Subject: Dysport SGM 2248-A P2025

Drug

DYSPORT  (abobotulinumtoxinA)

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 cervical dystonia in adults
• Treatment of spasticity in patients 2 years of age and older

Compendial Uses^2-7

• Blepharospasm
• Hemifacial spasm
• Chronic anal fissures
• Excessive salivation
• Primary axillary hyperhidrosis

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

Cervical Dystonia

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

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

Upper or Lower Limb Spasticity

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

• Member is 2 years of age or older
• Member has a primary diagnosis of upper or lower limb spasticity or as a symptom of a condition (including focal spasticity or equinus gait due to cerebral palsy).

Blepharospasm

Authorization of 12 months may be granted for treatment of blepharospasm, including blepharospasm associated with dystonia and benign essential blepharospasm.

Hemifacial Spasm

Authorization of 12 months may be granted for treatment of hemifacial spasm.

Chronic Anal Fissures

Authorization of 12 months may be granted for treatment of chronic anal fissures when the member has not responded to first-line therapy such as topical calcium channel blockers or topical nitrates.

Excessive Salivation

Authorization of 12 months may be granted for treatment of excessive salivation (chronic sialorrhea) when the member has been refractory to pharmacotherapy (e.g., anticholinergics).

Primary Axillary Hyperhidrosis

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

• Significant disruption of professional and/or social life has occurred because of excessive sweating; and
• Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash.

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. Dysport [package insert]. Wrexham, UK: Ipsen Biopharm, Ltd.; September 2023.
2. DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed August 17, 2025.
3. Lexi-Drugs. Hudson, OH: Lexicomp, 2019. http://online.lexi.com/. Accessed August 17, 2025.
4. Dashtipour K, Chen JJ, Frei K, et al. Systemic Literature Review of AbobotulinumtoxinA in Clinical Trials for Blepharospasm and Hemifacial Spasm. Tremor Other Hyperkinet Mov (NY). 2015;5:338.
5. Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: Anatomy, Pathophysiology and Treatment with Emphasis on the Role of Botulinum Toxins. Toxins 2013, 5, 1010-1031
6. Glader L, Delsing C, Hughes A et al. Sialorrhea in cerebral palsy. American Academy for Cerebral Palsy and Developmental Medicine Care Pathways.
7. Dysport [package insert]. Wrexham, UK: Ipsen Biopharm, Ltd.; September 2023.
8. DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed August 17, 2025.
9. Lexi-Drugs. Hudson, OH: Lexicomp, 2019. http://online.lexi.com/. Accessed August 17, 2025.
10. Dashtipour K, Chen JJ, Frei K, et al. Systemic Literature Review of AbobotulinumtoxinA in Clinical Trials for Blepharospasm and Hemifacial Spasm. Tremor Other Hyperkinet Mov (NY). 2015;5:338.
11. Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: Anatomy, Pathophysiology and Treatment with Emphasis on the Role of Botulinum Toxins. Toxins 2013, 5, 1010-1031
12. 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-palsyAccessed August 17, 2025.
13. Garuti G, Rao F, Ribuffo V et al. Sialorrhea in patients with ALS: current treatment options. Degener Neurol Neuromuscul Dis. 2019; 9: 19–26.
14. Accessed August 17, 2025.
15. 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