Leuprolide Acetate (Fensolvi®, Lupron Depot- PED®, Lupron Depot®)

Leuprolide acetate (Fensolvi, Lupron Depot‑PED, Lupron Depot) is covered for non‑oncology FDA‑approved or compendial off‑label indications (CPP for Fensolvi/Lupron Depot‑PED; endometriosis, fibroids—including preoperative anemia with iron—and abnormal uterine bleeding [Lupron Depot only]; and gender‑affirming care); oncology uses are excluded. Key requirements: indication‑specific documentation (including age ≥2 for Fensolvi and CPP evidence for pediatric products), prior trial of specified therapies for adult Lupron Depot unless contraindicated, prescriber/consultation by an endocrinologist or transgender care specialist for gender‑affirming use, adherence to product dosing and approval durations (6–12 months), and matching FDA/compendial use.

"Coverage guideline: For Lupron Depot, approval when the individual has endometriosis."

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