Zoledronic Acid (Reclast)

Reclast (zoledronic acid) is covered only for FDA‑approved indications (treatment/prevention of postmenopausal osteoporosis, treatment of osteoporosis in men, glucocorticoid‑induced osteoporosis, and Paget’s disease) and no off‑label uses meet coverage. Approval requires safety labs (serum calcium > lower limit of normal, CrCl ≥35 mL/min, no acute renal impairment), documentation of BMD/FRAX or fragility fracture as applicable, prior inadequate response/contraindication/intolerance to oral bisphosphonates for osteoporosis indications, adherence to specified dosing/frequency, a 12‑month authorization, and Paget’s retreatment only for relapse, persistent elevated alkaline phosphatase, or symptoms.

"Treatment and prevention of osteoporosis in postmenopausal women"

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