OnabotulinumtoxinA (Botox)

Covers FDA‑approved and compendial off‑label uses of onabotulinumtoxinA for the listed indications (e.g., overactive bladder, detrusor overactivity/urinary incontinence, chronic migraine, adult/pediatric spasticity, cervical dystonia, primary axillary hyperhidrosis, blepharospasm, strabismus, and other specified off‑label uses) and excludes use when indication‑specific exclusionary conditions apply (e.g., UTI/urinary retention for bladder indications) or criteria are not met. Approvals require documented prior treatment failures/intolerances and indication‑specific diagnostics (e.g., anticholinergic failure and no UTI for bladder, neurologic etiology for detrusor overactivity, ≥2 preventive agents plus ≥15 headache days/month for initial migraine), adherence to indication‑specific dosing/frequency maxima (e.g., 100–200 U for bladder every ≥12 weeks, 155 U for migraine every ≥12 weeks, adult spasticity up to 400 U, pediatric ≤6 U/kg or 200 U), and evidence of benefit for reauthorization (e.g., 50% reduction in headache days for migraine).