Summary Of Evidence

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Analysis of Evidence

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Chemodenervation refers to the use of chemical agents to produce neuromuscular blockade for the purpose of selective weakening of specific muscles, or muscle groups. This policy applies to the use of neurotoxins, as well as, other chemical agents used for this purpose.

Botulinum toxin, a neurotoxin produced by clostridium botulinum, produces a clinical effect by blocking the release of neurotransmitters, principally acetylcholine, from nerve endings. There are currently 4 botulinum neurotoxins available in the United States (US) with different Federal Drug Administration (FDA)-approved indication(s): 3 distinct serotype A botulinum toxin therapeutic products, onabotulinumtoxinA (BOTOX®), abobotulinumtoxinA (DYSPORT®) and incobotulinumtoxinA (XEOMIN®), and the serotype B botulinum toxin product, rimabotulinumtoxinB (MYOBLOC®).

The FDA-approved labeling for each product states that the potency units of the botulinum toxin products are not interchangeable. Labeling differs from product to product; dosing units are not comparable. It is the physician's responsibility to select the appropriate product and dose in accordance with FDA-approval indications for use, compendia-supported uses, and supported by peer reviewed specific scientific literature.

Chemodenervation techniques are indicated/covered for:

1. Chemodenervation of muscle innervated by the facial nerve in the management of blepharospasm or hemifacial spasm

2. Chemodenervation of cervical spinal muscles in the management of spasmodic torticollis

3. Chemodenervation of extremity muscles in the management of dystonias, cerebral palsy, upper and lower limb spasticity (see Note:) and multiple sclerosis

4. Chemodenervation of extraocular muscles in the management of strabismus

5. Chemodenervation of the lower esophageal sphincter in the management of achalasia

6. Chemodenervation of laryngeal muscles in the treatment of adductor spasmodic dysphonia

7. Chemodenervation of bilateral frontalis, trapezius, temporalis, sternocleidomastoid, and splenius capitis muscles for treatment of chronic tension headache and intractable daily headache 

8. Chemodenervation of procerus and bilateral frontalis, corrugator, occipitalis, temporalis, trapezius, and cervical paraspinal muscle group for the prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer) 

Note: Onabotulinamtoxin A (BOTOX®), is the only botulinum toxin product that is FDA-approved for the prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).

9. Chemodenervation of sweat glands for the treatment of severe primary hyperhidrosis that is inadequately managed with topical agents. Severe is defined for this purpose as level 3 (sweating barely tolerable/frequently interferes with daily activity) or level 4 (sweating intolerable/always interferes with daily activities) on the Hyperhidrosis Disease Severity Scale (HDSS).

10. Chemodenervation of the internal anal sphincter for the treatment of chronic anal fissure

11. Chemodenervation of the detrusor urinae muscle for the treatment of over activity associated with a neurologic condition in adults with an inadequate response to anticholinergic treatment and for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication

12. Chemodenervation of the parotid and submandibular salivary glands, bilaterally

Limitations

Chemodenervation for the treatment of headaches is limited to patients who experience headaches that may result in permanent cerebral dysfunction, or are intractable because the patient cannot tolerate or does not benefit from standard therapies. Candidates for this treatment are patients with:

1. Intractable migraines (with or without aura)

2. Intractable chronic tension-type headache with moderate to severe pain

3. Chronic daily headaches defined as patients experiencing more than 15 days of headache per month (either migraine or tension-type features)

4. Chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer) (for the prophylaxis of headaches - in adult patients only)

Note: Intractable headache is defined as a patient meeting 1 of the following criteria for treatment (applies only to disease states 1-3, listed above):

1. Failed trials of at least 3 preventive pharmacologic migraine therapies (e.g., beta-blockers, anticonvulsants, antidepressants) with or without concomitant behavioral and physical therapies, after titration to maximal tolerated doses or have medical contraindications to common therapies or who cannot tolerate common preventative therapies; or

2. Experience chronic daily headaches or recurrent headaches at least twice per month causing disability lasting 3 or more days per month; or

3. Standard abortive medication is required more than twice per week, or is contraindicated, ineffective or not tolerated.