• Treatment of strabismus in patients 12 years and older
• Treatment of blepharospasm associated with dystonia in patients 12 years and older
• Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia
• Treatment of severe primary axillary hyperhidrosis that is inadequately managed by topical agents in adult patients
• Treatment of upper limb spasticity in adult patients
• To prevent headaches in adult patients with chronic migraine (15 or more days per month with headache lasting 4 hours a day or longer)
• Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication

• Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naove and previously treated patients
• The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients <65 years of age
• Treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors

• Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naove and previously treated patients
• Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox)
• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
• Treatment of upper limb spasticity in adult patients

• For the treatment of adults with cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD

• Condition for which the toxin will be used

AND

• Anticipated frequency of injection

AND

• Total dose per visit

AND

• Previous therapies tried

AND

Diagnosis of one of the following:

• Strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older
• Hemifacial spasm
• Facial spasm
• Jaw-closing oromandibular dystonia
• Spasmodic dysphonia (laryngeal dystonia, lingual dystonia, laryngeal spasm)
• Spasmodic Torticollis (cervical dystonia)
• Focal task-specific dystonia
• Head and neck tremor
• Dynamic muscle contractions in pediatric cerebral palsy
• Limb spasticity
• Frey's Syndrome (gustatory sweating) secondary to parotid surgery
• Sialorrhea in Parkinson's Disease
• Detrussor sphincter dyssynergia (lower urinary tract dysfunction)

OR

• Overactive bladder or urinary incontinence due to detrusor overactivity associated with a neurologic condition

AND

• The patient has had an inadequate response to or clinically significant adverse reaction to at least two anticholinergic agents (oxybutynin immediate and extended release tabs, Oxytrol^R patch, Gelnique^R gel, tolteridine immediate and extended release, Toviaz^R, Enablex^R, Vesicare^R, trospium immediate and extended release).

OR

• Focal hand dystonias (organic writer's cramp) when incapacitating and refractive to medical treatment including oral medications

AND

• Documentation of functional limitations

AND

• The patient has failed or had a clinically significant adverse reaction to oral medications (baclofen, beta-blockers and benzodiazepines)
  

OR

• Symptomatic patients with primary, idiopathic esophageal achalasia
AND

• The patient has failed or had a clinically significant adverse reaction to conventional therapy (nitrates or calcium channel blockers)

OR

• The patient is ineligible for surgical treatment due to advance age or multiple co-morbidities (poor surgical risk

OR

• The patient is at high risk of complications of pneumatic dilation or surgical myotom

OR

• Failure of prior myotomy or dilatio

OR

• The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the ristk of dilation-induced perforation

OR

• Focal, primary axillary or palmar hyperhidrosis

AND

• The patient has failed or had a clinically significant adverse reaction to topical antiperspirants (e.g., Drysol)

AND

• Condition creates a significant disruption to patients daily life and ability to work/function or patient has recurrent or chronic irritations and/or infections, dermatitis, skin macerations

OR

• Chronic anal fissure

AND

• The patient has failed or had a clinically significant adverse reaction to topical nitroglycerin or a topical calcium channel blocker

OR

• Diagnosis of internal anal sphincter (IAS) achalasia

AND

• The patient has not responded to treatment with laxatives

AND

• The patient has not responded to or is not a candidate for anal sphincter myectomy

OR

• Chronic migraine headache

AND

• The patient has a persistent history of chronic, debilitating migraine headaches with frequent attacks on 15 or more days per month for longer than 3 months

AND

• A neurologist has thoroughly evaluated the patient and has established a diagnosis of chronic migraine headaches

AND

• There is documentation of significant functional disability (e.g., work absenteeism, multiple emergency department visits)

AND

• The patient has failed or had a clinically significant adverse reaction to abortive treatment with at least three (3) different therapy classes listed below

AND

• The patient has failed or had a clinically significant adverse reaction to prophylactic therapy from at least two (2) different therapy classes listed below

• Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles and periorbital wrinkles (crow's feet)
• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

• All botulinum toxin products have a black box warning which cautions patients that the effects of the drug may spread from the area of injection and cause symptoms similar to botulism, including potentially life-threatening swallowing and breathing difficulty.
• The potency Units of botulinum toxin products are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of one product cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
• Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) and is a Class 2b recommendation in Micromedex
• Safety and effectiveness have not been established for the treatment of all headache types except migraine as outlined above.
• For detrusor overactivity associated with a neurologic condition there was no additional benefit of Botox 300 Units over 200 Units.
• Safety and effectiveness have not been uniformly established for the treatment of temporomandibular disorders (TMD). Use of botulinumtoxin for this indication is a Class IIb recommendation in Micromedex based on a single study from 1999. A review of two clinical studies (from 2002 and 2011) (15 and 21 patients) found no significant differences in pain reduction between botulinumtoxin and placebo. Other small studies (from 2005 - Italy and 2008 - Turkey) have been performed and showed improvement in objective measures of pain (20 patients and 26 patients). The most common total dose of BTX-A used in the studies was 25u for each temporalis muscle and 50u for each masseter muscle. The studies did not repeat the dosing, but measured efficacy at 16 weeks post dose. The 2003 Guidelines for diagnosis and management of disorders involving the temporomandibular joint and related musculoskeletal structures mention Botox as a possible treatment option for TMJ based on its mechanism of action and the pathophysiology of TMD.
• TMD "gold standard" treatment continues to be: 1) TMJ intraoral orthotic; 2) Muscle relaxants by mouth; and 3) Home muscle relaxation exercises/techniques.
• Myobloc appears to be effective in the treatment of cervical dystonia in patients who have developed tolerance to or who are not responsive to botulinum toxin type A (Botox^R). Experience with Myobloc in patients who have not previously received Botox is limited. There is limited data supporting the use of Myobloc in blepharospasm, spasmodic dysphonia, axillary hyperhidrosis, plantar/palmar hyperhidrosis, gustatory sweating, sialorrhea, upper-limb spasticity due to stroke, anal fissure, detrusor hyperreflexia due to multiple sclerosis and myofascial pain syndrome.
• Limb spasticity may be caused by Heredity spastic paraplegia; multiple sclerosis or other demyelinating diseases of the central nervous system; Spastic hemiplegia; Infantile cerebral palsy; stroke.