Zoledronic Acid (Reclast®) Injection

Covered for FDA‑approved uses (treatment/prevention of osteoporosis in postmenopausal women and men, glucocorticoid‑induced osteoporosis, Paget’s disease) and compendial use for osteogenesis imperfecta; other off‑label uses are not covered. Approval requires documented diagnosis and meeting clinical criteria (fragility fracture or T‑score thresholds for osteoporosis, or T‑score −1.0 to −2.5 with high fracture risk for prevention), documentation of a 12‑month trial/failure or significant intolerance to oral bisphosphonates or inability to take them, glucocorticoid therapy ≥7.5 mg prednisone equivalent expected ≥12 months when applicable, specified dosing/frequency limits (5 mg IV yearly for treatment, every 2 years for prevention, single dose for Paget’s, weight‑based dosing for OI), and reauthorization evidence of stability, reduced fractures, or increased BMD (prevention requires ≥24 months since last dose).

"Treatment and prevention of osteoporosis in postmenopausal women."