OnabotulinumtoxinA (Botox®)

Covers onabotulinumtoxinA (Botox) for the listed FDA‑approved indications and select compendial off‑label uses (e.g., OAB, neurogenic detrusor overactivity urinary incontinence, chronic migraine, upper/lower limb spasticity, cervical dystonia, primary axillary hyperhidrosis, blepharospasm, strabismus, sialorrhea, achalasia, anal fissure, hemifacial spasm, spasmodic dysphonia, oromandibular dystonia), with exclusions for indication‑specific contraindications (e.g., UTI or urinary retention for bladder indications). Approvals require documented diagnosis, indication‑specific prior therapy failure or intolerance (e.g., ≥1 anticholinergic for OAB/DO; ≥2 preventive agents and ≥15 headache days/month for initial chronic migraine), objective baseline and follow‑up measures, adherence to per‑indication dosing and minimum intervals (generally not more frequently than every 12 weeks), and specified initial (6 months for migraine, 12 months others) and 12‑month reauthorization durations with demonstrated therapeutic benefit.