This policy is only for Armor Health

Botox/onabotulinumtoxin A (J0585)

I.  The use of Botulin Toxin Type A/Onabotulinumtoxin A, Botox (J0585) is Scientifically Validated for ANY of the following indications:

A. Achalasia:  In patients 18 years and older who are not good candidates for pneumatic dilation or surgical myotomy.

B.  Chronic Anal Fissure:  In patients 18 years and older who meet ALL of the following:

1.  Symptomatic fissure for at least two months (post defecation pain and bleeding) AND

2.  Have failed therapy with at least one of the following:

a.  Topical nitrates (nitroglycerine) OR

b.  Topical calcium channel blockers (nifedipine, diltiazem)

C.  Focal Dystonia:  In patients 16 years and older who have one of the following:

1.  Oromandibular dystonia (e.g. Orofacial dyskinesia, Meige syndrome) OR

2.  Laryngeal dystonia (e.g. Adductor spasmodic dsyphonia) OR

3.  Lingual dystonia OR

4.  Torsion dystonia

D.  Frey's syndrome (gustatory sweating) in patients 18 years and older.

E.  Hand dystonia (e.g. organic writer's cramp) in patients 16 years and older.

F.  Hemifacial spasm:  Characterized by sudden, unilateral contractions of muscles innervated by the facial nerve (Cranial nerve VII) in patients 12 years and older.

G.  Hyperhidrosis:  Of the axillae, palms, and soles in patients 18 years and older who meet ALL of the following:

1.  Severe symptoms that are disabling AND

2.  Unresponsive or unable to tolerate topical aluminum chloride (e.g. Drysol) or other extra strength antiperspirants.

H. Infantile esotropia or concomitant strabismus.

I.  Laryngeal Spasm in patients 18 years and older. 

J.  Neurogenic bladder (detrusor) over activity:  In patients 5 years and older who meet ALL of the following:

1.  Caused by spinal cord injury, or other neurologic condition such as multiple sclerosis AND

2.  Documentation of detrusor over activity confirmed by urodynamic testing AND
3.  Failure or intolerance to at least two anticholinergic medications, e.g. darifenacin (Enablex), fesoterodine (Toviax), oxybutynin (Ditorpan), solifenacin (Vesicare), tolterrodine (Detrol), trospium (Sanctura).

K.  Neuromyelitis Optica in patients 18 years and older. 

L.  Overactive bladder (OAB):  In patients 18 years and older who meet ALL of the following:

1.  Symptoms of urge incontinence, urgency, and frequency AND
2.  Failure or intolerance to at least two prescription medications  e.g. darifenacin (Enablex), fesoterodine (Toviax), oxybutynin (Ditorpan), solifenacin (Vesicare), tolterrodine (Detrol), trospium (Sanctura), mirabegron (Myrbetriq)

M.  Schilder's Disease in patients 18 years and older. 

N.  Upper extremity tremor:  In patients 18 years and older that is severe and interferes with activities of daily living (ADLs)

II.  The use of Botulinum Toxin Type A/Onabotulinumtoxin A, Botox (J0585) for all other indications not listed above is considered Investigational as its effectiveness for other indications has not been established.

Initial Review:  If above criteria is met:  Approval for 2 injections over the course of 6 months

Renewal Review:  After the initial trial period of 6 months, approval can be given for up to 4 injections over the course of 12 months, if clinical effectiveness has been documented.

III.  The use of Botulinum Toxin Type A/Onabotulinumtoxin A, Botox (J0585) may be medically necessary for Chronic Migraine Headache

            prevention in patients who meet the below criteria:

                    A.  15 or more headache days per month AND

                    B.  At least 8 days of which must meet migraine headache features per ICHD-3 criteria listed below:

                         1.  5 or more attacks of migraine without aura (for migraine with aura, only 2 attacks are sufficient  

                              for diagnosis); AND      

                         2.  Lasting 4 hours to 3 days; AND

                         3.  2 or more of the following characteristics: 

                           a.  Unilateral location

                           b. Pulsating quality

                           c.  Moderate or severe pain intensity

                           d.  Aggravation by or causing avoidance of routine physical activity; AND

                                     4.   1 or more of the following associated symptoms: 

                                 a.  Nausea

                                 b.  Vomiting

                                 c.  Sensitivity to both light (photophobia) AND sound (phonophobia); AND

                         5.  Have occurred for 3 or more months duration; AND

                         6.   The patient is 18 years and older; AND

              C.  Patient has tried and failed trials of at least 2 medications selected from at least 2 classes of migraine headache 

                    prophylaxis medications:  

                                       ·      Anti-depressants (e.g. amitriptyline (Elavil), venlafaxine (Effexor), doxepin)

                                       ·     Anti-epileptic (e.g. topiramate (Topamax), divalproex (Depakote), sodium valproate, valproic acid)

                                       ·     Beta blockers (e.g. metoprolol, propranolol, timolol, atenolol, nadolol)

                                       ·     Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (e.g. lisinopril, candesartan)

                                       ·     Calcium channel blockers (e.g. verapamil, nifedipine); AND  

              D.  The Patient is not being concurrently treated with a prophylactic CGRP inhibitor product (e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Qulipta (atogepant)); AND

  E.  The use of Botulinum Toxin Type A/Onabotulinumtoxin A, Botox (J0585) is not Medically Necessary if the patient has not tried and failed treatment with a CGRP inhibitor product (e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Qulipta (atogepant)) after an adequate trial of at least 12 weeks.       

 Notes:.

             ·      Preauthorization for initial therapy may be approved for 6 months. 

             ·      The recommended re-treatment schedule is every 12 weeks, however, if member does not respond to the initial injection/therapy course, treatment should be discontinued.

             ·      The recommended dose for treating chronic migraine is 155 Units administered intramuscularly; more than 200 Units is considered not medically necessary.                                                                               

Renewal Review:

     IV.  Continuing treatment with Botulinum toxin for ongoing prevention of chronic migraine headaches is considered medically necessary when:   

                    A.  Migraine headache frequency was reduced by at least 7 days per month (when compared to pre-treatment 

                         average) by the end of the initial trial; OR

                    B.  Migraine headache duration was reduced by at least 100 hours per month (when compared to pre-treatment average)

                         by the end of the initial trial, AND        

                    C.  The patient is not being concurrently treated with a prophylactic CGRP inhibitor product (e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Qulipta (atogepant)).

Xeomin/incobotulinumtoxina (J0588) or Dysport/botulinum toxin type a (J0586)

     I.  The following may Scientifically Validated for ANY of the following indications if criteria is met:

A.  Blepharospasms

The use of Xeomin/incobotulinumtoxina (J0588) is Scientifically Validated for patients 12 years and older for Blepharospasms.

BCBSNE preferred botulinum toxin products for the treatment of blepharospasm are Xeomin (incobutulinumtoxina).  For benefits to be available in this indication, use of Xeomin (incobotulinumtoxina) is required.  Benefits for other botulinum toxin products are not available for this indication.  The use of other products other than Xeomin for blepharospasm is not Medically Necessary.

B.  Cervical Dystonia (spasmodic torticollis): 

The use of Xeomin/incobotulinumtoxina (J0588) or Dysport/botulinum toxin type a (J0586) is Scientifically Validated for Cervical Dystonia (e.g. spasmodic torticollis) for patients 16 years and older when all of the following criteria are met:

1.  recurrent involuntary contractions of the neck muscles; AND

2.  head torsion or postural disturbance that results in pain and/or interferes with activities of daily living; AND

3.  other medical conditions such as infection, drugs (e.g. metoclopramide), trauma, and contracture have been considered and excluded.

BCBSNE preferred botulinum toxin products for the treatment of Cervical Dystonia are Xeomin (incobutulinumtoxina) and Dysport (botulinum toxin type a).  For benefits to be available for this indication, use of Xeomin or Dysport is required.  Benefits for other botulinum toxin products are not available for this indication.  The use of other products other than Xeomin or Dysport for Cervical Dystonia are not Medically Necessary.

C.  Upper limb spasticity

The use of Xeomin/incobotulinumtoxina (J0588) is Scientifically Validated for Upper Limb Spasticity but not fixed contracture in patients 2 years and older with cerebral palsy, multiple sclerosis, brain injury, stroke hereditary spastic paraplegia and other demyelinating diseases or tumors of the brain and spinal cord. 

BCBSNE preferred botulinum toxin products for the treatment of Upper Limb Spasticity is Xeomin (incobutulinumtoxina).  For benefits to be available in this indication, use of Xeonmin (incobotulinumtoxina) is required.  Benefits for other botulinum toxin products are not available for this indication.  The use of other products other than Xeomin for Upper Limb Spasticity is not Medically Necessary

D.  Upper and Lower Limb Spasticity

The use of Dysport/botulinum toxin type a (J0586) is Scientifically Validated for Upper and Lower Limb Spasticity but not fixed contracture in patients 2 years and older with cerebral palsy, multiple sclerosis, brain injury, stroke hereditary spastic paraplegia and other demyelinating diseases or tumors of the brain and spinal cord.

BCBSNE preferred botulinum toxin products for the treatment of Upper and Lower Limb Spasticity is Dysport (botulinum toxin type a).  For benefits to be available in this indication, use of Dysport (botulinum toxin type a) is required.  Benefits for other botulinum toxin products are not available for this indication.  The use of other products other than Dysport for Upper and Lower Limb Spasticity is not Medically Necessary

  E. Sialorrhea

The use of Xeomin/incobotulinumtoxina (J0588) is Scientifically Validated for the treatment of Sialorrhea in patients 2 years and older, when the following criteria is met:

1.  Patient has excessive secretion of saliva

2.  Patient is unresponsive to oral anticholinergics (e.g. hyoscyamine, amitriptyline, ipratropium, atropine)

BCBSNE preferred botulinum toxin product for the treatment of Sialorrhea is Xeomin (incobutulinumtoxina).  For benefits to be available for this indication, use of Xeomin is required.  Benefits for other botulinum toxin products are not available for this indication.  The use of other products other than Xeomin for Sialorrhea are not Medically Necessary.

Initial Review:  If above criteria is met:  Approval for 2 injections over the course of 6 months.

Renewal Review:  After the initial trial period of 6 months, approval can be given for up to 4 injections over the course of 12 months, if clinical effectiveness has been documented.

II.  The use of Dysport/adobotulinumtoxin A (J0586) for all other indications not listed above is considered Investigational as its effectiveness for other indications has not been established.

III. The use of Xeomin/incobotulinumtoxin A (J0588) for all other indications not listed above is considered Investigational as its effectiveness for other indications has not been established.

Myobloc/rimabotulinumtoxin B (J0587)

     IV.  Botulinum Toxin type B/Myobloc/Rimabotulinumtoxin B (J0587) is FDA approved for use in the treatment of Cervical Dystonia (e.g. spasmodic torticollis).  However, there are no benefits available as BCBSNE requires use of the botulinum toxin product Xeomin for this indication.  The use of other products other than Xeomin for Cervical Dystonia is not Medically Necessary.

Botulinum toxins are a family of neurotoxins produced by the anaerobic organism Clostridium botulinum. There are seven distinct serotypes designated as type A, B, C-1, D, E, F, and G. Each serotype is produced by a specific strain of Clostridium botulinum. In this country three preparations of botulinum toxin are approved and they are manufactured from two different strains of bacteria: onabotulinumtoxinA (Botox ®) and abobotulinumtoxinA (Dysport®) are made from the Hall strain and rimabotulinumtoxinB (Myobloc®) is made from the Bean strain. When administered intramuscularly, botulinum toxins reduce muscle tone by interfering with the release of acetylcholine from nerve endings.

Although similar in certain aspects, it is important to understand onabotulinumtoxinA, abobotulinumtoxinA, and rimabotulinumtoxinB are unique products that are not interchangeable. They are chemically, pharmacologically, and clinically distinct. The units of biological activity of one botulinum toxin product cannot be compared to nor converted into units of any other botulinum toxin product.