Botulinum Toxin Type A (Botox, Dysport); Type B (Myobloc)
Approve for the following conditions:
- anal fissures
- anismus/puborectalis syndrome
- blepharospasm associated with dystonia
- cervical dystonia/spasmodic torticollis
- focal limb dystonia (upper extremity)
- hand tremor
- hemifacial spasm (7th cranial nerve disorder)
- hyperhidrosis (axillary and palmar)
- migraine: prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
- pediatric (infantile) Cerebral Palsy
- piriformis syndrome
- spasmodic dysphonia/laryngeal spasm
- spastic hemiplegia (stroke related)
- strabismus associated with dystonia
- urinary incontinence due to detrusor over activity
Required information for prior authorization review
- achalasia: when dilatation therapy has failed and patient is a poor candidate for surgical intervention
- anal fissures: Idiopathic chronic anal fissures of > 2 months duration which do not respond to conservative treatment measures (laxatives, anal dilators, local anesthetics, topical NTG, oral medications to reduce anal sphincter contraction)
- cervical dystonia/spasmodic torticollis: clonic or tonic involuntary contractions of multiple neck muscles and sustained head torsion with limited range of motion cranial nerve disorder (hemifacial spasm): VII cranial nerve disorder being treated by a neurologist or ophthalmologist
- hyperhidrosis: failure to respond to either topical therapy or anticholinergics/beta blockers. Documentation that excessive sweating is disrupting professional or social life. Evidence of skin maceration with secondary infection is approvable indication.
- migraine (chronic): member must be treated by a neurologist or at a headache clinic site. Documentation of failure to at least two migraine prophylactic medications.
- sialorrhea: diagnosis of drooling due to neurodegenerative disease such as Parkinson's and failure of anticholinergic therapy.
- spasticity or dystonia resulting in functional impairment defined as interference with joint function and mobility, and/or pain in patients with any of the following hereditary, degenerative or demyelinating diseases (stroke, trauma, MS, cancer) of the central nervous system:
- idiopathic torsion dystonia
- symptomatic torsion dystonia
- orofacial dyskinesia
- organic writer’s cramp
- hereditary spastic paraplegia
- neuromyelitis optica
- Schilder’s disease
- spastic hemiplegia
- infantile cerebral palsy
- spasmodic torticollis
- laryngeal spasm
- urinary incontinence due to detrusor over activity: diagnosis of urge incontinence (idiopathic or neurogenic and failure/intolerance to at least two anticholinergic medications
The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee.
Any indication not listed above including:
- Cosmetic – wrinkles
- Chronic motor tic disorders
- Tics associates with Tourette’s Syndrome
- Temporomandibular joint disorder (TMJD or TMD), or TMJ syndrome
- Parkinson's Disease
- Focal Lower Limb Dystonia
- Tardive Dyskinesia
- Other forms of smooth muscle spasm not specifically addressed in the policy
Dosing Examples: See product information for dosing information on indications not listed.
- Blepharospasm: 1.25 -2.5 units injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. The maximum clinical effect is observed at 1-2 weeks post treatment and lasts approximately 3 months. Repeat injections can be continued indefinitely
- Achalasia: A sclerotherapy needle is used to administer 80 units (4 injections of 1 milliliter at 20 units/liter) of botulinum toxin within 1 centimeter proximal to the narrowing at the gastroesophageal junction. The response rate at 1 month is~ 70%.
- Anal Fissures: Based on individual response. May range from 5-25 U. Authorization on an episodic basis, per treatment basis
- Cervical Dystonia: No definitive dose. Up to 300 U divided among affected muscles in patients with an extended history of prior Botulinum Toxin Type A use. For naïve patients, a lower starting dose is recommended. Subsequent dosing is adjusted based on individual response.
- Strabismus: Vertical muscles and horizontal strabismus of < 20 prism diopters, initial dose is 1.25-2.5 U in any one muscle. Horizontal strabismus of 20-50 prism diopters, initial dose is 2.5-5 U in any one muscle. Persistent VI nerve palsy > 1 month duration, initial dose is 1.25-2.5 U in the medial rectus muscle. Pt. F/U 7-14 days after each inj. to assess the effect of dose. Pts. experiencing adequate paralysis of the target muscle, but require subsequent injections should receive a dose comparable to the initial dose. Patients who experience incomplete paralysis of the target muscle may be increased up to 2x the size of the previously administered dose. Subsequent injections should not be administered until the effects of the previous dose have dissipated.
Western Health Advantage Pharmacy and Therapeutics Committee
Approved: March 2013 | Revised: January 2016
Last review date: July 25, 2016