Subject: Xeomin SGM 2250-A P2025

Drug

XEOMIN  (incobotulinumtoxinA)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

• Treatment of chronic sialorrhea in patients 2 years of age and older
• Treatment of upper limb spasticity in adult patients
• Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy
• Treatment of cervical dystonia in adult patients
• Treatment of blepharospasm in adult patients

All other indications are considered experimental/investigational and not medically necessary.

Prescriber Specialties

The medication must be prescribed by or in consultation with a provider specialized in treating the member’s condition.

Exclusions

Coverage will not be provided for cosmetic use.

Coverage Criteria

Chronic Sialorrhea (Excessive Salivation)^1-5

Authorization of 12 months may be granted for treatment of chronic sialorrhea (excessive salivation) when all of the following criteria are met:

• Member is 2 years of age or older
• Member has been refractory to pharmacotherapy (e.g., anticholinergics).

Cervical Dystonia¹

Authorization of 12 months may be granted for treatment of adults with cervical dystonia (e.g., torticollis) when all of the following criteria are met:

• Member is 18 years of age or older
• There is abnormal placement of the head with limited range of motion in the neck.

Blepharospasm¹

Authorization of 12 months may be granted for treatment blepharospasm when all of the following criteria are met:

• Member has a diagnosis of blepharospasm including benign essential blepharospasm or blepharospasm associated with dystonia
• Member is 18 years of age or older.

Upper Limb Spasticity¹

Authorization of 12 months may be granted for the treatment of upper limb spasticity when all of the following are met:

• Member has a diagnosis of upper limb spasticity either as a primary diagnosis or as a symptom of a condition causing limb spasticity
• Member meets one of the following criteria:
  • Member is 18 years of age or older
  • Member is 2 to 17 years of age and the spasticity is not caused by cerebral palsy.

Continuation of Therapy

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria and be experiencing benefit from therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xeomin [package insert]. Raleigh, NC: Merz Pharmaceuticals LLC; July 2024.
2. Restivo D, Panebianco M, Casabona A et al. Botulinum Toxin A for Sialorrhea Associated with Neurological Disorders: Evaluation of the Relationship between Effect of Treatment and the Number of Glands Treated. Toxins 2018;55:1-10.
3. Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: Anatomy, Pathophysiology and Treatment with  Emphasis on the Role of Botulinum Toxins. Toxins 2013, 5, 1010-1031
4. Glader L, Delsing C, Hughes A et al. Sialorrhea in cerebral palsy. American Academy for Cerebral Palsy and Developmental Medicine Care Pathways. https://www.aacpdm.org/publications/care-pathways/sialorrhea-in-cerebral-palsy Accessed August 17, 2025.
5. Garuti G, Rao F, Ribuffo V et al. Sialorrhea in patients with ALS: current treatment options. Degener Neurol Neuromuscul Dis. 2019; 9: 19–26.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 13, 2025