Subject: Dysport 2248-A SGM P2022

Drug

DYSPORT  (abobotulinumtoxin A)

Policy:

I.    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. 

A.   FDA-Approved Indications
      1.   Treatment of cervical dystonia in adults
      2.   Treatment of spasticity in patients 2 years of age and older 

B.   Compendial Uses
      1.   Blepharospasm
      2.   Hemifacial spasm
      3.   Chronic anal fissures
      4.   Excessive salivation
      5.   Primary axillary hyperhidrosis 

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

II.  PRESCRIBER SPECIALTIES
      The medication must be prescribed by, or in consultation with one of the following:
      A.   Cervical dystonia, spasticity, hemifacial spasm: neurologist, orthopedist or physiatrist
      B.   Blepharospasm: neurologist or ophthalmologist
      C.   Chronic anal fissures: gastroenterologist, proctologist or colorectal surgeon
      D.   Excessive salivation: neurologist or otolaryngologist
      E.   Primary axillary hyperhidrosis: neurologist or dermatologist

III. EXCLUSIONS 

Coverage will not be provided for cosmetic use. 

IV. CRITERIA FOR INITIAL APPROVAL 

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

B.   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:
       1.   Member is 2 years of age or older
       2.   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) 

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

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

E.   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.

F.   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). 

G.   Primary axillary hyperhidrosis
      Authorization of 12 months may be granted for treatment of primary axillary hyperhidrosis when all of the following criteria are met:
      1.   Significant disruption of professional and/or social life has occurred because of excessive sweating; and
      2.   Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash.

V.   CONTINUATION OF THERAPY 

All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization 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.; July 2020.
2. DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed August 2, 2022.
3. Lexi-Drugs. Hudson, OH: Lexicomp, 2019. http://online.lexi.com/. Accessed August 2, 2022.
4. Clinical Pharmacology. Tampa (FL): Elsevier. 2019. Available from: http://www.clinicalpharmacology-ip.com. Accessed August 2, 2022.
5. Simpson DM, Hallett M, Ashman EJ et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016;86:1818-1826.
6. 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.
7. Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: Anatomy, Pathophysiology and Treatment with Emphasis on the Role of Botulinum Toxins. Toxins 2013, 5, 1010-1031
8. 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. Accessed August 2, 2022.
9. 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.

January 28, 2023