Clinical Policy: AbobotulinumtoxinA (Dysport)

Reference Number: CP.PHAR.230 Effective Date: 07.01.16 Last Review Date: 05.26 Line of Business: Commercial, HIM/ICHRA, Medicaid

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

AbobotulinumtoxinA (Dysport®) is an acetylcholine release inhibitor and a neuromuscular blocking agent.

FDA Approved Indication(s)

Abbreviations: cerebral palsy (CP); Hirschsprung disease (HD), internal anal sphincter (IAS) achalasia.
*See criteria set entitled Focal Dystonia and Essential Tremor

Dysport is indicated:

• For the treatment of cervical dystonia (CD) in adults
• For the treatment of spasticity in patients 2 years of age and older
• For temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients < 65 years of age [benefit exclusion]

Policy/Criteria

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

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CLINICAL POLICY

AbobotulinumtoxinA

Index

I. Initial Approval Criteria
A. Cervical Dystonia (focal dystonia)
B. Upper and Lower Limb Spasticity (includes cerebral palsy)
C. Overactive Bladder and Urinary Incontinence (off-label)
D. Chronic Migraine (off-label)
E. Axillary Hyperhidrosis (excessive underarm sweating) (off-label)
F. Blepharospasm (focal dystonia - abnormal eyelid muscle contraction) (off-label)
G. Strabismus (eye misalignment) (off-label)
H. Sialorrhea (off-label)
I. Focal Dystonia and Essential Tremor (off-label)
J. Esophageal Achalasia (off-label)
K. Hirschsprung Disease and Internal Anal Sphincter Achalasia (off-label)
L. Chronic Anal Fissure (off-label)
M. Other diagnoses/indications
II. Continued Approval Criteria
A. Chronic Migraine
B. Esophageal Achalasia
C. Cervical Dystonia and Upper/Lower Limb Spasticity
D. All Other Indications in Section I
E. Other diagnoses/indications
III.Diagnoses/Indications for which coverage is NOT authorized:
IV.Appendices
V. Dosage and Administration
VI.Product Availability
VII.References

It is the policy of health plans affiliated with Centene Corporation® that Dysport is medically necessary when one of the following criteria are met:

I. Initial Approval Criteria

A. Cervical Dystonia (focal dystonia) (must meet all):

1. Diagnosis of CD;
2. Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist;
3. Age ≥ 18 years;
4. Member is experiencing involuntary contractions of the neck and shoulder muscles (e.g., splenius, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis) resulting in abnormal postures or movements of the neck, shoulders, or head;
5. Contractions are causing pain and functional impairment;
6. Dysport is not prescribed concurrently with other botulinum toxin products;
7. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
8. Treatment plan details number of Units per indication and treatment session;
9. Dose does not exceed 500 Units per treatment session.

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B. Upper and Lower Limb Spasticity (includes cerebral palsy) (must meet all):

1. Diagnosis of upper or lower limb spasticity (e.g., associated with paralysis, central nervous system demyelinating diseases such as multiple sclerosis, cerebral palsy, stroke);
2. Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist;
3. Age ≥ 2 years;
4. Dysport is not prescribed concurrently with other botulinum toxin products;
5. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
6. Treatment plan details number of Units per indication and treatment session;
7. Request meets one of the following (a or b):
   a. Age ≥ 18 years (i, ii, or iii):
   i. Upper limb spasticity: Dose does not exceed 1,000 Units per treatment session;
   ii. Lower limb spasticity: Dose does not exceed 1,500 Units per treatment session;
   iii. Upper and lower limb spasticity: Dose does not exceed 1,500 Units per treatment session staying within per limb dosing guidelines;
   b. Age ≥ 2 years to < 18 years (i, ii, or iii):
   i. Upper limb spasticity: Dose does not exceed the lower of 16 Units/kg or 640 Units;
   ii. Lower limb spasticity: Dose does not exceed the lower of 15 Units/kg (one limb), 30 Units/kg (two limbs), or 1,000 Units per treatment session;
   iii. Upper and lower limb spasticity: Dose does not exceed the lower of 30 Units/kg or 1,000 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

C. Overactive Bladder and Urinary Incontinence (off-label) (must meet all):

1. Diagnosis of one of the following (a or b):
   a. OAB and member’s history is positive for urinary urgency, frequency, and nocturia with or without incontinence;
   b. Urinary incontinence and member’s history is positive for an associated neurologic condition (e.g., spinal cord injury, multiple sclerosis);
2. Prescribed by or in consultation with a neurologist or urologist;
3. Age ≥ 18 years;
4. Failure of one of the following (a or b) used for at least 30 days, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B):
   a. Two anticholinergic agents;
   b. One oral beta-3 agonist medication;

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5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Dose does not exceed 250 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

D. Chronic Migraine (off-label) (must meet all):

1. Diagnosis of chronic migraine (i.e., ≥ 15 headache days per month for at least 3 months with headache lasting 4 hours a day or longer);
2. Prescribed by or in consultation with a neurologist or pain specialist;
3. Age ≥ 18 years;
4. Failure of at least 2 of the following oral migraine preventative therapies, each for 8 weeks and from different therapeutic classes, unless clinically significant adverse effects are experienced or all are contraindicated (a, b, or c):*
   * For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395
   a. Antiepileptics (e.g., divalproex sodium, sodium valproate, topiramate);
   b. Beta-blockers (e.g., metoprolol, propranolol, timolol);
   c. Antidepressants (e.g., amitriptyline, venlafaxine);
5. Dysport is not prescribed concurrently with injectable calcitonin gene-related peptide (CGRP) inhibitors (e.g., Aimovig®, Ajovy®, Emgality®);
6. Dysport is not prescribed concurrently with other botulinum toxin products;
7. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
8. Treatment plan details number of Units per indication and treatment session;
9. Dose does not exceed 250 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

E. Primary Axillary Hyperhidrosis (excessive underarm sweating) (off-label) (must meet all):

1. Diagnosis of primary axillary hyperhidrosis;
2. Prescribed by or in consultation with a neurologist or dermatologist;
3. Age ≥ 18 years;
4. Failure of a 6-month trial of topical aluminum chloride, unless contraindicated or clinically significant adverse effects are experienced.*
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Dose does not exceed 200 Units per treatment session.

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Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

F. Blepharospasm (focal dystonia - abnormal eyelid muscle contraction) (off-label) (must meet all):

1. Diagnosis of blepharospasm;
2. Prescribed by or in consultation with a neurologist or ophthalmologist;
3. Age ≥ 18 years;
4. Member is experiencing significant disability in daily functional activities due to interference with vision;
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Dose does not exceed 120 Units per eye per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

G. Strabismus (eye misalignment) (off-label) (must meet all):

1. Diagnosis of one of the following (a, b, or c):
   a. Vertical strabismus (superior and inferior rectus muscles, superior and inferior oblique muscles);
   b. Horizontal strabismus (medial and lateral rectus muscles) (i or ii):
   i. Horizontal strabismus < 20 prism diopters;
   ii. Horizontal strabismus 20 to 50 prism diopters;
   c. Persistent sixth cranial nerve (VI; abducens nerve) palsy of ≥ one month involving the lateral rectus muscle;
2. Prescribed by or in consultation with a neurologist or ophthalmologist;
3. Age ≥ 12 years;
4. Dysport is not prescribed concurrently with other botulinum toxin products;
5. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
6. Treatment plan details number of Units per indication and treatment session;
7. Dose does not exceed 20 Units per treatment session.

Approval duration:
Medicaid/HIM/ICRHA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

H. Chronic Sialorrhea (off-label) (must meet all):

1. Diagnosis of chronic sialorrhea for at least the last three months due to one of the following (a or b):
   a. Underlying neurologic disorder (e.g., Parkinson disease, atypical parkinsonism, stroke, traumatic brain injury, cerebral palsy, amyotrophic lateral sclerosis);
   b. Craniofacial abnormality (e.g., Goldenhar syndrome);

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2. Prescribed by or in consultation with a neurologist or physiatrist;
3. Age ≥ 18 years;
4. Failure of at least one anticholinergic drug (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated.*
   * For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 16 weeks;
7. Treatment plan provided detailing number of Units per indication and treatment session;
8. Dose does not exceed 250 Units per treatment session;

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

I. Focal Dystonia and Essential Tremor (off-label) (must meet all):

1. Diagnosis of one of the following (a, b, c, or d):
   a. Laryngeal dystonia;
   b. Oromandibular dystonia (OMD);
   c. Upper extremity (UE) dystonia;
   d. UE essential tremor;
2. Prescribed by or in consultation with a neurologist, ENT specialist, orthopedist, orofacial pain specialist, or physiatrist;
3. Age meets one of the following (a or b):
   a. For upper extremity dystonia: Age ≥ 2 years;
   b. For all other indications: Age ≥ 18 years;
4. For UE dystonia: Failure of a trial of carbidopa/levodopa or trihexyphenidyl (see Appendix B), unless clinically significant adverse effects are experienced or both are contraindicated.*
   * For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Request meets one of the following (a or b):
   a. Laryngeal dystonia: Dose does not exceed 45 Units per treatment session;
   b. UE dystonia, UE essential tremor, OMD: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use and member age (prescriber must submit supporting evidence; Units per treatment session does not exceed the lower of 16 Units/kg body weight or 640 Units for pediatrics, or 1,000 Units for adults).

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

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J. Esophageal Achalasia (off-label) (must meet all):

1. Diagnosis of esophageal achalasia;
2. Prescribed by or in consultation with a gastroenterologist;
3. Age ≥ 18 years;
4. Member is not a candidate for pneumatic dilation or laparoscopic surgical myotomy (e.g., due to age, comorbidity);
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Dose does not exceed 250 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

K. Hirschsprung Disease, Internal Anal Sphincter Achalasia (off-label) (must meet all):

1. Diagnosis of one of the following (a or b):
   a. Hirschsprung disease (HD) and (i or ii):
   i. Member has an HD subtype known as ultra-short segment HD;
   ii. Dysport is prescribed for constipation post-surgery;
   b. Internal anal sphincter (IAS) achalasia;
2. Prescribed by or in consultation with a gastroenterologist;
3. Age ≥ 3 years;
4. Failure of a trial of stool softeners and laxatives (see Appendix B), unless clinically adverse effects are experienced or all are contraindicated.*
   * For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
5. Dysport is not prescribed concurrently with other botulinum toxin products;
6. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
7. Treatment plan details number of Units per indication and treatment session;
8. Dose does not exceed 200 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

L. Chronic Anal Fissure (off-label) (must meet all):

1. Diagnosis of chronic anal fissure;
2. Prescribed by or in consultation with a gastroenterologist or colorectal surgeon;
3. Age ≥ 18 years;
4. Failure of nitroglycerin ointment, unless contraindicated or clinically significant adverse effects are experienced;
5. Failure of one of the following (a or b), unless contraindicated or clinically significant adverse effects are experienced (see Appendix B):
   a. Oral/topical nifedipine;

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b. Oral/topical diltiazem;

6. Dysport is not prescribed concurrently with other botulinum toxin products;
7. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
8. Treatment plan details number of Units per indication and treatment session;
9. Dose does not exceed 100 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

M. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

II. Continued Approval

A. Chronic Migraine (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. If receipt of ≥ 2 Dysport treatment sessions, member has experienced and maintained a 30% reduction in monthly migraine headache frequency from baseline;
3. Dysport is not prescribed concurrently with injectable CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality);
4. Dysport is not prescribed concurrently with other botulinum toxin products;
5. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
6. Treatment plan details number of Units per indication and treatment session;
7. If request is for a dose increase, new dose does not exceed 250 Units per treatment session.

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Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

B. Esophageal Achalasia (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy;
3. Dysport is not prescribed concurrently with other botulinum toxin products;
4. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
5. If member has previously received ≥ 2 Dysport treatment sessions for esophageal achalasia, it has been at least 24 weeks since the last treatment session;
6. Treatment plan details number of Units per indication and treatment session;
7. If request is for a dose increase, new dose does not exceed 250 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

C. Cervical Dystonia and Upper/Lower Limb Spasticity (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy;
3. Dysport is not prescribed concurrently with other botulinum toxin products;
4. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
5. Treatment plan details number of Units per indication and treatment session;
6. If request is for a dose increase, request meets one of the following (a or b):
   a. Age ≥ 18 years (i, ii, iii, or iv):
   i. CD: Dose does not exceed an increase of 250 Units per treatment session up to a total of 1,000 Units per treatment session;
   ii. Upper limb spasticity: Dose does not exceed 1,000 Units per treatment session;
   iii. Lower limb spasticity: Dose does not exceed 1,500 Units per treatment session;
   iv. Upper and lower limb spasticity: Dose does not exceed 1,500 Units per treatment session staying within per limb dosing guidelines;

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b. Age ≥ 2 years to < 18 years (i, ii, or iii):
i. Upper limb spasticity: Dose does not exceed the lower of 16 Units/kg or 640 Units;
ii. Lower limb spasticity: Dose does not exceed the lower of 15 Units/kg (one limb), 30 Units/kg (two limbs), or 1,000 Units per treatment session;
iii. Upper and lower limb spasticity: Dose does not exceed the lower of 30 Units/kg or 1,000 Units per treatment session.

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

D. All Other Indications in Section I (off-label) (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy;
3. Dysport is not prescribed concurrently with other botulinum toxin products;
4. Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
5. Treatment plan details number of Units per indication and treatment session;
6. If request is for a dose increase, request meets one of the following:
   a. OAB/urinary incontinence, sialorrhea: Dose does not exceed 250 Units per treatment session;
   b. Axillary hyperhidrosis, HD, IAS achalasia: Dose does not exceed 200 Units per treatment session;
   c. Blepharospasm: Dose does not exceed 120 Units per eye per treatment session;
   d. Strabismus: Dose does not exceed 20 Units per treatment session;
   e. Focal dystonia and essential tremor (i or ii):
   i. Laryngeal dystonia: Dose does not exceed 45 Units per treatment session;
   ii. UE dystonia, UE essential tremor, OMD: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use and member age (prescriber must submit supporting evidence; Units per treatment session does not exceed the lower of 16 Units/kg body weight or 640 Units for pediatrics, or 1,000 Units for adults).
   f. Chronic anal fissure: Dose does not exceed 100 Units per treatment session;

Approval duration:
Medicaid/HIM/ICHRA – 12 months
Commercial – 6 months or to member’s renewal date, whichever is longer

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CLINICAL POLICY

AbobotulinumtoxinA

E. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section 1 above, diagnoses/indications for which coverage is NOT authorized AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

III.Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles and periorbital wrinkles (crow’s feet); C. Episodic migraine (≤ 14 headache days per month): Safety and efficacy have not been established per the package insert. D. Total treatment dose per session does not exceed the lower of 30 Units/kg body weight or 1,000 Units for pediatrics and 1,500 Units for adults.

IV.Appendices/General Information Appendix A: Abbreviation/Acronym Key CD: cervical dystonia CGRP: calcitonin gene-related peptide ER: extended release FDA: Food and Drug Administration HD: Hirschsprung disease IAS: internal anal sphincter IR: immediate release MS: multiple sclerosis OAB: overactive bladder OMD: oromandibular dystonia SCI: spinal cord injury UE: upper extremity

Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic name® when the drug is available by both brand and generic.

Appendix C: Contraindications and Boxed Warnings

• Contraindication(s):
  • Hypersensitivity to any botulinum toxin preparation or excipients
  • Hypersensitivity to cow’s milk protein
  • Infection at the proposed injection site
• Boxed warning(s): distant spread of toxin effect

Appendix D: Botulinum Toxin Product Interchangeability

• Potency Units of Dysport are not interchangeable with other botulinum toxin product preparations (e.g., Botox®, Myobloc®, Xeomin®).

Appendix E: Guideline Support for Botulinum Toxin Use

V. Dosage and Administration

VI.Product Availability Vials: 300 units, 500 units

VII.References

1. Dysport Prescribing Information. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; September 2023. Available at: https://www.dysport.com/en-us/hcp. Accessed January 30, 2026.
2. AbobotulinumtoxinA. In: Micromedex. Ann Arbor, MI: Merative™. Updated periodically. Available from www.micromedexsolutions.com. Accessed January 30, 2026.
3. Clinical Pharmacology [database online]. Philadelphia, PA: Elsevier. Updated periodically. Available at: http://www.clinicalpharmacology-ip.com/. Assessed January 30, 2026.
   • Migraine, Spasticity, Dystonia, Tremor*
4. Albanese A, Bhataia K, Bressman SB, et al. Phenomenology and classification of dystonia: a consensus update. Mov Disord. June 15, 2013; 28(7): 863-873.
5. Alipour A, Homam SM, Khorashadizadeh M, et al. The effect of abobotulinum toxin A in the prophylactic treatment of refractory migraine. Turk J Neurol. 2016;22:156-160.
6. Bunting HJ, Dawson ELM, Lee JP, Adams GGW. Role of inferior rectus botulinum toxin injection in vertical strabismus resulting from orbital pathology. Strabismus. 2013 Sep;21(3):165-168.
7. Cloud LJ, Jinnah HA. Treatment strategies for dystonia. Expert Opin Pharmacother 2010; 11(1):5-15.
8. France K, Stoopler ET. The American Academy of Oral Medicine clinical practice statement: Oromandibular dystonia. Oral Med Oral Pathol Oral Radiol, April 2018; 125 (4), 283-285.
9. Guglielmino G, Teixeira de Moraes B, Villanova LC, et al. Comparison of botulinum toxin and propranolol for essential and dystonic vocal tremors. Clinics (Sao Paulo). 2018 Jul 16;73:e87.
10. Hallett M, Benecke R, Biltzer A et al. Treatment of focal dystonias with botulinum neurotoxin. Toxicon., October 2009;54(5):628-633.
11. Menezes C, Rodrigues B, Magalhaes E, Melo A. Botulinum toxin type A in refractory chronic migraine: an open-label trial. Arq Neuropsiquiatr. 2007;65(3-A):596-598.
12. Silberstein SD, Holland S, Freitag F et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012; 78(17): 1337-1345.
13. Ailani J, Burch RC, Robbins MS et al. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache 2021;61:1021-1039
14. Simpson DM, Hallett M, Ashman EJ et al. Practice guideline update summary: botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016; 86(19): 1818-1826.
15. Stachler RJ, Francis DO, Schwartz SR, Damask CC, et al. Clinical practice guidelines: Hoarseness (dysphonia) (Update). American Academy of Otolaryngology—Head and Neck Surgery Foundation 2018. 1-42. https://doi.org/10.1177/0194599817751030
16. Position statement: botulinum toxin treatment. American Academy of Otolaryngology-Head and Neck Surgery. April 21, 2021. Available at: https://www.entnet.org/resource/position-statement-botulinum-toxin-treatment/. Accessed January 30, 2026.
17. Talebnejad MR, Sharif N, Nowroozzadeh MH. The role of botulinum toxin in management of acute traumatic third-nerve palsy. J AAPOS. 2008;12(5):510-513.
18. Truong D, Comella C, Fernandez HH, et al: Efficacy and safety of purified botulinum toxin type A (Dysport) for the treatment of benign essential blepharospasm: a randomized, placebo-controlled, phase II trial. Parkinsonism Relat Disord. 2008;14(5):407-414.
19. Zesiewicz TA, Elbe RJ, Louis ED et al. Evidence-based guideline update: Treatment of essential tremor. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology Nov 2011, 77 (19) 1752-1755 Sialorrhea
20. AACPD Sialorrhea Care Pathway Team: L Glader (team lead), C Delsing, A Hughes, J Parr, L Pennington, D Reddihough, K van Hulst, J van der Burg. Sialorrhea in cerebral palsy. Available at: https://www.aacpdm.org/publications/care-pathways/sialorrhea-in-cerebral-palsy. Last updated June 4, 2018. Accessed January 30, 2026.
21. Guidubaldi A, Fasano A, Ialongo T, et al. Botulinum toxin A versus B in sialorrhea: a prospective, randomized, double-blind, crossover pilot study in patients with amyotrophic lateral sclerosis or Parkinson’s disease. Movement Disorders. 2011;26(2):313-319.
22. Lakraj AA, Moghimi B, Jabbari B. Sialorrhea: Anatomy, pathophysiology and treatment with emphasis on the role of botulinum toxins. Toxins 2013, 5, 1010-1031;
23. Seppi K, Chahine L, Chaudhuri R et al. Update on treatments for nonmotor symptoms of Parkinson’s disease-an evidence-based medicine review. Mov Disord. 2019 Feb;34(2):180-198.
24. Sridharan K, Sivaramakrishnan G. Pharmacological interventions for treating sialorrhea associated with neurological disorders: A mixed treatment network meta-analysis of randomized controlled trials. Journal of Clinical Neuroscience 51 (2018) 12–17.
25. Young CA, Johnson EC, et al. Treatment for sialorrhea (excessive saliva) in people with motor neuron disease/amyotrophic lateral sclerosis. Cochrane Database Syst Rev. 2011 May 11;(5):CD006981. Overactive Bladder, Urinary Incontinence
26. Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline amendment 2019. J Urol 2019; 202: 558.
27. Irwin P, Somov P, Ekwueme K. Patient reported outcomes of abobotulinumtoxinA injection treatment for idiopathic detrusor overactivity: a pragmatic approach to management in secondary care. Journal of Clin Urol. 2013;6:1.
28. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. Neurourol Urodyn 2024;43:1742-1752. Primary Axillary Hyperhidrosis
29. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med. 2001;344:488-493.
30. Parisier DM, Ballard A. Topical therapies in hyperhidrosis care. Dermatol Clin. October 2014; 32(4): 485-90.
31. Cefolio RJ, Milanze De Campos RJ, Bryant AS et al. The Society of Thoracic Surgeons expert consensus for the surgical treatment of hyperhidrosis. Ann Thorac Surg 2011;91:1642-8. Esophageal Achalasia
32. Annesse V, Bassotti G, Coccia G, et al. Comparison of two different formulations of botulinum toxin A for the treatment of esophageal achalasia. Aliment Pharmacol Ther. 1999;13:1347-1350.
33. Vaezi MF, Pandolfino JE, Yadlapati RH. American College of Gastroenterology clinical guideline: Diagnosis and management of achalasia. Am J Gastroenterol. 2020; 115(9): 1393-1411. Hirschsprung Disease, Internal Anal Sphincter Achalasia
34. Han-Geurts IJM, Hendrix VC, de Blaauw I, et al. Outcome after anal intrasphincteric Botox injection in children with surgically treated Hirschsprung disease. JPGN. November 2014;59(5):604-607.
35. Langer JC, Rollins, MD, Levitt M. Guidelines for the management of postoperative obstructive symptoms in children with Hirschsprung disease. Pediatr Surg Int, 2017; 33:523-526.
36. Roorda D, Abeln ZAM, Oosterlaan J, et al. Botulinum toxin injections after surgery for Hirschsprung disease: Systematic review and meta-analysis. World J Gastroenterol. 2019 July 7;25(25):3268-3280. Chronic Anal Fissure
37. Pilkington SA, Bhome R, Welch RE et al. Bilateral versus unilateral botulinum toxin injections for chronic anal fissure: a randomised trial. Techniques in Coloproctology. 2018;22:545-551.
38. Wald A, Bharucha AE, Limketkai B, et al. American College of Gastroenterology clinical guideline: Management of benign anorectal disorders. Am J Gastroenterol 2021; 116(10): 1987-2008.

Coding Implications Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.

CLINICAL POLICY
AbobotulinumtoxinA

Note:
For Medicaid members, when state Medicaid coverage provisions conflict with the coverage
provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please
refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

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