|00259-1605-XX Xeomin 50 UNIT SOLR (MERZ PHARMACEUTICAL)|
|00259-1610-XX Xeomin 100 UNIT SOLR (MERZ PHARMACEUTICAL)|
|00259-1620-XX Xeomin 200 UNIT SOLR (MERZ PHARMACEUTICAL)|
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 applies only to incobotulinumtoxinA marketed as Xeomin®.
IncobotulinumtoxinA for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Upper limb spasticity
Hyperhidrosis, severe primary axillary
Incontinence due to neurogenic detrusor overactivity
IncobotulinumtoxinA for the prevention of chronic migraines is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
IncobotulinumtoxinA for the treatment of other conditions/diseases is considered investigational.
IncobotulinumtoxinA is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual evaluated for disorders which may contribute to respiratory or swallowing difficulty
Diagnosis of ANY ONE of the following:
Cervical dystonia with history of recurrent involuntary contraction of one or more muscles in the neck if ANY ONE of the following:
Sustained head tilt
Abnormal posturing with limited range of motion in neck
Chronic migraine prophylaxis if individual has ALL of the following:
Utilizing prophylactic intervention modalities (e.g., pharmacotherapy, behavioral therapy, or physical therapy, etc.)
Fifteen or more migraine-like headache days per month for at least 3 months
Headaches have diagnostic migraine features on at least 8 days per month for at least 3 months (see list of diagnostic migraine features with and without aura below) OR Suspected migraines are relieved by a triptan or ergot derivative medication
Failed a minimum of 3 month trial of any two oral medications for the prevention of migraines (see list of prophylactic medications below for examples)
Not used in combination with calcitonin gene-related peptide (CGRP) inhibitors (e.g., erenumab-aooe, etc.)
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 a 1 month or longer trial of two medications from either the antimuscarinic (i.e. darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (i.e. mirabegron) classes
Overactive bladder (OAB) if individual has ALL of the following:
Symptoms of urge urinary incontinence, urgency, and frequency
Failed a 1 month or longer trial of two medications from either the antimuscarinic (i.e. darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (i.e. mirabegron) classes
Spasticity Upper Limb
Sialorrhea if individual has ALL of the following:
Diagnosis of Parkinson’s disease, atypical Parkinsonism, stroke, traumatic brain injury or severe developmental delay
Duration of condition is of three months or more
Trial and failure of oral therapy
Migraine without aura – Recurrent, lasting 4 to 72 hours
Migraine with aura
IncobotulinumtoxinA 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 is evidenced by ANY ONE of the following:
Blepharospasms - Improvement of severity and/or frequency of eyelid spasms
Cervical Dystonia - 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 continuation to utilize prophylactic intervention modalities (i.e. pharmacotherapy, behavioral therapy, physical therapy, etc.
Hyperhidrosis, severe primary axillary - Significant reduction in spontaneous axillary sweat production AND significant improvement in activities of daily living
Incontinence due to neurogenic detrusor overactivity - Significant improvements in weekly frequency of incontinence episodes AND post-void residual (PVR) periodically assessed as medically appropriate
Overactive bladder (OAB) - 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 (Parkinson’s disease, atypical Parkinsonism, stroke, traumatic brain injury or severe developmental delay) - Significant decrease in saliva production
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Cervical Dystonia||120 units divided among the affected muscles every 12 weeks or longer, as necessary|
|Blepharospasm||1.25 - 5.6 units per injection site, not to exceed 35 units per eye, every 12 weeks or longer, as necessary|
|Upper limb spasticity||Up to 400 units total no sooner than every 12 weeks|
|Chronic Migraine||Up to 200 units divided among the affected muscles every 12 weeks|
|Severe primary axillary hyperhidrosis||50 Units intradermally per axilla every 16 weeks|
|Neurogenic bladder /Detrusor overactivity||Up to 200 units per treatment divided among the affected muscles every 12 weeks|
|Overactive Bladder (OAB)||Up to 100 units per treatment divided among the affected muscles every 12 weeks|
|Sialorrhea||30 Units per parotid gland and 20 Units per submandibular gland (total recommended dose is 100 Units per treatment session), repeated no sooner than every 16 weeks|
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
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).
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 8, 2018 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Treatment of hyperhidrosis (8.01.19). Retrieved January 8, 2018 from BlueWeb.
Escher, C. M., Paracka, L., Dressler, D., Kollewe, K. (2017). Botulinum toxin in the management of chronic migraine: clinical evidence and experience.Therapeutic Advances in Neurological Disorders. 10(2), 127-135.
Headache Classification Committee of the International Headache Society (IHS). (2013-2018). The International Classification of Headache Disorders, 3rd edition (ICHD-3). Cephalagia. 2018, 38 (1), 1-211. Retrieved March 22, 2018 from http://www.ihs-headache.org/binary data/3245_ichd-3-cephalalgia-2018-issue-1.pdf.
Lexi-Comp Online. (2018). AHFS DI. IncobotulinumtoxinA. Retrieved December 5. 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, July). IncobotulinumtoxinA. Retrieved August 24, 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. (2018, July). Center for Drug Evaluation and Research. Xeomin® (incobotulinumtoxinA). Retrieved December 5, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/98
MOST RECENT REVIEW DATE: 4/2/2019
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