Botulinum Toxin Injection "Notification"

Restricted Product(s):

• *abobotulinumtoxinA (Dysport®) intramuscular injection for administration by a healthcare professional 
• daxibotulinumtoxinA-lanm (Daxxify®) intramuscular injection for administration by a healthcare professional 
• *incobotulinumtoxinA (Xeomin®) intramuscular or intraglandular injection for administration by a healthcare professional 
• letibotulinumtoxinA-wlbg (Letybo®) intramuscular injection for administration by a healthcare professional 
• onabotulinumtoxinA (Botox®) intramuscular, intradetrusor, or intradermal injection for administration by a healthcare professional 
• rimabotulinumtoxinB (Myobloc®) intramuscular or intraglandular injection for administration by a healthcare professional
  

*preferred agent(s)

FDA Approved Use:

• AbobotulinumtoxinA (Dysport®) 
  • For the treatment of cervical dystonia in adults 
  • For the treatment of spasticity in patients 2 years or older 
  • **For temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years old 
• DaxibotulinumtoxinA-lanm (Daxxify®) 
  • For the treatment of cervical dystonia in adults 
  • **For temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults 
• IncobotulinumtoxinA (Xeomin®) 
  • For the treatment of cervical dystonia in adults 
  • For the treatment of upper limb spasticity in adults 
  • For the treatment of upper limb spasticity in patients 2 to 17 years old, excluding spasticity caused by cerebral palsy 
  • For the treatment of chronic sialorrhea in patients 2 years or older
  • For the treatment of blepharospasm in adults 
  • **For temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and/or corrugator muscle activity in adults
• **LetibotulinumtoxinA-wlbg (Letybo®) 
  • **For temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adult patients 
• OnabotulinumtoxinA (Botox®) 
  • For the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain 
  • For the treatment of spasticity in patients 2 years or older
    • Limitations of use: Not for improvement of upper extremity functional abilities or range of motion at a joint affected by a fixed contracture 
  • For the prophylaxis of headaches in adults with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) 
    • Limitations of use: Not for prophylaxis of episodic migraine (≤14 headache days per month) 
  • For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication 
  • For the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication 
  • For the treatment of neurogenic detrusor overactivity in pediatric patients 5 years or older who have an inadequate response to or are intolerant of an anticholinergic medication 
  • For the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders, in patients 12 years or older 
  • For the treatment of strabismus in patients 12 years or older 
  • For the treatment of severe axillary hyperhidrosis in adults that is inadequately managed by topical agents 
    • Limitations of use: Not for use in body areas other than axillary 
  • **For temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and/or corrugator muscle activity, moderate to severe lateral canthal lines associated with orbicularis oculi activity, and moderate to severe forehead lines associated with frontalis muscle activity in adults 
• RimabotulinumtoxinB (Myobloc®) 
  • For the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults 
  • For the treatment of chronic sialorrhea in adults 

**The restricted products within this policy may be FDA approved for temporary improvement of the appearance of glabellar (frown) lines and upper facial lines in adults; however, use of these products for cosmetic purposes are considered a benefit exclusion and are not addressed in this medical policy. Please refer to the Member’s Benefit Booklet for availability of benefits and for the definition of cosmetic and reconstructive services. Member's benefits may vary according to benefit design; therefore, member benefit language should be reviewed before applying the terms of this medical policy. NOTE: LetibotulinumtoxinA-wlbg (Letybo) is FDA approved only for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adult patients, which is considered use for cosmetic purposes and therefore use of this product is considered a benefit exclusion.   

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

Botulinum toxin may be considered medically necessary when the following criteria are met:

1. The patient will NOT be using the requested agent for cosmetic purposes (e.g., glabellar lines, wrinkles); AND 
2. The patient has a diagnosis of blepharospasm; AND 
   1. The patient is 12 years of age or older; AND 
   2. If the requested agent is Botox, Daxxify, or Myobloc AND the patient is 18 years of age or older, one of the following: 
      1. The patient has tried and had an inadequate response with Xeomin [medical record documentation required]; OR 
      2. The patient has a clinical contraindication or intolerance to Xeomin [medical record documentation required]; OR 
      3. The patient’s blepharospasm is associated with dystonia or facial nerve (VII) disorders (including benign essential blepharospasm and hemifacial spasm); OR
3. The patient has a diagnosis of hemifacial spasm; OR 
4. The patient has a diagnosis of cervical dystonia (spasmodic torticollis; applicable whether congenital, due to child birth injury, or traumatic injury); AND 
   1. The patient is 16 years of age or older; AND 
   2. The patient’s cervical dystonia is associated with sustained head tilt or abnormal posturing with limited range of motion in the neck; AND 
   3. The patient has a history of recurrent involuntary contraction(s) of one or more of the muscles of the neck (e.g., sternocleidomastoid, splenius, trapezius, or posterior cervical muscles); AND 
   4. If the requested agent is Botox, Daxxify, or Myobloc, one of the following: 
      1. The patient has tried and had an inadequate response with Xeomin AND Dysport [medical record documentation required]; OR 
      2. The patient has a clinical contraindication or intolerance to BOTH Xeomin AND Dysport [medical record documentation required]; OR
5. The patient has a diagnosis of dystonia; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has at least ONE of the following focal dystonias:
      1. Focal upper-limb dystonia (e.g., organic writer’s cramp); 
      2. Oromandibular dystonia (e.g., orofacial dyskinesia, Meige syndrome); 
      3. Laryngeal dystonia (e.g., adductor spasmodic dysphonia); 
      4. Idiopathic (primary or genetic) torsion dystonia; 
      5. Symptomatic (acquired) torsion dystonia; AND
   3. The patient’s dystonia results in functional impairment (interference with joint function, mobility, communication, nutritional intake) with or without pain; AND 
   4. The requested agent will NOT be used for treatment of temporomandibular joint (TMJ) disorders; AND 
   5. If the requested agent is Botox, Daxxify, or Myobloc, one of the following: 
      1. The patient has tried and had an inadequate response with Xeomin AND Dysport [medical record documentation required]; OR 
      2. The patient has a clinical contraindication or intolerance to BOTH Xeomin AND Dysport [medical record documentation required]; OR
6. The patient has a diagnosis of spasticity; AND 
   1. The patient is 2 years of age or older; AND 
   2. The patient has at least ONE of the following spastic conditions:
      1. Upper and/or lower limb spasticity; 
      2. Cerebral palsy; 
      3. Spasticity related to stroke; 
      4. Acquired spinal cord or brain injury; 
      5. Hereditary spastic paraparesis; 
      6. Spastic hemiplegia; 
      7. Neuromyelitis optica; 
      8. Multiple sclerosis or Schilder’s disease; AND
   3. The patient’s spasticity results in functional impairment (interference with joint function, mobility, communication, nutritional intake) with or without pain; AND 
   4. If the requested agent is Botox, Daxxify, or Myobloc, one of the following: 
      1. The patient has tried and had an inadequate response with Xeomin AND Dysport [medical record documentation required]; OR 
      2. The patient has a clinical contraindication or intolerance to BOTH Xeomin AND Dysport [medical record documentation required]; OR
7. The patient has a diagnosis of chronic anal fissure; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has a tried and had an inadequate response to ONE of the following conventional therapies: topical nitrates or topical calcium channel blockers (e.g., diltiazem, nifedipine); OR
   3. The patient has a clinical contraindication or intolerance to ALL topical nitrates and topical calcium channel blockers (e.g., diltiazem, nifedipine); OR
8. The patient has a diagnosis of chronic migraine headache; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has ≥ 15 headache days per month for a minimum of 3 months; AND 
   3. The patient ≥ 8 migraine headache days per month for a minimum of 3 months; AND 
   4. The patient will be using the requested agent for chronic migraine prophylaxis; AND 
   5. The patient has been evaluated for and does NOT have medication overuse headache; AND 
   6. ONE of the following: 
      1. The patient has tried and had an inadequate response to at least TWO agents from different migraine prophylaxis classes (anticonvulsants [i.e., divalproex, valproate, topiramate], beta blockers [i.e., atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [i.e., amitriptyline, venlafaxine], calcitonin gene-related peptide receptor antagonists [i.e., fremanezumab, galcanezumab, erenumab, eptinezumab]) after an adequate trial as defined by BOTH of the following: 
         1. The trial length was at least 6 weeks for each class at generally accepted doses; AND 
         2. The patient was ≥ 80% adherent to the prophylaxis agent during the trial; OR 
      2. The patient has a clinical contraindication or intolerance to ALL anticonvulsants, beta blockers, antidepressants, AND prophylactic calcitonin gene-related peptide receptor antagonists listed above; AND
   7. If the requested agent is Botox, one of the following: 
      1. The patient has tried and had an inadequate response to at least one calcitonin gene-related peptide (CGRP) receptor antagonist for chronic migraine headache prophylaxis (e.g., fremanezumab, galcanezumab, erenumab, or eptinezumab) [medical record documentation required]; OR 
      2. The patient has a clinical contraindication or intolerance to ALL calcitonin gene-related peptide (CGRP) receptor antagonists (e.g., fremanezumab, galcanezumab, erenumab, or eptinezumab) [medical record documentation required]; AND 
   8. ONE of the following: 
      1. The patient will NOT be using the requested agent in combination with a calcitonin gene-related peptide (CGRP) receptor antagonist for migraine prophylaxis (e.g., fremanezumab, galcanezumab, erenumab, or eptinezumab); OR 
      2. The patient will be using the requested agent in combination with a CGRP receptor antagonist for the treatment of chronic migraine; AND 
         1. The patient is continuing to experience 4 or more migraine headache days per month after treatment with ONE of the following preventative therapies for chronic migraine [medical record documentation required]: 
            1. At least a 6-month trial (2 injection cycles) with a botulinum toxin agent [medical record documentation required]; OR 
            2. At least a 3-month trial with a calcitonin gene-related peptide (CGRP) receptor antagonist [medical record documentation required]; OR
9. The patient has a diagnosis of esophageal achalasia; AND 
   1. The patient has NOT responded to dilation therapy; OR 
   2. The patient is considered a poor surgical candidate; OR
10. The patient has a diagnosis of Hirschsprung disease; AND 
    1. The patient has developed obstructive symptoms after a pull-through operation; OR
11. The patient has a diagnosis of overactive bladder (OAB); AND 
    1. The patient is 18 years of age or older; AND 
    2. The patient has symptoms of urge urinary incontinence, urgency, and frequency; AND 
    3. The patient has tried and had an inadequate response to ONE anticholinergic agent (e.g., oxybutynin, tolterodine, trospium, darifenacin, solifenacin or fesoterodine); OR 
    4. The patient has tried and had an inadequate response to a beta-3 adrenergic agonist (e.g., Myrbetriq [mirabegron]); OR 
    5. The patient has a clinical contraindication or intolerance to ALL anticholinergic agents AND beta-3 adrenergic agonists; OR
12. The patient has a diagnosis of urinary incontinence with detrusor muscle overactivity associated with neurogenic causes (e.g., spinal cord injury, multiple sclerosis); AND 
    1. The patient is 18 years of age or older; AND 
    2. The patient has tried and had an inadequate response to ONE anticholinergic agent (e.g., oxybutynin, tolterodine, trospium, darifenacin, solifenacin or fesoterodine); OR 
    3. The patient has tried and had an inadequate response to a beta-3 adrenergic agonist (e.g., Myrbetriq [mirabegron]); OR 
    4. The patient has a clinical contraindication or intolerance to ALL anticholinergic agents AND beta-3 adrenergic agonists; OR
13. The patient has a diagnosis of neurogenic detrusor overactivity (NDO); AND 
    1. The patient is 5 years of age or older; AND 
    2. The patient has tried and had an inadequate response to ONE anticholinergic agent (e.g., oxybutynin, solifenacin); OR 
    3. The patient has a clinical contraindication or intolerance to ALL anticholinergic agents; OR
14. The patient has a diagnosis of chronic sialorrhea (drooling); AND 
    1. The patient is 18 years of age or older; OR 
    2. If the requested agent is Xeomin, the patient is 2 years of age or older; AND 
    3. The patient’s diagnosis is associated with a neurological disorder (e.g., amyotrophic lateral sclerosis, atypical parkinsonian disorders, cerebral palsy, Parkinson disease, stroke, traumatic brain injury); AND 
    4. The patient has experienced excessive salivation for ≥ 3 months; AND 
    5. The patient has tried and had an inadequate response to at least 2 months continuous treatment with at least one conventional agent (e.g., anticholinergics, benztropine, oral hyoscyamine, glycopyrrolate); OR 
    6. The patient has a clinical contraindication or intolerance to ALL conventional agents above; AND 
    7. If the requested agent is Botox, Daxxify, or Myobloc, one of the following: 
       1. The patient has tried and had an inadequate response with Xeomin [medical record documentation required]; OR 
       2. The patient has a clinical contraindication or intolerance to Xeomin [medical record documentation required]; OR 
15. The patient has a diagnosis of strabismus; AND 
    1. The patient is 12 years of age or older; OR
16. The patient has a diagnosis of severe primary axillary or palmar hyperhidrosis; AND 
    1. The patient is 18 years of age or older; AND  
    2. The patient has focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least TWO of the following characteristics: 
       1. Bilateral and relatively symmetric; 
       2. Impairs daily activities; 
       3. Frequency of at least one episode per week; 
       4. Age of onset is less than 25 years; 
       5. Positive family history; 
       6. Cessation of focal sweating during sleep; AND
    3. The patient has one of the following associated medical conditions: 
       1. Acrocyanosis of the hands; 
       2. History of recurrent skin maceration with bacterial or fungal infections; 
       3. History of recurrent secondary infections; 
       4. History of persistent eczematous dermatitis despite medical treatments with topical dermatologic or systemic anticholinergic agents; OR
    4. The patient’s hyperhidrosis causes functional impairment (e.g., inability to perform activities of daily living and/or manual tasks in a professional setting); AND 
    5. Potential causes of secondary hyperhidrosis have been ruled out (e.g., hyperthyroidism); AND 
    6. The patient has tried and had an inadequate response with topical agents (e.g., aluminum chloride 20% solution); OR 
    7. The patient has a clinical contraindication or intolerance to ALL topical agents; OR
17. The patient has another diagnosis that is an FDA approved indication for botulinum toxins; AND 
18. The patient will NOT be receiving botulinum toxin more frequently than every 12 weeks, regardless of diagnosis; AND 
19. The requested quantity does NOT exceed the maximum units/visits allowed for the duration of approval (see table below). 

Duration of Approval:

Migraine: 168 days (24 weeks)
All other indications: 336 days (48 weeks)

Continuation Criteria for Approval:

Botulinum toxin may be considered medically necessary when the following criteria are met:

1. The patient will NOT be using the requested agent for cosmetic purposes (e.g., glabellar lines, wrinkles); AND 
2. The patient was approved through Blue Cross NC initial criteria for approval (above) or would have met initial criteria for approval upon the start of therapy; AND 
3. The patient has a diagnosis of chronic migraine headache; AND 
   1. ONE of the following: 
      1. The patient’s migraine headache frequency has been reduced by at least 7 days per month compared to pre-treatment frequency; OR 
      2. The patient’s migraine headache duration has been reduced by at least 100 hours per month compared to pre-treatment duration; AND
   2. ONE of the following: 
      1. The patient will NOT be using the requested agent in combination with a calcitonin gene-related peptide (CGRP) receptor antagonist for migraine prophylaxis (e.g., fremanezumab, galcanezumab, erenumab, or eptinezumab); OR 
      2. The patient will be using the requested agent in combination with a CGRP receptor antagonist for the treatment of chronic migraine; AND 
         1. The patient is continuing to experience 4 or more migraine headache days per month after treatment with ONE of the following preventative therapies for chronic migraine [medical record documentation required]: 
            1. At least a 6-month trial (2 injection cycles) with a botulinum toxin agent [medical record documentation required]; OR 
            2. At least a 3-month trial with a calcitonin gene-related peptide (CGRP) receptor antagonist [medical record documentation required]; OR
4. The patient has a diagnosis of dystonia; AND 
   1. The patient has had a positive clinical response to botulinum toxin therapy; AND
   2. The requested agent will NOT be used for treatment of temporomandibular joint (TMJ) disorders; OR
5. The patient is continuing botulinum toxin therapy for one of the indications listed in the initial coverage criteria; AND
   1. The patient has had a positive clinical response to botulinum toxin therapy; AND
6. The patient will NOT be receiving botulinum toxin more frequently than every 12 weeks, regardless of diagnosis; AND 
7. The requested quantity does NOT exceed the maximum units/visits allowed for the duration of approval (see table below).

Duration of Approval: 336 days (48 weeks)