CurrentUnitedHealthcarePolicy CSOH2026D0017.E

Botulinum Toxins A and B (for Ohio Only)

Defines medical benefit drug coverage for botulinum toxin type A and B products for members in Ohio, including indications governed by InterQual criteria and FDA-approved use for Daxxify in cervical dystonia.

Policy Summary

PayerUnitedHealthcare

PolicyBotulinum Toxins A and B (for Ohio Only)

Policy CodePolicy CSOH2026D0017.E

Change TypeApplicable codes updated

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit prior authorization referencing the InterQual guideline for the requested botulinum product or document FDA‑approved Daxxify criteria and TWSTRS scores when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Removed ICD-10 diagnosis codes G24.09, G24.1, G24.2, G24.4, G24.5, G24.8, and G24.9 from the applicable codes list.

Updated supporting information and references to reflect most current information; archived previous policy version CSOH2025D0017.D.

5botulinum products referenced

Ohiostate-specific applicability

J0585-J0589HCPCS codes listed

G24.3Diagnosis code listed

Coverage Criteria

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inv-01: Daxxify (daxibotulinumtoxinA-lanm) - Initial Coverage Criteria

Covered when ALL of the following are met:

Daxxify - Cervical Dystonia (FDA-approved): Patient is an adult with a clinical diagnosis of cervical dystonia (spasmodic torticollis)

Daxxify (daxibotulinumtoxinA-lanm) is FDA approved for treatment of cervical dystonia in adults.

Intended use: Treatment with daxibotulinumtoxinA-lanm is intended for non-cosmetic use consistent with the FDA-approved indication

Prior botulinum toxin exposure timing (if applicable): If the patient previously received another botulinum toxin for cervical dystonia, at least 14 weeks have elapsed since the most recent botulinum toxin administration>= 14 weeks since prior botulinum toxin if previously treated

Required by the pivotal trial protocol for previously treated patients.

inv-02: InterQual-governed products — Covered when InterQual criteria are met for the specific product and indication:

Covered when InterQual criteria are met for the specific product and indication:

InterQual-governed products: Use of onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, or rimabotulinumtoxinB must meet the current InterQual clinical coverage criteria for the requested indication.Refer to InterQual guidelines per product

InterQual product-specific references (Botox, Dysport, Myobloc, Xeomin) are cited in policy.

This policy applies only to services provided to members in the state of Ohio. Requests for services that are identified in this policy as unproven or that are subject to coverage or quantity limits will be evaluated for medical necessity using Ohio Administrative Code 5160-1-01. Determinations of coverage or exclusion under those circumstances follow the medical necessity standards in that rule.

The procedure and diagnosis codes listed in this policy are provided for reference only and are not, by themselves, a guarantee of coverage or payment. Listing of a code does not imply the service described is a covered or non-covered health service; actual benefit coverage is determined by applicable federal, state, or contractual requirements and other applicable laws. Inclusion of a code does not establish a right to reimbursement—other policies, guidelines, and contractual terms may apply.

Coding and Diagnosis

Covered HCPCS Codes (reference)HCPCSCovered

J0585	Injection, onabotulinumtoxinA, 1 unit
J0586	Injection, abobotulinumtoxinA, 5 units
J0587	Injection, rimabotulinumtoxinB, 100 units
J0588	Injection, incobotulinumtoxinA, 1 unit
J0589	Injection, daxibotulinumtoxina-lanm, 1 unit

Diagnosis Codes (referenced)ICD-10

G24.3

Spasmodic torticollis

inv-07: TWSTRS entry criteria in pivotal Daxxify trial — score thresholds and timing since prior botulinum toxin

TWSTRS total score (entry)TWSTRS total score ≥ 20 at baseline in pivotal Daxxify trial

TWSTRS severity componentTWSTRS severity score ≥ 15 at baseline in pivotal Daxxify trial

TWSTRS disability componentTWSTRS disability score ≥ 3 at baseline in pivotal Daxxify trial

TWSTRS pain componentTWSTRS pain score ≥ 1 at baseline in pivotal Daxxify trial

Prior botulinum toxin timingIf previously treated with botulinum toxin, ≥14 weeks must have passed since the most recent administration to enter the trial

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required per InterQual/FDA Indication

Prior authorization is required. Requests must meet the InterQual criteria and/or FDA indication for the specific botulinum toxin product requested (Botox, Dysport, Myobloc, Xeomin, Daxxify). Submit clinical documentation that demonstrates the indication aligns with the current InterQual guideline for the named product or the FDA‑approved indication.

Affected products: Botox (onabotulinumtoxinA), Dysport (abobotulinumtoxinA), Myobloc (rimabotulinumtoxinB), Xeomin (incobotulinumtoxinA), Daxxify (daxibotulinumtoxinA-lanm)
Prior authorization must reference the applicable InterQual guideline release for the specific product

Documentation Required

Medical Necessity Evaluation per Ohio Administrative Code (OAC)

When evaluating requests for services that are listed as unproven or for which coverage or quantity limits apply, medical necessity determinations will be made in accordance with Ohio Administrative Code 5160-1-01. This policy applies only to the state of Ohio and Ohio OAC requirements supersede when assessing medical necessity for such services.

Application limited to Ohio: OAC 5160-1-01 applies for unproven services and quantity limits

Billing Rule

Coding and Diagnosis Documentation

Document the diagnosis and submit appropriate procedure and drug billing codes. Include clinical notes supporting the diagnosis, prior treatment history, and dosing. Use the following HCPCS/J‑codes and ICD‑10 diagnosis codes as applicable.

HCPCS / J‑codes: J0585 (onabotulinumtoxinA, 1 unit), J0586 (abobotulinumtoxinA, 5 units), J0587 (rimabotulinumtoxinB, 100 units), J0588 (incobotulinumtoxinA, 1 unit), J0589 (daxibotulinumtoxina-lanm, 1 unit)
Diagnosis code example: G24.3 (Spasmodic torticollis)
Include: documentation of clinical diagnosis, TWSTRS or other relevant scales when applicable, prior therapies, and dose/units administered

Step Therapy

Step/Timing Considerations for Prior Toxin Exposure

If the patient has received a prior botulinum toxin for the same condition, document timing of the most recent administration. For Daxxify, pivotal trial inclusion required ≥ 14 weeks since the most recent botulinum toxin; similar timing considerations may be requested to evaluate appropriateness and dosing intervals.

Document date and product of most recent botulinum toxin administration
Operational expectation: allow ≥ 14 weeks since prior botulinum toxin administration for patients previously treated (per Daxxify pivotal trial)

Background

Botulinum toxin type A and B products are bacterial neurotoxins used therapeutically to treat a range of movement and neuromuscular disorders. Daxxify (daxibotulinumtoxinA-lanm) is a proprietary formulation of botulinum toxin type A that has been FDA-approved for the non-cosmetic treatment of cervical dystonia in adults. The approval and coverage rationale for Daxxify is supported by randomized, placebo-controlled trial evidence demonstrating improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores in patients with cervical dystonia.

Definitions

inv-13: TWSTRS — Toronto Western Spasmodic Torticollis Rating Scale details

Scale name and purposeToronto Western Spasmodic Torticollis Rating Scale (TWSTRS) evaluates severity of dystonia, patient-perceived disability, and pain

Score rangeTotal score range 0–85

ComponentsThree components: severity, disability, and pain (component scores contribute to total)

Use in trial entryTWSTRS used as baseline eligibility and primary efficacy endpoint (mean change in TWSTRS total score averaged over weeks 4 and 6) in the Daxxify trial

inv-14: Daxxify — definition and approved use in adult cervical dystonia

Generic and branddaxibotulinumtoxinA-lanm (Daxxify)

FDA-approved indicationApproved for treatment of cervical dystonia in adult patients (non-cosmetic use)

Evidence basisEfficacy established in randomized, double-blind, placebo-controlled multicenter trial (NCT03608397) showing significant improvement in TWSTRS total score

Typical trial dosingSingle administration of 125 or 250 Units (2.5 mL) divided among affected muscles in pivotal trial