Botulinum Toxins A and B

Coverage Summary

UnitedHealthcare Medical Benefit Drug Policy CS2026D0017AQ covers FDA-approved botulinum toxin A and B products including Dysport (abobotulinumtoxinA), Daxxify (daxibotulinumtoxinA‑lanm), Xeomin (incobotulinumtoxinA), Botox (onabotulinumtoxinA), and Myobloc (rimabotulinumtoxinB). The policy designates Botox and Xeomin as preferred products, and requires clinical justification (prior trial/failure or intolerance to preferred agents plus physician attestation) for coverage of non‑preferred products (e.g., Dysport, Daxxify, Myobloc). Certain states are excluded from this policy and state‑specific guidance applies; consult the state policies where noted. The policy and all FDA‑approved botulinum toxin products carry a boxed warning regarding distant spread of toxin effect.

Key thresholds and limits

Initial authorization durationNo more than 6 months

Reauthorization durationNo more than 12 months

Minimum interval between administrationsNo more frequent than every 12 weeks

Botox dose limit for chronic migraine≤ 155 units administered intramuscularly divided over 31 injection sites across 7 head and neck muscles every 12 weeks

Botox dose limit for overactive bladder≤ 100 units divided over 20 injection sites every 12 weeks

Initial Therapy Criteria

Documentation Required

Submit diagnosis and supporting records for initial therapy

Provide diagnosis and medical records documenting history and physical exam showing severity of the condition, plus laboratory results or diagnostic evidence supporting the indication when requesting initial botulinum toxin therapy.

Prior Authorization

Authorization duration and frequency limits

Initial authorization will be for no more than 6 months. Botulinum toxin administration is no more frequent than every 12 weeks.

Initial authorization ≤ 6 months
No more frequent than every 12 weeks

Diagnosis-Specific Criteria (by product)

Diagnosis-Specific Criteria: Dysport (abobotulinumtoxinA)

Dysport is medically necessary for the listed indications when the following diagnosis-specific criteria are met.

Achalasia

Diagnosis of achalasia as confirmed by esophageal manometry
Patient has failed or is not a candidate for pneumatic dilation or myotomy
Other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy

Chronic anal fissures

Diagnosis of chronic anal fissure

Continuation Therapy Criteria

Documentation Required

Continuation therapy documentation

For continuation (reauthorization) provide documentation of a positive clinical response to botulinum toxin therapy and a statement of the expected frequency and duration of proposed treatment.

Unproven / Not Medically Necessary Uses

Unproven / Not Medically Necessary

The following uses are considered unproven and not medically necessary for specified products:

Unproven for chronic migraine

Daxxify, Dysport, Myobloc, and Xeomin are unproven and not medically necessary for the treatment of chronic migraine headache

Unproven for listed other conditions

Botox, Daxxify, Dysport, Myobloc, and Xeomin are unproven and not medically necessary for the treatment of the following conditions: Acquired nystagmus; Anismus (pelvic floor dyssynergia); Benign prostatic hyperplasia; Brachial plexus palsy; Chronic daily headache; Chronic low back pain; Chronic prostatic pain; Cricopharyngeal dysphagia (excludes achalasia); Epiphora following salivary gland transplantation; Esophageal spasm; Gastroparesis (including diabetic gastroparesis); Gustatory epiphora (crocodile tears); Lateral epicondylitis (tennis elbow); Lichen simplex; Lower urinary tract (voiding) dysfunction; Motor tics; Myofascial pain syndrome; Nasal hypersecretion; Pain and/or wound healing after hemorrhoidectomy; Pancreas divisum; Pelvic floor spasticity (and associated pain conditions); Piriformis syndrome; Post-parotidectomy sialoceles; Post-thoracotomy pseudoangina; Proctalgia fugax; Severe bruxism; Severe paradoxical vocal cord movement; Sphincter of Oddi dysfunction; Stiff-person syndrome; Temporomandibular disorders; Tension-type headache; Thyroid associated ophthalmopathy; Tourette's syndrome; Traumatic sixth nerve palsy; Trigeminal neuralgia; Trismus and stridor in amyotrophic lateral sclerosis

Applicable Codes

J-Codes for botulinum toxin productsHCPCS

J0585	Injection, onabotulinumtoxinA, 1 unit. Brand: Botox
J0586	Injection, abobotulinumtoxinA, 5 units. Brand: Dysport
J0587	Injection, rimabotulinumtoxinB, 100 units. Brand: Myobloc
J0588	Injection, incobotulinumtoxinA, 1 unit. Brand: Xeomin
J0589	Injection, daxibotulinumtoxina-lanm, 1 unit. Brand: Daxxify

Applicable Diagnosis Codes referencedICD-10

G24.3	Spasmodic torticollis
G24.5	Blepharospasm
G25.0	Essential tremor
G43.701	Chronic migraine without aura, not intractable, with status migrainosus
G43.709	Chronic migraine without aura, not intractable, without status migrainosus
G43.711	Chronic migraine without aura, intractable, with status migrainosus
G43.719	Chronic migraine without aura, intractable, without status migrainosus
G35.A	Relapsing-remitting multiple sclerosis
G36.0	Neuromyelitis optica [Devic]
G24.1	Genetic torsion dystonia

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Applicable ICD-10 codes with J0585-J0589 indicatorsICD-10

I63.349	Cerebral infarction due to thrombosis of unspecified cerebellar artery
I63.39	Cerebral infarction due to thrombosis of other cerebral artery
I63.40	Cerebral infarction due to embolism of unspecified cerebral artery
I63.411	Cerebral infarction due to embolism of right middle cerebral artery
I63.412	Cerebral infarction due to embolism of left middle cerebral artery
I63.413	Cerebral infarction due to embolism of bilateral middle cerebral arteries
I63.419	Cerebral infarction due to embolism of unspecified middle cerebral artery
I63.421	Cerebral infarction due to embolism of right anterior cerebral artery
I63.422	Cerebral infarction due to embolism of left anterior cerebral artery
I63.423	Cerebral infarction due to embolism of bilateral anterior cerebral arteries

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FDA-approved product indications (informational)mixed

Botox (onabotulinumtoxinA)	FDA approved for prophylaxis of headaches in adult chronic migraine (≥15 days/month, headaches ≥4 hours/day); treatment of spasticity (≥2 years); cervical dystonia; strabismus; blepharospasm; overactive bladder with urge urinary incontinence/urgency/frequency after anticholinergic inadequate response; urinary incontinence due to neurogenic detrusor overactivity in adults after anticholinergic inadequate response; NDO in pediatric ≥5 years; severe primary axillary hyperhidrosis inadequately managed with topical agents.
Dysport (abobotulinumtoxinA)	FDA approved for adults with cervical dystonia; indicated for treatment of spasticity in pediatric patients 2 years and older.
Xeomin (incobotulinumtoxinA)	FDA approved for adults with cervical dystonia; adults with blepharospasm; adult upper limb spasticity; chronic sialorrhea in patients ≥2 years; upper limb spasticity in pediatric patients 2-17 years (excluding CP-caused spasticity).
Myobloc (rimabotulinumtoxinB)	FDA approved for adults with cervical dystonia and chronic sialorrhea in adults.
Daxxify (daxibotulinumtoxinA-lanm)	FDA approved for treatment of cervical dystonia in adults (non-cosmetic use).

FDA black box warning (informational)mixed

BlackBox

All FDA-approved botulinum toxin products carry a boxed warning about distant spread of toxin effect causing symptoms (asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties) that can be life-threatening; risk highest in children treated for spasticity but also in adults.

Billing Rule

Use appropriate J-code

Report the botulinum toxin using the specific J-code for the brand and bill unit-based per the product listed.

J0585-J0589 — bill units per brand as listed in policy

Provider Actions

Prior Authorization

Non-preferred product justification

When requesting Dysport, Daxxify, Myobloc, or other non-preferred products, submit documentation of prior trial/failure or intolerance to Botox or Xeomin and include physician attestation that the non-preferred product is expected to be superior or that the same adverse event would not be expected.

Documentation Required

Submit diagnosis and supporting records for initial therapy

Clinical Evidence Summary

BlackBoxAll FDA-approved botulinum toxin products carry boxed warning for distant spread of toxin effect

Summary of key evidence noted in the policy: the PREEMPT clinical program of onabotulinumtoxinA (Botox) demonstrated significant reductions in headache days and improved health‑related quality of life in chronic migraine with expected adverse events such as neck pain and muscle weakness. The pivotal randomized Daxxify trial in cervical dystonia met its primary endpoint showing improvement in TWSTRS scores for Daxxify 125U and 250U versus placebo. Comparative randomized data (Yun et al.) found Dysport non‑inferior to Botox at a 2.5:1 dosing ratio in cervical dystonia with a trend favoring Botox but not statistically significant. Long‑term open‑label extension data for intradetrusor onabotulinumtoxinA (200U) in neurogenic detrusor overactivity showed consistent reductions in urinary incontinence episodes and a median duration of effect of 9.0 months, with urinary tract infection and urinary retention as common adverse events. Systematic reviews/Cochrane findings indicate pneumatic dilation is superior to botulinum toxin for long‑term remission in achalasia, and botulinum toxins may reduce migraine days in chronic migraine by approximately 2–3 days/month with variable quality of evidence; treatment increases nonserious adverse events. Hayes technology assessments assigned onabotulinumtoxinA a C rating (potential but unproven) for migraine prevention, while abobotulinumtoxinA and rimabotulinumtoxinB received lower ratings for migraine.

Background & Definitions

Background: the policy lists the FDA‑approved botulinum toxin A and B products and explicitly designates Botox and Xeomin as preferred. Coverage of non‑preferred products (Dysport, Daxxify, Myobloc, or other non‑preferred botulinum toxins) requires documentation of a prior trial with Botox or Xeomin resulting in minimal response or intolerance/contraindication plus physician attestation of expected superiority or differing safety. General requirements include documentation of diagnosis and supporting clinical evidence, administration no more frequent than every 12 weeks, initial authorization up to 6 months, and reauthorization up to 12 months. The policy notes exclusions for certain states and that FDA prescribing information and the black box warning about distant spread of toxin effect apply; FDA approval is informational and not by itself a coverage guarantee.

Term	Definition
Botulinum toxin potency units
Units are specific to preparation and assay method and are not interchangeable between products.
TWSTRS
Toronto Western Spasmodic Torticollis Rating Scale, measures severity/disability/pain in cervical dystonia
I-QOL
Incontinence Quality of Life questionnaire
Chronic migraine
Version cited: ≥15 headache days per month with headache lasting ≥4 hours per day (FDA definition for onabotulinumtoxinA indication).
Recommendation Levels (AAN)
Level A: established; Level B: probably effective; Level C: possibly effective; Level U: data inadequate or conflicting.

Revision History

2026-04-01revisedLatest

Template Update: Removed content/language pertaining to the state of Louisiana and archived previous policy version CS2026D0017AP. (Administrative/template change; non-material)

Diagnosis-Specific Criteria: Botox (onabotulinumtoxinA)

Botox is medically necessary for the listed indications when diagnosis-specific criteria are met.

Achalasia

Diagnosis of achalasia as confirmed by esophageal manometry
Patient has failed or is not a candidate for pneumatic dilation or myotomy
Other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) are ruled out by upper gastrointestinal endoscopy

Chronic anal fissures

Diagnosis of chronic anal fissure
Symptoms (at least one)
- At least 2 months of symptoms including nocturnal pain and bleeding
- At least 2 months of symptoms including post defecation pain
Prior therapy (one of)
- History of failure, contraindication, or intolerance to topical nitrates
- History of failure, contraindication, or intolerance to topical calcium channel blockers (e.g., diltiazem, nifedipine)

Cervical dystonia

Diagnosis of cervical dystonia
Symptoms including sustained head tilt or abnormal posturing resulting in pain and/or functional impairment
Recurrent involuntary contraction of one or more muscles of the neck (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical)

Detrusor overactivity or detrusor-sphincter dyssynergia due to spinal cord injury or disease

Diagnosis of detrusor overactivity
Diagnosis of detrusor-sphincter dyssynergia due to spinal cord injury or disease
History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine)

Chronic migraine prophylaxis

Diagnosis of chronic migraine, defined by: greater than or equal to 15 headache days per month; and greater than or equal to 8 migraine days per month; and headaches last 4 hours per day or longer
History of failure (after a trial of at least two months), contraindication, or intolerance to prophylactic therapy with one agent from two of the following classes: antidepressant (e.g., amitriptyline, venlafaxine), antiepileptic drug (e.g., divalproex sodium, topiramate), beta blocker (e.g., atenolol, propranolol, nadolol, timolol, metoprolol ER)
Botox dose does not exceed 155 units administered intramuscularly divided over 31 injection sites across 7 head and neck muscles every 12 weeks<= 155 units every 12 weeks
Dose threshold

Overactive bladder

Diagnosis of overactive bladder
Symptoms (one of)
- Urge urinary incontinence
- Urgency
- Frequency
History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine)
Botox dose does not exceed 100 units divided over 20 injection sites every 12 weeks

Other listed indications

Oromandibular dystonia
Sialorrhea
Spasmodic dysphonia (laryngeal dystonia)
Spasticity
Strabismus
Tongue dystonia
Torsion dystonia