BlueCross BlueShield of Tennessee Medical Policy Manual

AbobotulinumtoxinA

NDC CODE(S)

15054-0530-xx Dysport 300 UNIT SOLR (IPSEN BIOPHARMACEUTICALS)

 

15054-0050-xx Dysport 500 UNIT SOLR (IPSEN BIOPHARMACEUTICALS)

 

15054-0500-xx Dysport 500 UNIT SOLR (IPSEN BIOPHARMACEUTICALS)

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 addresses only the type A formulation abobotulinumtoxinA marketed as Dysport®.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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
Cervical Dystonia

Initial dose: 500 units divided among the affected muscles

Re-treatment: 250-1000 units every 12 -16 weeks or longer as necessary
Hemifacial Spasms

Up to 220 units per treatment session based on sites and severity of the spasm

Subsequent 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, total

Adults - 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 history

Re-treatment: 500 – 1000 units every 12 – 16 weeks or longer, as necessary

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).

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.

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).

BlueCross BlueShield Association. Medical Policy Reference Manual. (04:2016). Botulinum toxin (5.01.05). Retrieved May 3, 2016 from BlueWeb.

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2015). Treatment of hyperhidrosis (8.01.19). Retrieved May 5, 2016 from BlueWeb.

Lexi-Comp Online. (2017). AHFS DI. AbobotulinumtoxinA. Retrieved February 20, 2017 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. (2016, December). AbobotulinumtoxinA. Retrieved February 20, 2017 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. (2016, December). Center for Drug Evaluation and Research. Dysport® (abobotulinumtoxinA). Retrieved February 20, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1998

MOST RECENT REVIEW DATE:  4/11/2017

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.

Pharmaceutical Decision Support Tree

 

AbobotulinumtoxinA (Dysport®)

  1. Is this the initial request for treatment?

If yes, go to question #2

If no, go to question #15

  1. Is the individual 18 years of age or older or 2 years of age or older with lower limb spasticity?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request for treatment of chronic anal fissure in an individual who has failed conventional therapy?

If yes, go to question #13

If no, go to question #4

  1. Is the request for treatment of blepharospasms with pain and/or functional impairment due to the condition?

If yes, go to question #13

If no, go to question #5

  1. Is the request for treatment of cervical dystonia with ANY ONE of the following?

If yes, go to question #13

If no, go to question #6

  1. Is the request for treatment of ANY ONE of the following?

If yes, go to question #13

If no, go to question #7

  1. Is the request for prophylaxis of chronic migraines with ALL of the following?

If yes, go to question #13

If no, go to question #8

  1. Is the request for the treatment of severe primary axillary hyperhidrosis if the individual has ALL of the following?

If yes, go to question #13

If no, go to question #9

  1. Is the request for treatment of incontinence due to neurogenic detrusor overactivity if the individual failed therapy with anticholinergics?

If yes, go to question #13

If no, go to question #10

  1. Is the request for overactive bladder (OAB) if the individual has ALL of the following?

If yes, go to question #13

If no, go to question #11

  1. Is the request for spasticity in the upper limb and the individual has increased muscle tone in elbow flexors, wrist flexors and finger flexors?

If yes, go to question #13

If no, go to question #12

  1. Is the request for sialorrhea associated with neurological disorders and the individual has ANY ONE of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for billable units per 12 weeks (84 days) as per ANY ONE of the following?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the dosage requested ANY ONE of the following for a period no longer than 6 months?

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
Cervical Dystonia

Initial dose: 500 units divided among the affected muscles

Re-treatment: 250-1000 units every 12 -16 weeks or longer as necessary
Hemifacial Spasms

Up to 220 units per treatment session based on sites and severity of the spasm

Subsequent 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, total

Adults (18 and older) - 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 history

Re-treatment: 500 – 1000 units every 12 – 16 weeks or longer, as necessary

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the approval criteria in questions 2 through 14?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response shown to the treatment?

If yes, go to question #17

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for renewal of prophylaxis for chronic migraines?

If yes, go to question #18

If no, go to question #19

  1. Is there documentation of significant decrease in number and frequency of headaches AND improvement in function?

If yes, go to question #19

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.