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Botulinum Toxin Treatment for Migraine Headache

Thursday, September 22nd, 2011

Purpose of Technology

Botulinum toxin (BTX), a neurotoxin produced by the bacterium Clostridium (C.) botulinum, is used as a prophylactic or acute treatment for chronic or recurrent headaches. The theoretical basis of its action is that BTX relieves muscle tension by blocking the release of the neurotransmitter acetylcholine at the neuromuscular junction, thereby interfering with nerve transmission and blocking subsequent muscle contraction.

Questions addressed in this report include:

  • OnabotulinumtoxinA (BTX-A) marketed as Botox®/Botox® Cosmetic
  • AbobotulinumtoxinA (BTX-A) marketed as Dysport®
  • RimabotulinumtoxinB (BTX-B) marketed as Myobloc®
  • Does BTX reduce the frequency, severity, or duration of migraine headache?
  • Does BTX improve quality of life in patients who have chronic migraine headache?
  • Is there a difference in efficacy among serotypes and BTX products?
  • How does efficacy of BTX compare with other prophylactic treatments for chronic migraine headache?
  • Is BTX safe for the treatment of migraine headache?
  • Have definitive patient selection criteria been established for the use of BTX for the prevention of migraine headache?

These questions provide a framework for review and synthesis of the best available evidence, which is presented in this report, along with the Hayes Ratings for the technology. This report also provides background information about the condition being treated, a description of the technology, and the context for development of the technology. Other key elements addressed in the report include the regulatory status; applicable Medicare and commercial payer coverage policies; relevant ICD-9 and ICD-10 diagnosis codes; cost and cost effectiveness; credentialing; hospital length of stay; need for large case management; and ongoing and future clinical trials of the technology.

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