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, 09/2015, 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, 01/2020, 05/2020, 05/2021, 05/2022, 05/2023, 12/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed annually thereafter.

2. Dosing Limits

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

      Cervical Dystonia

• 100 billable units per 12 weeks (84 days)

Upper Limb Spasticity

• 150 billable units per 12 weeks (84 days)

Chronic Migraine Prophylaxis

• 100 billable units per 12 weeks (84 days)

Chronic Sialorrhea

• 50 billable units per 12 weeks (84 days)

Severe Primary Axillary Hyperhidrosis

• 100 billable units per 12 weeks (84 days)

Overactive Bladder

• 150 billable units per 12 weeks (84 days)

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient does not have a hypersensitivity to any botulinum toxin product; 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., abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, daxibotulinumtoxinA, etc.); AND  

Cervical Dystonia † Ф ^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

Chronic Sialorrhea † ^1,13-18,33

• Patient has a history of troublesome sialorrhea for at least a 3-month period

Upper Limb Spasticity ‡ ^2-6

Prophylaxis for Chronic Migraines ‡ ^{7-10,19-22,24,31,34,35,39}

• 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

Severe Primary Axillary Hyperhidrosis ‡ ^{11,12,25,26,32,36}

• 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.)

Overactive Bladder (OAB) ‡ ^37.38

• 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

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

4. Renewal Criteria ¹

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
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: symptoms of a toxin spread effect (i.e., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, swallowing/breathing difficulties, etc.), serious hypersensitivity reactions (i.e., angioedema, urticaria, rash, anaphylaxis, serum sickness, soft tissue edema, and dyspnea), etc.; AND
• Disease response as evidenced by the following:

Cervical Dystonia ^1,2

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

Upper Limb Spasticity ^2-6,30

• 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.)

Prophylaxis for Chronic Migraines ^20,24,31

• 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.)

Chronic Sialorrhea ^1,13-18,33

• Significant decrease in saliva production

Severe Primary Axillary Hyperhidrosis ^{11,12,25,26,32}

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

Overactive Bladder (OAB) ^37,38

• 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

5. Dosage/Administration ^{1-12,30,31,37}

6. Billing Code/Availability Information

HCPCS Code:

• J0587 – Injection, rimabotulinumtoxinB, 100 units; 1 billable unit = 100 units

NDC(s):

6. • Myobloc 2,500 unit/0.5 mL single-dose vial solution for Injection: 10454-0710-xx
   • Myobloc 5,000 unit/mL single-dose vial solution for Injection: 10454-0711-xx
   • Myobloc 10,000 unit/2mL single-dose vial solution for Injection: 10454-0712-xx
7. References

1. Myobloc [package insert]. Rockville, MD; Solstice Neurosciences, Inc.; March 2021. 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. Gracies JM, Bayle N, Goldberg S, Simpson DM. Botulinum toxin type B in the spastic arm: a randomized, double-blind, placebo-controlled, preliminary study. Arch Phys Med 29 Rehabil 2014; 95:1303-1311.
4. Brashear A, McAfee A, Kuhn E, et al. Botulinum Toxin Type B in Upper-Limb Poststroke Spasticity: A Double-Blind, Placebo-Controlled Trial, Arch Phys Med Rehabil 2004;85:705-9.
5. Brashear A, McAfee A, Kuhn E, et al. Treatment with botulinum toxin type B for upper-limb spasticity. Arch Phys Med Rehabil 2003; 84:103-7.
6. Hecht J, Preston L, McPhee S. Effects of botulinum toxin type B on shoulder pain, hypertonia, and function in adults with spastic hemiparesis. Poster presented at the 63rd Annual Assembly of the American Academy of Physical Medicine and Rehabilitation; November 21-24, 2002; Orlando, Florida.
7. Gwynn, MW, English, JB, Baker, TS. Double-blind, placebo-controlled study of Myobloc (botulinum toxin type B) for preventing chronic headache. Poster presented at 45th Annual Scientific Meeting of the American Headache Society; June 19-22, 2003, Chicago, Illinois.
8. Lake AE III, Saper JR. Botulinum toxin type B for migraine prophylaxis: a 4-month, open-label, prospective outcome study. Poster presented at the 22nd Annual Scientific Meeting of the American Pain Society; March 20-23, 2003, Chicago, Illinois.
9. Opida CL. Open-label study of Myobloc (botulinum toxin type B) in the treatment of patients with transformed migraine headaches. Poster presented at the International Conference 2002: Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins; June 8-11, 2002, Hannover, Germany
10. Alvarez M, Grogan P. Effectiveness of botulinum toxin type-A and type-B in exploding, imploding, and ocular migraine headache. Presented at the 5th World Congress of the World Institute of Pain; March 13-16, 2009, New York, New York.
11. Dressler D, Saberi FA, Benecke R. Botulinum toxin type B for treatment of axillary hyperhidrosis. J Neuol (2002) 249:1729-1732. DOI 10.1007/s00415-002-0929-4.
12. Baumann L, Slezinger A, Halem M et al. Pilot study of the safety and efficacy of Myobloc™ (botulinum toxin type B) for treatment of axillary hyperhidrosis. International Journal of Dermatology, 44: 418–424. doi: 10.1111/j.1365-4632.2004.02531.x
13. Chinnapongse R, Gullo K, Nemeth P, et al. Safety and Efficacy of Botulinum Toxin Type B for Treatment of Sialorrhea in Parkinson’s Disease: A Prospective Double-Blind Trial. Mov Disord. 2012; 27:219-226.
14. Lagalla G, Millevolte M, Capecci M, et al. Long Lasting Benefits of botulinum toxin type B in Parkinson’s disease-related drooling. J Neurol. 2009;256:563-567
15. Costa J, Rocha ML, Ferreira J, et al. Botulinum toxin type-B improves sialorrhea and quality of life in bulbar-onset amyotrophic lateral sclerosis. J Neurol. 2008; 255:545-550.
16. 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. Mov Disord. 2011; 26:313-319.
17. Basciani M, Di Rienzo F, Fontana A, et al. Botulinum toxin type B for Sialorrhea in Children with Cerebral Palsy: a randomized trial comparing three doses. Dev Med & Child Neurol. 2011; 53:559-564.
18. Wright E. Botulinum toxin type B (Myobloc®) for treatment of pediatric sialorrhea. Poster presented at: 63rd Annual Assembly of the American Academy of Physical Medicine and Rehabilitation; November 21- 24, 2002; Orlando, Florida.
19. 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.
20. Schwedt TJ. Chronic Migraine. BMJ. 2014;348:g1416.
21. Hein HA, Gonzalez A. Migraine Headache Prophylaxis. Am Fam Physician. 2019 Jan 1; 99(1):17-24.
22. 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.
23. 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.
24. 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.
25. Haider A, Solish N. Focal hyperhidrosis: diagnosis and management. CMAJ. 2005;172(1):69-75.
26. 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.
27. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004; 62:37-40.
28. Racette BA, Good L, Sagitto S, Perlmutter JS. Botulinum toxin B reduces sialorrhea in Parkinsonism. Mov Disord. 2003; 18:1059-1061.
29. Jackson CE, Gronseth G, Rosenfeld J, et al. Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients. Muscle Nerve. 2009;39(2):137.
30. Goldberg S, Weisz D, Simpson D et al. Effects of botulinum toxin type B in the hemiplegic upper limb: a double-blind, placebo-controlled, dose ranging study. Guided Poster Session: 16th International Congress on Parkinson's Disease and Related Disorders, Berlin Germany, June 5-9, 2005.
31. The International Classification of Headache Disorders, 3rd edition. Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018; 38(1):1-211.
32. Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007 Aug; 33(8):908-23.
33. Isaacson SH, Ondo W, Jackson CE, et al; MYSTICOL Study Group. Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial. JAMA Neurol. 2020 Apr 1;77(4):461-469. doi: 10.1001/jamaneurol.2019.4565.
34. 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.
35. Garza I, Schwedt TJ. (2024) Chronic Migraine. In Swanson JW (Ed). Last updated October 3, 2024. 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.
36. Mcconaghy J, Fosselman D. Hyperhidrosis: Management Options. Am Fam Physician. 2018;97(11):729-734. Available from: https://www.aafp.org/pubs/afp/issues/2018/0601/p729.html
37. Dykstra D, Enriquez A, Valley M. Treatment of overactive bladder with botulinum toxin type B: a pilot study. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Dec;14(6):424-6.
38. 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
39. 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
40. 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.
41. Noridian Healthcare Solutions, 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.
42. 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.
43. 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.
44. 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.
45. 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.
46. 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.
47. 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.