosis at high fracture risk, increasing bone mass in men with osteoporosis at high fracture risk, and glucocorticoid‑induced osteoporosis (prednisone‑equivalent ≥7.5 mg/day expected ≥6 months) — oncology uses are excluded. Coverage requires documented diagnostic criteria (osteoporotic/fragility fracture or T‑score ≤‑2.5, or T‑score −1.0 to −2.5 with high fracture risk), prior trial of oral bisphosphonate for 12 months (or documented intolerance/contraindication or prior IV bisphosphonate where applicable), CrCl assessment with MBD evaluation if CrCl <30 mL/min, planned dosing 60 mg SC every 6 months with 12‑month authorization, and reauthorization must show stability, reduced vertebral fractures, or increased BMD.

"For patients with advanced chronic kidney disease (CrCL < 30 mL/min), the presence of mineral and bone disorder (MBD) has been evaluated to reduce the risk of denosumab-induced hypocalcemia."