CurrentCignaPolicy IP0639

Xeomin (incobotulinumtoxinA) coverage

Defines prior authorization, medical necessity criteria, dosing, and billing codes for Xeomin (incobotulinumtoxinA) for Cigna-administered health benefit plans. Affects prescribers, providers billing for administration, and utilization review staff.

Policy Summary

PayerCigna

PolicyXeomin (incobotulinumtoxinA) coverage

Policy CodePolicy IP0639

Change TypeNew policy

Effective DateJul 15, 2025

Next Review DateN/A

Key ActionPrior authorization is recommended for prescription benefit coverage of Xeomin; approvals are provided for the duration noted in the criteria and require prescribing by or in consultation with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

New policy created for Xeomin (incobotulinumtoxinA).

4FDA-approved indications listed

1 yearTypical approval duration

J0588HCPCS code (per unit)

NCApplicable state

Coverage Criteria for Xeomin (incobotulinumtoxinA)

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Sialorrhea, chronic (FDA-approved)

Approve for 1 year if the patient is 63 2 years of age.

Sialorrhea dosing options: A) If patient is ≥ 18 years: Approve up to a maximum dose of 100 units (50 units per side) administered not more frequently than once every 16 weeks; OR B) If patient is < 18 years: Approve up to a maximum dose of 75 units (37.5 units per side) administered not more frequently than once every 16 weeksAge-based dosing

Approval applies to chronic sialorrhea in patients ≥ 2 years of age.

Upper limb spasticity (FDA-approved)

Approve for 1 year if the patient is 63 2 years of age.

Upper limb spasticity dosing options: A) If patient is ≥ 18 years: Approve up to a maximum dose of 400 units administered not more frequently than once every 12 weeks; OR B) If patient is < 18 years: Approve up to a maximum dose of 16 units/kg (not to exceed 400 units) administered not more frequently than once every 12 weeksAge and weight-based dosing

For pediatric patients, excludes spasticity caused by cerebral palsy.

Xeomin (incobotulinumtoxinA) for any use other than the FDA‑approved indications listed in this policy is considered not medically necessary. This includes cosmetic uses; examples include facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platysmal bands, and rejuvenation of the periorbital region.

Initial Therapy Criteria and Dosing by Indication

Initial therapy

Initial approval criteria and dosing by indication.

Initial therapy - general: Prior authorization and documentation as specified; prescribed by or in consultation with an appropriate specialist; dosing limits per indicationSee indication-specific thresholds

Dosing, frequency, and duration should be clinically appropriate and based on severity, alternative treatments, and prior response.

Continuation Therapy and Reauthorization

Continuation therapy

Continuation approvals align with stated approval durations and dosing intervals; approvals provided for 1 year where noted.

Continuation considerations: Ongoing therapy should follow dosing intervals and maximum dose limits per indication; dosing adjusted based on severity, alternative treatments, and previous responseFollow indication-specific intervals (12 or 16 weeks)

Continuation approvals are provided for the durations noted in the indication-specific criteria (commonly 1 year).

Billing and Coding

BlepharospasmCPT | HCPCSCovered

64612	Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm)
J0588	Injection, IncobotulinumtoxinA, 1 unit

Cervical dystoniaCPT | HCPCSCovered

64616	Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis)
J0588	Injection, IncobotulinumtoxinA, 1 unit

Sialorrhea (salivary glands)CPT | HCPCSCovered

64611	Chemodenervation of parotid and submandibular salivary glands, bilateral
J0588	Injection, IncobotulinumtoxinA, 1 unit

Upper limb and trunk spasticityCPT | HCPCSCovered

64642	Chemodenervation of one extremity; 1-4 muscle(s)
64643	Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s)
64644	Chemodenervation of one extremity; 5 or more muscles
64645	Chemodenervation of one extremity; each additional extremity, 5 or more muscles
64646	Chemodenervation of trunk muscle(s); 1-5 muscle(s)
64647	Chemodenervation of trunk muscle(s); 6 or more muscles
J0588	Injection, IncobotulinumtoxinA, 1 unit

Blepharospasm dosing limit

Maximum dose100 units total (50 units per eye)

Minimum intervalAdministered not more frequently than once every 12 weeks

Approval durationApprove for 1 year when criteria met

Cervical dystonia dosing limit

Maximum dose120 units total

Minimum intervalAdministered not more frequently than once every 12 weeks

Approval durationApprove for 1 year when criteria met

Sialorrhea dosing limits

Adults (≥ 18 years)Maximum 100 units total (50 units per side), administered not more frequently than once every 16 weeks

Pediatrics (< 18 years)Maximum 75 units total (37.5 units per side), administered not more frequently than once every 16 weeks

Approval durationApprove for 1 year for patients ≥ 2 years of age

Upper limb spasticity dosing limits

Adults (≥ 18 years)Maximum 400 units total, administered not more frequently than once every 12 weeks

Pediatrics (< 18 years)16 units/kg, not to exceed 400 units, administered not more frequently than once every 12 weeks

Approval durationApprove for 1 year for patients ≥ 2 years of age

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Xeomin. All approvals are provided for the duration noted in the applicable criteria. In cases where the approval is authorized in months, 1 month = 30 days. Because of the specialized skills required for evaluation and diagnosis of patients treated with Xeomin as well as the monitoring required for adverse events and long‑term efficacy, approval requires Xeomin to be prescribed by a physician who has consulted with or who specializes in the condition.

Prior authorization recommended for Xeomin; approvals provided for the duration noted in criteria (months = 30 days).
Prescriber requirement: must be prescribed by or in consultation with a physician who specializes in or has consulted on the condition.

Step Therapy

No step therapy requirements specified in this policy.

Documentation Required

Documentation is required where noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, laboratory tests, claims records, and/or other information. Examples of documentation required in the criteria include confirmation of diagnosis (e.g., blepharospasm, cervical dystonia), description of signs/symptoms (e.g., intermittent or sustained eyelid closure; sustained head torsion/tilt and limited range of motion), and prescriber specialty or consultation note.

Documentation may include chart notes, laboratory tests, claims records, and/or other information.
Examples: diagnosis confirmation for blepharospasm or cervical dystonia; clinical description of symptoms; prescriber consultation notes.

Denial Risk

Claim Denial Risk

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Step	Requirement
1	No specific step therapy steps are defined in this policy.

Site of Care Requirements

Note

Specialist prescribing / office site-of-care

Because specialized skills are required for evaluation, diagnosis, and monitoring of patients treated with Xeomin, the drug must be prescribed by or in consultation with a physician who has consulted with or specializes in the relevant condition.

Site of care: office; prescribe by or in consultation with an appropriate specialist (e.g., neurologist, ophthalmologist, pain medicine specialist, PM&R) as indicated by the specific diagnosis.

Background and Drug Information

Xeomin (incobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for treatment of several movement and neuromuscular conditions, including blepharospasm, cervical dystonia, chronic sialorrhea, and upper limb spasticity. Dosing and age indications vary by condition and approvals in this policy are time‑limited per indication.

Definitions

Blepharospasm definition

DefinitionIntermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

Typical age groupIndication listed for adults

Related conditionsIncludes blepharospasm associated with dystonia, benign essential blepharospasm, seventh (VII) nerve disorders

Cervical dystonia definition

DefinitionSustained head torsion and/or tilt with limited range of motion in the neck (also known as spasmodic torticollis).