Botulinum toxin - Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan (2024)

Subject: Botulinum toxin

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary,Botox, Dysport, Myobloc, and Xeomin are subject to precertification. Ifprecertification requirements apply Aetna considers these drugs to bemedically necessary for those members who meet ALL of the following precertification criteria:

1. OnabotulinumtoxinA (Botox Brand of Botulinum Toxin Type A): Aetna considers onabotulinumtoxinA (Botox) medically necessary for any of the following conditions:

A.Strabismus (including gaze palsies accompanying diseases, such as neuromyelitis optica and Schilder's disease), for deviations less than 50 prism diopters.

Note: Strabismus repair is considered cosmetic in adults with uncorrected congenital strabismus and no binocular fusion.

B.Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

C.Post-facial (7th cranial) nerve palsy synkinesis (hemifacial spasms), characterized by sudden, unilateral, synchronous contractions of muscles innervated by the facial nerve.

D.Laryngeal spasm.

E.Cervical dystonia (spasmodic torticollis) of moderate or greater severity when all of the following criteria are met:

• There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles); and

• There is sustained head torsion and/or tilt with limited range of motion in the neck; and

• The duration of the condition is greater than 6 months; and

• Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures, or other neuromuscular disorders.

F. Focal hand dystonias (i.e., organic writers cramp), when both of the following criteria are met:

• Documentation that abnormal muscle tone is causing persistent pain and/or interfering with functional ability, and

• Documented failure on conservative medical therapy

G. Focal dystonias, including:

• Adductor laryngeal dystonia;

• Focal dystonias in corticobasilar degeneration;

• Jaw-closing oromandibular dystonia, characterized by dystonic movements involving the jaw, tongue, and lower facial muscles;

• Lingual dystonia;

• Symptomatic torsion dystonia (but not lumbar torsion dystonia).

H. Limb spasticity, including:

• Equinus varus deformity in children with cerebral palsy

• Hereditary spastic paraplegia;

• Limb spasticity due to multiple sclerosis;

• Limb spasticity due to other demyelinating diseases of the central nervous system (including adductor spasticity and pain control in children undergoing adductor-lengthening surgery as well as children with upper extremity spasticity);

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• Spastic hemiplegia, such as due to stroke or brain injury.

When the following criteria are met:

• Documentation that abnormal muscle tone is either interfering with functional ability, or is expected to result in joint contracture with future growth, and

• Documented failure to standard medical treatments, and

• Surgical intervention is considered to be the last option, and

• Treatment is being requested to enhance function or allow additional therapeutic modalities to be employed

I. Esophageal achalasia, for individuals who have any of the following:

• Are at high risk of complications of pneumatic dilation or surgical myotomy; or

• Have failed conventional therapy; or

• Have failed a prior myotomy or dilation; or

• Have had a previous dilation-induced perforation; or

• Have an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilation-induced perforation.

J. Chronic anal fissure unresponsive to conservative therapeutic measures (e.g., nitroglycerin ointment).

K. Intractable, disabling focal primary hyperhydrosis, when all of the following are met:

• Member is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anticholinergics, beta-blockers, or benzodiazepines) if sweating is episodic; and

• Significant disruption of professional and/or social life has occurred because of excessive sweating; and

• Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash.

L. Ptyalism/sialorrhea (excessive secretion of saliva, drooling) that meets both of the following criteria:

• Refractory to pharmacotherapy (including anticholinergics); and

• Documentation of medically significant complications of sialorrhea, such as chronic skin maceration or infections that cannot be controlled with topical treatments or hygiene.

M. Facial myokymia and trismus associated with post-radiation myokymia.

N. Hirschsprung’s disease with internal sphincter achalasia following endorectal pull-through.

O. Medically refractory upper extremity tremor that interferes with activities of daily living (ADLs). (Additional botulinum toxin injections are considered medically necessary if response to a trial of botulinum toxin enables ADLs or communication).

P. Detrusor-sphincter dyssynergia after spinal cord injury.

Q. Neurogenic detrusor (bladder) overactivity resulting from a neurologic condition (e.g., multiple sclerosis or spinal cord injury), when the following criteria are met:

• Documentation of detrusor overactivity confirmed by urodynamic testing, and

• Documented failure of behavioral therapy, and

• Documented failure/intolerance to at least one adequately titrated anticholinergic medication (e.g. oxybutynin, tolterodine, trospium, darifenacin, fesoterodine, solifenacin)
  

R. Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who meet the following criteria:

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• Documented failure of behavioral therapy, and

• Documented failure/intolerance to at least threeadequately titrated prescription overactive bladder medications (e.g., oxybutynin(Ditropan), trospium(Sanctura), tolterodine (Detrol), darifenacin (Enablex), fesoterodine (Toviaz), mirabegron (Myrbetriq), solifenacin (Vesicare), duloxetine (Cymbalta)) or twoadequately titrated prescription overactive bladder medicationsand an OTC bladder medication (oxybutynin transdermal patch (Oxytrol for Women).

S. Frey's syndrome

T. Orofacial tardive dyskinesia when conventional therapies had been tried and failed (e.g., benzodiazepines, clozapine, and tetrabenazine).

U. Migraines -- for prevention of chronic (more than 14 days per month with headaches lasting 4 hours a day or longer) migraine headaches in adults who have tried and failed trials of at least 3medications selected from at least twoclasses of migraine headache prophylaxis medications of at least two months (60 days) duration for each medication:

• Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (e.g., candesartan, lisinopril);

• Anti-depressants (e.g., amitriptyline, clomipramine, doxepin, mirtazapine, nortryptiline, protriptyline);

• Anti-epileptic drugs (e.g., divalproex, gabapentin, topiramate, valproic acid);

• Beta blockers (e.g., atenolol, metoprolol, nadolol, propranolol, timolol);

• Calcium channel blockers (e.g., diltiazem, nifedipine, nimodipine, verapamil).

Botulinum toxin is considered experimental and investigational for migraines that do not meet the above-listed criteria

Note: Continuing treatment with botulinum toxin injection for ongoing prevention of chronic migraine headaches is considered medically necessary when:

•Migraine headache frequency was reduced by at least 7 days per month (when compared to pre-treatment average) by the end of the initial trial; or

•Migraine headache duration was reduced by at least 100 total hours per month (when compared to the pre-treatment average) by the end of the initial trial.

V. Painful bruxism

W. Palatal myoclonus with disabling symptoms (e.g., objective, intrusive clicking tinnitus)

2. RimabotulinumtoxinB (Myobloc Brand of Botulinum Toxin Type B): Aetna considers rimabotuninumtoxinB (Myobloc) medically necessary for the treatment of any of the following conditions:

A. Individuals with cervical dystonia (spasmodic torticollis) of moderate or greater severity when the following criteria are met:

• Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures; or other neuromuscular disorders; and
• There is sustained head torsion and/or tilt with limited range of motion in the neck; and
• The duration of the condition is greater than 6 months; and
• There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles.

B. Ptyalism/sialorrhea (excessive secretion of saliva, drooling) that meets the following criteria:

• Refractory to pharmacotherapy (including anticholinergics); and

• Documentation of medically significant complications of sialorrhea, such as chronic skin maceration or infections that cannot be controlled with topical treatments or hygiene.

C. Intractable, disabling focal primary hyperhydrosis, when all of the following are met:

• Member is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anticholinergics, beta-blockers, or benzodiazepines) if sweating is episodic; and

• Significant disruption of professional and/or social life has occurred because of excessive sweating; and

• Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash.

3. AbobotulinumtoxinA (Dysport Brand of Botulinum Toxin Type A): Aetna considers abobotulinumtoxin A (Dysport) medically necessary for the treatment of any of the following indications:

A. Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

B. Cervical dystonia, (spasmodic torticollis) of moderate or greater severity when all of the following criteria are met:

• Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures, or other neuromuscular disorders; and
• There is sustained head torsion and/or tilt with limited range of motion in the neck; and
• The duration of the condition is greater than 6 months; and
• There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles).

C. Limb spasticity, including:

• Equinus varus deformity in children with cerebral palsy

• Hereditary spastic paraplegia;

• Limb spasticity due to multiple sclerosis;

• Limb spasticity due to other demyelinating diseases of the central nervous system (including adductor spasticity and pain control in children undergoing adductor-lengthening surgery as well as children with upper extremity spasticity);

• Spastic hemiplegia, such as due to stroke or brain injury.

When the following criteria are met:

• Documentation that abnormal muscle tone is either interfering with functional ability, or is expected to result in joint contracture with future growth, and

• Documented failure to standard medical treatments, and

• Surgical intervention is considered to be the last option, and

• Treatment is being requested to enhance function or allow additional therapeutic modalities to be employed.
  

4. IncobotulinumtoxinA (Xeomin Brand of Botulinum Toxin Type A): Aetna considers incobotulinumtoxinA (Xeomin) medically necessary for the treatment of any of the following indications:

A. Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

B. Cervical dystonia, (spasmodic torticollis) of moderate or greater severity when all of the following criteria are met:

• Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures, or other neuromuscular disorders; and
• There is sustained head torsion and/or tilt with limited range of motion in the neck; and
• The duration of the condition is greater than 6 months; and
• There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles).

C. Post-stroke spasticity of the upper limb.

Cosmetic Indications: Aetna considers botulinum toxin cosmetic for the following indications:

• Aging neck; or
• Blepharoplasty (eyelid lift); or
• Glabellar lines; or
• Wrinkles, frown lines

Place of Service:

Outpatient

The above policy is based on the following references:

1.AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2.DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3.Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4.PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5.Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

March 30, 2015

Additional Information

*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
+RxStep=Rx Step
^ETM=Essential Therapy Management

*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.