Botulinum toxin type A and B are chemically, pharmacologically, and clinically distinct products and are not interchangeable. FDA labeling states that "units of biological activity cannot be compared to nor converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method."

OnabotulinumtoxinA (BOTOX®)
OnabotulinumtoxinA, BOTOX®, (J0585) is eligible when it's used in the treatment of any of the following conditions:

• Achalasia
  Achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates
• Acute dystonia due to drugs
• Anal fissure
• Athetoid cerebral palsy
• Blepharospasm
• Demyelinating disease of central nervous system, unspecified
• Diplegia of upper limbs
• Facial spasms
• Hemifacial spasms 
• Hereditary spastic paraplegia
• Hyperhidrosis, primary, axilla
  Considered medically necessary when the patient has severe, primary axillary hyperhidrosis involving focal, visible and excessive sweating of at least six months duration without apparent cause that includes all of the following characteristics:
  
  
  • Sweating is bilateral and relatively symmetrical
  • Sweating significantly impairs daily activities
  • Episodes occur at least once per week
  • The age of onset is less than 25 years
  • Focal sweating stops during sleep

  The patient must be classified as “severe” or a “4” on the Hyperhidrosis Disease Severity Scale prior to treatment for primary axillary hyperhidrosis. This is a four-point scale that includes the following:

  1 - sweating is never noticeable and never interferes with daily activities
  2 - sweating is tolerable but sometimes interferes with daily activities
  3 - sweating is barely tolerable and frequently interferes with daily activities
  4 - sweating is intolerable and always interferes with daily activities

  The patient must have documented treatment with 10-35% aluminum chloride of at least six months duration that failed to reduce the severity index scale before the initiation of onabotulinumtoxinA injections.

• Idiopathic torsion dystonia
• Incontinence due to detrusor overreactivity (urge incontinence), either idiopathic or due to neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is inadequately controlled with anticholinergics
• Infantile cerebral palsy
• Laryngeal spasm
• Late effects of cerebrovascular disease
• Migraines - for prevention of chronic (≥15 days per month with headaches lasting four hours a day or longer) migraine headaches in adult patients.
  An initial six month trial is considered medically necessary when all of the following criteria are met:
  
  • A neurologist has evaluated the member,
  • A diagnosis of chronic migraine headache has been established using the International Classification of Headache Disorders, Second Edition (ICHD-II)
  • There is a persistent three month history of recurring debilitating headaches (15 or more days per month with migraine headaches lasting four hours per day or longer) as documented by a headache diary,
  • The headaches are not caused by medication rebound (the patient is not taking narcotics or triptans exceeding more than 18 doses per month), lifestyle issues (e.g., sleep patterns, caffeine use, etc.), and
  • Adequate trials of prophylactic therapy from at least three different therapy classes (e.g., antiseizure, beta blockers, tricyclic antidepressants) were either not effective or not tolerated. Documentation of trials and failure should include that these medications have been prescribed at adequate doses and for a reasonable length of time (i.e., six weeks each).

    Continued treatment beyond six months (up to four injection treatments in a 12-month period) is considered medically necessary when all the following criteria are met:

  • Migraine headache frequency reduced by at least seven days per month, or
  • Migraine headaches duration reduced at least 100 hours per month.
• Monoplegia of lower limb
• Monoplegia of upper limb 
• Multiple sclerosis
• Neuromyelitis optica
• Organic writer's cramp
• Orofacial dyskinesia
• Other acquired torsion dystonia
• Other demyelinating diseases of central nervous system
• Paraplegia
• Quadriplegia and quadriparesis
• Sialorrhea (drooling) in patients with functional impairment originating from spasticity or dystonia (conditions of involuntary sustained muscle contraction) resulting from Parkinson disease who have been refractory to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine).
• Schilder's disease
• Spasmodic dysphonia
• Spasmodic torticollis
• Spastic hemiplegia
• Strabismus
• Subacute dyskinesia due to drugs 
• Torticollis
  Whether congenital, due to childbirth injury or traumatic
• Unspecified monoplegia 
• Urinary incontinence due to detrusor overactivity associated with a neurological condition (e.g. spinal cord injury, multiple sclerosis) in adults, who have an inadequate response to or are intolerant of an anticholinergic medication.

AbobotulinumtoxinA (DYSPORT™)
AbobotulinumtoxinA DYSPORT™ (J0586) is eligible for the treatment of adults with cervical dystonia.

IncobotulinumtoxinA (Xeomin®)
IncobotulinumtoxinA (Xeomin®) (J0588) is eligible for the treatment of:

• Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients
• Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox® )

RimabotulinumtoxinB (MYOBLOC®)
RimabotulinumtoxinB MYOBLOC®, (J0587) is eligible for the treatment of patients with cervical dystonia.

Cervical dystonia, also known as spasmodic torticollis, is a neurological movement disorder in which a person's neck and shoulder muscles have contractions that force the head and neck into abnormal and sometimes painful positions.

If abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, or rimabotuliniumtoxinB is reported for other conditions not listed on this policy, it should be denied as not medically necessary. The appropriate chemodenervation code (46505, 64611, 64612, 64613, 64614, 64615, 64650, 64653, 64999, 67345, S2340, S2341) would also be denied if the drug is not covered. A participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Place of Service: Inpatient/Office

Description

Normal muscle movement occurs when a nerve sends a chemical signal to a muscle, which makes it contract. The nerve ending is separated from the muscle by a small gap called the neuromuscular junction. The chemical signal, acetylcholine, travels across the gap and causes a muscle contraction. Some neurological diseases cause muscle spasms, tightness, or pain.

Chemodenervation is a procedure whereby small amounts of botulinum toxin are injected into excessively contracted muscles. Botulinum toxin prevents the release of the chemical signal, which leads to muscle relaxation. Unlike surgical denervation, chemodenervation is not permanent, although the effect lasts for months.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition.

Safety and Efficacy of NeuroBloc (Botulinum Toxin Type B) in Type A-resistant Cervical Dystonia, Neurology, Vol. 53, October 1999

Safety and Efficacy of NeuroBloc (Botulinum Toxin Type B) in Type-A responsive Cervical Dystonia, Neurology, Vol. 53, October 1999

The Safety and Efficacy of Botulinum Toxin Type B in the Treatment of Patients with Cervical Dystonia: Summary of Three Controlled Clinical Trials, Neurology, Vol. 55, January 2000

Dystonia Study Group. Comparison of Botulinum Toxin Serotypes A and B for the Treatment of Cervical Dystonia, Neurology, 2005; 65

Marchetti A, Magar R, Findley L, et al. Retrospective evaluation of the dose of Dysport and Botox in the management of cervical dystonia and blepharospasm: The REAL DOSE study. Movement Disorders. 2005;20(8):937-944.

Comparison of Botulinum Neurotoxin Preparations for the Treatment of Cervical Dystonia. Clinical Therapeutics. 2007: 29(7)

Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers' product summaries. J Clin Pharm and Thera. 2007;32:387-402.

Brashear A. Clinical comparisons of botulinum neurotoxin formulations. The Neurologist. 2008;14:289-298.

Myobloc® (rimabotulinumtoxinB) [package insert]. South San Francisco, CA: Solstice Neurosciences, Inc; 07/2009.

Botox® (onabotulinumtoxinA) [package insert]. Irvine, CA: Allergan, Inc; 07/2009.

Dysport® (abobotulinumtoxinA) [package insert]. Wrexham, UK: Ipsen Biopharm Ltd; 05/2009.

Xeomin® (incobotulinumtoxinA)  [package insert]. Greensboro, NC: Merz Pharmaceuticals, LLC; 08/2010.

Hosseini SMV, Foroutan HR, Zeraatian S, Sabet B.  Botulinum toxin, as a bridge to transanal pullthrough in neonate with Hirschsprungs disease. J Indian Assoc Pediatr Surg. 2008 Apr-Jun;13(2):69-71.

Langer JC. Persistent obstructive symptoms after surgery for Hirschsprung’s Disease: Development of a diagnostic and therapeutic algorithm. J Pediatr Surg. 2004;39(10):1458-1462.

Messineo A, Codrich D, Monai M, Martellossi S, Ventura A. The treatment of internal anal sphincter achalasia with botulinum toxin. Pediatr Surg Int. 2001;17:521-523.

Minkes RK, Langer JC. A prospective study of botulinum toxin for internal anal sphincter hypertonicity in children with Hirschsprung’s Disease. J Pediatr Surg. 2000;35(12):1733-1736.

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Lin YC, Shieh J, Cheng ML, Yang PY. Botulinum toxin type A for control of drooling in Asian patients with cerebral palsy. Neurology. 2008;70(4):316-318.

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Truong DD, Bhidayasiri R. Evidence for the effectiveness of botulinum toxin for sialorrhoea. J Neural Transm. 2008;115(4):631-635.

Raval TH, Elliot CA. Botulinum toxin injection to the salivary glands for the treatment of sialorrhea with chronic aspiration.  Ann Otol Rhinol Laryngol. 2008 Feb;117(2):118-22.

Laing TA, Laing ME, O’Sullivan ST. Botulinum toxin for treatment of glandular hypersecretory disorders. J Plast Reconstr Aesthet Surg. 2008 Sep;61(9):1024-8. Epub 2008 Jul 10.

Krause E, Bötzel K, de la Chaux R, Gürkov R. Local botulinum toxin A for treating chronic sialorrhea. HNO. 2008 Sep;56(9):941-6.

Wilken B, Aslami B, Backes H. Successful treatment of drooling in children with neurological disorders with botulinum toxin A or B. Neuropediatrics. 2008 Aug;39(4):200-4. Epub 2009 Jan 22.

Bomeli SR, Desai SC, Johnson JT, Walvekar RR.  Management of salivary flow in head and neck cancer patients-A systematic review. Oral Oncology. 2008;44:1000-1008.

Fuster Torres MA, Aytés LB, Escoda CG. Salivary gland application of botulinum toxin for the treatment of sialorrhea. Med Oral Patol Oral Cir Bucal. 2007;12(7):E511-E517.

Benson J, Daugherty KK. Botulinum toxin A in the treatment of sialorrhea. Ann Pharmacother. 2007 Jan;41(1):79-85. Epub 2006 Dec 26.

Verma A, Steel J. Botulinum toxin improves sialorrhea and quality of living in bulbar amyotrophic lateral sclerosis. Muscle Nerve. 2006;34(2):235-237.

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Cady R, Schreiber C. Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues. Headache. 2008;48:900-913.

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Saper JR, Mathew NT, Loder EW, DeGryse R, VanDenburgh AM, for the BoNTA-009 Study Group. A double-blind, randomized, placebo-controlled comparison of botulinum toxin A injection sites and doses in the prevention of episodic migraine. Pain Med. 2007;8(6):478-485.

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Silberstein SD, Stark SR, Lucas SM, et al, for the BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: A randomized, double-blind, placebo-controlled trial.  Mayo Clin Proc.  2005;80(9):1126-1137.

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Blue Cross Blue Shield Association Medical Policy 5.01.05, Botulinum Toxin.

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Dogu O, Apaydin D, Sevim S, Talas DU, Aral M.  Ultrasound-guided versus ‘blind’ intraparotid injections of botulinum toxin-A for the treatment of sialorrhea in patients with Parkinson’s disease. Clin Neurol Neurosurg. 2004 Mar;106(2):93-96.

Jiang DP, Li ZZ, Zhang YB, Jiang ZT.  Treatment of anal achalasia after transanal endorectal pull-through for Hirschsprung’s disease with topical botulinum toxin. Journal of Tropical Pediatrics. 2007;54(3);211.

Koivusalo AI, Pakarinen MP, Rintala RJ.  Botox injection treatment for anal outlet obstruction in patients with internal anal sphincter achalasia and Hirschsprung’s disease. Pediatr Surg Int. 2009;25:873-876.

Jiang DP, Xu CQ,  Wu B, et al.  Effects of botulinum toxin injection on anal achalasia after pull-through operations for Hirschsprung’s disease: a 1-year follow-up study.  Int J Colorectal Dis. 2009;24:597-598.

Chumpitazi BP, Fishman SJ, Nurko S.  Long-term clinical outcome after botulinum toxin injection in children with nonrelaxing internal anal sphincter.  Am J Gastroenterol. 2009;104(4):976-983.

Lagalla G, Millevolte M, Capecci M, Provinciali L, Ceravolo MG. Botulinum toxin type A for drooling in Parkinson's disease:  A double-blind, randomized, placebo-controlled study. Mov Disord. 2006 May;21(5):704-707.

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Stone CA, O’Leary N.  Systematic review of the effectiveness of botulinum toxin or radiotherapy for sialorrhea in patients with amyotrophic lateral sclerosis. J Pain Symptom Manage. 2009;37:246-258.

Erasmus CE, Van Hulst K, Van den Hoogen FJA, et al. Thickened saliva after effective management of drooling with botulinum toxin A.  Developmental Medicine & Child Neurology. 2010;52(6):e114-e118.

Gilio F, Iacovelli E, Gabriele M, et al.  Botulinum toxin type A for the treatment of sialorrhea in amyotrophic lateral sclerosis: a clinical and neurophysiological study. Amyotroph Lateral Scler. 2010;11(4):259-363.

Scheffer AR, Erasmus C, Van Hulst, K, et al. Botulinum toxin versus submandibular duct relocation for severe drooling.  Developmental Medicine & Child Neurology. 2010;52(11)Epub ahead of print.

Scheffer AR, Erasmus C, Van Hulst, K, et al. Efficacy and duration of botulinum toxin treatment for drooling in 131 children. Archives of Otolaryngology-Head & Neck Surgery. 2010;136(9)873-877.

Waqas UK, Campisi P, Nadarajah S, et al. Botulinum toxin A for treatment of sialorrhea in children. Archives of Otolaryngology-Head & Neck Surgery. Published online January 17, 2011. Doi:10.1001/archoto.2010.240.

Singh B, Box B, Lindsey I, et al. Botulinum toxin reduces anal spasm but has no effect on pain after haemorrhoidectomy. Colorectal Dis. 2009 Feb;11(2):203-207.

Rao SSC, Paulson J, Mata M, Zimmerman B. Clinical trial: effects of botulinum toxin on levator ani syndrome–a double-blind, placebo-controlled study. Ailment Pharmacol Ther. 29;(9):985-991.

Farid M, El Monem HA, Omar W, et al.  Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009;24:115-120.

Faried M, El Nakeeb A, Youssef M, Omar W, El Monem H.  Comparative study between surgical and non-surgical treatment of anismus in patients with symptoms of obstructed defecation:  A prospective randomized study. J Gastrointes Surg. 2010;14:1235-1243.

Farid M, Youssef T, Mahdy T, et al. Comparative study between botulinum toxin injection and partial division of puborectalis for treating anismus. Int J Colorectal Dis. 2009;24:327-334.

Gomes C, de Castro Filh J, Rejowski R, et al. Experience with different botulinum toxins for the treatment of refractory neurogenic detrusor overactivity. Int Braz J Urol. 2010 Feb;36(1):66-74.

Herschorn S, Gajewski J, Ethans K, et al. Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial. J Urol. 2011 Jun;185(6):2229-35.

Miyagawa I. Experience with injections of botulinum toxin type A into the detrusor muscle. Aktuelle Urol. 2010 Jan;41(1):S24-6.

Rechberger T. The quality of life of patients with overactive bladder after local injections of botulinum toxin A--a preliminary report. Ginekol Pol. 2010 Jan;81(10:24-30.

BCBSA Medical Policy 5.01.05, Botulinum Toxin, 2011

Vivancos-Matellano F, Ybot-Gorrin I, Diez-Tejedor E. A 17-year Experience of AbobotulinumtoxinA in Cervical Dystonia. Int J Neurosci. 2012;122(7):354-357.

Pagan FL, Harrison A. A guide to dosing in the treatment of cervical dystonia and blepharospasm with Xeomin(®): A new botulinum neurotoxin A. Parkinsonism Relat Disord. 2012;18(5):441-445.

Nitti VW, Dmochowski R, Herschorn S, et al. OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3 Randomized Placebo-Controlled Trial. J Urol. 2012 Dec 13.

Sussman D, Patel V, Del Popolo G, et al. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2012 Sep 10.

Granese R, Adile G, Gugliotta G,et al. Botox(®) for idiopathic overactive bladder: efficacy, duration and safety. Effectiveness of subsequent injection. Arch Gynecol Obstet. 2012 Oct;286(4):923-9.

Fowler CJ, Auerbach S, Ginsberg D,et al. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57.

Cruz F, Herschorn S, Aliotta P, et al. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50.

Bauer RM, Gratzke C, Roosen A, et al. Patient-reported side effects of intradetrusor botulinum toxin for idiopathic overactive bladder syndrome. Urol Int. 2011;86(1):68-72.

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) In Adults: AUA/SUFU GUIDELINE

BCBSA Medical Policy Reference Manual 5.01.05, Botulinum Toxin