BlueCross BlueShield of Tennessee Medical Policy Manual

IncobotulinumtoxinA

NDC CODE(S)

00259-1605-XX XEOMIN 50UNIT Solution Reconstituted (MERZ PHARMACEUTICAL)

00259-1610-XX XEOMIN 100UNIT Solution Reconstituted (MERZ PHARMACEUTICAL)

00259-1620-XX XEOMIN 200UNIT Solution Reconstituted (MERZ PHARMACEUTICAL)

46783-0160-XX XEOMIN 100UNIT Solution Reconstituted (MERZ NORTH AMERICA)

DESCRIPTION

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®.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

Migraine-Prophylaxis Oral Medications (list not all-inclusive)

·         Antidepressants (e.g., amitriptyline, fluoxetine, nortriptyline, etc.)

·         Beta blockers (e.g., propranolol, metoprolol, nadolol, timolol, atenolol, pindolol, etc.)

·         Angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ex. lisinopril, candesartan, etc.)

·         Anti-epileptics (e.g., divalproex, valproate, topiramate, etc)

·         Calcium channels blockers (e.g., verapamil, etc)

Migraine Features

Migraine without aura – Recurrent, lasting 4 to 72 hours

·         Headache has at least two of the following characteristics:

o   Unilateral location

o   Pulsating quality

o   Moderate or severe pain intensity

o   Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs)

·         During headache at least one of the following:

o   Nausea and/or vomiting

o   Photophobia and phonophobia

Migraine with aura

·         One or more of the following fully reversible aura symptoms:

o   Visual

o   Sensory

o   Speech and/or language

o   Motor

o   Brainstem

o   Retinal

·         At least two of the following characteristics:

o   At least one aura symptom spreads gradually over ≥5 minutes, and/or two or more symptoms occur in succession

o   Each individual aura symptom lasts 5 to 60 minutes

o   At least one aura symptom is unilateral

o   The aura is accompanied, or followed within 60 minutes, by headache

 

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Cervical Dystonia

The recommended initial total dose for cervical dystonia is 120 Units.

Initial dose is 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

Ventral Hernia

500 units divided among abdominal muscles, injected 2-4 weeks prior to AWR surgery. May not be renewed.

Note: The recommended maximum cumulative dose for any indication should not exceed 400 Units in a treatment session.

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.

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, the express terms of the health plan will govern.

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).

SOURCES

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).

American Headache Society. (2019, January). The American Headache Society position statement on integrating new Migraine treatments into clinical practice. Headache. 2019, 59(1), 1-18.

Elstner, K. E., Read, J. W., Saunders, J., Cosman, P. H., Rodriguez-Acevedo, O., Jacombs, A. S. W., et al. (2019, April). Selective muscle botulinum toxin A Component Paralysis in complex ventral hernia repair. Hernia. 2019 (April 4).

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 May 19, 2020 from https://ichd-3.org/1-migraine/1-3-chronic-migraine/

Lexi-Comp Online. (2020, March). AHFS DI. AbobotulinumtoxinA. Retrieved May 19, 2020 from Lexi-Comp Online with AHFS.

Liberman, D., Milhouse, O., Johnson-Mitchell, M., Siegel, S.W. (2018, November/December). Real-world retention rates after intravesical onabotulinumtoxinA for idiopathic overactive bladder. Female Pelvic Medical Reconstructive Surgery. 2018, 24(6), 404-407.

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. (2020, February). IncobotulinumtoxinA. Retrieved May 19, 2020 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.

Rodriguez-Acevedo, O., Elstner, K. E., Jacombs, A. S. W., Read, J. W., Martins, R. T., Arduini, F., et al. (2018, February). Preoperative botulinum toxin A enabling defect closure and laparoscopic repair of complex ventral hernia. Surgical Endoscopy, 32(2), 831-839.

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. (2019, May). Center for Drug Evaluation and Research. Xeomin® (incobotulinumtoxinA). Retrieved May 19, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125360s074lbl.pdf.  

ORIGINAL EFFECTIVE DATE:  12/98

MOST RECENT REVIEW DATE:  9/30/2020

ID_MRx

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.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Indication

Billable Units

Per # days

Cervical dystonia

200

84

Blepharospasms

100

84

Upper limb spasticity

400

84

Prophylaxis for chronic migraines

200

84

Incontinence due to neurogenic detrusor overactivity

200

84

Overactive bladder (OAB)

100

84

Severe primary axillary hyperhidrosis

100

112

Sialorrhea

100

112

Ventral Hernia

500

N/A