The use of botulinum toxin may be considered medically necessary for the following:
• Cervical dystonia (spasmodic torticollis; applicable whether congenital, due to child birth injury, or traumatic injury). For this use, cervical dystonia must be associated with sustained head tilt or abnormal posturing with limited range of motion in the neck AND a history of recurrent involuntary contraction of one or more of the muscles of the neck, eg, sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.a (See additional details in Policy Guidelines section.)
• Upper-limb spasticitya
• Dystonia/spasticity resulting in functional impairment (interference with joint function, mobility, communication, nutritional intake) and/or pain in patients with any of the following:
o Focal dystonias:
§ Focal upper-limb dystonia (eg, organic writer’s cramp)
§ Oromandibular dystonia (orofacial dyskinesia, Meige syndrome)
§ Laryngeal dystonia (adductor spasmodic dysphonia)
§ Idiopathic (primary or genetic) torsion dystonia
§ Symptomatic (acquired) torsion dystonia
o Spastic conditions
§ Cerebral palsy
§ Spasticity related to stroke
§ Acquired spinal cord or brain injury
§ Hereditary spastic paraparesis
§ Spastic hemiplegia
§ Neuromyelitis optica
§ Multiple sclerosis or Schilder disease
• Strabismusa
• Blepharospasm or facial nerve (VII) disorders (including hemifacial spasm)a
• Prevention (treatment) of chronic migraine headache in the following situationsa:
o Initial 6-month trial: Adults who:
§ meet International Classification of Headache Disorders diagnostic criteria for chronic migraine headache (see Policy Guidelines) and
§ have symptoms that persist despite adequate trials of at least 2 agents from different classes of medications used in the treatment of chronic migraine headaches (eg, antidepressants, antihypertensives, antiepileptics). Patients who have contraindications to preventive medications are not required to undergo a trial of these agents.
o Continuing treatment beyond 6 months:
§ Migraine headache frequency reduced by at least 7 days per month compared with pretreatment level, or
§ Migraine headache duration reduced at least 100 hours per month compared with pretreatment level.
• Esophageal achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates
• Sialorrhea (drooling) associated with Parkinson disease
• Chronic anal fissure
• Urinary incontinence due to detrusor overactivity associated with neurogenic causes (eg, spinal cord injury, multiple sclerosis) in patients unresponsive to or intolerant of anticholinergicsa
• Overactive bladder in adults unresponsive to or intolerant of anticholinergics.a
a Food and Drug Administration-approved indication for at least one of the agents.
With the exception of cosmetic indications, the use of botulinum toxin is considered investigational for all other indications not specifically mentioned above, including, but not limited to:
• headaches, except as noted above for prevention (treatment) of chronic migraine headache
• sialorrhea (drooling) except that associated with Parkinson disease
• internal anal sphincter achalasia
• benign prostatic hyperplasia
• interstitial cystitis
• detrusor sphincteric dyssynergia (after spinal cord injury)
• chronic low back pain
• joint pain
• mechanical neck disorders
• neuropathic pain
• myofascial pain syndrome
• temporomandibular joint disorders
• trigeminal neuralgia
• pain after hemorrhoidectomy or lumpectomy
• tremors such as benign essential tremor (upper extremity)
• tinnitus
• chronic motor tic disorder and tics associated with Tourette syndrome (motor tics)
• lateral epicondylitis
• prevention of pain associated with breast reconstruction after mastectomy
• Hirschsprung disease
• gastroparesis
• facial wound healing
• depression.
The use of botulinum toxin may be considered investigational as a treatment of wrinkles or other cosmetic indications.
The use of assays to detect antibodies to botulinum toxin is considered investigational.
