CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Daxxify (daxibotulinumtoxinA) intramuscular for cervical dystonia — Coverage Criteria

Clinical coverage policy for Daxxify (daxibotulinumtoxinA) injections for adults with cervical dystonia across Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaxxify (daxibotulinumtoxinA) intramuscular for cervical dystonia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for adult patients (≥18 years) with cervical dystonia meeting the policy's universal and indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

125-250recommended dose range

250max units/140 days

3100-unit vials/140 days

6initial auth (months)

G24.3, M43.6covered ICD-10

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inv-01: Initial Approval - Cervical Dystonia — Covered when ALL of the following are met

Covered when ALL of the following are met

Age: Patient is at least 18 years of age>=18 years

Diagnosis of cervical dystonia (ICD-10 G24.3 or M43.6)

Universal safety criteria: Patient evaluated for disorders which may contribute to respiratory or swallowing difficulty; no hypersensitivity to any botulinum toxin product; no active infection at the proposed injection site; not on concurrent treatment with another botulinum toxin (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB)

Indication-specific clinical features: History of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders with sustained head tilt OR abnormal posturing with limited range of motion in the neck

FDA-approved indication

Dosing within recommended range: Planned dose between 125 and 250 Units given intramuscularly as divided doses among affected muscles; when initiating treatment use the lowest recommended dose; consider prior botulinum toxin dose/response/adverse events when selecting initial Daxxify dose125-250 Units

Re-treatment no sooner than 12 weeks from prior injection; pivotal trial frequencies 5–6 months

inv-02: Renewal Criteria - Cervical Dystonia — Renewal is approved when ALL of the following are met

Renewal is approved when ALL of the following are met

Continued eligibility: Patient continues to meet universal and indication-specific criteria as identified for initial approval

Absence of unacceptable toxicity: No evidence of unacceptable toxicity (examples include symptoms of toxin spread such as generalized muscle weakness, dysphagia, dysarthria, respiratory compromise; severe hypersensitivity; severe pulmonary effects; corneal exposure/ulceration; significant infections; autonomic dysreflexia; urinary retention)

Examples listed in policy

Clinical response: Documented improvement in severity and frequency of pain and improvement of abnormal head positioning

Daxxify 50-unit vials are indicated for cosmetic use only and are not covered for cosmetic indications. Coverage is limited to medically indicated formulations and dosing consistent with the clinical criteria for cervical dystonia. Additionally, members must meet the policy’s universal safety criteria (e.g., evaluation for disorders contributing to respiratory or swallowing difficulty, no hypersensitivity to any botulinum toxin product, and no active infection at the proposed injection site) prior to approval.

Use of Daxxify in patients who are concurrently receiving another botulinum toxin product (for example, onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, etc.) is not permitted and is considered not medically necessary. Concurrent treatment with another botulinum toxin is a contraindication and will result in denial of coverage.

Billing Codes, Limits, and Frequency

Covered HCPCS CodesHCPCSCovered

J0589

Injection, daxibotulinumtoxina-lanm, 1 unit

Covered ICD-10 Diagnosis CodesICD-10Covered

G24.3	Spasmodic torticollis
M43.6	Torticollis

NDCsNDC

72960-0112-xx

Daxxify 100-unit powder for injection; single-dose vial NDC

Maximum dosing frequency & quantity limits — retreatment interval and vial/unit limits

Retreatment intervalNo sooner than every 12 weeks (policy specifies max dosing frequency as 250 units every 140 days)

Maximum units (HCPCS unit limit)250 Units per 140 days

Quantity limit — 100‑unit vial (medical benefit)3 vials per 140 days

Medicaid pharmacy benefit fill frequency1 fill per 140 days

Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization required for adult patients (≥18 years) with cervical dystonia meeting criteria in the policy. Ensure prior auth is obtained before treatment.

Patient ≥ 18 years
Indication: cervical dystonia (G24.3, M43.6)

Denial Risk

Concurrent Botulinum Toxin Use — Denial Risk

Concurrent treatment with another botulinum toxin (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB) is a contraindication. Claims will be denied if concurrent botulinum toxin use is documented.

Concurrent use of any other botulinum toxin product

Documentation Required

Renewal Documentation Required

Documentation required for renewal must demonstrate absence of unacceptable toxicity and clinical benefit. Examples of unacceptable toxicity include signs of toxin spread (e.g., dysphagia, breathing difficulties), severe hypersensitivity (e.g., anaphylaxis), significant pulmonary effects, corneal exposure/ulceration, and other listed severe adverse events.

Document no unacceptable toxicity (e.g., dysphagia, generalized weakness, anaphylaxis)
Document disease response: improvement in pain severity/frequency and improvement in abnormal head positioning for cervical dystonia

Billing Rule

Pre‑treatment Evaluation and Billing Considerations

Providers must evaluate for disorders contributing to respiratory or swallowing difficulty, confirm no hypersensitivity to botulinum toxin, and ensure no active infection at the injection site prior to treatment.

Evaluation for respiratory or swallowing disorders
No hypersensitivity to botulinum toxin
No active infection at proposed injection site

OpenPayer

Daxxify (daxibotulinumtoxinA) intramuscular for cervical dystonia — Coverage Criteria

Coverage and Medical Necessity

Billing Codes, Limits, and Frequency

Authorization, Documentation, and Denial Conditions

Clinical Background

Key Definitions