Denosumab (Prolia®)

Covers Prolia (denosumab) for FDA‑approved non‑oncology indications — postmenopausal osteoporosis at high fracture risk, osteoporosis in men at high fracture risk, and glucocorticoid‑induced osteoporosis (must be on ≥7.5 mg/day prednisone equivalent and expected ≥6 months); oncology uses are excluded. Approval (12 months) requires documented diagnosis and meeting diagnostic criteria (fracture or T‑score ≤‑2.5 or low bone mass with high fracture risk), prior‑therapy/practical criteria (12‑month oral bisphosphonate failure or documented intolerance, or listed exceptions such as IV bisphosphonate trial, inability to take oral agents, or severe renal impairment/CKD), dosing of 60 mg SC every 6 months, and reauthorization requires objective benefit (stability, reduced 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..."