Subject: Dysport 2248-A SGM P2021

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.  EXCLUSIONS

            Coverage will not be provided for cosmetic use.

    III.  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 there is 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 either as a primary diagnosis or as a
                 symptom of a condition causing limb spasticity.

            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.  Member is unresponsive or unable to tolerate oral
                     pharmacotherapy prescribed for excessive sweating (e.g.,
                     anticholinergics, beta-blockers, or benzodiazepines); and
                2.  Significant disruption of professional and/or social life has
                     occurred because of excessive sweating; and
                3.  Topical aluminum chloride or other extra-strength antiperspirants
                     are ineffective or result in a severe rash.

    IV.  CONTINUATION OF THERAPY

           All members (including new members) requesting authorization for
           continuation of therapy must meet all initial authorization criteria.

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, 2021.
3. Lexi-Drugs. Hudson, OH: Lexicomp, 2019. http://online.lexi.com/. Accessed August 2, 2021.
4. Clinical Pharmacology. Tampa (FL): Elsevier. 2019. Available from: http://www.clinicalpharmacology-ip.com. Accessed August 2, 2021.
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, 2021.
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.

December 30, 2021