CurrentCentenePolicy CP PHAR.651

Clinical Policy: DaxibotulinumtoxinA-lanm (Daxxify)

Policy governs medical necessity and prior authorization criteria for Daxxify (daxibotulinumtoxinA-lanm) for treatment of cervical dystonia and cosmetic glabellar lines for members covered by Centene lines of business.

Policy Summary

PayerCentene

PolicyDaxibotulinumtoxinA-lanm (Daxxify) clinical policy

Policy CodePolicy CP PHAR.651

Change TypeNo material change

Effective DateDec 1, 2023

Next Review DateNov 24, 2024

Key ActionSubmit prior authorization with documentation showing diagnosis of cervical dystonia, age ≥18, prior Botox/Dysport trial or contraindication, treatment plan, and dose ≤250 units.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250maximum dose

12 weeksminimum interval

J0589HCPCS

50,100vial sizes

Commercial,HIM,Medicaidlines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval for Cervical Dystonia: 1) Diagnosis of cervical dystonia; 2) Age ≥ 18 years; 3) Member is experiencing involuntary contractions of neck/shoulder muscles (e.g., splenius capitis, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis) resulting in abnormal postures or movements of the neck, shoulders, or head; 4) Contractions are causing pain and functional impairment; 5) Daxxify is not prescribed concurrently with other botulinum toxin products; 6) Failure of Botox and Dysport unless clinically significant adverse effects are experienced or both are contraindicated; 7) Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks; 8) Treatment plan provided detailing number of units per indication and per treatment session; 9) Dose does not exceed 250 units per treatment sessiondose <= 250 Units; interval >= 12 weeks

Approval duration: Commercial 6 months or to the member's renewal date; Medicaid/HIM 12 months

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continuation Therapy for Cervical Dystonia: 1) Member currently receiving medication via Centene benefit or has previously met initial approval criteria (including continuity of care provisions where applicable); 2) Member is responding positively to therapy; 3) Daxxify is not prescribed concurrently with other botulinum toxin products; 4) Treatment plan provided detailing number of units per indication and per treatment session; 5) Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks; 6) If request is for a dose increase, the new dose does not exceed 250 units per treatment sessiondose <= 250 Units; interval >= 12 weeks

Approval durations: Commercial 6 months or to the member's renewal date; Medicaid/HIM 12 months

Cosmetic treatment of upper-face hyperfunctional wrinkles, including glabellar frown lines, forehead wrinkles, and periorbital wrinkles (crow’s feet), is not authorized under this policy.

Coverage and administration of benefits under this clinical policy are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal requirements and Health Plan-level administrative policies and procedures. Providers should confirm member-specific benefit limitations and exclusions in the member’s coverage documents before requesting authorization.

Non‑FDA approved indications that are not specifically addressed in this policy are not covered unless the provider supplies sufficient documentation of efficacy and safety consistent with the Health Plan’s off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP PMN.53 for Medicaid) or unless coverage is otherwise supported in the member’s evidence of coverage.

Provider Actions and Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is subject to plan medical necessity guidelines and member benefit documents; coverage decisions are subject to the member's benefit terms, conditions, exclusions, and limitations.

Prior authorization required per plan-level policies and member benefit documents.
Coverage decisions governed by Health Plan medical necessity guidelines and member benefit documents.

Documentation Required

Documentation & Criteria

Providers must submit documentation demonstrating the member meets all approval criteria. Failure to submit required documentation or to meet listed criteria may result in denial.

Provider must submit office chart notes, lab results, treatment plans, and other clinical information supporting diagnosis and clinical need.
If supporting documentation is incomplete or absent, the request may be denied.

Documentation Required

Documentation and Administrative Compliance

Providers must follow Health Plan administrative policies and documentation requirements when submitting requests. Requests that conflict with state Medicaid provisions may be subject to denial where state rules take precedence.

Follow Health Plan administrative submission requirements and any state-specific addendums.
For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy when conflicts exist.

Step Therapy

Clinical and Step Therapy Requirements

Prior authorization approval requires that the member has met clinical criteria and that required therapeutic steps and documentation are provided. Step therapy requirements apply as specified.

Member must have diagnosis of cervical dystonia and be ≥18 years when specified.
Member must have involuntary neck/shoulder muscle contractions causing functional impairment or pain.
Daxxify must not be prescribed concurrently with other botulinum toxin products.
Prior failure of Botox and Dysport is required unless contraindicated or clinically significant adverse effects occurred.
Botulinum toxin therapy for cosmetic or medical conditions must not have been administered within the last 12 weeks.
Treatment plan must detail number of units per indication and per session; dose must not exceed 250 units per treatment session.

Documentation Required

Required Documentation

Required documentation includes office chart notes, current treatment plan, prior medication history (including prior botulinum toxin products and dates), and any pertinent lab or imaging results.

Office chart notes documenting diagnosis, symptom severity, and functional impairment.
Documentation of prior therapies including Botox and Dysport, dates administered, and reasons for discontinuation if applicable.
Treatment plan with units per muscle and total units per session, and rationale for dose or dose increases.

Denial Risk

Denial Risk and Benefit Limits

Denial risk is tied to benefit limits and applicable plan terms. Even if clinical criteria are met, coverage may be denied if member benefits do not cover the service or if submission does not comply with plan rules.

Coverage is subject to the member's coverage terms, exclusions, and limitations in the evidence of coverage or contract.
Noncompliance with benefit rules, administrative policies, or missing documentation may result in denial.

Initial Therapy Criteria

inv-23: Initial Therapy

Initial approval requires all listed conditions and documentation

Initial Therapy: 1) Diagnosis of cervical dystonia; 2) Age ≥ 18 years; 3) Documented involuntary contractions of neck/shoulder muscles producing abnormal postures or movements; 4) Symptoms cause pain and functional impairment; 5) Not prescribed concurrently with other botulinum toxin products; 6) Documented failure of Botox and Dysport unless both are contraindicated or clinically significant adverse effects occurred; 7) No botulinum toxin administered within the past 12 weeks; 8) Submission of a treatment plan detailing units per indication and per session; 9) Requested dose ≤ 250 units per treatment sessiondose <= 250 Units; interval >= 12 weeks

Provider must submit supporting documentation (office chart notes, labs, other clinical information) demonstrating that member meets all approval criteria

Continuation Therapy Criteria

inv-24: Continuation Therapy

Continuation approval requires ongoing benefit enrollment or prior meeting of initial criteria and positive response to therapy

Continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria (including applicable continuity of care provisions); 2) Member is responding positively to therapy; 3) Not prescribed concurrently with other botulinum toxin products; 4) Treatment plan provided detailing number of units per indication and per treatment session; 5) No botulinum toxin administered within the last 12 weeks; 6) If a dose increase is requested, the new dose does not exceed 250 units per treatment sessiondose <= 250 Units; interval >= 12 weeks

Approval durations: Commercial 6 months or to the member's renewal date; Medicaid/HIM 12 months

Step	Requirement	Notes
1	Trial and failure (or contraindication) of competitor botulinum toxin products (Botox and Dysport) prior to approval of Daxxify	Failure of both Botox (onabotulinumtoxinA) and Dysport (abobotulinumtoxinA) is required unless clinically significant adverse effects or contraindications exist; therapeutic alternatives listed in Appendix B

Definitions and Key Terms

inv-19: CD — cervical dystonia

AbbreviationCD = cervical dystonia

Clinical contextCervical dystonia involves involuntary contractions of neck/shoulder muscles causing abnormal postures or movements and functional impairment/pain

Guideline supportCervical dystonia treatment with botulinum toxin supported by guidelines (AAN 2016)

inv-20: Boxed warning — risk of distant spread of toxin effect

Boxed warningRisk of distant spread of toxin effect

Contraindications relatedHypersensitivity to any botulinum toxin preparation or components; infection at proposed injection sites

Safety noteProviders should be aware of boxed warning when considering botulinum toxin therapy

inv-21: Clinical policy definition — guide to medical necessity to assist coverage decisions; not medical advice

DefinitionClinical policy — a guide to medical necessity to assist in coverage decisions; not medical advice or a directive for provider practice

PurposeIntended to support coverage determinations, not to dictate clinical care

Provider responsibilityProviders are expected to exercise professional medical judgment in treating members

inv-22: Provider status — providers referenced are independent contractors not agents or employees of the Health Plan

Provider statusProviders referenced in the policy are independent contractors and not agents or employees of the Health Plan

AutonomyProviders exercise independent judgment; Health Plan has no control or right of control over them

Contractual noteProviders, members, and their representatives are bound by terms and conditions through contractual agreements or by providing services/submitting claims

OpenPayer

Clinical Policy: DaxibotulinumtoxinA-lanm (Daxxify)

Coverage Criteria

Coding and Dosing

Provider Actions and Administrative Requirements

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy Requirements

Quantity Limits

Background

Definitions and Key Terms