CurrentUnitedHealthcarePolicy CSIND0017.08

Botulinum Toxins A and B (for Indiana Only)

Medical benefit drug policy governing coverage and medical necessity criteria for botulinum toxin products (A and B) for members in Indiana, including product-specific guidance and applicable coding. Affects providers submitting requests for coverage of these agents for Indiana members.

Policy Summary

PayerUnitedHealthcare

PolicyBotulinum Toxins A and B (for Indiana Only)

Policy CodePolicy CSIND0017.08

Change TypeRemoved diagnosis codes

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization for listed botulinum toxin J‑codes and document diagnosis of cervical dystonia with symptoms (sustained head tilt or abnormal posturing with pain/functional impairment and recurrent involuntary neck muscle contractions).

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 Applicable Codes.

5botulinum products listed

5HCPCS/J-codes listed

1FDA indication called out for Daxxify

1state-specific (Indiana)

301

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Coverage Criteria

inv-01: Daxxify (daxibotulinumtoxinA-lanm) — Initial therapy

Covered when ALL of the following are met for Daxxify (daxibotulinumtoxinA-lanm):

Daxxify for cervical dystonia: Diagnosis of cervical dystonia (spasmodic torticollis).

Symptoms including both: (a) sustained head tilt or abnormal posturing resulting in pain and/or functional impairment; and (b) recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).

FDA approval: Use consistent with FDA-approved indication for Daxxify: treatment of cervical dystonia in adults.

Clinical trial supportive parameters (informational): Trial enrollment characteristics supporting clinical expectations: baseline TWSTRS total ≥ 20; TWSTRS severity ≥ 15; TWSTRS disability ≥ 3; TWSTRS pain ≥ 1. For patients previously treated with botulinum toxin, ≥14 weeks since the most recent botulinum toxin administration was required in the pivotal trial (NCT03608397).TWSTRS thresholds and ≥14 weeks since prior botulinum toxin when applicable

These parameters are cited as supporting evidence for efficacy and expected clinical documentation.

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

Covered when InterQual criteria are met for listed products:

InterQual-referenced products: Medical necessity determinations for onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxina (Myobloc), and incobotulinumtoxinA (Xeomin) must meet the current release of the InterQual Specialty Rx Non-Oncology criteria specific to each product.

InterQual topics referenced: OnabotulinumtoxinA (Botox); AbobotulinumtoxinA (Dysport); RimabotulinumtoxinB (Myobloc); IncobotulinumtoxinA (Xeomin).

The list of procedure and diagnosis codes in this policy is provided for reference only. Listing of a code in this policy does not imply the service described by the code is a covered or non-covered health service; benefit coverage is determined by federal, state, or contractual requirements and applicable law and may require coverage under different terms. The inclusion of a code does not guarantee reimbursement or claim payment and other policies or guidelines may apply. (See applicable codes for J0585–J0589 and diagnosis code G24.3.)

This policy was revised effective 02/01/2026 to remove several ICD-10 diagnosis codes from the Applicable Codes section. The removed codes are: G24.09, G24.1, G24.2, G24.4, G24.5, G24.8, and G24.9 (recorded in the policy history).

The document does not list specific indications as explicitly "not medically necessary." Instead, coverage determinations for botulinum toxin products other than Daxxify are driven by the referenced clinical criteria. Medical necessity determinations for onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxinB (Myobloc), and incobotulinumtoxinA (Xeomin) must meet the current release of the InterQual Specialty Rx Non‑Oncology criteria, and those InterQual requirements, together with benefit terms, govern authorization decisions.

Providers should therefore follow InterQual criteria and document clinical findings consistent with those guidelines when requesting coverage, since the policy itself does not provide discrete "not medically necessary" statements for particular indications.

Coding

HCPCS/J-codesHCPCS

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

Relevant diagnosis codesICD-10

G24.3

Spasmodic torticollis

TWSTRS total / subscore thresholds

TWSTRS total score≥ 20

TWSTRS severity subscore≥ 15

TWSTRS disability subscore≥ 3

TWSTRS pain subscore≥ 1

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required for Listed Botulinum Toxin J‑Codes

Prior authorization is required for the listed botulinum toxin HCPCS J‑codes prior to administration. Submit clinical documentation that supports medical necessity consistent with the coverage criteria (including InterQual when referenced) and the member's benefit plan.

J0585 – onabotulinumtoxinA, 1 unit
J0586 – abobotulinumtoxinA, 5 units
J0587 – rimabotulinumtoxinB, 100 units
J0588 – incobotulinumtoxinA, 1 unit
J0589 – daxibotulinumtoxinA‑lanm, 1 unit

Step Therapy

InterQual‑Referenced Step/Coverage Guidance

Coverage decisions follow InterQual® clinical criteria where indicated; providers should reference the current InterQual guideline for the specific product (Botox, Dysport, Myobloc, Xeomin) to determine whether initial or continuation therapy criteria are met.

Background

Cervical dystonia (spasmodic torticollis) is characterized by sustained head tilt or abnormal posturing caused by recurrent involuntary contraction of one or more neck muscles, commonly producing pain and functional impairment. Patients may present with involvement of muscles such as the sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.

Daxxify (daxibotulinumtoxinA‑lanm) is FDA‑approved for the treatment of cervical dystonia in adults. Randomized trial evidence evaluated efficacy in a multicenter, double‑blind, placebo‑controlled study population (N=301); many participants had prior exposure to botulinum toxin. Trial enrollment characteristics referenced in this policy included baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) thresholds used to define severity (for example, TWSTRS total score ≥ 20; severity ≥ 15; disability ≥ 3; pain ≥ 1) and, when applicable for previously treated patients, a minimum interval since the last botulinum toxin administration (≥14 weeks).

Definitions

TWSTRS baseline thresholds

Definition of cervical dystoniaSustained head tilt or abnormal posturing with recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).

TWSTRS baseline thresholds used in pivotal trialTotal score ≥ 20; severity ≥ 15; disability ≥ 3; pain ≥ 1

Prior botulinum toxin interval in trial≥ 14 weeks since last botulinum toxin administration for previously treated patients

Cervical dystonia

TermCervical dystonia (spasmodic torticollis): sustained head tilt or abnormal posturing with recurrent involuntary contraction of one or more neck muscles.

Typical symptomatic featuresSustained head tilt or abnormal posturing resulting in pain and/or functional impairment; recurrent involuntary neck muscle contractions.

Initial Therapy Criteria

inv-15: Daxxify initial therapy

Daxxify initial therapy criteria

Initial Daxxify criteria: Diagnosis of cervical dystonia; symptoms with sustained head tilt or abnormal posturing resulting in pain and/or functional impairment; recurrent involuntary contraction of one or more neck muscles.

Supporting trial-based thresholds: Baseline TWSTRS thresholds observed in pivotal randomized trial (NCT03608397): total TWSTRS ≥ 20; severity ≥ 15; disability ≥ 3; pain ≥ 1.TWSTRS total ≥ 20; severity ≥ 15; disability ≥ 3; pain ≥ 1

Informational—these were trial inclusion criteria and may guide assessment of disease severity.

Prior botulinum toxin exposure timing (when applicable): For patients previously treated with a botulinum toxin, documentation may reflect that ≥14 weeks have passed since the most recent botulinum toxin administration (as required in the pivotal trial).

Step Therapy

Step	Requirement
1
For onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), rimabotulinumtoxinB (Myobloc), and incobotulinumtoxinA (Xeomin): medical necessity must meet the current release of the InterQual Specialty Rx Non‑Oncology criteria specific to each product (refer to InterQual CP topics: OnabotulinumtoxinA, AbobotulinumtoxinA, RimabotulinumtoxinB, IncobotulinumtoxinA).
2
Daxxify (daxibotulinumtoxinA‑lanm) has specific coverage criteria for cervical dystonia and is medically necessary when ALL of the following are met: (a) diagnosis of cervical dystonia (spasmodic torticollis); and (b) symptoms including sustained head tilt or abnormal posturing resulting in pain and/or functional impairment AND recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).