CurrentCentenePolicy CP.PHAR.651

DaxibotulinumtoxinA-lanm (Daxxify) (PDF)

Defines medical necessity, clinical criteria, dosing limits, approvals durations, and coding for Daxxify (daxibotulinumtoxinA-lanm) for commercial, HIM, and Medicaid lines of business, with specific criteria for cervical dystonia and exclusions for cosmetic and non‑FDA indications.

Policy Summary

PayerCentene

PolicyDaxibotulinumtoxinA-lanm (Daxxify) (PDF)

Policy CodePolicy CP.PHAR.651

Change TypeCoding update; step therapy bypass added for IL HIM

Effective DateDec 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical info) supporting that member meets all approval criteria, including a treatment plan detailing number of Units per indication and treatment session.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J0589 and removed C9399 and J3590.

Added step therapy bypass for IL HIM per IL HB 5395.

4Q 2024 annual review: no significant changes; references reviewed and updated.

1Covered Indications (FDA)

2Approval Duration Options

250Per session maximum dose

Coverage Summary

Coverage stance: covered_with_criteria for Daxxify (daxibotulinumtoxinA-lanm) when used to treat cervical dystonia. Scope applies to Commercial, HIM, and Medicaid lines of business. FDA-approved indications include treatment of cervical dystonia in adults; cosmetic uses (e.g., glabellar lines) are excluded from coverage under this policy. Policy identifier is CP.PHAR.651. Effective date is 12.01.23 and last review date is 11.25 (per policy header and revision log).

Quick facts & thresholds

Minimum age≥ 18 years

Maximum dose per treatment session250 Units

Interval since prior botulinum toxin therapy≥ 12 weeks

Covered indications (FDA)1 (glabellar lines; cervical dystonia)

Approval duration optionsMedicaid/HIM: 12 months; Commercial: 6 months or to member renewal date

Initial Therapy Criteria — Cervical Dystonia

Initial Approval Criteria - Cervical Dystonia

Daxxify is medically necessary when ALL of the following are met:

Diagnosis and prescriber: Diagnosis of cervical dystonia (CD); prescribed by or in consultation with a neurologist, orthopedist, or physiatrist
Age ≥ 18 years≥ 18 years
Clinical features: Member is experiencing involuntary contractions of the neck and shoulder muscles (e.g., splenius capitis, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis) resulting in abnormal postures or movements causing pain and functional impairment
Prior therapy (step therapy): Failure of Botox and Dysport unless clinically significant adverse effects or contraindications exist
IL HIM requests bypass this step therapy per IL HB 5395
Concurrent botulinum toxin use: Daxxify is not prescribed concurrently with other botulinum toxin products
Interval since prior botulinum toxin: No botulinum toxin therapy for cosmetic or medical conditions administered within the last 12 weeks≥ 12 weeks since prior botulinum toxin therapy
Treatment plan provided detailing number of Units per indication and treatment session
Providers must submit supporting documentation (office notes, labs, or other clinical info)
Dose limit: Dose does not exceed 250 Units per treatment session<= 250 Units per treatment session
Dosing: 125 to 250 Units IM divided among affected muscles every 12 weeks; maximum 250 Units per session

Continuation / Renewal Criteria — Cervical Dystonia

Continuation/Renewal Criteria - Cervical Dystonia

For continuation approval, ALL of the following must be met:

Continuity of care: Member currently receiving medication via Centene benefit or previously met initial approval criteria, OR member is currently receiving medication and enrolled in a state/product with continuity of care regulations
Refer to state-specific addendums for continuity of care
Response to therapy: Member is responding positively to therapy
Concurrent botulinum toxin use: Daxxify is not prescribed concurrently with other botulinum toxin products
Interval since prior botulinum toxin: No botulinum toxin therapy for cosmetic or medical conditions administered within the last 12 weeks≥ 12 weeks since prior botulinum toxin therapy
Treatment plan provided detailing number of Units per indication and treatment session
Providers must submit supporting documentation (office notes, labs, or other clinical info)
Dose increase: If request is for a dose increase, new dose does not exceed 250 Units per treatment session<= 250 Units per treatment session
Do not bill for doses exceeding 250 Units per treatment session (HCPCS J0589 billed per unit).

Other Indications & Exclusions

Other Diagnoses/Indications

If requested use is not listed in section III and a recent label change does not apply, follow applicable formulary/non-formulary or off-label policy:

Recent label change handling: If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the appropriate formulary or non-formulary policy for the line of business (references: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
Off-label use handling: If requested use is not listed under section III and recent label-change criterion does not apply, refer to the off-label use policy for the relevant line of business (references: CP.CPA.09, HIM.PA.154, CP.PMN.53)

Diagnoses/Indications NOT authorized

Coverage is NOT authorized for the following:

Non-FDA approved indications: Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents
References: CP.CPA.09, HIM.PA.154, CP.PMN.53
Cosmetic uses not authorized: Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles, and periorbital wrinkles (crow's feet) is not authorized
Daxxify is FDA‑approved for glabellar lines as an indication, but cosmetic use for upper-face hyperfunctional wrinkles is listed here as not authorized under this policy unless off-label criteria are met.

Provider Actions & Billing Guidance

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation supporting that the member meets all approval criteria. Required documentation includes office chart notes or other clinical information and a treatment plan that details the number of Units per indication and per treatment session.

Office chart notes or clinical documentation
Treatment plan detailing number of Units per indication and per treatment session

Step Therapy

Step therapy requirement (failure of Botox and Dysport)

For initial approval of Daxxify for cervical dystonia, documentation of prior failure of Botox® and Dysport® is required unless clinically significant adverse effects or contraindications exist. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 effective 2026-01-01.

Failure of Botox® and Dysport® required for initial approval unless contraindicated or significant adverse effects
IL HIM requests bypass step therapy per IL HB 5395 effective 2026-01-01

Billing Rule

Dose limit billing

Do not bill for doses exceeding 250 Units per treatment session. J0589 is the unit-level HCPCS code for daxibotulinumtoxina-lanm and should be billed per unit.

Maximum dose per treatment session: 250 Units
HCPCS J0589 = Injection, daxibotulinumtoxina-lanm, 1 unit (bill per unit)

Documentation Required

Concurrent botulinum toxins

Daxxify must not be prescribed concurrently with other botulinum toxin products. Concurrent botulinum toxin therapy is prohibited and claims may be denied if concurrent therapy is evident.

Do not prescribe Daxxify concurrently with other botulinum toxin products
Claims may be denied if concurrent therapy is present

Clinical Evidence & References

Key evidence references supporting the policy include the American Academy of Neurology (2016) practice guideline supporting botulinum toxin use for cervical dystonia and the Daxxify Prescribing Information (Revance Therapeutics, November 2023), which are cited as the primary references in the policy.

Evidence & prescribing info

Guideline supportAmerican Academy of Neurology (2016) supports botulinum toxin use for cervical dystonia

Prescribing informationDaxxify Prescribing Information, Revance Therapeutics, November 2023

HCPCS codingJ0589 - Injection, daxibotulinumtoxina-lanm, 1 unit

Background

Background: Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent. The FDA approvals include temporary improvement of moderate to severe glabellar lines and the treatment of cervical dystonia in adults. The policy aligns coverage for cervical dystonia with requirements for specialty prescriber or consultation (neurologist, orthopedist, or physiatrist), minimum age ≥ 18 years, prior therapy failure of Botox® and Dysport® (with Illinois HIM step-therapy bypass per IL HB 5395 where applicable), documentation of an individualized treatment plan including number of Units per indication and session, dosing limits of ≤ 250 Units per treatment session, and listed safety contraindications (e.g., hypersensitivity, infection at injection site, boxed warning for distant spread of toxin effect).

Revision History

2024-02-20coding_change

Removed HCPCS codes C9399 and J3590 and added HCPCS code J0589 (Injection, daxibotulinumtoxina-lanm, 1 unit).

07.16.24annual_review