BlueCross BlueShield of Tennessee Medical Policy Manual

OnabotulinumtoxinA

NDC CODE(S)

00023-1145-01 Botox 100 UNIT SOLR ALLERGAN DERMATOLOGICS

 

00023-3921-02 Botox 200 UNIT SOLR ALLERGAN DERMATOLOGICS

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 onabotulinumtoxinA, commercially available as Botox®.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

Note:  When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 Units in a 3 month (12 week) interval.

Unless otherwise stated, re-treatment should occur no sooner than 12 weeks from the prior injection.

INDICATION(S) DOSAGE & ADMINISTRATION
Blepharospasm 1.25-2.5 Units (0.05—0.1 ml per site) injected into each of 3 sites per affected eye every three months. There appears to be little benefit obtainable from injecting more than 5 Units per site. The effect of treatment lasts an average of 12 weeks. Cumulative dose in 30 days should not exceed 200 units
Cervical Dystonia 198 Units to 300 Units divided among the affected muscles. No more than 50 Units per site. May re-treat in 12 weeks.
Strabismus Based on muscle(s) affected, 1.25-2.5 Units in any one muscle initially. Subsequent doses may be increased up to two-fold compared to previously administered dose. No more than 25 Units in any one muscle for recurrent cases
Achalasia 100 Units (20-25 Units per quadrant) per administration
Upper Limb Spasticity Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, or adverse event history with BOTOX. In clinical trials, doses ranging from 75 Units to 400 Units were divided among selected muscles at a given treatment session, no sooner than every 12 weeks.
Lower Limb Spasticity 300 to 400 Units divided among 5 muscle groups (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus), no sooner than every 12 weeks
Chronic Migraine 155 Units administered intramuscularly (IM) as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas. The recommended re-treatment schedule is every 12 weeks.
Focal Spasticity (cerebral palsy patients, ages 2-18 years) 4 Units/kg IM (up to 200 Units) divided into 2 injections in the affected leg every 12 weeks
Severe primary axillary hyperhidrosis 50 Units intradermally per axilla every 16 weeks
Sialorrhea 15-40 Units in the parotid gland injected in two places and 10-15 Units in the submandibular glands (total dose from 50-100 Units per patient/administration).
Neurogenic bladder/Detrusor overactivity 200 Units per treatment injected into the detrusor muscle using 30 injections (6.7 units each). Re-inject no sooner than 12 weeks from the prior bladder injection.
Overactive Bladder (OAB) 100 Units per treatment injected into the detrusor muscle using 20 injections (5 units each). Re-inject no sooner than 12 weeks from the prior bladder injection.
Palmar Hyperhidrosis 1.5 to 2 U/cm2 (100 – 150 U) per palm
All other indications (unless otherwise specified) Not to exceed a cumulative dose of 400 U (for one or more indications) 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.

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 onabotulinumtoxinA for the treatment or prevention of other conditions or diseases.

SOURCES

American Academy of Neurology and Child Neurology Society (January, 2010). 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. (2016, March). AHFS DI. OnabotulinumtoxinA. Retrieved May 3, 2016 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, February). OnabotulinumtoxinA. Retrieved May 3, 2016 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.

U. S. Food and Drug Administration. (2015, April). Center for Drug Evaluation and Research. Botox® (onabotulinumtoxinA). Retrieved May 3, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1998

MOST RECENT REVIEW DATE:  12/1/2016

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

OnabotulinumtoxinA (Botox®)

  1. Is this the initial request for treatment?

If yes, go to question #2

If no, go to question #18

  1. Is the request for the treatment of esophageal achalasia in an individual 18 years of age or older if ANY ONE of the following?

If yes, go to question #17

If no, go to question #3

  1. Is the request for a diagnosis of blepharospasm in an individual 12 years of age or older with pain and/or functional impairment due to the condition?

If yes, go to question #17

If no, go to question #4

  1. Is the request for an individual with cerebral palsy with concurrent equinus gait if 18 years of age or older?

If yes, go to question #17

If no, go to question #5

  1. Does the individual have a diagnosis of cerebral-palsy-related spasticity, localized or segmental and is 2 years of age or older?

If yes, go to question #17

If no, go to question #6

  1. Does the individual have cervical dystonia and is 16 years of age or older with ANY ONE of the following?

If yes, go to question #17

If no, go to question #7

  1. Is the individual 18 years of age or older with chronic anal fissure and has failed conventional therapy?

If yes, go to question #17

If no, go to question #8

  1. Is the individual 18 years of age with a diagnosis of ANY ONE of the following?

If yes, go to question #17

If no, go to question #9

  1. Does the individual have a diagnosis of focal upper limb dystonia (e.g., organic writer’s cramp) and is 18 years of age or older and has ANY ONE of the following?

If yes, go to question #17

If no, go to question #10

  1. Is the individual 18 years of age or older with a diagnosis of severe primary hyperhidrosis that is not adequately managed with topical agents and location of ANY ONE of the following?

If yes, go to question #11

If no, go to question #12

  1. Does the condition cause ANY ONE of the following?

If yes, go to question #17

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

  1. Is the request for oromandibular dystonia (orofacial dyskinesia) in an individual 18 years of age or older who has pain and/or functional impairment due to the condition?

If yes, go to question #17

If no, go to question #13

  1. Does the individual have a diagnosis of overactive bladder (OAB) if ALL of the following?

If yes, go to question #17

If no, go to question #14

  1. Does the individual have sialorrhea (drooling) associated with neurologic disorders of ANY ONE of the following?

If yes, go to question #17

If no, go to question #15

  1. Does the individual have a diagnosis of urinary incontinence if ALL of the following?

If yes, go to question #17

If no, go to question #16

  1. Is the request for prevention of chronic migraine headaches in an individual 18 years of age or older if ALL of the following?

If yes, go to question #17

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

  1. Is the request for 400 billable units per 12 weeks (84 days) for dosage at the lowest recommended dose to initiate treatment as per the dosage chart below, not to exceed 400 units in a 3 month interval with re-treatment occurring no sooner than 12 weeks from the prior injection for a maximum request of 6 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

INDICATION(S) DOSAGE & ADMINISTRATION
Blepharospasm 1.25-2.5 Units (0.05—0.1 ml per site) injected into each of 3 sites per affected eye every three months. There appears to be little benefit obtainable from injecting more than 5 Units per site. The effect of treatment lasts an average of 12 weeks. Cumulative dose in 30 days should not exceed 200 units
Cervical Dystonia 198 Units to 300 Units divided among the affected muscles. No more than 50 Units per site. May re-treat in 12 weeks.
Strabismus Based on muscle(s) affected, 1.25-2.5 Units in any one muscle initially. Subsequent doses may be increased up to two-fold compared to previously administered dose. No more than 25 Units in any one muscle for recurrent cases
Achalasia 100 Units (20-25 Units per quadrant) per administration
Upper Limb Spasticity Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, or adverse event history with BOTOX. In clinical trials, doses ranging from 75 Units to 400 Units were divided among selected muscles at a given treatment session, no sooner than every 12 weeks.
Lower Limb Spasticity 300 to 400 Units divided among 5 muscle groups (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus), no sooner than every 12 weeks
Chronic Migraine 155 Units administered intramuscularly (IM) as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas. The recommended re-treatment schedule is every 12 weeks.
Focal Spasticity (cerebral palsy patients, ages 2-18 years) 4 Units/kg IM (up to 200 Units) divided into 2 injections in the affected leg every 12 weeks
Severe primary axillary hyperhidrosis 50 Units intradermally per axilla every 16 weeks
Sialorrhea 15-40 Units in the parotid gland injected in two places and 10-15 Units in the submandibular glands (total dose from 50-100 Units per patient/administration).
Neurogenic bladder/Detrusor overactivity 200 Units per treatment injected into the detrusor muscle using 30 injections (6.7 units each). Re-inject no sooner than 12 weeks from the prior bladder injection.
Overactive Bladder (OAB) 100 Units per treatment injected into the detrusor muscle using 20 injections (5 units each). Re-inject no sooner than 12 weeks from the prior bladder injection.
Palmar Hyperhidrosis 1.5 to 2 U/cm2 (100 – 150 U) per palm
All other indications (unless otherwise specified) Not to exceed a cumulative dose of 400 U (for one or more indications) every 12 weeks
  1. Does the individual continue to meet initial approval criteria from questions 2 through 17 as applicable?

If yes, go to question #19

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

  1. Does the disease show response to treatment with absence of unacceptable toxicity?

If yes, go to question #20

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

  1. Is the request for treatment of chronic migraine headaches?

If yes, go to question #21

If no, this satisfies medical necessity and medical appropriateness criteria

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

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.