Anthem Blue Cross California Botulinum Toxin Form

Medical Drug Clinical Criteria Publish Date: Last Review Date:/ 12/01/2023 11/17/2023 Overview Clinical criteria Overview Coding Document history References This document addresses the use of botulinum toxin agents: Daxxify (daxibotulinumtoxinA-lanm), Dysport (abobotulinumA), Xeomin (incobotulinumtoxin A), Botox (onabotulinumtoxin A), and Myobloc (rimabotulinumtoxin B). Botulinum is a family of toxins produced by the anaerobic organism Clostridia botulinum. There are seven distinct serotypes designated as type A, B, C-1, D, E, F, and G. In this country, four preparations of botulinum are available, produced by two different strains of bacteria: type A (Botox [onabotulinumtoxinA], Dysport [abobotulinumtoxinA], and Xeomin [incobotulinumtoxinA]) and type B (Myobloc [rimabotulinumtoxinB]). When administered intramuscularly, all botulinum toxins reduce muscle tone by interfering with the release of acetylcholine from nerve endings. However, it should be noted that these drugs are not interchangeable and the potency ratios for dosing cannot be converted. Careful adherence to the specific instructions for dosing in the package insert is recommended. The U.S. Food and Drug Administration (FDA) approved label for Botox states that it is indicated for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain; severe primary axillary hyperhidrosis that is inadequately managed with topical agents; strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or facial nerve (VII nerve) disorders in individuals older than 12 years; urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication; 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; neurogenic detrusor overactivity in children 5 years of age and older who have an inadequate response to or are intolerant of an anticholinergic medication; prophylaxis of chronic migraine headaches in adults; spasticity in individuals 2 years of age and older; and several cosmetic indications including the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus 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 less than or equal to 65 years of age. The FDA approved label for Myobloc states it is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain in adults and for the treatment of chronic sialorrhea in adults. The FDA approved label for Dysport specifies that it is indicated for the treatment of cervical dystonia in adults; spasticity in adults and in pediatric patients 2 years of age and older; and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Xeomin received FDA approval for the treatment of cervical dystonia in adults; blepharospasm in adults; upper limb spasticity in adults; excessive salivation (chronic sialorrhea) in individuals 2 years of age and older; upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy; and the temporary improvement in the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. Daxxify received FDA approval for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults and for the treatment of cervical dystonia in adults. Dystonia is a general term describing a state of abnormal or disordered tonicity of muscle. As an example, achalasia is a dystonia of the lower esophageal sphincter, while cervical dystonia is also known as torticollis. Spasticity is a subset of dystonia, describing a velocity-dependent increase in tonic-stretch reflexes with exaggerated tendon jerks. Spasticity typically is associated with injuries to the central nervous system. Spasticity is a common feature of cerebral palsy. Since its FDA approval in 1991, Botox has been used for a wide variety of off-label indications; all associated with dystonia, ranging from achalasia, spasticity after strokes, cerebral palsy, and anal fissures. In addition to widening indications, Botox has also been used in children under 12, particularly for the treatment of cerebral palsy and is now FDA approved to treat various conditions in the pediatric population. Botulinum toxin has been utilized for many other conditions including anismus (pelvic floor dyssynergia), Behcet's syndrome, benign 1 prostatic hyperplasia, brachial plexus palsy, carpel tunnel, myofascial pain syndrome, Raynaud’s syndrome, atypical facial pain (also known as persistent idiopathic facial pain [PIFP]), low back pain, Tourette’s syndrome and Parkinson’s disease. There is limited evidence for efficacy of botulinum toxin in these conditions. Botulinum toxin agents have black box warnings regarding the potential for distant spread of toxin effect. This can produce symptoms including asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk is likely greatest in children treated for spasticity but can also occur in adults. Dysport contains lactose as an inactive ingredient. Individuals with a severe milk protein allergy should avoid use due to the risk of anaphylactic reactions. Botulinum toxin agents are not interchangeable and dosing units of one agent cannot be converted or compared to dosing units of another botulinum toxin agent. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Botulinum Toxin Requests for botulinum toxin may be approved if the following criteria are met: I. Individual has one of the following diagnoses: A. Disorders listed below if associated with spasticity or dystonia: Facial nerve (VII) dystonia; OR 1. Blepharospasm; OR 2. Cerebral palsy; OR 3. 4. Hemifacial spasm; OR 5. Hereditary spastic paraparesis; OR Idiopathic torsion dystonia; OR 6. 7. Lower limb spasticity; OR 8. Multiple sclerosis; OR 9. Neuromyelitis optica; OR 10. Organic writer's cramp; OR 11. Orofacial/oromandibular dystonias including jaw closure dystonia and Meige’s syndrome; OR 12. Schilder's disease; OR 13. Spasmodic dysphonia or laryngeal dystonia (a disorder of speech due to abnormal control of the laryngeal muscles present only during the specific task of speaking); OR 14. Spastic hemiplegia; OR 15. Spasticity related to stroke, spinal cord injury, or traumatic brain injury; OR 16. Dystonia-associated strabismus; OR 17. Symptomatic torsion dystonia; OR 18. Other forms of upper motor neuron spasticity; OR 19. Upper limb spasticity; OR Achalasia, including but not limited to internal anal sphincter achalasia with abnormal rectoanal inhibitory reflex (RAIR) or internal anal sphincter hypertonicity shown by anorectal manometry (ARM) (Irani 2008); OR Anal fissures; OR Significant drooling in individuals who are unable to tolerate anticholinergic therapy (ex. glycopyrrolate, scopolamine); OR Idiopathic overactive bladder in adults who are unresponsive or intolerant of a trial of anticholinergic therapy; OR Neurogenic overactive bladder (also referred to as detrusor overactivity or detrusor sphincter dyssynergia) that is inadequately controlled with anticholinergic therapy; OR B. C. D. E. F. G. Hirschsprung disease and associated functional obstruction caused by the inability of the internal anal sphincter to relax after prior surgical treatment; OR II. III. IV. Individual has a history of recurrent clonic or tonic involuntary contractions of one or more of the following Individual has a diagnosis of cervical dystonia (spasmodic torticollis) of moderate or greater severity; AND Individual is requesting initial treatment; AND muscles: sternocleidomastoid, splenius, trapezius or posterior cervical muscles; AND V. Abnormal posturing, with limited range of motion in the neck, or sustained head tilt; AND VI. The duration of the condition is greater than 6 months; OR 2 Individual has a diagnosis of cervical dystonia (spasmodic torticollis) of moderate or greater severity; AND VII. VIII. Individual is requesting subsequent injections; AND IX. There is clinically significant improvement or stabilization in clinical signs and symptoms of the disease; OR X. XI. XII. Individual has a diagnosis of chronic migraine headaches; AND Individual is requesting initial treatment; AND Individual has 15 (fifteen) or more headache-days per month for more than 3 months, which, on at least 8 days per month, has features of a migraine headache (ICHD-3); AND XIII. Individual has had a trial of and inadequate response to a 2 month trial at target or usual effective dose or intolerance to two agents for migraine prophylaxis (at least one agent in any two of the following classes) or has a contraindication to all of the following medications (AAN/AHA 2012/2015, Level A and B evidence; ICSI 2013, high quality evidence, AHS 2021): A. One of the following antidepressants: amitriptyline, duloxetine, nortriptyline, venlafaxine; OR B. One of the following beta blockers: atenolol, metoprolol, nadolol, nebivolol, propranolol, timolol (oral); OR C. The following calcium channel blocker: verapamil; OR D. One of the following antiepileptic agents: divalproex sodium, gabapentin, topiramate, valproate sodium; AND XIV. If individual is also currently using a calcitonin gene-related peptide (CGRP) agent for chronic migraine prophylaxis and is going to be using CGRP and botulinum toxin together (i.e., not switching from one agent to another), the following must apply: A. Individual has had a reduction in the overall number of migraine days or reduction in number of severe migraine days per month with CGRP use; AND B. Individual continues to experience a significant number of migraine headache days or severe migraine days per month requiring additional therapy for migraine prevention; Initial approval duration for chronic migraine headaches: 6 months Individual has a diagnosis of chronic migraine headaches; AND OR XV. XVI. Individual is requesting continued treatment; AND XVII. Individual has completed an initial 6-month trial the following criteria are met: A. Individual has a reduction in the overall number of migraine days or reduction in number of severe migraine days per month; AND B. Individual has obtained clinical benefit deemed significant by individual or prescriber including any of the following (AHS 2021): 1. 50% reduction in frequency of days with headache or migraine; OR 2. Significant decrease in attack duration; OR 3. Significant decrease in attack severity; OR 4. Improved response to acute treatment; OR 5. Reduction in migraine-related disability and improvements in functioning in important areas of life; OR Improvements in health related quality of life and reduction in psychological stress due to migraine; 6. AND If individual is using concurrently with a CGRP agent for migraine prophylaxis, the following must apply: C. 1. Individual has had further reduction in the overall number of migraine days or reduction in number of severe migraine days per month compared to monotherapy with the initial agent (either botulinum toxin or the CGRP agent); Renewal approval duration for chronic migraine headaches: 1 year OR XVIII. Individual has a diagnosis of primary hyperhidrosis; AND XIX. Individual has failed a 6 month trial of any one or more types of non-surgical treatment (for example, topical dermatologics such as aluminum chloride, tannic acid, glutaraldehyde or anticholinergics, systemic anticholinergics, tranquilizers or non- steroid anti-inflammatory drugs); AND Individual has one of the following: A. Presence of medical complications or skin maceration with secondary infection; OR B. Significant functional impairment (including but not limited to social, occupational, physical or emotional impairment), as XX. defined by frequent interference with daily activities; OR XXI. Individual has a diagnosis of secondary hyperhidrosis; AND 3 XXII. Condition is related to surgical complications; AND XXIII. Individual has one of the following: A. Presence of medical complications or skin maceration with secondary infection; OR B. Significant functional impairment (including but not limited to social, occupational, physical or emotional impairment), as defined by frequent interference with daily activities. Requests for botulinum toxin may not be approved for the following: I. II. III. Fibromyalgia/fibromyositis; OR Individual is using for skin wrinkles or other cosmetic indications; OR Individual has headache diagnosis other than chronic migraine (example, tension, episodic migraine [14 migraine days per month or less], or chronic daily headaches); OR Individual has any diagnosis not listed as an approvable diagnosis, including, but not limited to, the following: A. Anismus (pelvic floor dyssynergia); OR B. Behcet's syndrome; OR C. Benign prostatic hyperplasia; OR D. Brachial plexus palsy; OR E. Carpal tunnel syndrome; OR F. Chronic motor tic disorder; OR G. Disorders of the esophagus (except as listed above in the approvable section) ; OR H. Epicondylitis; OR I. J. Gastroparesis; OR K. Low back pain; OR L. Myofascial pain syndrome; OR M. Neck pain not related to conditions mentioned above; OR N. Nystagmus; OR O. Parkinson's disease; OR P. Post-mastectomy reconstruction syndrome; OR Q. Reynaud's syndrome; OR R. Sphincter of Oddi dysfunction; OR S. Stuttering; OR T. Tics associated with Tourette's Syndrome; OR U. Tinnitus; OR V. Tourette's Syndrome; OR W. Tremors; OR X. Urinary and anal sphincter dysfunction (except as listed above in the approvable section) ; OR Y. Vaginismus; OR Z. Whiplash-related disorders; OR AA. Zygomatic fractures. Quantity Limits Botulinum Toxin Quantity Limits* Drug Limit Per Indication Botox (onabotulinumtoxinA) 100 unit, 200 unit vial NOTE: follow indication- specific dosage and administration recommendations; in a 3 month interval do not exceed a total dose [cumulative for all indications treated] of: • Adults: 400 units • Pediatrics: the lesser of 10 units/kg or 340 units Idiopathic Overactive Bladder: 100 units as frequently as every 12 weeks Neurogenic Overactive Bladder (including neurogenic detrusor overactivity in children age 5 and older): 200 units as frequently as every 12 weeks Chronic Migraine: 155 units as frequently as every 12 weeks Cervical Dystonia: 400 units§ as frequently as every 12 weeks Axillary hyperhidrosis: 50 units per axilla as frequently as every 8 weeks Blepharospasm: 200 units as frequently as every 12 weeks Dystonia-associated strabismus: 25 units per muscle; as frequently as every 12 weeks Upper limb spasticity in adults: Dose selected based on muscles affected, severity of muscle activity, prior response to treatment and adverse event history (maximum dose 400 units) as frequently as every 12 weeks Lower limb spasticity in adults: 300 units to 400 units divided across lower limb muscles as frequently as every 12 weeks Upper limb spasticity in pediatric patients: 3 Units/kg to 6 Units/kg (maximum 200 Units) as frequently as every 12 weeks Lower limb spasticity in pediatric patients: 4 units/kg to 8 units/kg (maximum 300 units) as frequently as every 12 weeks Maximum amount allowed for indication* 100 units 200 units 200 units 400 units 100 units 200 units 100 units 400 units 400 units 200 units 300 units 4 Daxxify (daxibotulinumtoxinA- lanm) 50 unit, 100 unit vial Dysport (abobotulinumtoxinA) 300 unit, 500 unit vial Myobloc (rimabotulinumtoxinB) 2500 unit, 5000 unit, 10000 unit vial Xeomin (incobotulinumtoxinA) 200 unit, 100 unit, 50 unit vial Achalasia: 100 units as frequently as every 12 weeks (DP) Hemifacial spasm: 25 units as frequently as every 12 weeks (DP) Spasmodic Dysphonia: 25 units as frequently as every 12 weeks (DP) Other indications: Up to 400 units as frequently as every 12 weeks Cervical Dystonia: 125 to 250 units as a divided dose among affected muscles as frequently as every 3 months Upper and lower limb spasticity in adults: 1500 units (cumulative for all treated muscles) as frequently as every 12 weeks Cervical Dystonia: 1000 units as frequently as every 12 weeks Other indications: Up to 1500 units as frequently as every 12 weeks Upper limb spasticity in pediatric patients: 8 units/kg to 16 units/kg per limb; maximum per treatment session 16 units/kg or 640 units, whichever is lower; as frequently as every 16 weeks Lower limb spasticity in pediatric patients: 10 units/kg to 15 units/kg; total dose must not exceed 15 units/kg for unilateral lower limb or 30 units/kg for bilateral injections or 1000 units, whichever is lower; as frequently as every 12 weeks Blepharospasm: 120 units per eye as frequently as every 12 weeks (DP) Hemifacial spasm: 220 units as frequently as every 12 weeks (DP) Cervical dystonia: Initial dose of 2,500 – 5,000 units divided among effected muscles as frequently as every 12 weeks; subsequent doses should be based on individual response to treatment, up to 10,000 units as frequently as every 12 weeks Chronic sialorrhea in adults: 1,500 – 3.500 units (500 units – 1,500 units per parotid gland and 250 units per submandibular gland) as frequently as every 12 weeks All other Indications: 10,000 units as frequently as every 12 weeks Cervical dystonia: Initial dose of 120 units as frequently as every 12 weeks; subsequent doses should be based on past dose, response to treatment, duration of effect and adverse event history; up to 400 units as frequently as every 12 weeks Chronic sialorrhea: 100 units as frequently as every 16 weeks Blepharospasm: Initial dose 50 units (25 units per eye) as frequently as every 12 weeks; subsequent doses based on past dose, response to treatment, duration of effect and adverse event history; dose should not exceed 100 units per treatment session (50 units per eye) as frequently as every 12 weeks Upper limb spasticity: 400 units as frequently as every 12 weeks Other indications: Up to 400 units as frequently as every 12 weeks 100 units 100 units 100 units 400 units 250 units 1500 units 1000 units 1500 units 800 units 1000 units 300 units 300 units 10,000 units 5000 units 10,000 units 400 units 100 units 100 units 400 units 400 units *Based on maximum dose for condition and vial size available DP = DrugPoints off label use/dosing § Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history; mean dose in clinical study was 236 units (25th to 75th percentile range of 198 units to 300 units) Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non- coverage of these services as it applies to an individual member. CPT 31573 46505 52287 64647 67345 46505 64611 64612 Laryngoscopy, flexible; with therapeutic injection(s) (eg, chemodenervation agent or corticosteroid, injected percutaneous, transoral, or via endoscope channel), unilateral Chemodenervation of internal anal sphincter [for diagnosis of anal fissure] Cystourethroscopy, with injection(s) for chemodenervation of the bladder [for specified related bladder and incontinence disorders] Chemodenervation of trunk muscle(s); 6 or more muscles Chemodenervation of extraocular muscle [for diagnosis of strabismus] Chemodenervation of internal anal sphincter [for diagnosis of Hirschsprung's disease] Chemodenervation of parotid and submandibular salivary glands, bilateral [for significant drooling] Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm or hemifacial spasm) 5 64615 64616 64617 64642 64643 64644 64645 64646 64647 64650 64653 HCPCS J0585 J0586 J0587 J0588 S2340 S2341 J3590 C9160 Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine) Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis) Chemodenervation of muscle(s); larynx, unilateral, percutaneous, (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed Chemodenervation of one extremity; 1-4 muscle(s) Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) Chemodenervation of one extremity; 5 or more muscles Chemodenervation of one extremity; each additional extremity, 5 or more muscles Chemodenervation of trunk muscle(s); 1-5 muscle(s) Chemodenervation of trunk muscle(s); 6 or more muscles Chemodenervation of eccrine glands; both axillae Chemodenervation of eccrine glands; other area(s) (eg, scalp, face, neck), per day Injection, onabotulinumtoxinA, 1 unit [e.g., Botox] Injection, abobotulinumtoxinA, 5 units [Dysport] Injection, rimabotulinumtoxinB, 100 units [Myobloc] Injection, incobotulinumtoxinA, 1 unit [Xeomin] Chemodenervation of abductor muscle(s) of vocal cord Chemodenervation of adductor muscle(s) of vocal cord Unclassified biologic (when specified as [Daxxify] (daxibotulinumtoxinA-lanm)) Injection, daxibotulinumtoxina-lanm, 1 unit [Daxxify] ICD-10 Diagnosis G11.4 Hereditary spastic paraplegia G24.01-G24.09 Drug induced dystonia G24.1-G24.2 Genetic torsion dystonia, idiopathic nonfamilial dystonia G24.3 G24.4 G24.5 G24.8 G24.9 G25.89 G35 G36.0 G37.0 G37.5 Spasmodic torticollis Idiopathic orofacial dystonia Blepharospasm Other dystonia Dystonia, unspecified Other specified extrapyramidal and movement disorders [specified as organic writer's cramp] Multiple sclerosis Neuromyelitis optica Diffuse sclerosis of central nervous system (Schilder's disease) Concentric sclerosis [Balo] of central nervous system G43.001-G43.919 Migraine G51.0-G51.9 G80.0-G80.9 Facial nerve disorders Cerebral palsy G81.10-G81.14 Spastic hemiplegia G83.4 G95.89 H49.00-H49.9 H50.00-H50.9 I69.00-I69.998 Cauda equina syndrome Other specified diseases of spinal cord (cord bladder NOS) Paralytic strabismus Other strabismus Sequelae of cerebrovascular disease 6 J38.3 J38.5 K11.7 K22.0 K59.89 Other diseases of vocal cords (spastic dysphonia) Laryngeal spasm Disturbance of salivary secretion Achalasia of cardia (cardiospasm) Other specified functional intestinal disorders K60.0-K60.2 Anal fissure L74.510-L74.519 Primary focal hyperhidrosis L74.52 M43.6 M62.838 Secondary focal hyperhidrosis Torticollis Other muscle spasm N31.0-N31.9 Neuromuscular dysfunction of bladder, not elsewhere classified N32.81 N36.44 N39.3 Overactive bladder (detrusor muscle hyperactivity) Muscular disorders of urethra (bladder sphincter dyssynergy) Stress incontinence N39.41-N39.498 Other specified urinary incontinence Q43.1 Q68.0 R25.2 R32 Hirschsprung's disease Congenital deformity of sternocleidomastoid muscle Cramp and Spasm Unspecified urinary incontinence R49.8-R49.9 Other and unspecified voice and resonance disorders R61 Generalized hyperhidrosis S06.0X0S-S06.9X9S Intracranial injury, sequela [code range, includes codes within this range with 7th character 'S'] S14.101S-S14.159S S24.101S-S24.159S S34.101S-S34.139S Other and unspecified injury of cervical spinal cord [code range, includes codes within this range with 7th character 'S'] Other and unspecified injury of thoracic spinal cord [code range, includes codes within this range with 7th character 'S'] Other and unspecified injury of lumbar and sacral spinal cord [code range, includes codes within this range with 7th character 'S'] Document History Revised: 11/17/2023