Xeomin (incobotulinumtoxinA) — Medical Mutual

Initial criteria

• Patient age ≥ 18 years (unless otherwise specified); AND
• Evaluated for disorders which may contribute to respiratory or swallowing difficulty; AND
• No hypersensitivity to any botulinum toxin product; AND
• No active infection at injection site; AND
• Not on concurrent treatment with another botulinum toxin product; AND
• Cervical Dystonia: History of recurrent involuntary contraction of neck/shoulder muscles AND sustained head tilt OR abnormal posturing with limited range of motion; OR
• Blepharospasm: Clinical diagnosis present; OR
• Spasticity: Upper limb spasticity in adults post-stroke OR Pediatric upper limb spasticity in patients aged 2–17 years excluding cerebral palsy; OR
• Prophylaxis for Chronic Migraine: Utilizing prophylactic intervention modalities; AND Diagnosis of chronic migraine (≥15 headache days/month for >3 months); AND ≥5 attacks with migraine features; AND On ≥8 days/month headaches resemble migraine or relieved by triptan/ergot; AND (Failed ≥8-week trial of two migraine prophylactic oral medications OR Prior treatment with a CGRP antagonist); OR
• Neurogenic Detrusor Overactivity: Detrusor overactivity associated with neurologic condition confirmed by urodynamics; AND Failed ≥1 month trial with two medications from antimuscarinic or beta-adrenergic class; OR
• Overactive Bladder (OAB): Symptoms of urge incontinence, urgency, frequency; AND Failed ≥1 month trial with two medications from antimuscarinic or beta-adrenergic classes; OR
• Severe Primary Axillary Hyperhidrosis: Failed ≥1 month trial of a topical agent; AND (History of medical complications OR Significant disease impact on daily living); OR
• Chronic Sialorrhea: Troublesome sialorrhea for ≥3 months; AND Diagnosis of Parkinson's disease, atypical Parkinsonism, stroke, traumatic brain injury, severe developmental delay, cerebral palsy, other genetic/congenital disorder, or traumatic brain injury; AND age ≥ 2 years; OR
• Ventral Hernia: Large ventral hernia with loss of domain or contamination; AND Planned abdominal wall reconstruction; preoperative use only.

Reauthorization criteria

• Continues to meet universal and indication-specific criteria; AND
• Authorization duration not exceeded; AND
• No unacceptable toxicity (e.g., toxin spread, hypersensitivity, corneal ulceration, ectropion, etc.); AND
• Evidence of disease response by indication:
• → Blepharospasms: Improvement in severity/frequency of eyelid spasms
• → Cervical Dystonia: Improvement in pain and abnormal head positioning
• → Upper Limb Spasticity: Decreased tone/resistance via validated tool
• → Severe Axillary Hyperhidrosis: Significant reduction in sweat production AND improvement in daily functioning
• → Chronic Migraine: Decrease in frequency/intensity of headaches AND functional improvement AND continued prophylactic modality use
• → Neurogenic Detrusor Overactivity: Significant reduction in incontinence episodes AND periodic PVR assessment
• → Overactive Bladder: Improvement in incontinence or micturition frequency/volume AND periodic PVR assessment
• → Chronic Sialorrhea: Significant decrease in saliva production
• Note: Ventral Hernia indication may NOT be renewed

Approval duration

12 months