CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Daxxify (daxibotulinumtoxinA) (Intramuscular) — Cervical Dystonia Coverage Criteria

Policy governing coverage, dosing limits, authorization and renewal criteria for Daxxify (daxibotulinumtoxinA) for treatment of cervical dystonia for Medicaid, Commercial, and Medicare‑Medicaid Plan members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaxxify (daxibotulinumtoxinA) (Intramuscular) — Cervical Dystonia Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review DateJun 6, 2025

Key ActionObtain prior authorization: initial approval for 6 months (renewable for 12 months) and confirm patient is ≥18 years with a covered diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250max units / 140 days

3max 100‑unit vials / 140 days

6 moinitial auth

≥18min age

J0589HCPCS

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Coverage Criteria for Daxxify (daxibotulinumtoxinA)

Initial Therapy (Cervical Dystonia)

Covered when ALL of the following are met:

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

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

Indication-specific clinical features: Patient has cervical dystonia defined by history of recurrent involuntary contraction of one or more neck or upper shoulder muscles with sustained head tilt or abnormal posturing with limited neck range of motion

Orphan Drug

Dosing considerations: Recommended Daxxify dose for cervical dystonia ranges from 125 to 250 Units divided among affected muscles; initiate with the lowest recommended dose; re-treatment no sooner than 12 weeks (pivotal trials used 5–6 month intervals); prior botulinum toxin history should inform initial dosing125–250 Units per treatment; re-treatment >=12 weeks

Renewal Criteria

Renewal / continuation coverage is allowed when ALL of the following are met:

Continuation of criteria: Patient continues to meet universal and indication-specific criteria

Safety: Absence of unacceptable toxicity (examples include symptoms of toxin spread and clinically significant effects with pre-existing neuromuscular disorders such as generalized muscle weakness, dysphagia, diplopia; severe hypersensitivity reactions; severe pulmonary effects; corneal exposure/ulceration; significant infections or autonomic complications)

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

Daxxify 50‑unit vials are for cosmetic use only and are not indicated or covered for treatment of cervical dystonia. Concurrent administration of Daxxify with another botulinum toxin product is not allowed; the patient must not be receiving other botulinum toxin treatments (examples include onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB).

Therapy is not medically acceptable when the patient has a known hypersensitivity to any botulinum toxin product. Treatment is also contraindicated in the presence of an active infection at the intended injection site. Additionally, coverage is denied if the patient is undergoing concurrent treatment with another botulinum toxin product (for example, onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB).

Before initiating therapy, the patient must be evaluated for disorders that could contribute to respiratory or swallowing difficulty; unresolved disorders that increase these risks may preclude coverage.

Billing, Codes, and Limits

Covered HCPCS CodesHCPCSCovered

J0589

Injection, daxibotulinumtoxina-lanm; 1 unit

NDC (product)NDCCovered

72960-0112-XX

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

Covered ICD-10 Diagnosis CodesICD-10Covered

G24.3	Spasmodic torticollis
M43.6	Torticollis

inv-08: Maximum units per period

Maximum units per period250 Units every 140 days

Measurement unitHCPCS units (1 unit = J0589)

RationaleAligns with dosing limits specified for Daxxify over a 140‑day period

inv-09: Maximum 100-unit vials

Maximum 100-unit vials (medical benefit)3 vials per 140 days

Vial size100‑unit single‑dose vial (SDV)

Applicability

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization is provided for up to 6 months; renewals may be approved for up to 12 months.

Initial approval: up to 6 months
Renewal approvals: up to 12 months

Step Therapy

Step Therapy / Treatment Sequencing

No formal step-therapy sequence is required; however, members must not be receiving concurrent treatment with another botulinum toxin product.

Confirm absence of concurrent botulinum toxin therapy (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB)

Background

Daxxify (daxibotulinumtoxinA) is a botulinum toxin type A formulation used as an intramuscular therapy for cervical dystonia. Cervical dystonia is characterized by recurrent involuntary contractions of one or more muscles in the neck and upper shoulders, often producing a sustained head tilt or abnormal posturing with limited neck range of motion and pain. Clinical evaluation should include assessment for conditions that could worsen respiratory or swallowing function prior to injection.

Note that only the 100‑unit Daxxify single‑dose vial (NDC 72960-0112-XX) is indicated for this therapeutic use; the 50‑unit vial is intended for cosmetic indications and is not appropriate for cervical dystonia treatment.

Definitions

inv-16: Cervical dystonia

DefinitionHistory of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders

Clinical featuresSustained head tilt

Clinical featuresAbnormal posturing with limited range of motion in the neck

Usage noteOrphan drug designation noted in source