Denosumab (Prolia)

Denosumab (Prolia) is covered only for FDA‑approved non‑oncology osteoporosis indications — postmenopausal women at high fracture risk, men with osteoporosis at high fracture risk, and glucocorticoid‑induced osteoporosis (patients on ≥7.5 mg/day prednisone‑equivalent expected ≥6 months); non‑FDA indications are excluded. Approval requires documented osteoporotic/fragility fracture or T‑score ≤ −2.5 (or low bone mass with high fracture risk) plus prior inadequate response to or intolerance/inability to take oral bisphosphonates (or trial of IV bisphosphonate, or severe renal impairment/CKD), with supporting BMD, medication, and renal documentation; authorization is limited to 12 months and dosing is 60 mg SC every 6 months.

"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..."