OnabotulinumtoxinA (Botox®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
2. Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults or pediatric patients 5 years of age or older who have an inadequate response to or are intolerant of an anticholinergic medication
3. Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
4. Treatment of spasticity in patients 2 years of age and older
5. Treatment of cervical dystonia in adults, to reduce the severity of abnormal head position and neck pain
6. Treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. Safety and effectiveness have not been established in patients under age 18.
7. Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older
B. Compendial Uses
1. Achalasia
2. Chronic anal fissures
3. Essential tremor
4. Excessive salivation (ptyalism)
5. Hemifacial spasm
6. Spasmodic dysphonia (laryngeal dystonia)
7. Oromandibular dystonia
8. Myofascial pain syndrome
9. Focal hand dystonia
10. Facial myokymia
11. Hirschsprung disease with internal sphincter achalasia
12. Orofacial tardive dyskinesia
13. Painful bruxism
14. Palatal myoclonus
15. First bite syndrome
16. Palmar or gustatory (Frey’s syndrome) hyperhidrosis
All other indications are considered experimental/investigational and not medically necessary.
II. PRESCRIBER SPECIALTIES
The medication must be prescribed by, or in consultation with one of the following:
A. Blepharospasm, Strabismus: neurologist or ophthalmologist
B. Overactive bladder, urinary incontinence: neurologist or urologist
C. Spasticity, cervical dystonia, hemifacial spasm, myofascial pain syndrome, focal hand dystonia, facial myokymia: neurologist, orthopedist or physiatrist
D. Hyperhidrosis: neurologist or dermatologist
E. Migraine prophylaxis, tremor, orofacial tardive dyskinesia: neurologist
F. Chronic anal fissures, achalasia, Hirschsprung disease: gastroenterologist, proctologist or colorectal surgeon
G. Excessive salivation, spasmodic dystonia, oromandibular dystonia, bruxism, palatal myoclonus: neurologist or otolaryngologist
H. First bite syndrome: neurologist or oncologist
III. EXCLUSIONS
Coverage will not be provided for cosmetic use.
IV. CRITERIA FOR INITIAL APPROVAL
A. Blepharospasm
Authorization of 12 months may be granted for treatment of blepharospasm when all of the following are met:
1. Member is 12 years of age or older
2. Member is diagnosed with blepharospasm including blepharospasm associated with dystonia, benign essential blepharospasm or VII nerve disorder.
B. Cervical dystonia
Authorization of 12 months may be granted for the treatment of adults with cervical dystonia (e.g., torticollis) when all of the following are met:
1. There is abnormal placement of the head with limited range of motion in the neck
2. Member is 18 year of age and older.
C. Chronic migraine prophylaxis
Authorization of 6 months (two injection cycles) may be granted for treatment of chronic migraine prophylaxis when all of the following criteria are met:
1. Member experiences headaches 15 days or more per month.
2. Member experiences headaches lasting 4 hours or longer on at least 8 days per month.
3. Member completed an adequate trial of (or has a contraindication to) two oral migraine preventative therapies coming from at least 2 of the following classes with a trial of each medication at least 60 days in duration:
a. Antidepressants (e.g., amitriptyline, venlafaxine)
b. Antiepileptic drugs (AEDs) (e.g., divalproex sodium, topiramate, valproate sodium)
c. Beta-adrenergic blocking agents (e.g., metoprolol, propranolol, timolol, atenolol, nadolol)
4. Member has signs and symptoms consistent with chronic migraine diagnostic criteria as defined by the International Headache Society (IHS).
5. Member is 18 years of age or older
D. Overactive bladder with urinary incontinence
Authorization of 12 months may be granted for treatment of overactive bladder with urinary incontinence, urgency, and frequency when all of the following criteria are met:
1. The member has tried and failed behavioral therapy.
2. The member has had an inadequate response or experienced intolerance to two agents from either of the following classes:
a. Anticholinergic medication (e.g., Vesicare [solifenacin], Enablex [darifenacin], Toviaz [fesoterodine], Detrol/Detrol LA [tolterodine], Sanctura/Sanctura XR [trospium], Ditropan XL [oxybutynin]).
b. Beta-3 adrenergic agonist (e.g., Myrbetriq [miraberon], Gemtesa [vibegron]).
3. Member is 18 years of age or older.
E. Primary axillary, palmar, and gustatory (Frey’s syndrome) hyperhidrosis
Authorization of 12 months may be granted for treatment of primary axillary, palmar, or gustatory (Frey’s syndrome) hyperhidrosis when all of the following criteria are met:
1. Significant disruption of professional and/or social life has occurred because of excessive sweating; and
2. Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash.
3. Member is 18 years of age or older.
F. Strabismus
Authorization of 12 months may be granted for treatment of strabismus when all of the following are met:
1. Strabismus interference with normal visual system development is likely to occur and spontaneous recovery is unlikely.
2. Member is 12 years of age or older.
Note: Strabismus repair is considered cosmetic in adults with uncorrected congenital strabismus and no binocular fusion.
G. Upper or lower limb spasticity
Authorization of 12 months may be granted for treatment of upper or lower limb spasticity when all of the following are met:
1. Member is 2 years of age or older
2. Member has a primary diagnosis of upper or lower limb spasticity or as a symptom of a condition causing limb spasticity (including focal spasticity or equinus gait due to cerebral palsy).
H. Urinary incontinence associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis)
Authorization of 12 months may be granted for treatment of urinary incontinence associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) when all of the following criteria are met:
1. The member has tried and failed behavioral therapy
2. The member has had an inadequate response or experienced intolerance to one agent from either of the following classes:
a. Anticholinergic medication (e.g., Vesicare [solifenacin], Enablex [darifenacin], Toviaz [fesoterodine], Detrol/Detrol LA [tolterodine], Sanctura/Sanctura XR [trospium], Ditropan XL [oxybutynin]).
b. Beta-3 adrenergic agonist (e.g., Myrbetriq [miraberon]
3. Member is 5 years of age or older.
I. Achalasia
Authorization of 12 months may be granted for treatment of achalasia when the member has tried and failed or is a poor candidate for conventional therapy such as pneumatic dilation and surgical myotomy.
J. Chronic anal fissures
Authorization of 12 months may be granted for treatment of chronic anal fissures when the member has not responded to first line therapy such as topical calcium channel blockers or topical nitrates.
K. Essential tremor
Authorization of 12 months may be granted for treatment of essential tremor.
L. Excessive salivation
Authorization of 12 months may be granted for treatment of excessive salivation (chronic sialorrhea or ptyalism) when the member has been refractory to pharmacotherapy (e.g., anticholinergics).
M. Hemifacial Spasm
Authorization of 12 months may be granted for treatment of hemifacial spasm.
N. Spasmodic dysphonia (laryngeal dystonia)
Authorization of 12 months may be granted for treatment of spasmodic dysphonia (laryngeal dystonia).
O. Oromandibular dystonia
Authorization of 12 months may be granted for treatment of oromandibular dystonia.
P. Myofascial Pain Syndrome
Authorization of 12 months may be granted for treatment of myofascial pain syndrome when the member has tried and failed all of the following:
1. Physical therapy
2. Injection of local anesthetics into trigger points
3. Injection of corticosteroids into trigger points
Q. Focal hand dystonia
Authorization of 12 months may be granted for the treatment of focal hand dystonias.
R. Facial myokymia
Authorization of 12 months may be granted for the treatment of facial myokymia.
S. Hirschsprung disease with internal sphincter achalasia
Authorization of 12 months may be granted for the treatment of Hirschsprung’s disease with internal sphincter achalasia following endorectal pull through and the member is refractory to laxative therapy.
T. Orofacial tardive dyskinesia
Authorization of 12 months may be granted for the treatment of orofacial tardive dyskinesia when conventional therapies have been tried and failed (e.g., benzodiazepines, clozapine, or tetrabenazine).
U. Painful bruxism
Authorization of 12 months may be granted for the treatment of painful bruxism when the member has had an inadequate response to a night guard and has had an inadequate response to pharmacologic therapy such as diazepam.
V. Palatal myoclonus
Authorization of 12 months may be granted for the treatment of palatal myoclonus when the member has disabling symptoms (e.g., intrusive clicking tinnitus) who had an inadequate response to clonazepam, lamotrigine, carbamazepine or valproate.
W. First bite syndrome
Authorization of 12 months may be granted for the treatment of first bite syndrome when the member has failed relief from analgesics, antidepressants or anticonvulsants.
V. CONTINUATION OF THERAPY
A. All members (including new members) requesting authorization for continuation of therapy for approvable conditions other than migraine prophylaxis must meet ALL initial authorization criteria and be experiencing benefit from therapy.
B. Authorization of 12 months may be granted for treatment of chronic migraine prophylaxis when the member has achieved or maintained a reduction in monthly headache frequency since starting therapy with Botox.
VI. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Adults: Dosing should not exceed a cumulative dose of 400 units every 84 days
Pediatric (patients less than 18 years of age): Dosing should not exceed the lessor of 10 units/kg or 340 units every 84 days.
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.
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).
REFERENCES
1. Botox [package insert]. Madison, NJ: Allergan USA, Inc; July 2021.
2. DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed August 1, 2022.
3. AHFS Drug Information. http://online.lexi.com/lco. Accessed August 1, 2022.
4. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337-45.
5. Snow V, Weiss K, Wall EM, et al. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med. 2002;137(10):840-849.
6. Evers S, Afra J, Frese A, et al. EFNS guideline on the drug treatment of migraine--revised report of an EFNS task force. Eur J Neurol. 2009;16(9):968-981.
7. Pringsheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012;39(2 Suppl 2):S1-59.
8. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Internal Medicine Programs; November 2015.
9. Zesiewics TA, Elble RJ, Louis ED et al. Evidence-based guideline update: Treatment of essential tremor: Report of the Quality Standards Subcommittee of the American Academy of Neurology: Neurology 2011; 77: 1752-1755.
10. Restivo D, Panebianco M, Casabona A et al. Botulinum Toxin A for Sialorrhea Associated with Neurological Disorders: Evaluation of the Relationship between Effect of Treatment and the Number of Glands Treated. Toxins 2018;55:1-10.
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12. Zoons E, Dijkgraaf M, Dijk J et al. Botulinum toxin as treatment for focal dystonia: a systematic review of the pharmaco-therapeutic and pharmaco-economic value. J Neurol 2012;259: 2519-2526.
13. Conrin L, Karp BI, Alter K et al. Long Term Follow-up Botulinum Toxin Therapy for Focal Hand Dystonia: Outcome at 10 or More Years: Mov Disord. 2011 Mar; 26(4): 750–753.
14. Daele D, Finnegan E, Rodnitzky R et al. Head and Neck Muscle Spasm After Radiotherapy. Otolaryngol Head and Neck Surg 2002;128:956-959.
15. Han-Guerts I, Hendrix V, Blaauw I et al. Outcome after Anal Intrasphincteric Botox Injection in Children with Surgically Treated Hirschsprung Disease. JPGN 2014; 59: 604-607.
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17. Gosain A, Frykman PK, Cowles RA, et al. Guidelines for the diagnosis and management of Hirschsprung-associated enterocolitis. Pediatr Surg Int. 2017; 33(5):517–521.
18. Thuruthiath N, Arayamparambil R. Essential palatal myoclonus: A rare cause of objective tinnitus. J Adv Med Heath Res 2016;3:1-3.
19. Laccourreye O, Werner A, Garcia D, Malinvaud D, Tran Ba Huy P, Bonfils P. First bite syndrome. Euro Ann Otolaryngol Head Neck Diseases. 2013; 130:269-273.
20. Linkov G et al. First bite syndrome: incidence, risk factors, treatment, and outcomes. The Laryngoscope. 2012; 122: 1773-1778.
21. Slotema CW;van Harten PN;Bruggeman R;Hoek HW. Botulinum toxin in the treatment of orofacial tardive dyskinesia: a single blind study. Prog Neuropsychopharmacol Biol Psychiatry 2008;32(2):507-509.
22. Odderson IR. Hyperhidrosis treated by botulinum A exotoxin. Dermatol Surg. 1998;24(11):1237-1241.
23. Solomon BA, Hayman R. Botulinum toxin type A therapy for palmar and digital hyperhidrosis. J Am Acad Dermatol. 2000;42(6):1026-1029.
24. Naver H, Swartling C, Aquilonius SM. Palmar and axillary hyperhidrosis treated with botulinum toxin: One-year clinical follow-up. Eur J Neurol. 2000;7(1):55-62.
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26. Glader L, Delsing C, Hughes A et al. Sialorrhea in cerebral palsy. American Academy for Cerebral Palsy and Developmental Medicine Care Pathways. https://www.aacpdm.org/publications/care-pathways/sialorrhea. Accessed August 3, 2021.
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ORIGINAL EFFECTIVE DATE: 12/98
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
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.
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