CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Daxxify (daxibotulinumtoxinA) (Intramuscular) - Coverage Criteria for Cervical Dystonia

Policy governing coverage, dosing limits, authorization and renewal criteria for Daxxify (daxibotulinumtoxinA) intramuscular use, primarily for treatment of cervical dystonia for Medicaid, Commercial, and MMP members aged 18 and older.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaxxify (daxibotulinumtoxinA) (Intramuscular) - Coverage Criteria for Cervical Dystonia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review Date

Key ActionObtain prior authorization; ensure patient is >=18 years, not on concurrent botulinum toxin therapy, and meets universal and indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250maximum units allowed every 140 days

3vial limit per 140 days

6initial auth (months)

>=18minimum patient age

J0589HCPCS code

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Coverage Criteria for Daxxify (daxibotulinumtoxinA)

Initial Approval Criteria

Covered when ALL of the following are met

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

Universal criteria: Patient evaluated for any 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 (Cervical Dystonia)

Sustained head tilt
Abnormal posturing with limited range of motion in the neck

Treatment intent: Injection with daxibotulinumtoxinA (Daxxify) for symptomatic management of cervical dystonia

Renewal Criteria

Renewal criteria — coverage can be renewed when ALL of the following are met

Continued criteria: Patient continues to meet universal and indication-specific criteria as identified in Initial Approval Criteria (Section III)

Safety: Absence of unacceptable toxicity from the drug (examples include symptoms of toxin spread effect, clinically significant effects in patients with pre-existing neuromuscular disorders such as asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria; severe hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea; and severe pulmonary effects)

Examples listed are non‑exhaustive; see policy for full list

Clinical response: Demonstrated disease response: improvement in severity and frequency of pain AND improvement of abnormal head positioning for cervical dystonia

Daxxify 50‑unit vials are designated for cosmetic use only and are not covered for the cervical dystonia indication. Prior to authorization, the provider must confirm that the requested formulation and vial size are appropriate for the documented neurologic indication and not for cosmetic administration. Additionally, the provider must confirm the patient is not receiving concurrent treatment with another botulinum toxin product; concurrent use with agents such as onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, or similar will preclude coverage.

Coverage is excluded when the patient is receiving concurrent treatment with another botulinum toxin (for example, onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB). Coverage is also not permitted for patients with a documented hypersensitivity to any botulinum toxin product, or when other Universal Criteria contraindications (such as active infection at the proposed injection site) apply.

Billing, Limits, and Codes

Covered HCPCS CodesHCPCSCovered

J0589

Injection, daxibotulinumtoxina-lanm, 1 unit

Covered Diagnosis CodesICD-10Covered

G24.3	Spasmodic torticollis
M43.6	Torticollis

NDCNDC

72960-0112-xx

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

inv-08: Max units per period

Maximum units allowed250 Units every 140 days

HCPCS unit basisMeasured as HCPCS units (J0589 = Injection, daxibotulinumtoxina-lanm, 1 unit)

ApplicabilityApplies to medical benefit dosing limits as stated in policy

inv-09: Vial limit (medical benefit)

Vial limit (medical benefit)3 x 100-unit vials per 140 days

Vial sizeDaxxify 100-unit powder for injection; single-dose vial

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is available for patients aged 18 years and older who meet the indication-specific criteria for cervical dystonia.

Length of initial authorization: 6 months; renewals may be for 12 months.
Covered population: patients >= 18 years with documented cervical dystonia meeting the policy criteria.

Denial Risk

Concurrent Toxin Exclusion — Confirm No Concurrent Botulinum Toxin

Providers must confirm the patient is not currently receiving another botulinum toxin product prior to authorization and at each renewal. Concurrent use of onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, or other botulinum toxin formulations is excluded.

Verify no concurrent botulinum toxin treatment (examples: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB).

Clinical Background

Cervical dystonia (spasmodic torticollis) is a movement disorder characterized by recurrent, involuntary contractions of neck and upper‑shoulder muscles that produce a sustained head tilt or other abnormal neck posturing and limited range of motion. Botulinum toxin injections, including Daxxify when used per the criteria in this policy, are an FDA‑approved symptomatic treatment intended to reduce abnormal positioning and associated pain. Prior to treatment, patients should be evaluated for conditions that might contribute to respiratory or swallowing difficulty and for contraindications such as hypersensitivity to botulinum toxins or active infection at the proposed injection site.

Definitions and Terminology

inv-16: Cervical dystonia / Spasmodic torticollis

DefinitionRecurrent involuntary contraction of one or more muscles in the neck and upper shoulders resulting in sustained head tilt or abnormal posturing with limited range of motion

ICD-10 codesG24.3 = Spasmodic torticollis; M43.6 = Torticollis

FDA statusListed as an FDA‑approved indication in the policy