Botulinum toxin (BTX) has been used at Baylor College of Medicine Movement Disorders Clinic in the treatment of dystonia and related disorders since 1983. Its safety and efficacy has been established, partly as a result of the pioneering work at the Movement Disorder Clinic. The first double-blind, placebo controlled trial of BTX in cranial-cervical dystonia was conducted at Baylor and the findings were used to obtain the initial approval for BTX by the Food and Drug Administration.
Dystonia is a neurological condition manifested by involuntary contractions (spasms) of muscles producing twisting, squeezing or pulling movements and abnormal postures. Examples of dystonia include blepharospasm (spasms of eyelids causing involuntary eye closure), cervical dystonia or torticollis (spasms of neck muscles causing twisting and other movements of the neck, abnormal head posture, and neck pain), laryngeal dystonia or spasmodic dysphonia (spasms of vocal cords causing a strained or breathy voice), oromandibular (mouth and jaw spasms) dystonia, and task-specific dystonias (writer's cramps). In addition to dystonias, BTX has been used also to relieve other focal spasms, such as hemifacial spasms, tremors, tics, spasticity, and other movement disorders. At Baylor Movement Disorders Clinic, BTX has been also used to treat muscle contraction (tension) and migraine headaches, excessive drooling (sialorrhea), excessive sweating (hyperhidrosis), and other conditions for which BTX has been found to be effective. Studies involving thousands of patients have demonstrated the usefulness and safety of BTX treatments in these conditions.
BTX is a protein that acts by binding to certain nerve endings thus preventing the release of the neurotransmitter acetylcholine. An injection of BTX into the muscle blocks transmission of impulses from the nerve to the muscle causing local and temporary weakness of the target muscle. This process, called "chemodenervation," provides effective relief of dystonias and other disorders manifested by abnormal and unwanted muscular contractions or abnormal secretions. The onset of improvement is often noted within a few days after injection and the benefits usually wear off after 3 to 6 months at which time a repeat injection is needed. Because BTX acts only locally without spreading into the circulation, it does not usually cause any systemic reactions. Most patients obtain safe and substantial relief, but a few experience side effects after the treatment. Except for occasional temporary feeling of generalized malaise and weakness, nearly all other side effects are confined to the injected body part. Injections into the eyelids, for example, may result in transient local swelling, droopy eyelids, blurring of vision, and tearing. Injections into the neck muscles may cause temporary neck weakness or pain and difficulties with swallowing. Swallowing problems as well as chewing, speech and voice difficulties may also result from injections into the jaw and vocal cord muscles. Injections into the arm or hand muscles may cause temporary weakness of fingers and hands. These side effects are usually mild, occur infrequently, and most resolve in a few weeks without any specific treatment. If swallowing problems occur, it is advisable to change to a soft or liquid diet. Of course, any troublesome side effects should be reported to the treating or primary care physician.
BTX treatments do not represent a cure, but they usually provide satisfactory relief of symptoms that can be maintained by repeating treatments when the effects of previous BTX injections begin to wear off. Rarely, some patients become unresponsive to the treatment because they develop blocking antibodies. Such immunoresistance is quite uncommon and occurs only after repeated treatments, usually with relatively high doses or when injected more frequently than every 2-3 months. There are several ways that the presence of immunoresistance can be detected. The simplest and least expensive way is to inject small amounts of BTX into the medial portion of right eyebrow. If the eyebrow is weakened by the injection and one week later the patient is unable to contract the muscle on that side while frowning, this indicates that the patient does not have blocking antibodies – no immunoresistance. Besides this unilateral brow injection (UBI) BTX antibodies can be also detected by a mouse bioassay. This test involves sending a frozen blood serum to Northview Pacific Laboratories, 2800 7th St., Berkeley, CA 94710, (510) 548-8440, along with a check for about $200. When the blood sample is forwarded to the Northview Pacific Laboratories by physicians other than those at Baylor, it is important that you are identified as a patient at Baylor College of Medicine and that the results are forwarded to us.
Patients who have become immunoresistant as a result of BTX antibodies no longer respond to subsequent injections with the same type of BTX-A, but may respond to other types of BTX. In December 1989, after extensive laboratory and clinical testing of BTX-A (Botox®, Allergan Pharmaceuticals, California) the Food and Drug Administration approved this biologic as a therapeutic agent in patients with strabismus, blepharospasm and other facial nerve disorders, including hemifacial spasm. In December 2000, the FDA approved Botox® and BTX-B (MYOBLOC®, Solstice Neurosciences, Inc, California) as a treatment for cervical dystonia. In 2002, FDA also approved Botox® for treatment of frown lines between the brows and in 2004 BTX was approved for severe underarm sweating (hyperhidrosis). In 2010, Botox® received approval for spasticity and headaches. Other indications are still pending. Two variants of botulinum toxin A (Dysport® and Xiomen®) were recently introduced to the market in 2009 and 2010 respectively. Both are indicated to treat cervical dystonia in Botox naïve and previously treated patients. Additionally, Xiomen® is indicated to treat blepharospasm in previously treated patients. The procedure requires specialized skills and, therefore, only some centers are performing this treatment. The actual cost of the medication and procedure depends on the total dose and sites required to treat the specific condition and will be determined at the time of the visit and. To cover the cost of the medication and our overhead, we require that all charges for the medication and for the procedure must be paid or a documentation of pre-approval is presented before the treatment visit.
Diagnostic Codes for Filing Insurance Claims
We are genuinely concerned about the cost of the BTX treatments and we are trying to keep the cost as low as possible. Because BTX is approved by the FDA (at least for some indications), many insurance carriers and Medicare provide reimbursement for the cost of the drug and the chemodenervation procedure. The following codes should be used for filing claims:
Botulinum Toxin A (BOTOX©)
Botulinum Toxin B (MYOBLOC™)
Onabotulinumtoxin A (DYSPORT®)
Incobotulinumtoxin B (XEOMIN®)
©2011 Joseph Jankovic, M.D.
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