Subject: Botox 2247-A SGM P2021

Drug

BOTOX  (onabotulinumtoxin A)

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.    EXCLUSIONS

              Coverage will not be provided for cosmetic use.

 

    III.    CRITERIA FOR INITIAL APPROVAL

              A.   Blepharospasm
                    Authorization of 12 months may be granted for treatment of
                    blepharospasm, including blepharospasm associated with
                    dystonia and benign essential blepharospasm.

              B.   Cervical dystonia
                    Authorization of 12 months may be granted for the treatment of
                    adults with cervical dystonia (e.g., torticollis) when there is
                    abnormal placement of the head with limited range of motion in
                    the neck.

              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) three 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:
                          i.   Antidepressants (e.g., amitriptyline, venlafaxine)
                         ii.   Antiepileptic drugs (AEDs) (e.g., divalproex sodium,
                               topiramate, valproate sodium)
                         iii.  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).

               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 anticholinergic medications (e.g., Vesicare
                          [solifenacin], Enablex [darifenacin], Toviaz [fesoterodine],
                          Detrol/Detrol LA [tolterodine], Sanctura/Sanctura XR
                          [trospium], Ditropan XL [oxybutynin]).

               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.   Member is unresponsive or unable to tolerate oral
                          pharmacotherapy prescribed for excessive sweating (e.g.,
                          anticholinergics, beta-blockers, or benzodiazepines); and
                    2.   Significant disruption of professional and/or social life has
                          occurred because of excessive sweating; an
                    3.   Topical aluminum chloride or other extra-strength
                          antiperspirants are ineffective or result in a severe rash.

                F.  Strabismus
                    Authorization of 12 months may be granted for treatment of
                    strabismus when interference with normal visual system
                    development is likely to occur and spontaneous recovery is
                    unlikely.
                    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 either as a primary diagnosis or as
                    a symptom of a condition causing limb spasticity.

                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 an anticholinergic medication (e.g., Vesicare
                         [solifenacin], Enablex [darifenacin], Toviaz [fesoterodine],
                         Detrol/Detrol LA [tolterodine], Sanctura/Sanctura XR
                         [trospium], Ditropan XL [oxybutynin]).

                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.

 
        IV.  CONTINUATION OF THERAPY

 
              A.   All members (including new members) requesting authorization
                    for continuation of therapy must meet ALL initial authorization
                    criteria for all approvable conditions other than chronic migraine
                    prophylaxis.

              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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Botox [package insert]. Madison, NJ: Allergan USA, Inc; February 2021.
2. DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed August 3, 2021.
3. AHFS Drug Information. http://online.lexi.com/lco. Accessed August 3, 2021.
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. 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.
9. 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.
10. Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: Anatomy, Pathophysiology and Treatment with Emphasis on the Role of Botulinum Toxins. Toxins 2013, 5, 1010-1031
11. 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.
12. 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.
13. Daele D, Finnegan E, Rodnitzky R et al. Head and Neck Muscle Spasm After Radiotherapy.  Otolaryngol Head and Neck Surg 2002;128:956-959.
14. 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.
15. Asutay F, Atalay Y, Asutay H, Huseyin Acar A. The Evaluation of the clinical effects of Botulinum Toxin on Nocturnal Bruxism.  Pain Research and Management 2017;1-5.
16. 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.
17. Thuruthiath N, Arayamparambil R. Essential palatal myoclonus: A rare cause of objective tinnitus.  J Adv Med Heath Res 2016;3:1-3.
18. 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.
19. Linkov G et al. First bite syndrome: incidence, risk factors, treatment, and outcomes. The Laryngoscope. 2012; 122: 1773-1778.
20. 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.
21. Odderson IR. Hyperhidrosis treated by botulinum A exotoxin. Dermatol Surg. 1998;24(11):1237-1241.
22. Solomon BA, Hayman R. Botulinum toxin type A therapy for palmar and digital hyperhidrosis. J Am Acad Dermatol. 2000;42(6):1026-1029.
23. 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.
24. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders: 3nd edition. Cephalalgia. 2018;Vol. 38(1) 1–211.
25. 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.
26. Garuti G, Rao F, Ribuffo V et al. Sialorrhea in patients with ALS: current treatment options. Degener Neurol Neuromuscul Dis. 2019; 9: 19–26.
27. Digre KB for the American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache 2019;59:1-18. doi: 10.1111/head.13456.

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.

December 29, 2021