CurrentUnitedHealthcarePolicy CSOH2026D0017.E

Botulinum Toxins A and B (for Ohio Only)

Ohio-specific UnitedHealthcare medical benefit drug policy covering select botulinum toxin products for non-cosmetic medical indications; applies to providers requesting coverage under Ohio benefit rules.

Policy Summary

PayerUnitedHealthcare

PolicyBotulinum Toxins A and B (for Ohio Only)

Policy CodePolicy CSOH2026D0017.E

Change TypeCodes updated (diagnosis removals and code list revisions)

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization using InterQual criteria or FDA-consistent indication documentation (e.g., TWSTRS scores and prior botulinum toxin timing) when requesting coverage for Daxxify and other botulinum products.

SourceLink

POLICY UPDATE CHANGES

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

Applicable Codes were updated.

Supporting information and References section updated to reflect current information.

5botulinum products referenced

1FDA-approved indication specified for Daxxify

1InterQual guidance used

J0585-J0589HCPCS codes listed

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Coverage Criteria

inv-01: Daxxify — Initial therapy

Covered when ALL of the following are met for Daxxify:

Daxxify (daxibotulinumtoxinA-lanm): 1) Patient has a diagnosis of cervical dystonia (spasmodic torticollis). 2) Use is consistent with FDA-approved indication for adults. 3) Clinical documentation aligns with pivotal trial eligibility (e.g., TWSTRS thresholds: total >=20; severity >=15; disability >=3; pain >=1) and prior botulinum toxin timing when applicable.TWSTRS total >=20; severity >=15; disability >=3; pain >=1; >=14 weeks since prior botulinum toxin when previously treated

Based on FDA approval and pivotal trial evidence (NCT03608397).

inv-02: InterQual-based coverage for other botulinum toxins

Covered with criteria per InterQual guidance when ALL apply:

Botox, Dysport, Myobloc, Xeomin: Medical necessity for onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxinB (Myobloc), and incobotulinumtoxinA (Xeomin) is determined using the current release of InterQual Specialty Rx Non-Oncology criteria specific to each product.Refer to InterQual for product-specific thresholds and prior-therapy requirements

InterQual criteria define indications, dosing, and any step/ prior therapy requirements.

This policy addresses non-cosmetic medical uses of select botulinum toxin A and B products for members covered under Ohio benefits. It focuses on FDA‑approved and InterQual‑supported indications for these products and does not provide coverage guidance for cosmetic applications. Providers should note that listing a procedure or diagnosis code in this policy does not imply coverage; benefit determinations remain subject to federal, state (Ohio Administrative Code), and contractual requirements and applicable laws.

For specific product coverage, UnitedHealthcare follows FDA approval language for Daxxify (daxibotulinumtoxinA‑lanm) and uses the current release of InterQual Specialty Rx Non‑Oncology criteria to determine medical necessity for onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxinB (Myobloc), and incobotulinumtoxinA (Xeomin).

Services that are not supported by InterQual criteria or that do not meet medical necessity requirements per the InterQual guidance and applicable Ohio Administrative Code (OAC 5160‑1‑01) will be considered not medically necessary. UnitedHealthcare may rely on the current InterQual Specialty Rx Non‑Oncology criteria when evaluating requests for onabotulinumtoxinA, abobotulinumtoxinA, rimabotulinumtoxinB, and incobotulinumtoxinA, and prior authorization is required in accordance with those determinations.

When determining coverage, UnitedHealthcare may use third‑party clinical decision support tools such as InterQual to define indications, prior therapy requirements, dosing, and continuation rules. Providers must follow plan and state requirements; in the event of conflict, federal, state (OAC), or contractual requirements govern. Inclusion of a code in the Applicable Codes list is for reference only and does not guarantee reimbursement.

Coding and Clinical Measures

Covered HCPCS/J-codes (listed for reference)HCPCS

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 referencedICD-10

G24.3

Spasmodic torticollis

inv-07: TWSTRS baseline eligibility thresholds in Daxxify trial

TWSTRS total score thresholdTWSTRS total score ≥ 20 (trial baseline requirement)

TWSTRS severity score thresholdTWSTRS severity score ≥ 15 (trial baseline requirement)

TWSTRS disability score thresholdTWSTRS disability score ≥ 3 (trial baseline requirement)

TWSTRS pain score thresholdTWSTRS pain score ≥ 1 (trial baseline requirement)

inv-08: Minimum interval since prior botulinum toxin in trial participants

Minimum interval since prior botulinum toxin>= 14 weeks (required in trial for previously treated patients)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for botulinum toxin products when medical necessity is not established by claims alone. Requests for Daxxify (daxibotulinumtoxinA-lanm) for non-cosmetic, FDA‑approved use (treatment of cervical dystonia in adults) should be submitted with supporting documentation per InterQual or FDA indication.

Prior authorization required per InterQual or FDA indication
A single administration dosing and prior exposure intervals (e.g., ≥14 weeks since prior botulinum toxin for cervical dystonia) may be considered when applying InterQual criteria

Step Therapy

InterQual-Based Coverage Guidance

Coverage decisions for botulinum toxin products are guided by InterQual clinical criteria; follow the current InterQual guideline for the specific product requested (OnabotulinumtoxinA, AbobotulinumtoxinA, RimabotulinumtoxinB, IncobotulinumtoxinA). Daxxify coverage should follow InterQual where available and the FDA‑approved indication for cervical dystonia.

Background

Cervical dystonia, also known as spasmodic torticollis, is a focal movement disorder characterized by involuntary, sustained or intermittent contractions of neck muscles that produce abnormal postures and movements of the head and neck. The condition can cause pain, functional disability, and reduced quality of life.

Clinical severity and treatment response are commonly evaluated using standardized tools such as the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Daxxify (daxibotulinumtoxinA‑lanm) is FDA approved for the treatment of cervical dystonia in adults and pivotal trial eligibility used baseline TWSTRS thresholds (for example, a higher total and domain scores) and required a minimum interval since prior botulinum toxin when applicable.

Definitions

inv-14: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

PurposeEvaluates severity, disability, and pain in cervical dystonia; score range 0–85.

Components and thresholds used in Daxxify trialTotal score and subscales: total ≥20; severity ≥15; disability ≥3; pain ≥1.

Primary efficacy endpoint linkagePrimary efficacy endpoint was mean change in TWSTRS total score from baseline averaged over weeks 4 and 6.

Usage in documentationTWSTRS scores may be required in clinical documentation to align with trial eligibility and coverage criteria.

Initial Therapy Criteria

inv-15: Initial therapy

Initial therapy coverage notes:

Initial therapy for InterQual products: Medical necessity determinations for Botox, Dysport, Myobloc, and Xeomin should follow the current InterQual Specialty Rx Non-Oncology criteria for each product.See InterQual guidelines

Providers should reference InterQual for indication-specific initial therapy requirements.

Continuation Therapy Criteria

inv-16: Continuation therapy

Continuation/maintenance therapy expectations (product-specific):

Daxxify continuation: Ongoing dosing and continued authorization should be supported by clinical benefit documented by the treating clinician; documentation may include TWSTRS improvement or other objective clinical response and dosing consistent with product labeling.Clinical response per TWSTRS or treating clinician

Pivotal trial used a single administration with effect measured through weeks 4 and 6; documentation of benefit may be required for subsequent authorization. InterQual continuation rules may apply for other products.

Step Therapy

Step	Guidance
1	Use of InterQual criteria may include prior treatment or stepwise therapy; medical necessity determinations for onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxinB (Myobloc), and incobotulinumtoxinA (Xeomin) should follow the current InterQual Specialty Rx Non‑Oncology criteria for each product.

Site of Care

Note

Office site-of-care note

No specific site-of-care restrictions are stated for office settings in this policy, but coverage decisions remain subject to applicable plan, federal, or state rules.

Verify plan-specific or state requirements before scheduling services in the office setting.