Botulinum Toxin
Botulinum toxin, produced by the bacterium Clostridium botulinum, is one of the most potent naturally occurring neurotoxins known. It induces chemodenervation by binding to acceptors on motor nerve terminals, entering the terminals and blocking the release of acetylcholine and other neurotransmitters at the neuromuscular junction. This renders smooth and striated muscles incapable of contraction. Additionally, as sympathetic innervation of the sweat glands is mediated by acetylcholine, botulinum toxin disrupts the cholinergic outflow to the skin and halts glandular secretion.
The minute amount of toxin used clinically produces only partial, localized chemical denervation with transient results. Axons generate temporary sprouts which release acetylcholine and the original nerve terminal is eventually re-established, ending the toxin’s therapeutic activity.
Seven antigenic-specific serotypes of botulinum toxin have been identified, types A, B, C-1, D, E, F and G, but only botulinum toxin types A and B are commercially available. These two serotypes have different formulations and/or potency and their use is not interchangeable.
An example of a preparation of botulinum toxin type A is Botox® or Dysport®.
An example of a preparation of botulinum toxin type B is Myobloc®.
REFER TO DECISION SUPPORT TREE
POLICY
Botulinum toxin type A (Botox® or Dysport®) for the treatment of the following conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Strabismus
Severe primary axillary hyperhidrosis
Urinary incontinence
Botulinum toxin type A (Botox® or Dysport®) for the treatment of blepharospasm or VII nerve disorders is considered medically necessary.
Both botulinum toxin types A (Botox® or Dysport®) and B (Myobloc®), for the treatment of the following conditions, are considered medically necessary:
Achalasia
Cervical dystonia
Chronic anal fissure
Hereditary spastic paraplegia
Idiopathic torsion dystonia
Infantile cerebral palsy, spastic
Organic writer's cramp
Orofacial dyskinesia
Oromandibular dystonia
Spasmodic dysphonia
Spasmodic torticollis
Spastic hemiplegia
Symptomatic torsion dystonia
Both botulinum toxin types A (Botox® or Dysport®) and B (Myobloc®), for the treatment of other conditions/diseases, including, but not limited to, the following, are considered investigational:
Anismus
Chronic motor tic disorder; (e.g., de la Tourette syndrome)
Conditions in an individual who is pregnant or nursing
Occipital neuralgia
Stuttering and/or any other vocal tremors
Temporomandibular joint disease
Treatment of headache or migraine
Myofascial pain syndrome
Chronic paralytic strabismus except when used with surgical repair to reduce antagonist contracture
Duane's syndrome with lateral rectus weakness
Restrictive strabismus
Secondary strabismus caused by prior surgical over-recession of the antagonist
Strabismus deviations over 50 prism diopters
Treatment of hyperhidrosis adequately managed with topical agents and without associated functional impairment or medical complications
Both botulinum toxin types A (Botox® or Dysport®) and B (Myobloc®), for the treatment of facial wrinkles, are considered cosmetic.
MEDICAL APPROPRIATENESS
Botulinum toxin A (Botox® or Dysport®), for the treatment of ANY ONE of the following conditions, is considered medically appropriate if the criteria are met:
Strabismus with ALL of the following:
Strabismus is associated with dystonia
ABSENCE of ALL of the following:
Duane’s syndrome with lateral rectus weakness
Restrictive strabismus
Strabismus secondary to prior surgical over-recession of the antagonist
Strabismus deviations more than 50 prism diopters
Chronic paralytic strabismus unless the agent is to be used with surgical repair to reduce antagonist contracture
Severe primary axillary hyperhidrosis with ALL of the following:
Treatment is not adequately managed with topical agents
The condition causes ANY ONE of the following:
Functional impairment
Medical complications
Urinary incontinence with ALL of the following:
Individual has undergone urodynamic studies with diagnosis of idiopathic detrusor overactivity (IDO)
Anticholinergic therapy has failed to provide adequate control
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
Refer to Dystonia definition located in the Glossary section of this manual.
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
Evidence in the published literature is insufficient to permit conclusions about the effects on health outcomes of the use of botulinum toxin types A and B for use in any other conditions/diseases.
SOURCES
BlueCross and BlueShield Association. Medical Policy Reference Manual. (6:2007). Botulinum toxin (5.01.05). Retrieved July 17, 2008 from BlueWeb.
BlueCross and BlueShield Association. Medical Policy Reference Manual. (2:2008). Treatment of hyperhidrosis (8.01.19). Retrieved July 17, 2008 from BlueWeb.
BlueCross and BlueShield Association. Medical Policy Reference Manual. (2:2008). Treatment of tinnitus (8.01.39). Retrieved August 5, 2008 from BlueWeb.
Brubaker, L., Richter, H. E., Visco, A., Mahajan, S., Nygaard, I., Braun, T. M., et al. (2008). Refractory idiopathic urge urinary incontinence and botulinum A injection. The Journal of Urology, 180 (1), 217-222. (Level 1 Evidence)
Drugs for migraine. (2008, March). The Medical Letter On Drugs and Therapeutics, 6 (Issue 67), 21.
Lexi-Comp Online. (2008). AHFS DI. Botulinum Toxin. Retrieved July 17, 2008 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Botulinum Toxin Type A. Retrieved July 17, 2008 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Botulinum Toxin Type B. Retrieved July 17, 2008 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Botulinum Toxin Type F. Retrieved July 17, 2008 from MICROMEDEX Healthcare Series.
Riverbend: Government Benefits Administrator. Local Coverage Determinations (LCDs). (October, 2007). LCD for botulinum toxin type A (L1321). Retrieved July 17, 2008 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=1321&lcd_version=30&show=al
U. S. Department of Health & Human Services. Center for Medicare & Medicaid Services. LMRPs/LCDs for Cigna Government Services (2008, March). LCD for botulinum toxin (L6102). Retrieved July 17, 2008 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=6102&lcd_version=42&basket=lcd%3A6102%3A42%3ABotulinum+Toxin%3ACarrier%3ACIGNA+Government+Services+%2805440%29%3A.
U. S. Food and Drug Administration. (2004, July). Center for Drug Evaluation and Research. Botox® (Botulinum toxin type A). Retrieved July 17, 2008 from http://www.fda.gov/cder/foi/label/2004/103000s5050lbl.pdf.
U. S. Food and Drug Administration. (2009, April). Center for Drug Evaluation and Research. Dysport® for injection. Retrieved August 5, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf.
U. S. Food and Drug Administration. (2000, December). Center for Drug Evaluation and Research. Myobloc® (Botulinum type B). Retrieved July 17, 2008 from http://www.fda.gov/cder/foi/label/2000/botelan120800lb.pdf.
U. S. Food and Drug Administration. (2000, December). Center for Drug Evaluation and Research. Product Approval Information - Licensing Application: Myobloc®. Retrieved August 6, 2008 from http://www.fda.gov/cder/foi/appletter/2000/botelan120800L.htm.
U. S. Food and Drug Administration. (2004, July). Center for Drug Evaluation and Research. Product Approval Information - Supplemental Licensing Application: Botox®. Retrieved August 6, 2008 from http://www.fda.gov/cder/biologics/ltr/103000_5050ltr.pdf.
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 6/30/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Botulinum Toxin
Botulinum Toxin Type A (Botox® or Dysport®) or Botulinum Toxin Type B (Myobloc®)
Is the requested medication being used to treat ANY ONE of the following?
Anismus
Chronic motor tic disorder; (e.g., de la Tourette syndrome)
Chronic paralytic strabismus except when used with surgical repair to reduce antagonist contracture
Conditions in an Individual who is pregnant or nursing
Duane's syndrome with lateral rectus weakness
Facial wrinkles
Occipital neuralgia
Restrictive strabismus
Secondary strabismus caused by prior surgical over-recession of the antagonist
Strabismus deviations over 50 prism diopters
Stuttering; any other vocal tremors
Temporomandibular joint disease
Treatment of headache or migraine, and myofascial pain syndrome
Treatment of hyperhidrosis adequately managed with topical agents, and when there is a lack of functional impairment or medical complications associated with the condition
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of ANY ONE of the following?
Achalasia
Cervical dystonia
Chronic anal fissure
Hereditary spastic paraplegia
Idiopathic torsion dystonia
Infantile cerebral palsy, spastic
Organic writer's cramp
Orofacial dyskinesia
Oromandibular dystonia
Spasmodic dysphonia
Spasmodic torticollis
Spastic hemiplegia
Symptomatic torsion dystonia
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Botulinum Toxin Type A (Botox® or Dysport®)
Does the individual have a diagnosis of strabismus?
If yes, go to question #4
If no, go to question #5
Does the strabismus condition have ALL of the following?
Strabismus is associated with dystonia
ABSENCE of ALL of the following:
Duane’s syndrome with lateral rectus weakness
Restrictive strabismus
Strabismus secondary to prior surgical over-recession of the antagonist
Strabismus deviations more than 50 prism diopters
Chronic paralytic strabismus unless the agent is to be used with surgical repair to reduce antagonist contracture
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness
Does the individual have a diagnosis of blepharospasm or VII nerve disorders?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Does the individual have a diagnosis of severe primary axillary hyperhidrosis?
If yes, go to question #7
If no, go to question #8
Does the hyperhidrosis condition have ALL of the following?
Treatment is not adequately managed with topical agents
The condition causes ANY ONE of the following:
Functional impairment
Medical complications
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness
Does the individual have urinary incontinence?
If yes, go to question #9
If no, this does not meet medical necessity and/or medical appropriateness
Does the incontinent condition have ALL of the following?
Individual has undergone urodynamic studies with diagnosis of idiopathic detrusor overactivity (IDO)
Anticholinergic therapy has failed to provide adequate control
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness
This document has been classified as public information.