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    Botulinum Toxins

    Drugs
    Botox® (onabotulinumtoxinA)
    Myobloc® (rimabotulinumtoxinB)
    Dysport® (abobotulinumtoxinA)
    Xeomin® (incobotulinumtoxinA)

    July 2020

    Therapeutic area - botulinum toxins

    Approval Criteria

    • Treatment for the medical uses listed in the tables or for spasticity, including spasticity in cerebral palsy, or for excessive drooling associated with a neurologic disorder not managed by oral therapy
    • Botox may also be approved for use of severe bruxism, particularly those with associated movement disorders, when all conservative treatments have failed (mouth guard, oral meds, physical therapy)
    • Use of botulinum toxin, type A or type B, will not be approved for cosmetic purposes such as removal of facial wrinkles
    • Authorizations may be granted for up to 12 months. Each subsequent authorization requires documentation verifying the patient’s response to the treatment. The prior authorization will only be granted if the documentation shows a positive response to the treatment.

    Botulinum toxins – type A

    Brand name Botox® Onabotulinumtoxin A Dysport® Abobotulinumtoxin A Xeomin® Incobotulinumtoxin A
    Medical use

    Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain

    Treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents

    Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above

    Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication

    Treatment of overactive bladder in adult patients who have an inadequate response to or are intolerant of 3 anticholinergic medications and mirabegron

    Treatment of upper and lower limb spasticity in adult patients

    Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age

    Prophylaxis of headaches in adult patients with chronic migraine *

    Treatment of adults with cervical dystonia

    Treatment of upper limb spasticity in adults

    Treatment of upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy

    Treatment of lower limb spasticity in pediatric patients 2 years of age and older

    Treatment of spasticity in adults

    Treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients

    Treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox®)

    Treatment of adults with upper limb spasticity

    Treatment of chronic sialorrhea in adult patients
    HCPCS code J0585 J0586 J0588
    HCPCS code descriptor Injection, onabotulinumtoxinA, 1 unit Injection, abobotulinumtoxinA, 5 units Injection, incobotulinumtoxin A, 1 unit
    Vial sizes 100 units, 200 units 300 units, 500 units 50 units, 100 units

    * Botulinum toxin for the treatment of chronic migraine headaches may be initially covered when ALL of the following criteria are met:

    • Patient must be at least 18 years of age AND
    • Prescription must be written by, or in consultation with, a neurologist AND
    • Patient must have a diagnosis of chronic migraine, which is defined as ≥ 15 days per month with headache lasting 4 hours a day or longer as supported by clinical documentation AND
    • Documentation that the prescriber has conducted a comprehensive review of all of patient’s current medications and rebound headache risk mitigation strategies, which include the following, have been tried and failed (unless contraindicated or inappropriate in order to maintain stable function)
      • Tapering opioids or barbiturates OR
      • Addressing over-/under-utilization of triptans, ergots, combination analgesics AND
    • Patient must not be on concurrent CGRP antagonists for migraine prevention; AND
    • The patient must have tried and failed at least one agent in each of the following therapeutic class (e.g., beta blockers or antiepileptics) at maximum daily dosage or at highest tolerated daily dose and at minimum duration of therapy as supported by pharmacy claims data or other relevant documentation, unless contraindicated
    Drug Maximum daily dosage Minimum duration of adherent therapy

    Beta blockers - Metoprolol

    		 200 mg 3 months
    Propranolol 160 mg 3 months
    Timolol 30 mg 3 months
    Antiepileptics - Divalproex 1500 mg 3 months
    Topiramate 200 mg 3 months
    • Initial approval is for 6 months
    • Renewal request may be approved for 6 months if the number of headache days per 30 days is reduced as supported by clinical documentation

    Botulinum toxins – type B

    Brand name Myobloc® rimabotulinumtoxinB
    Medical uses

    The treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain

    Treatment of chronic sialorrhea in adults
    HCPCS Code J0587
    HCPCS Code descriptor Injection, rimabotulinumtoxinB, 100 units
    Vial sizes 2,500 units, 5,000 units, 10,000 units

    Note: Lack of interchangeability among botulinum toxin products

    The potency units of the botulinum toxins are specific to the preparation and assay method utilized. Therefore, units of biological activity of one botulinum toxin product cannot be compared to nor converted into units of any other botulinum toxin product.

    Billing for botulinum toxins

    All formulations and presentations of botulinum toxins must be billed as a medical claim.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 1-800-366-5411

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