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."

Onabotulinum Toxin Type A (BOTOX®)
Onabotulinum toxin type A, BOTOX®, (J0585) is eligible when it's used in the treatment of any of the following conditions:

• 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 onabotulinum toxin type A injections.

• Idiopathic torsion dystonia
• Infantile cerebral palsy
• Laryngeal spasm
• Late effects of cerebrovascular disease
• 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
• 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 

Abobotulinum Toxin Type A (Dysport™ )
Abobotulinum Toxin Type A Dysport™ (J0586) is eligible for the treatment of adults with cervical dystonia.

Rimabotulinum Toxin Type B (MYOBLOC®)
Rimabotulinum toxin type B, 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 onabotulinum toxin type A, abobotulinum toxin type A, or rimabotulinum toxin type B is reported for other conditions not listed on this policy, it should be denied as not medically necessary. The appropriate chemodenervation code (46505, 64612, 64613, 64614, 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.

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

Prescribing Information. Botox, October 2006. Allergan Pharmaceuticals. Irvine, CA

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

FDA Notifies Public of Adverse Reactions Linked to Botox Use, FDA News. Rockville, MD: FDA, February 3, 2008

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.

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

BOTOX® [package insert]. Irvine, CA: Allergan, Inc; 07/2009.

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