Last Review Date: 12/03/2024

Date of Origin: 09/05/2023

Dates Reviewed: 09/2023, 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]:

2. • 300 billable units every 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 evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
• 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 is not on concurrent treatment with another botulinum toxin (i.e., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, etc.); AND  

Cervical Dystonia † ^1-4

• 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

† FDA Approved Indication; ‡ Literature Supported Indication; Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet 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 and clinically significant effects with pre-existing neuromuscular disorders (i.e., asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, swallowing/breathing difficulties, etc.), severe hypersensitivity reactions (i.e., anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea, etc.), severe pulmonary effects (i.e., reduced pulmonary function), corneal exposure/ulceration, retrobulbar hemorrhage, bronchitis/upper-respiratory tract infections, autonomic dysreflexia, urinary tract infection, and urinary retention, etc.; AND
• Disease response as evidenced by the following:

Cervical Dystonia ¹

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

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J0589 – Injection, daxibotulinumtoxina-lanm, 1 unit; 1 billable unit = 1 unit

NDC:

• Daxxify 100 unit powder for injection; single-dose vial: 72960-0112-xx

*Note: Daxxify 50 Unit vials is indicated for cosmetic use only

7. References

1. Daxxify [package insert].  Newark, CA; Revance Therapeutics, Inc; November 2023. Accessed November 2024.
2. Albanese A, Barnes MP, Bhatia KP, et al. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006;13(5):433-444
3. 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.

4. Solish N, Carruthers J, Kaufaman J, et al. Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs 81, 2091–2101 (2021). https://doi.org/10.1007/s40265-021-01631-w
5. 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.
6. 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.
7. 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.
8. 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.
9. 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

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.