Defines prior-authorization clinical criteria, age limits, prescriber specialties, indication-specific dosing/quantity limits, initial and reauthorization approval durations, and non-covered/off-label guidance for Botox (onabotulinumtoxinA) under the Arkansas PASSE pharmacy policy.
Policy Summary
PayerCareSource
PolicyPHARMACY POLICY STATEMENT Arkansas PASSE
Policy CodePolicy N/A
Change TypeRevisions to criteria and specialist/age limits
Effective DateApr 1, 2025
Next Review Date
Key ActionPrior authorization is required for Botox (onabotulinumtoxinA) under the medical benefit; submit documentation to demonstrate all indication-specific criteria are met.
09/25/2024 revision removed age limits and specialists for blepharospasm and strabismus and removed specialist for cervical dystonia.
07/09/2024 migraine criteria changed from 2 prior prophylactic trials to 1 and candesartan added as an option; topical hyperhidrosis trial reduced from 60 to 30 days; anal fissure added (off-label).
Multiple historical updates between 2018-2022 clarifying specialists, dosing, trial requirements, reauthorization durations, and added/removed criteria across indications.
13Indications listed (including off-label)
2Off-label indications explicitly addressed
MultipleSpecialist prescriber requirements
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Coverage Summary & Indications
Coverage stance: covered_with_criteria. This Arkansas PASSE policy defines prior-authorization clinical criteria for Botox (onabotulinumtoxinA) and will consider coverage when indication-specific requirements are met.
Scope summary: Defines prior-authorization clinical criteria, age limits, prescriber specialty requirements, indication-specific dosing and quantity limits, initial and reauthorization approval durations, and non-covered/off-label guidance for Botox under the Arkansas PASSE medical benefit.
Background: For Arkansas PASSE, Botox (onabotulinumtoxinA) is a medical-benefit product (Botox = Medical) used for multiple FDA-approved and selected off-label indications; this policy sets clinical criteria, prescriber specialties, dosing limits, and reauthorization requirements for coverage under Arkansas PASSE.
Prescriber: Medication must be prescribed by or in consultation with a dermatologist
Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been ruled out
Diagnosis duration and severity: Member has a diagnosis of severe axillary hyperhidrosis, with documentation of visible, excessive sweating of at least 6 months duration which significantly impairs daily activities>= 6 months
Topical trial: Member has tried and failed topical prescription-strength aluminum chloride (e.g., Xerac) for at least 30 days>= 30 days
Primary Axillary Hyperhidrosis - Dosing/Approval
Dose limit: Dosage allowed/Quantity limit: 50 Units per axilla50 Units per axilla
Approval duration initial: If all requirements met, approval duration: 6 months6 months
Primary Axillary Hyperhidrosis - Reauthorization
Chart improvement: Chart notes show improvement of signs and symptoms (i.e., reduced axillary sweat production)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Blepharospasm - Initial Authorization
Covered when ALL of the following are met:
Diagnosis: Member has a diagnosis of blepharospasm, characterized by spasms inducing narrowing or closure of the eyelids
Dose limit: Dosage allowed/Quantity limit: cumulative dose in a 30-day period should not exceed 200 Units; treatment may be repeated every 3 months<= 200 Units per 30 days; repeat every 3 months
If all requirements met, approval duration: 6 months
Blepharospasm - Reauthorization
Chart improvement: Chart notes show improved signs and symptoms (e.g., lessening of involuntary contraction)
Cervical Dystonia - Initial Authorization
Covered when ALL of the following are met:
Diagnosis: Member has a documented diagnosis of moderate to severe cervical dystonia
Approval duration initial: If met, approval duration: 6 months6 months
Cervical Dystonia - Reauthorization
Chart improvement: Chart notes show improved signs and symptoms (e.g., severity of abnormal head position, neck pain)
Prescriber: Medication must be prescribed by or in consultation with a gastroenterologist
Diagnosis confirmation: Member has a diagnosis of achalasia confirmed by high resolution esophageal manometry
Not candidate for definitive procedures: Chart notes must document that the member is NOT a candidate for ALL of the following: Laparoscopic Heller myotomy, pneumatic dilation, and peroral endoscopic myotomy (POEM)
Migraine frequency: Medication is being prescribed for prevention of chronic migraine with documented: at least 15 headache days per month for at least 3 months AND at least 8 migraine days per month for at least 3 months>= 15 headache days/month and >= 8 migraine days/month for >= 3 months
Prescriber: Medication must be prescribed by a neurologist or a headache specialist
Prior prophylactic trial: Member has tried and failed at least 1 prophylactic medication for 8 weeks; examples include: calcium channel blockers (e.g., verapamil), antidepressants (e.g., amitriptyline or venlafaxine), beta-blockers (e.g., metoprolol, timolol, propranolol), anticonvulsants (e.g., topiramate or valproic acid), candesartan
Overactive Bladder - Initial Authorization
Covered when ALL of the following are met:
Age: Member is at least 18 years of age
Prescriber: Medication must be prescribed by or in consultation with a urologist or gynecologist
Diagnosis: Member has a diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
No UTI: Member does not have a urinary tract infection
Spasticity - Initial Authorization
Covered when ALL of the following are met:
Age: Member is at least 2 years of age
Prescriber: Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R)
Diagnosis: Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life
Etiology: Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury
Strabismus - Initial Authorization
Covered when ALL of the following are met:
Diagnosis: Member has a diagnosis of a strabismus type with binocular potential, unlikely to spontaneously resolve
Dose: Dosage allowed: See package insert
If all requirements met, approval duration: 6 months
Strabismus - Reauthorization
Chart improvement: Chart notes show that the member's ocular alignment has improved
Approval duration reauth: If met, approval duration for reauthorization: additional 6 months
Prescriber: Medication is prescribed by or in consultation with a urologist, neurologist, or gynecologist
Diagnosis: Member has a diagnosis of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., brain or spinal cord injury, stroke, multiple sclerosis, Parkinson's, spina bifida)
No UTI: Member does not have a urinary tract infection
Prescriber: Medication must be prescribed by or in consultation with a gastroenterologist or colorectal surgeon
Duration: Member has a diagnosis of chronic anal fissure, present for at least 6 weeks>= 6 weeks
Topical trial: Member has tried and failed topical calcium channel blocker (nifedipine or diltiazem) for 8 weeks OR topical nitrate for 3 weeks8 weeks (CCB) or 3 weeks (nitrate)
Prior authorization is required for Botox (onabotulinumtoxinA) under the medical benefit. Submit prior authorization with documentation demonstrating that all indication‑specific criteria are met (see indication sections for required age, specialist involvement, prior therapy trials, and objective improvement).
Documentation Required
Specialist Prescriber and Chart Documentation
Many indications require the medication be prescribed by or in consultation with a specified specialist and supporting chart documentation. Specialists named in the policy include: dermatologist, neurologist, headache specialist, gastroenterologist, urologist, gynecologist, PM&R (physical medicine & rehabilitation), and colorectal surgeon. Chart notes must document the diagnosis, prior therapy trials (when required), and objective improvement on treatment for reauthorization.
Chart improvement: Chart notes show improvement of signs and symptoms (i.e., reduced axillary sweat production)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Approval duration note: If all initial requirements were met and reauthorization criteria satisfied, approval duration: additional 12 months12 months
Not Medically Necessary / Off-Label Exclusions
Not Medically Necessary / Off-Label
Not Medically Necessary / Off-Label: Botox is considered not medically necessary for treatment of conditions that are not listed in this document; refer to the Off-Label policy for other indications
Applicable Codes & Billing Category
DrugNDC
No codes listed
Benefit Type / Billing Categorymixed
Medical benefit
Botox (onabotulinumtoxinA) is designated as Medical benefit in Arkansas PASSE
Evidence & References
Evidence includes the Botox package insert: Botox [package insert], Allergan USA, Inc.; 2023 cited in the policy references.
Guidelines and society references cited include multiple professional societies and reviews such as the American Academy of Neurology evidence assessments, ISDE/ACG/ASGE/EAU achalasia guidelines, American Headache Society statements, AUA guidance on overactive bladder, ASCRS/Association of Coloproctology guidance on anal fissure, Cochrane reviews, and other systematic reviews and consensus statements.
Note: The policy cites multiple society guidelines and systematic reviews and lists package insert evidence plus a range of guideline sources and literature to support indication-specific criteria and dosing limits.
Background & Definitions
Botox (onabotulinumtoxinA) is a botulinum toxin serotype A neurotoxin that inhibits acetylcholine release at peripheral nerve endings to produce neuromuscular blockade; it was initially FDA-approved for blepharospasm in 1989 and later for additional indications including overactive bladder, chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, and strabismus.
Policy purpose: This Arkansas PASSE medical-benefit policy specifies prior-authorization requirements—including indication-specific clinical criteria, prescriber specialty requirements, dosing/quantity limits, and reauthorization documentation—to guide coverage decisions for Botox under the PASSE program.
Operational note: Prior authorization is required and the policy details required chart documentation of diagnosis, prior therapy trials where applicable, objective improvement for reauthorization, and adherence to dose and frequency limits to avoid claim denials.
Revision History / Policy Updates
09/25/2024revisionLatest
Revision removed age limits and specialist requirements for blepharospasm and strabismus, and removed specialist requirement for cervical dystonia.
07/09/2024material_change
Migraine criteria changed from two prior prophylactic trials to one and candesartan was added as an option; topical hyperhidrosis trial length reduced from 60 to 30 days; chronic anal fissure added as an off-label indication.
Multiple dates 2018-2022
Policy Summary
PayerCareSource
PolicyPHARMACY POLICY STATEMENT Arkansas PASSE
Policy CodePolicy N/A
Change TypeRevisions to criteria and specialist/age limits
Effective DateApr 1, 2025
Next Review Date
Key ActionPrior authorization is required for Botox (onabotulinumtoxinA) under the medical benefit; submit documentation to demonstrate all indication-specific criteria are met.
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
If met, approval duration for reauthorization: additional 12 months
12 months
Other causes ruled out: Other esophageal motility disorders and malignancy have been ruled out
Dose and approval: Dosage allowed/Quantity limit: 100 units every 6 months (off label); approval duration: 6 months100 units every 6 months
Esophageal Achalasia - Reauthorization
Symptomatic improvement: Chart notes show the member had symptomatic improvement of dysphagia and/or regurgitation
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
>= 8 weeks
No CGRP combination: Medication is NOT being used in combination with a prophylactic CGRP product (e.g., Emgality, Aimovig, Ajovy, or Vyepti)
No medication-overuse headache: Member does not have medication-overuse headaches
Dose and approval: Dosage allowed/Quantity limit: 155 Units every 3 months; approval duration: 6 months155 Units every 3 months
Chronic Migraine - Reauthorization
Improvement: Member has improvement in prevention of migraines documented in chart notes (e.g., reduced migraine frequency, reduced use of acute migraine medications)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Prior therapies:
Member has tried and failed at least TWO prior pharmacologic therapies for at least 30 days each (e.g., oxybutynin, solifenacin, Myrbetriq)
>= 2 trials, >= 30 days each
Dose and approval: Dosage allowed/Quantity limit: 100 Units every 12 weeks; if met, approval duration: 3 months100 Units every 12 weeks
Overactive Bladder - Reauthorization
Chart improvement: Chart notes show decreased symptoms of urge urinary incontinence, urgency, and frequency
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Trial of conventional treatment: Member has tried or is unable to trial one conventional treatment modality such as physical therapy or oral medication (e.g., baclofen, tizanidine)
Dose limits: Dosage allowed/Quantity limit: Adults: Not to exceed 400 total units every 12 weeks (divided doses); Pediatrics: Not to exceed 340 total units or 10 units/kg (whichever is lower) every 3 months; approval duration: 6 monthsAdults <= 400 U/12 weeks; Pediatrics <= 340 U or 10 U/kg every 3 months
Spasticity - Reauthorization
Chart improvement: Chart notes show improved signs and symptoms (e.g., decreased severity of increased muscle tone, increased functional ability or range of motion)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
6 months
Prior anticholinergic trial: Member has tried or failed appropriate anticholinergic therapy (examples partially listed in policy)
Dose and approval: Dosage allowed/Quantity limit: For adults and pediatric patients weighing >=34 kg: 200 units per treatment, no sooner than every 12 weeks; If weight <34 kg: 6 mg/kg no sooner than every 12 weeks; approval duration: 6 months>=34 kg: 200 U every >=12 weeks; <34 kg: 6 mg/kg every >=12 weeks
Chart improvement: Chart notes have been provided that show decreased frequency of urinary incontinence
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Dosage allowed/Quantity limit: 20-50 units single injection; may repeat after 2 months if healing incomplete or fissure recurs (off label); approval duration: 3 months
20-50 units; may repeat after 2 months
Chronic Anal Fissure - Reauthorization
No reauth: Medication will not be re-authorized for this indication
Not Medically Necessary / Off-Label
Not covered indications: Botox is considered not medically necessary for treatment of conditions not listed in this document; refer to the Off-Label policy for other indications
Billing Rule
Dose and Frequency Limits
Adhere to indication‑specific dosing and frequency/quantity limits. Key limits in the policy include: 50 Units per axilla for primary axillary hyperhidrosis; cumulative blepharospasm dose not to exceed 200 Units in a 30‑day period (treatments may be repeated every 3 months); 155 Units every 3 months for chronic migraine prophylaxis; 100 Units every 12 weeks for overactive bladder; adult spasticity not to exceed 400 total units every 12 weeks; pediatric spasticity not to exceed 340 total units or 10 units/kg every 3 months (whichever is lower); esophageal achalasia 100 units every 6 months (off‑label); chronic anal fissure 20–50 units as a single injection (may repeat after 2 months if needed, off‑label). Claims exceeding these limits risk denial.
Denial Risk
Off-Label and Unlisted Indications
Uses not listed in this policy are considered not medically necessary and may be denied. The policy includes specific off‑label indications with criteria for achalasia (esophageal achalasia with high‑resolution manometry confirmation and 100 units every 6 months) and chronic anal fissure (20–50 units single injection after failure of topical therapy). For other off‑label uses, refer to the Off‑Label policy and ensure any required off‑label criteria are met.
Blepharospasm - Reauthorization
For reauthorization:
Chart improvement: Chart notes show improved signs and symptoms (e.g., lessening of involuntary contraction)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Blepharospasm reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Cervical Dystonia - Reauthorization
For reauthorization:
Chart improvement: Chart notes show improved signs and symptoms (e.g., severity of abnormal head position, neck pain)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Cervical Dystonia reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Esophageal Achalasia - Reauthorization
For reauthorization:
Symptomatic improvement: Chart notes must show the member had symptomatic improvement of dysphagia and/or regurgitation
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Esophageal Achalasia reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Chronic Migraine - Reauthorization
For reauthorization:
Improvement: Member has improvement in prevention of migraines documented in chart notes (e.g., reduced migraine frequency, reduced use of medication for acute migraines attacks)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Chronic Migraine reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Overactive Bladder - Reauthorization
For reauthorization:
Chart improvement: Chart notes have been provided that show decreased symptoms of urge urinary incontinence, urgency, and frequency
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Overactive Bladder reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Spasticity - Reauthorization
For reauthorization:
Chart improvement: Chart notes show improved signs and symptoms (e.g., decrease in severity of increased muscle tone, increased functional ability or range of motion)
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Spasticity reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Strabismus - Reauthorization
For reauthorization:
Chart improvement: Chart notes have been provided showing that the member's ocular alignment has improved
Approval duration reauth: If met, approval duration for reauthorization: additional 6 months6 months
Strabismus reauth note: If all the above requirements are met; the medication will be approved for an additional 6 months6 months
Chart improvement: Chart notes have been provided that show decreased frequency of urinary incontinence
Approval duration reauth: If met, approval duration for reauthorization: additional 12 months12 months
Urinary Incontinence reauth note: If all the above requirements are met; the medication will be approved for an additional 12 months12 months
Chronic Anal Fissure - Reauthorization
For reauthorization:
No reauth: Medication will not be re-authorized for this indication
Chronic Anal Fissure note: Medication will not be re-authorized for this indication
historical_updates
Multiple historical updates between 2018 and 2022 clarifying specialists, dosing and frequency limits, prior therapy/ trial requirements, reauthorization durations, and adding or removing criteria across indications (e.g., changes to hyperhidrosis trial products/durations, overactive bladder trial counts, spasticity and cervical dystonia wording).