15054-0530-XX Dysport 300 UNIT SOLR (IPSEN BIOPHARMACEUTICALS)
15054-0500-XX Dysport 500 UNIT SOLR (IPSEN BIOPHARMACEUTICALS)
Botulinum toxin, produced by the bacterium Clostridium botulinum, is one of the most potent naturally occurring neurotoxins known. It induces chemodenervation by first binding to acceptors on motor nerve terminals. It then enters the terminals and blocks the release of acetylcholine and other neurotransmitters at the neuromuscular junction. This renders smooth and striated muscles incapable of contraction. Acetylcholine also mediates the sympathetic innervation of the sweat glands, explaining how botulinum toxin disrupts the cholinergic outflow to the skin and halts glandular secretion.
The minute amount of toxin used clinically produces only partial, localized chemical denervation with transient results. Over time, axons generate temporary sprouts which release acetylcholine and the original nerve terminal is eventually re-established, ending the toxin’s therapeutic activity.
Seven antigenic-specific serotypes of botulinum toxin have been identified, types A, B, C-1, D, E, F and G, but only botulinum toxin types A and B are commercially available. These commercial preparations of the two serotypes (three of serotype A and one of serotype B) vary widely in potency and dosage. They have been given different names to reinforce these differences and to prevent medication errors. It is emphasized that the use and dosage of different formulations of botulinum toxin is not interchangeable.
This policy addresses only the type A formulation abobotulinumtoxinA marketed as Dysport®.
AbobotulinumtoxinA for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Anal fissure, chronic
Severe primary hyperhidrosis, axillary
Incontinence due to neurogenic detrusor overactivity
Sialorrhea associated with neurological disorders
AbobotulinumtoxinA for the prevention of chronic migraines is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
AbobotulinumtoxinA for the treatment of other conditions/diseases is considered investigational.
AbobotulinumtoxinA is considered medically appropriate if ALL of the following criteria are met:
Individual is evaluated for any disorders which may contribute to respiratory or swallowing difficulty
Individual is ANY ONE of the following:
18 years of age or older unless otherwise indicated
2 years of age or older with lower limb spasticity
Diagnosis of ANY ONE of the following:
Anal fissure, chronic, if individual has failed conventional therapy
Blepharospasms with pain and/or functional impairment due to condition
Cervical dystonia if ANY ONE of the following
Sustained head tilt
Abnormal posturing with limited range of motion in neck and history of recurrent involuntary contraction of one or more muscles in the neck
Chronic migraine prophylaxis if individual has ALL of the following:
15 or more migraine days per month with each headache lasting 4 or more hours
History of chronic migraines for at least 6 months
Failed a 1 month or longer trial of two or more of the following oral agents:
Antidepressants (e.g., amitriptyline, fluoxetine, nortriptyline)
Beta blockers (e.g., atenolol, propranolol, metoprolol, nadolol, timolol)
Angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ex. lisinopril, candesartan)
Anti-epileptics (e.g., valproate, topiramate)
Calcium channel blockers (e.g., verapamil)
Hyperhidrosis, severe primary axillary if individual has ALL of the following:
Failed with topical agents
Failed or has contraindications to oral pharmacotherapy
History of medical complications such as skin infections, significant functional impairments OR has had a significant impact to activities of daily living due to condition
Incontinence due to neurogenic detrusor overactivity if failed 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (e.g., mirabegron) classes
Overactive bladder (OAB) if individual has ALL of the following:
Symptoms of urge urinary incontinence, urgency, and frequency
Failed 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (e.g., mirabegron) classes
Sialorrhea associated with neurological disorders if individual has ANY ONE of the following:
Severe developmental delays and failed oral therapy
Cerebral palsy and failed oral therapy
Spasticity in Adult
Spasticity of lower limb if 2 years of age or older with decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (e.g. Ashworth Scale, etc.)
AbobotulinumtoxinA is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent, e.g., symptoms of a toxin spread effect (e.g. asthenia, diplopia, ptosis, dysphagia, dysphonia, dysarthria, breathing difficulties, etc.)
Disease response as evidenced by ANY ONE of the following:
Anal fissure, chronic with complete healing of fissure or symptomatic improvement of persistent fissures
Blepharospasms show improvement of severity and/or frequency of eyelid spasms
Cervical dystonia shows improvement in the severity and frequency of pain and improvement of abnormal head positioning
Chronic migraine prophylaxis, significant decrease in number and frequency of headaches,
and improvement in function and individual continues to utilize prophylactic intervention modalities (i.e. pharmacotherapy, behavioral therapy, physical therapy, etc.)
Hemifacial Spasms show decrease in frequency and/or severity of spasm, or a decrease in tone and/or improvement in asymmetry to the affected side of the face
Hyperhidrosis, severe primary axillary, with significant reduction in spontaneous axillary sweat production and a significant improvement in activities of daily living
Incontinence due to detrusor overactivity with significant improvements in weekly frequency of incontinence episodes and post-void residual (PVR) periodically assessed as medically appropriate
Overactive bladder (OAB) with significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition and post-void residual (PVR) periodically assessed as medically appropriate
Sialorrhea associated with neurological disorders, shows significant decrease in saliva production
Spasticity, including lower limbs, decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (e.g., Ashworth Scale, etc.)
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Chronic anal fissure||Up to 150 units divided among the affected muscles every 12 weeks|
|Blepharospasms||Up to 180 units per affected eye every 12 weeks|
Initial dose: 500 units divided among the affected musclesRe-treatment: 250-1000 units every 12 -16 weeks or longer as necessary
Up to 220 units per treatment session based on sites and severity of the spasmSubsequent injections administered upon recurrence of spasm, every 12 weeks, if needed
|Chronic Migraine Prophylaxis||Up to 240 units divided among the affected muscles every 12 weeks|
|Neurogenic detrusor overactivity - OAB||Up to 750 units divided among the affected muscles every 12 weeks|
|Severe primary axillary hyperhidrosis||Up to 200 units per axilla not more often than every 12 weeks|
|Sialorrhea||Up to 450 units divided among the affected muscles every 12 weeks|
|Lower Limb Spasticity||
Pediatrics - Up to 10-15 units/kg divided among gastrocnemius-soleus complex muscles, per limb, every 12 weeks. Maximum dose per treatment session is 1000 units, totalAdults - Up to 1500 units divided among the affected muscles every 12 weeks
|Upper Limb Spasticity||
Initial dose: 500 – 1000 units based on muscles affected, severity of muscle spasticity, prior response and adverse reaction historyRe-treatment: 500 – 1000 units every 12 – 16 weeks or longer, as necessary
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Click here to view DOSAGE LIMITS
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.
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, the express terms of the health plan will govern.
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).
No controlled studies were found in the published literature that validate the use of abobotulinumtoxinA for the treatment or prevention of other conditions or diseases.
American Academy of Neurology and Child Neurology Society (2010, January). Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review). Retrieved May 9, 2016 from the National Guideline Clearinghouse (NGC: 007677).
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Botulinum toxin (5.01.05). Retrieved January 22, 2018 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Treatment of hyperhidrosis (8.01.19). Retrieved January 22, 2018 from BlueWeb.
Lexi-Comp Online. (2018). AHFS DI. AbobotulinumtoxinA. Retrieved January 22, 2018 from Lexi-Comp Online with AHFS.
Mazlan, M., Rajasegaran, S., Engkasan, J. P., Nawawi, O., Goh, K. J., Freddy, S .J. (2015). A double-blind randomized controlled trial investigating the most efficacious dose of botulinum toxin-A for sialorrhea treatment in Asian adults with neurological diseases. Toxins, 2015(7), 3758-3770.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, November). AbobotulinumtoxinA. Retrieved January 22, 2018 from MICROMEDEX Healthcare Series.
Møller, E., Pedersen, S. A., Vinicoff, P. G., Bardow, A., Lykkeaa, J., Svendsen, P., Bakke, M. (2015). OnabotulinumtoxinA treatment of drooling in children with cerebral palsy: a prospective, longitudinal open-label study. Toxins, 2015 (7), 2481-2493.
Simpson, D. M., Blitzer, A., Brashear, A., Comella, C., Dubinsky, R., Hallett, M., et al. (2008, January). Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 2008 (70), 1699-1706.
U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Dysport® (abobotulinumtoxinA). Retrieved January 22, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 4/10/2018
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 5 units