Botulinum Toxin
Botulinum toxin is a neuromuscular blocking agent produced by the bacterium clostridium botulinum. In large doses this bacteria causes food poisoning. Injections of these toxins produce a chemical denervation by reducing or abolishing the release of acetylcholine and producing muscle weakness. The therapeutic effect may last up to three months. The treatment may lose some effectiveness if the individual develops antibodies.
An example of a preparation of botulinum toxin type A is Botox®.
An example of a preparation of botulinum toxin type B is Myobloc®.
REFER TO DECISION SUPPORT TREE
POLICY
Botulinum toxin type A for the treatment of the strabismus, except for those types listed as investigational, is considered medically necessary.
Botulinum toxin type A for the treatment of blepharospasm, or VII nerve disorders is considered medically necessary.
Botulinum toxin type A, for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents, and when there is functional impairment or medical complications associated with the condition is considered medically necessary.
Botulinum toxin type A and B, 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
Botulinum toxin type A and B, 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; 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
Urinary detrusor sphincter dyssynergia
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
Botulinum toxin type A and B, for the treatment of facial wrinkles, are considered cosmetic.
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 (e.g., AHFS Drug Information, USP DI Drug Information for the Health Care Professional) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts.
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., Drug Information for the Health Care Professional: USP-DI).
The literature evidence is insufficient to permit conclusions about the effects on health outcomes of botulinum toxin type A and B injections for any other conditions/diseases.
Botulinum toxin A and B for the treatment of the other conditions/diseases do not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2006). Botulinum toxin (5.01.05). Retrieved December 27, 2006 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2004). Treatment of hyperhidrosis (8.01.19). Retrieved December 27, 2006 from BlueWeb.
Botulinum toxin for (botox cosmetic) for frown lines. (2002, May). The Medical Letter on Drugs and Therapeutics, 44 (W1131A), 47-48.
Botulinum toxin for axillary hyperhidrosis. (2004, September). The Medical Letter on Drugs and Therapeutics, 46 (Issue 1191), 76-77.
Botulinum toxin for cervical dystonia. (2001, July). The Medical Letter on Drugs and Therapeutics, 43 (Issue 1109), 63-64.
Health Technology Advisory Committee. (2001, July). Use of botulinum toxin-A in pain associated with neuromuscular disorders. Retrieved April 28, 2003 from http://www.health.state.mn.us/htac/botox.htm.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2006). Botulinum toxin type A. Retrieved December 27, 2006, from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2006). Botulinum toxin type B. Retrieved December 27, 2006 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. USP DI Drug Information for the Health Care Professional. (2006). Botulinum toxin type A (parenteral-local). Retrieved December 27, 2006 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. USP DI Drug Information for the Health Care Professional. (2006). Botulinum toxin type B (parenteral-local). Retrieved December 27, 2006 from MICROMEDEX Healthcare Series.
National Institutes of Health. (1990, November). Clinical use of botulinum toxin. Retrieved August 10, 1998 from http://consensus.nih.gov/cons/083/083_statement.htm.
The Technology Evaluation Center. (1996, July). Botulinum-A toxin for treatment of chronic spasticity (Vol. 11, No.6). Washington, DC: BlueCross BlueShield Association.
The Technology Evaluation Center. (2002, December). Botulinum toxin for treatment of primary chronic headache disorders (Vol. 17, No.16). Chicago: BlueCross BlueShield Association.
U. S. Food and Drug Administration. (2000, December). Center for Biologics Evaluation and Research. Product Approval Information - Licensing Action. Botulinum toxin type B. Retrieved October 7, 2004 from http://www.fda.gov/cder/biologics/products/botelan120800.htm.
U. S. Food and Drug Administration. (2002, March). Center for Biologics Evaluation and Research. Product Approval Information - Licensing Action. Retrieved October 7th, 2004 from http://www.fda.gov/cder/foi/label/2002/botuall041202LB.pdf.
U. S. Food and Drug Administration. (2004, July). Center for Biologics Evaluation and Research. Botox (botulinum toxin type A) purified neurotoxin complex. Retrieved October 8, 2004 from http://www.fda.gov/medwatch/SAFETY/2004/jul_PI/Botox_PI.pdf.
U. S. Food and Drug Administration. 3 (2000, December). Center for Biologics Evaluation and Research. Product Approval Information - Licensing Action. Retrieved October 7, 2004 from http://www.fda.gov/cder/foi/appletter/2000/botaller122100L.htm.
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EFFECTIVE DATE |
3/28/2007 |
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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 Type A (Botox®) or Botulinum Toxin Type B (Myobloc®)
Botulinum Toxin Type A or Botulinum Toxin Type B
Is the requested medication being used to treat any of the following conditions?
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 any of the following diagnosis?
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
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Botulinum Toxin Type A
Does the individual have a diagnosis of severe primary axillary hyperhidrosis that is inadequately managed with topical agents, and functional impairment or medical complications associated with the condition?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of any of the following?
Strabismus (except the types listed as investigational under botulinum toxin type A or type B, question #1)
Blepharospasm
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.