BlueCross BlueShield of Tennessee Medical Policy Manual
AbobotulinumtoxinA (Dysport®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 Indications
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
EXCLUSIONS
Coverage will not be provided for cosmetic use.
CRITERIA FOR INITIAL APPROVAL
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:
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:
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:
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.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Dysport (AbobotulinumtoxinA)
|
Blepharospasm |
Route of Administration: Subcutaneous 120Units per affected eye. May repeat no sooner than every 12 weeks |
Dysport (AbobotulinumtoxinA) |
Cervical Dystonia |
Route of Administration: Intramuscular ≥18 year(s) 1000Units divided among the affected muscles. May re-treat no sooner than every 12 weeks. |
Dysport (AbobotulinumtoxinA) |
Chronic Anal Fissures |
Route of Administration: Intramuscular 150Units per treatment. May re-treat no sooner than every 12 weeks. |
Dysport (AbobotulinumtoxinA) |
Excessive Salivation (Chronic Sialorrhea or Ptyalism) |
Route of Administration: Injection 450Units per treatment. May re-treat no sooner than every 12 weeks. |
Dysport (AbobotulinumtoxinA) |
Hemifacial Spasm |
Route of Administration: Subcutaneous 220Units per treatment. May re-treat no sooner than every 12 weeks. |
Dysport (AbobotulinumtoxinA) |
Primary Axillary Hyperhidrosis |
Route of Administration: Intradermal 200 Units per axilla. May re-treat no sooner than every 12 weeks. |
Dysport (AbobotulinumtoxinA) |
Upper or Lower Limb Spasticity |
Route of Administration: Intramuscular ≥2 to <18 year(s) 1000Units per treatment. May re-treat no sooner than every 12 weeks.
≥18 year(s) 1500Units per treatment. May re-treat no sooner than every 12 weeks. |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 12/98
MOST RECENT REVIEW DATE: 1/14/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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