Last Review Date: 12/03/2024

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 02/2013, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 03/2015, 06/2015, 08/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 04/2019, 09/2019, 10/2019, 01/2020, 05/2020, 08/2020, 05/2021, 05/2022, 05/2023, 12/2024

1. Length of Authorization ³⁶

Coverage will be provided for 6 months and may be renewed annually thereafter (unless otherwise specified).

• Chronic Anal Fissures: Coverage will be provided for 6 months and may be renewed at 6-month intervals.
• Ventral Hernia: Initial coverage will be provided for 6 months and may NOT be renewed.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

3.  Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria ¹

• Patient does not have a hypersensitivity to any botulinum toxin product; AND
• Patient does not have a hypersensitivity to cow’s milk protein; AND
• Patient does not have an active infection at the proposed injection site; AND
• Patient evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
• Patient is not on concurrent treatment with another botulinum toxin (i.e., incobotulinumtoxinA, onabotulinumtoxinA, daxibotulinumtoxinA, rimabotulinumtoxinB, etc.); AND  

Cervical Dystonia †  ^1,2

• Patient has a history of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders; AND
  • Patient has sustained head tilt; OR
  • Patient has abnormal posturing with limited range of motion in the neck

Spastic Conditions † ‡  ^{1,2,12-14,20,21,39}

• Patient has one of the following:
  • Upper/Lower Limb Spasticity in adults (i.e., spasticity post-stroke, traumatic brain or spinal cord injuries) †
  • Upper/Lower Limb Spasticity in pediatric patients at least 2 years of age † Ф
  • Spasticity of the lower limbs due to multiple sclerosis or Schilder’s disease ‡
  • Hemifacial Spasm ‡

Blepharospasms ‡  ^2,9-11

Prophylaxis for Chronic Migraines ‡ ^{3,22,38,40,41,43}

• Patient is utilizing prophylactic intervention modalities (i.e. avoiding migraine triggers, pharmacotherapy, behavioral therapy, or physical therapy, etc.); AND
• Patient has a diagnosis of chronic migraines defined as 15 or more headache (tension-type-like and/or migraine-like) days per month for > 3 months; AND
  • Patient has had at least five attacks with features consistent with migraine (with and/or without aura)§; AND
  • On at least 8 days per month for > 3 months:

• Headaches have characteristics and symptoms consistent with migraine§; OR
• Patient suspected migraines are relieved by a triptan or ergot derivative medication; AND

• One of the following apply:
  • Patient has failed at least an 8-week trial of any two oral medications for the prevention of migraines (see list of migraine-prophylactic medications below for examples ±) ; OR
  • Patient had previous treatment with a CGRP antagonist used for prevention of migraines

Sialorrhea associated with Neurological Disorders ‡ ^4,5

• Patient has a history of troublesome sialorrhea for at least a 3-month period; AND
  • Patient has Parkinson’s disease; OR
  • Patient has severe developmental delays; OR
  • Patient has cerebral palsy

Chronic Anal Fissure ‡ ^6-8

• Other causes of disease have been ruled out (i.e., Crohn’s Disease, etc.); AND
• Patient has failed on non-pharmacologic supportive measures (i.e., sitz baths, psyllium fiber, bulking agents, etc.); AND
• Patient has tried and failed a ≥ 1 month trial of conventional pharmacologic therapy (e.g. oral/topical nifedipine, diltiazem, and/or topical nitroglycerin, bethanechol, etc.)

Incontinence due to Neurogenic Detrusor Overactivity ‡ ^15-17,23,35

• Patient has detrusor overactivity associated with a neurologic condition (i.e., spinal cord injury, multiple sclerosis, etc.) that is confirmed by urodynamic testing; AND
• Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium, etc.) or beta-adrenergic (e.g., mirabegron, vibegron, etc.) classes

Overactive Bladder (OAB) ‡ ^{15-17,23,35,44}

• Patient has symptoms of urge urinary incontinence, urgency, and frequency; AND
• Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium, etc.) or beta-adrenergic (e.g., mirabegron, vibegron, etc.) classes

Severe Primary Axillary Hyperhidrosis ‡ ^18,19,42

• Patient has tried and failed ≥ 1 month trial of a topical agent (e.g., 20% aluminum chloride, glycopyrronium, aluminum zirconium trichlorohydrate, etc.); AND
  • Patient has a history of medical complications such as skin infections or significant functional impairments; OR
  • Patient has had a significant burden of disease or impact to activities of daily living due to condition (e.g., impairment in work performance/productivity, frequent change of clothing, difficulty in relationships and/or social gatherings, etc.)

Ventral Hernia ‡ ^36,37

• Patient has a large ventral hernia with loss of domain or contaminated ventral hernia; AND
• Used preoperatively in patients scheduled to receive abdominal wall reconstruction (AWR)

† FDA approved indication(s); ‡ Literature Supported Recommendation; Ф Orphan Drug

4. Renewal Criteria ^1-37

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and indication specific criteria as identified in section III; AND
• Duration of authorization has not been exceeded (refer to Section I); AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include:  symptoms of a toxin spread effect (e.g., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties, etc.), serious hypersensitivity reactions (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea, etc.); AND
• Disease response as evidenced by the following:

Blepharospasms ^2,9-11

• Improvement of severity and/or frequency of eyelid spasms

Cervical Dystonia ¹

• Improvement in the severity and frequency of pain; AND
• Improvement of abnormal head positioning

Upper/Lower Limb Spasticity ¹

• Decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (e.g., Ashworth Scale, Physician Global Assessment, Clinical Global Impression (CGI), etc.)

Severe Primary Axillary Hyperhidrosis ^18,19

• Significant reduction in spontaneous axillary sweat production; AND
• Patient has a significant improvement in activities of daily living

Prophylaxis for Chronic Migraines ^24,29,38

• Significant decrease in the number, frequency, and/or intensity of headaches; AND
• Improvement in function; AND
• Patient continues to utilize prophylactic intervention modalities (i.e., pharmacotherapy, behavioral therapy, physical therapy, etc.)

Sialorrhea associated with Neurological Disorders ^4,5

• Significant decrease in saliva production

Incontinence due to Detrusor Overactivity ^15-17,23

• Significant improvements in weekly frequency of incontinence episodes; AND
• Patient’s post-void residual (PVR) periodically assessed as medically appropriate

Overactive Bladder (OAB) ^15-17.23

• Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition; AND
• Patient’s post-void residual (PVR) periodically assessed as medically appropriate

      Hemifacial Spasms ^20,21

• Decrease in frequency and/or severity of spasm, or a decrease in tone and/or improvement in asymmetry to the affected side of the face

      Chronic Anal Fissure ^6-8

• Complete healing of anal fissure; OR
• Symptomatic improvement of persistent fissures

5. Dosage/Administration ^{1-4,6-8,15-17,19,20,36}

6. Billing Code/Availability Information

HCPCS Code:

• J0586 – Injection, abobotulinumtoxinA, 5 units; 1 billable unit = 5 units      

NDC(s):

• Dysport 300 unit powder for injection; single-dose vial: 15054-0530-xx
• Dysport 500 unit powder for injection; single-dose vial: 15054-0500-xx                  

7. References

1. Dysport [package insert]. Wrexham, UK; Ipsen Biopharm Ltd; September 2023. Accessed November 2024.
2. 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: 86:1-9
3. Chankrachang S, Arayawichanont A, Poungvarin N, et al. Prophylactic botulinum type A toxin complex (DYSPORT®) for migraine without aura. Headache 2011; 51(1):52-63.
4. Mancini F, Zangaglia R, Cristina S, et al. Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonism. Move Disord, 2003; 18(6): 685-688
5. Pal PK, Calne DB, Calne S, Tsui JK. Botulinum toxin A as treatment for drooling saliva in PD. Neurology 2000; 54:244–247.
6. Brisinda G, Albanese A, Cadeddu F, et al. Botulinum neurotoxin to treat chronic anal fissure: results of a randomized ‘Botox vs. DYSPORT®’ controlled trial. Aliment Pharmacol Ther. 2004; 19:695-701.
7. Brisinda G, Cadeddu F, Brandara F, Marniga G, and Maria G. Randomized clinical trial comparing botulinum toxin injections with 0.2 percent nitroglycerin ointment for chronic anal fissure. Br J Surg. 2007; 94:162-167.
8. Jost W.H. and Schrank B. Chronic anal fissures treated with botulinum toxin injections: a dose-finding study with DYSPORT®. Colorectal Disease. 1999; 1:26-28.
9. 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 & Related Disorders Volume 14, Issue 5, July 2008, Pages 407–414. doi:10.1016/j.parkreldis.2007.11.003.
10. Bentivoglio AR, Fasano A, Ialongo T, et al. Fifteen-Year Experience in Treating Blepharospasm with Botox or Dysport: Same Toxin, Two Drugs. Neurotoxicity Research April 2009, Volume 15, Issue 3, pp 224-231. DOI 10.1007/s12640-009-9023-3
11. Ching-Piao Tsai, Ming-Chang Chiu, Der-Jen Yen, Yuh-Cherng Guo, Chih-Lun Yuan, and Tzu-Chi Lee. Quantitative Assessment of Efficacy of Dysport Botulinum Toxin Type A) in the Treatment of Idiopathic Blepharospasm and Hemifacial Spasm. Acta Neurologica Taiwanica Vol 14 No 2 June 2005
12. Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000; 68:707–712.
13. Pittock SJ, Moore AP, Hardiman O, et al. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis 2003; 15:289–300.
14. Gusev YI, Banach M, Simonow A, et al. Efficacy and safety of botulinum type A toxin in adductor spasticity due to multiple sclerosis. J Musculoskel Pain 2008; 16:175-188.
15. Ravindra P, Jackson BL, Parkinson RJ. Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox®) or abobotulinumtoxinA (Dysport®) make a difference? BJU International Volume 112, Issue 1, pages 94–99, July 2013. DOI: 10.1111/bju.12028
16. Frohme C, Varga Z, Olbert P, Schrader AJ, Hofmann R, Hegele A.  [Effects of botulinum toxin type A in the single and repeated treatment of overactive bladder. A prospective analysis]. Der Urologe. Ausg. A[2010, 49(5):639-644] DOI:10.1007/s00120-009-2208-9
17. Abeywickrama L, Arunkalaivanan A, Quinlan M. Repeated botulinum toxin type A (Dysport®) injections for women with intractable detrusor overactivity: a prospective outcome study. International Urogynecology Journal. May 2014, Volume 25, Issue 5, pp 601-605
18. Montaser-Kouhsari L, Zartab H, Fanian F, et al. Comparison of intradermal injection with iontophoresis of abobotulinum toxin A for the treatment of primary axillary hyperhidrosis: A randomized, controlled trial. Journal of Dermatological Treatment. Volume 25, Issue 4, 2014. DOI: 10.3109/09546634.2012.739679.
19. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001; 344:488-493.
20. Jitpimolmard S, Tiamkao S, & Laopaiboon M: Long term results of botulinum toxin type A (Dysport) in the treatment of hemifacial spasm: a report of 175 cases. J Neurol Neurosurg Psychiatry 1998; 64(6):751-757.
21. Van Den Bergh P, Francart J, Mourin S, et al: Five-year experience in the treatment of focal movement disorders with low-dose Dysport botulinum toxin. Muscle Nerve 1995; 18(7):720-729.
22. The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2013 Jul;33(9):629-808.
23. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985. Available from: https://www.auajournals.org/doi/10.1097/JU.0000000000003985
24. Schwedt TJ. Chronic Migraine. BMJ. 2014;348:g1416.
25. Hein HA, Gonzalez A. Migraine Headache Prophylaxis. Am Fam Physician. 2019 Jan 1; 99(1):17-24.
26. Pringheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can Jneurol Sci. 2012 Mar; 39(2 Suppl 2):S1-S9.
27. The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2013 Jul;33(9):629-808.
28. Glaser DA, Hebert AA, Nast A, et al. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2019;80(1):128. Epub 2018 Jul 10
29. American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019 Jan;59(1):1-18. doi: 10.1111/head.13456. Epub 2018 Dec 10.
30. Haider A, Solish N. Focal hyperhidrosis: diagnosis and management. CMAJ. 2005;172(1):69-75.
31. Nawrocki S, Cha J. The Etiology, Diagnosis and Management of Hyperhidrosis: A Comprehensive Review. Part II. Therapeutic Options. J Am Acad Dermatol. 2019 Jan 30. pii: S0190-9622(19)30167-7.
32. American Society for Gastrointestinal Endoscopy (ASGE): Standards of practice for the role of endoscopy in patients with anorectal disorders. Gastro Endo. Volume 72, No. 6 : 2010
33. Wald A, Bharucha AE, Cosman BC, et al. American Gastroenterological Association. American Gastroenterological Association medical position statement: Diagnosis and care of patients with anal fissure. Gastroenterology. 2003;124(1):233.
34. Stewart DB, Gaertner W, Glasgow S, et al. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum 2017; 60: 7–14.
35. Kuo HC, Chen SL, Chou CL, et al. Taiwanese Continence Society clinical guidelines for diagnosis and management of neurogenic lower urinary tract dysfunction. Urological Science, Volume 25, Issue 2, 2014, pp. 35-41
36. Motz BM, Schlosser KA, Heniford BT. Chemical Components Separation: Concepts, Evidence, and Outcomes. Plast Reconstr Surg. 2018 Sep;142(3 Suppl):58S-63S. doi: 10.1097/PRS.0000000000004856.
37. Elstner KE, Read JW, Saunders J, et al. Selective muscle botulinum toxin A component paralysis in complex ventral hernia repair. Hernia. 2019 Apr 4. doi: 10.1007/s10029-019-01939-3.
38. The International Classification of Headache Disorders, 3rd edition (beta version). Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018 Jan;38(1):1-211.
39. Safarpour Y, Mousavi T, Jabbari B. Botulinum Toxin Treatment in Multiple Sclerosis-a Review. Curr Treat Options Neurol. 2017 Aug 17;19(10):33. doi: 10.1007/s11940-017-0470-5.
40. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153.
41. Garza I, Schwedt TJ. (2024) Chronic Migraine. In Swanson JW (Ed). UpToDate. Accessed on November 11, 2024). Available from https://www.uptodate.com/contents/chronic-migraine?search=chronic%20migraine&source=search_result&selectedTitle=1~68&usage_type=default&display_rank=1.
42. Mcconaghy J, Fosselma D. Hyperhidrosis: Management Options. Am Fam Physician. 2018;97(11):729-734. https://www.aafp.org/pubs/afp/issues/2018/0601/p729.html#afp20180601p729-b4
43. Charles A, Digre K, Goadsby P, et al. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024; 64: 333-341. doi:10.1111/head.14692
44. National Government Services, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A52848). Centers for Medicare & Medicaid Services, Inc. Updated on 09/25/2024 with effective date 07/01/2024. Accessed November 2024.
45. Noridian Administrative Services, LLC Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B (A57186). Centers for Medicare & Medicaid Services, Inc. Updated on 03/25/2024 with effective date 04/01/2024. Accessed November 2024.
46. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article:  Billing and Coding: Botulinum Toxin Type A & Type B (A57474). Centers for Medicare & Medicaid Services, Inc. Updated on 01/23/2024 with effective date 01/01/2024. Accessed November 2024.
47. CGS, Administrators, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxins (A56472). Centers for Medicare & Medicaid Services, Inc. Updated on 11/29/2023 with effective date 12/07/2023. Accessed November 2024.
48. Noridian Healthcare Solutions, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B Policy (A57185). Centers for Medicare & Medicaid Services, Inc. Updated on 03/25/2024 with effective date 04/01/2024. Accessed November 2024.
49. Palmetto GBA. Local Coverage Article: Billing and Coding: Chemodenervation (A56646). Centers for Medicare & Medicaid Services, Inc. Updated on 08/19/2024 with effective date 10/01/2024. Accessed November 2024.
50. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A57715). Centers for Medicare & Medicaid Services, Inc. Updated on 03/27/2024 with effective date 04/01/2024. Accessed November 2024.
51. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A58423). Centers for Medicare & Medicaid Services, Inc. Updated on 03/27/2024 with effective date 04/01/2024. Accessed November 2024.

Appendix 1 – Covered Diagnosis Codes

Dual coding requirements:

• Primary G and M codes require a secondary G or I code in order to be payable

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.