Zoledronic Acid (Reclast) Injection

Covered for FDA‑approved uses (treatment/prevention of postmenopausal osteoporosis, treatment of osteoporosis in men, glucocorticoid‑induced osteoporosis, Paget’s disease) and compendial use for osteogenesis imperfecta; other indications are not covered. Approvals require documentation of high fracture risk (fragility fracture or BMD ≤ −2.5, or T‑score −1.0 to −2.5 with high risk), prior 12‑month oral bisphosphonate failure or intolerance or prior IV bisphosphonate (unless fragility fracture), indication‑specific criteria (e.g., active systemic glucocorticoid use for GIOP; ALP ≥2×ULN or symptoms for Paget’s; weight and 0.05 mg/kg dosing for OI), and dosing/frequency limits (generally 5 mg IV no more often than once yearly for treatment, no more often than every 2 years for prevention; Paget’s single‑dose approval; prevention reauthorization ≥24 months since last dose).

"Treatment and prevention of osteoporosis in postmenopausal women"