MEDICAL COVERAGE POLICY SERVICE: Botulinum Toxin Injection for Chemodenervation. SERVICE: Botulinum Toxin Injection for chemo-denervation

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1 Important note Even though this policy may indicate that a particular service or supply may be considered covered, this conclusion is not based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the Evidence of Coverage to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and selffunded non-erisa (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Senior Care members, this policy will apply unless Medicare policies extend coverage beyond this Medical Policy & Criteria Statement. Senior Care policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan benefits. CMS's Coverage Issues Manual can be found on the CMS website. chemo-denervation PRIOR AUTHORIZATION: Required. POLICY: The determination of medical necessity for the use of botulinum toxin injections is always made on a case-by-case basis. Botulinum toxin injections utilizing botulinum toxin-a may be considered medically necessary for the treatment of patients presenting with the following conditions: Spasticity Cervical dystonia (spasmodic torticollis) Focal dystonia Blephorospasm Laryngeal dystonia/spasm Hemi-fascial spasm Upper extremity essential tremor Upper or lower extremity focal dystonia Axillary hyperhidrosis Chronic migraine headaches occurring many times each month. Anal fissures failing 2 months of conservative treatment Repeat botulinum toxin injections are typically not indicated unless there is documented evidence of functional improvement, clinically meaningful reduction in pain, reduction of the need for treatment of musculoskeletal complications, facilitating ease of care, and/or for improving the general appearance, mobility and/or phonation in patients presenting with spasticity or dystonia for a minimum of eight (8) weeks following the injection(s). Based on the typical response of properly administered botulinum toxin injections, injections are typically performed every three (3) months. Injections performed on a more frequent basis may be considered not medically necessary. In addition, more than four (4) injections per region per year are considered not medically necessary. The use of electrical muscle stimulation (95873) or needle electromyography (95874) may be considered medically necessary for guidance in conjunction with botulinum toxin injections (chemodenervation). Based on the limited evidence of efficacy and the increased side-effects profile, the use of botulinum toxin type-b may be considered medically necessary ONLY in the management of patients who have become non-responsive to botulinum toxin type-a. Botulinum Toxin Injection for Page 1 of 9

2 Botulinum Toxin Injection for Page 2 of 9 MEDICAL COVERAGE POLICY In all other conditions, the use of botulinum toxin injections may be considered NOT medically necessary. Conditions for which botulinum toxin injections are considered NOT medically necessary include, but are not limited to: Myofascial trigger points Myofascial tender points (Myofascitis or Fibromyositis or Fibromyalgia) Neck Pain Low Back Pain. SWHP also considers the use botulinum toxin injections not medically necessary for cosmetic purposes as well as all other indications not explicitly stated as covered in this policy. OVERVIEW: Botulinum toxin injections are intramuscular injections of botulinum neurotoxins which are purified forms of Clostridium botulinum exotoxins. The botulinum toxin acts by blocking release of acetylcholine at the neuromuscular junction thus reducing the tone of overactive muscles. There are several commercial products (consisting of either serotype-a or serotype-b) currently available for use. Each differs in its unit potency, side effects, and duration of action. The clinical goals for utilizing botulinum toxin injections are to result in a temporary chemodenervation of the effected muscle at the neuromuscular junction thus: reducing pain or increasing comfort, improving function, preventing or treating musculoskeletal complications, facilitating ease of care, and/or for improving the general appearance, mobility and/or phonation in patients presenting with spasticity or dystonia. The Food and Drug Administration (FDA) has approved Botox injection (onabotulinumtoxina) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future symptoms. Botox is not approved to treat migraine headaches that occur 14 days or less per month, or for other forms of headache. Botulinum toxin injections are not without risk, and can expose patients to potential serious complications. As a result, certain patients may not be optimal candidates for botulinum toxin injections. Optimal candidates include those: with a limited number of muscles that need treatment; who do not have a fixed contracture. MANDATES: none CODES: 31513; 31570; 31571; 43201; 43236; 64612; 64613; 64614; 64650; 64653; 67345; CPT Codes: 95873; HCPCS codes JO585; JO586; S2340;S2341; JO587 CPT Not Covered: ICD9 codes: ; 333.1; 333.2; 333.6; ; ; ;333.81; ; ; ; 334.1; 340; ; ; ; ; 351.8; ; ; ; 527.7; 530.0; 530.6; 553.3; 564.6; ; 751.3;

3 ICD10 codes: G04.1 G11.4 G23.8 G23.9 G24.1 G25.0 G35 G37.9 G G51.8 G G83.9 G G I through I I I I I I I I I I I K60.1 Chronic anal fissure L Primary focal hyperhidrosis, axilla M43.6 Torticollis S14.101A - S14.159S S24.0xxA - S24.159S S34.01xA - S34.3xxS Botulinum Toxin Injection for Page 3 of 9 MEDICAL COVERAGE POLICY Hayes Rating: B - for use in cervical dystonia and blepharospasm, C or D for all other dystonias. C - for local treatment for cervicogenic and occipital neuralgia C - For onabotulinumtoxina for prevention of migraine headache in adults who do not have contraindications to this treatment. This Rating reflects the relatively small benefit obtained from treatment, lack of long-term follow-up to assess the durability of benefits, and limited data comparing onabotulinumtoxina with other current treatments for the prevention of migraine. D - for treatment of all other headache. B - for treatment of children with moderate spasticity of lower extremities (only) due to cerebral palsy; C or D for all other treatments for spasticity related to cerebral palsy. B - for axillary hyperhidrosis C and D - for other hyperhidrosis; B - for chronic anal fissures failing 2 months of conservative treatment D - for gastroparesis CMS: No CMS National Coverage Determination (NCD or LCD) was found for botulinum toxin for the treatment of neurologic or ophthalmologic conditions, headache, esophageal achalasia, hyperhidrosis, spasticity or tremors. POLICY HISTORY: Status Date Action New 12/17/2010 New policy Reviewed 12/17/2011 Reviewed.

4 Reviewed 11/15/2012 Reviewed. Reviewed 10/3/2013 Revised, ICD10 codes added, ICD9 codes updated. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Al-Khodairy AT, Gobelet C, Rossier AB. Has botulinum toxin type A a place in the treatment of spasticity in spinal cord injury patients? Spinal Cord 1998; 36: Argoff CE. The use of botulinum toxins for chronic pain and headaches. Curr Treat Options Neurol. 2003;5(6): Bakheit AM, Fedorova NV, Skoromets AA, Timerbaeva SL, Bhakta BB, Coxon L. The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles. J Neurol Neurosurg Psychiatry 2004;75: Bakheit AM, Pittock S, Moore AP, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. Eur J Neurol 2001;8: Bakheit AM, Pittock S, Moore AP, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. Eur J Neurol 2001; 8: Bakheit AM, Severa S, Cosgrove A, et al. Safety profile and efficacy of botulinum toxin A (Dysport) in children with muscle spasticity. Dev Med Child Neurol 2001; 43: Bakheit AM, Thilmann AF, Ward AB, et al. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke 2000;31: Bakheit AM, Thilmann AF, Ward AB, et al. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke 2000; 31: Barnes M. Botulinum toxin--mechanisms of action and clinical use in spasticity. Journal of Rehabilitation Medicine. (41 Suppl):56-9, 2003 May. 10. Barwood S, Baillieu C, Boyd R, et al. Analgesic effects of botulinum toxin A: a randomized, placebo-controlled clinical trial. Dev Med Child Neurol 2000;42: Bell KR. Williams F. Use of botulinum toxin type A and type B for spasticity in upper and lower limbs. Physical Medicine & Rehabilitation Clinics of North America. 14(4):821-35, 2003 Nov. 12. Bhakta BB, Cozens JA, Bamford JM, et al. Use of botulinum toxin in stroke patients with severe upper limb spasticity. J Neurol Neurosurg Psychiatry 1996; 61: Bhakta BB, Cozens JA, Chamberlain MA, et al. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomized double blind placebo controlled trial. J Neurol Neurosurg Psychiatry 2000; 69: Blitzer A, Brin MF, Fahn S, Lange D, Lovelace RE. Botulinum toxin for the treatment of spastic dysphonia. Laryngoscope 1986; 96: Blitzer A, Brin MF, Greene PE, Fahn S. Botulinum toxin injection for the treatment of oromandibular dystonia. Ann Otol Rhinol Laryngol 1989; 98: Blitzer A, Brin MF, Stewart C, Aviv JE, Fahn S. Abductor laryngeal dystonia: a series treated with botulinum toxin. Laryngoscope 1992; 102: Botulinum Toxin Injection for Page 4 of 9

5 17. Blitzer A, Brin MF, Stewart CF. Botulinum toxin management of spasmodic dysphonia (laryngeal dystonia): a 12-year experience in more than 900 patients. Laryngoscope 1998; 108: Borg-Stein J, Pine ZM, Miller JR, et al. Botulinum toxin for the treatment of spasticity in multiple sclerosis. Am J Phys Med Rehab 1993; 72: Brashear A, Ambrosius WT, Eckert GJ, Siemers ER. Comparison of treatment of tardive dystonia and idiopathic cervical dystonia with botulinum toxin type A. Mov Disord 1998; 13: Brashear A, McAfee AL, Kuhn ER, Fyffe J. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil 2004;85: Brashear A. McAfee AL. Kuhn ER. Ambrosius WT. Treatment with botulinum toxin type B for upper-limb spasticity. Archives of Physical Medicine & Rehabilitation. 84(1):103-7, 2003 Jan. 22. Brin MF, Lew MF, Adler CH, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology 1999; 53: Brin MF. Dosing, administration, and a treatment algorithm for use of botulinum toxin A for adult-onset spasticity. Muscle Nerve 1997;suppl 6:S Burbaud P, Wiart L, Dubos JL, et al. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry 1996;61: Bushara KO, Park DM, Jones JC, Schutta HS. Botulinum toxin-a possible new treatment for axillary hyperhidrosis. Clin Exp Dermatol 1996; 21: Carr LJ, Cosgrove AP, Gringras P, Neville BG. Position paper on the use of botulinum toxin in cerebral palsy. UK Botulinum Toxin and Cerebral Palsy Working Party. Arch Dis Child 1998; 79: Cheshire WP, Abashian SW, Mann JD. Botulinum toxin in the treatment of myofascial pain syndrome. Pain 1994; 59: Comella CL, Jankovic J, Shannon KM, et al. Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia. Neurology 2005;65: Corry IS, Cosgrove AP, Walsh EG, McClean D, Graham HK. Botulinum toxin A in the hemiplegic upper limb: a double-blind trial. Dev Med Child Neurol 1997;39: Cosgrove AP, Corry IS, Graham HK. Botulinum toxin in the management of the lower limb in cerebral palsy. Dev Med Child Neurol 1994; 36: Criswell SR. Crowner BE. Racette BA. The use of botulinum toxin therapy for lower-extremity spasticity in children with cerebral palsy. Neurosurgical Focus. 21(2):e1, Dauer WT, Burke RE, Greene P, et al. Current concepts on the clinical features, aetiology and management of idiopathic cervical dystonia. Brain 1998; 121(pt 4): De Andrés J, Cerda-Olmedo G, Valía JC, Monsalve V, Lopez-Alarcón M, Minguez A. Use of botulinum toxin in the treatment of chronic myofascial pain. Clin J Pain. 2003;19(4): Difazio M, Jabbari B. Afocused review of the use of botulinum toxins for low back pain. Clin J Pain. 2002;18(Suppl 6):S Dunne JW, Heye N, Dunne SL. Treatment of chronic limb spasticity with botulinum toxin A. J Neurol Neurosurg Psychiatry 1995; 58: Dutton JJ. Botulinum-A toxin in the treatment of craniocervical muscle spasms: short- and long-term, local and systemic effects. Surv Ophthalmol 1996; 41: Eleopra R, Tugnoli V, Rossetto O, Montecucco C, De Grandis D. Botulinum neurotoxin serotype C: a novel effective botulinum toxin therapy in human. Neurosci Lett 1997; 224: Esquenazi A. Mayer N. Botulinum toxin for the management of muscle overactivity and spasticity after stroke. Current Atherosclerosis Reports. 3(4):295-8, 2001 Jul. 39. Fehlings D, Rang M, Glazier J, Steele C. An evaluation of botulinum-a toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr 2000;137: Frasson E, Priori A, Ruzzante B, Didone G, Bertolasi L. Nerve stimulation boosts botulinum toxin action in spasticity. Mov Disord 2005;20: Botulinum Toxin Injection for Page 5 of 9

6 41. Freund BJ, Schwartz M. Treatment of whiplash associated neck pain with botulinum toxin-a: Report of 8 cases. J Rheumatol 1999; 26: Frueh BR, Felt TH, Wojno TH, Musch DC. Treatment of blepharospasm with botulinum toxin: a preliminary report. Arch Ophthalmol 1984; 102: Gallien P, Nicolas B, Petrilli S, et al. Role for botulinum toxin in back pain treatment in adults with cerebral palsy: report of a case. Joint Bone Spine. 2004;71(1): Garcia Ruiz PJ, Pascual IP, Bernardos VS. Progressive response to botulinum A toxin in cerebral palsy. Eur J Neurol 2000; 7: Gelb DJ, Yoshimura DM, Olney RK, Lowenstein DH, Aminoff MJ. Change in pattern of muscle activity following botulinum toxin injections for torticollis. Ann Neurol 1991; 29: Gobel H, Heinze A, Reichel G, Hefter H, Benecke R. Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upper back myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study. Pain. 2006;125(1-2): Goldstein EM. Spasticity management: an overview. J Child Neurol 2001; 16: Gordon MF, Brashear A, Elovic E, et al. Repeated dosing of botulinum toxin type A for upper limb spasticity following stroke. Neurology 2004;63: Gormley ME, Gaebler-Spira D, Delgado MR. Use of botulinum toxin type A in pediatric patients with cerebral palsy: a three-center retrospective chart review. J Child Neurol 2001; 16: Gormley ME, O'Brien CF, Yablon SA. A clinical overview of treatment decisions in the management of spasticity. Muscle Nerve 1997;suppl 6:S Gracies JM. Singer BJ. Dunne JW. The role of botulinum toxin injections in the management of muscle overactivity of the lower limb. Disability & Rehabilitation. 29(23): , 2007 Dec Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 2003;60: Graham HK, Aoki KR, Autti-Rämö I, et al. Recommendations for the use of botulinum toxin type A in the management of cerebral palsy. Gait Posture 2000; 11: Greene PE, Fahn S. Use of botulinum toxin type F injections to treat torticollis in patients with immunity to botulinum toxin type A. Mov Disord 1993; 8: Hallan RI, Williams NS, Melling J, Waldron DJ, Womack NR, Morrison JF. Treatment of anismus in intractable constipation with botulinum toxin. Lancet 1988; 2: Hesse S, Brandl-Hesse B, Bardeleben A, et al. Botulinum toxin A treatment of adult upper and lower limb spasticity. Drugs Aging 2001; 18: Hesse S, Reiter F, Konrad M, Jahnke MT. Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial. Clin Rehabil 1998;12: Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (DysportTM) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomized, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000; 68: Jabbari B, Ney J, Sichani A, Monacci W, Foster L, Difazio M. Treatment of refractory, chronic low back pain with botulinum neurotoxin A: an open-label, pilot study. Pain Med. 2006;7(3): Jankovic J, Schwartz K. Botulinum toxin treatment of tremors. Neurology 1991; 41: Jankovic J. Botulinum toxin in the treatment of dystonic tics. Mov Disord 1994; 9: Jitpimolmard S, Tiamkao S, Laopaiboon M. Long term results of botulinum toxin type A (Dysport) in the treatment of hemifacial spasm:a report of 175 cases. J Neurol Neurosurg Psychiatry 1998; : Kamanli A. Kaya A. Ardicoglu O. Ozgocmen S. Zengin FO. Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatology International. 25(8):604-11, 2005 Oct. 64. Kay RM, Rethlefsen SA, Fern-Buneo A, Wren TA, Skaggs DL. Botulinum toxin as an adjunct to serial casting treatment in children with cerebral palsy. J Bone Joint Surg Am 2004;86-A: Botulinum Toxin Injection for Page 6 of 9

7 65. Kern U. Martin C. Scheicher S. Muller H. [Long-term treatment of phantom- and stump pain with Botulinum toxin type A over 12 months. A first clinical observation]. [German] Nervenarzt. 75(4):336-40, 2004 Apr. 66. Kesselring J, Thompson A. Spasticity, ataxia and fatigue in multiple sclerosis. Baillieres Clin Neurol 1997; 6: Kim KS, Kim SS, Yoon JH, Han JW. The effect of botulinum toxin type A injection for intrinsic rhinitis. J Laryngol Otol 1998; 112: Kirschner J, Berweck S, Mall V, et al. Botulinum toxin treatment in cerebral palsy: evidence for a new treatment option. J Neurol 2001; 248(suppl 1):I/ Kolaski K. Ajizian SJ. Passmore L. Pasutharnchat N. Koman LA. Smith BP. Safety profile of multilevel chemical denervation procedures using phenol or botulinum toxin or both in a pediatric population. American Journal of Physical Medicine & Rehabilitation. 87(7):556-66, 2008 Jul. 70. Koman LA, Mooney 3rd JF, Smith BP, Walker F, Leon JM. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop 2000;20: Koman LA, Mooney JF, Smith BP, et al. Botulinum toxin type A neuromuscular blockage in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. J Pediatr Orthop 2000; 20: Krack P, Deuschl G, Benecke R, Ceballos BA, Marion MH, Oertel WH, Poewe W. Dose standardization of botulinum toxin. Mov Disord 1998; 13: Lagalla G, Danni M, Reiter F, et al. Post-stroke spasticity management with repeated botulinum toxin injections in the upper limb. Am J Phys Med Rehab 2000; 79: Lang AM. Botulinum toxin type A therapy in chronic pain disorders. Archives of Physical Medicine & Rehabilitation. 84(3 Suppl 1):S69-73; quiz S74-5, 2003 Mar. 75. Lang AM. Botulinum toxin type B in piriformis syndrome. Am J Phys Med Rehabil. 2004;83(3): Latimer PR, Hodgkins PR, Vakalis AN, Butler RE, Evans AR, Zaki GA. Necrotising fasciitis as a complication of botulinum toxin injection. Eye 1998; 12: Lew MF, Brashear A, Factor S. The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Neurology 2000; 55(12 suppl 5):S Lu L, Atchabahian A, Mackinnon SE, Hunter DA. Nerve injection injury with botulinum toxin. Plast Reconstr Surg 1998; 101: Ludlow CL, Hallett M, Rhew K, Cole R, Shimizu T, Sakaguchi V, Bagley JA, Schulz GM, Yin SG, Koda J. Therapeutic use of type F botulinum toxin. N Engl J Med 1992; 326: Mahant N, Clouston PD, Lorentz IT. The current use of botulinum toxin. J Clin Neurosci 2000; 7: Watanabe Y, Bakheit AMO, McLellan DL. A study of the effectiveness of botulinum toxin type A (Dysport) in the management of muscle spasticity. Disabil Rehabil 1998; 20: Metaxiotis D, Siebel A, Doederlein L. Repeated botulinum toxin A injections in the treatment of spastic equinus foot. Clin Orthop 2002; 394: Mezaki T, Kaji R, Kohara N, Fujii H, Katayama M, Shimizu T, Kimura J, Brin MF. Comparison of therapeutic efficacies of type A and F botulinum toxins for blepharospasm: a double-blind, controlled study. Neurology 1995; 45: Modugno N, Priori A, Berardelli A, Vacca L, Mercuri B, Manfredi M. Botulinum toxin restores presynaptic inhibition of group Ia afferents in patients with essential tremor. Muscle Nerve 1998; 21: Nagarajan V, Al-Shubaili A, Ayad YM, Alexander J, Al-Ramezi K. Low back ache treatment with botulinum neurotoxin type A. Local experience in Kuwait. Med Princ Pract. 2007;16(3): Naumann M, Flachenecker P, Brocker EB, Toyka KV, Reiners K. Botulinum toxin for palmar hyperhidrosis. Lancet 1997; Naumann M, So Y, Argoff CE, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008;70: Botulinum Toxin Injection for Page 7 of 9

8 87. Ney JP, Difazio M, Sichani A, Monacci W, Foster L, Jabbari B. Treatment of chronic low back pain with successive injections of botulinum toxin a over 6 months: a prospective trial of 60 patients. Clin J Pain. 2006;22(4): O'Brien CF, Seeberger LC, Smith DB. Spasticity after stroke: epidemiology and optimal treatment. Drugs Aging 1996; 9: O'Brien CF. Treatment of spasticity with botulinum toxin. Clinical Journal of Pain. 18(6 Suppl):S182-90, 2002 Nov-Dec. 90. Odergren T, Hjaltason H, Kaakkola S, Solders G, Hanko J, Fehling C, et al. A double blind, randomized, parallel group study to investigate the dose equivalence of Dysport and Botox in the treatment of cervical dystonia. J Neurol Neurosurg Psychiatry 1998; 64: Pauri F, Boffa L, Cassetta E, Pasqualetti P, Rossini PM. Botulinum toxin type-a treatment in spastic paraparesis: a neurophysiological study. J Neurol Sci 2000;181: Pavesi G, Brianti R, Medici D, et al. Botulinum toxin type A in the treatment of upper limb spasticity among patients with traumatic brain injury. J Neurol Neurosurg Psychiatry 1998; 64: Pidcock FS. The emerging role of therapeutic botulinum toxin in the treatment of cerebral palsy. Journal of Pediatrics. 145(2 Suppl):S33-5, 2004 Aug. 94. Porta M, Maggioni G. Botulinum toxin (BoNT) and back pain. J Neurol. 2004;251(Suppl 1):I Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 85(1-2):101-5, 2000 Mar. 96. Richardson D, Sheean G, Werring D, et al. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry 2000;69: Rosales RL, Arimura K, Takenaga S, Osame M. Extrafusal and intrafusal muscle effects in experimental botulinum toxin-a injection. Muscle Nerve 1996; 19: Russman BS, Tilton A, Gormley MEJ. Cerebral palsy:a rational approach to a treatment protocol, and the role of botulinum toxin in treatment. Muscle Nerve 1997; 6 (Suppl.):S181-S Schapiro RT. Management of spasticity, pain, and paroxysmal phenomena in multiple sclerosis. Curr Neurol Neurosci Rep 2001; 1: Schnider P, Binder M, Kittler H, Birner P, Starkel D, Wolff K, Auff E. A randomized, double-blind, placebocontrolled trial of botulinum A toxin for severe axillary hyperhidrosis. Br J Dermatol 1999; 140: Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology 1980; 87: Shakespeare DT. Boggild M. Young C. Anti-spasticity agents for multiple sclerosis.[update of Cochrane Database Syst Rev. 2001;(4):CD001332; PMID: ]. Cochrane Database of Systematic Reviews. (4):CD001332, Simpson DM, Alexander DN, O Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial. Neurology 1996;46: Simpson DM, Alexander DN, O'Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity. Neurology 1996; 46: Simpson DM, Blitzer A, Brashear A, et al. 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: Simpson DM. Gracies JM. Graham HK. Miyasaki JM. Naumann M. Russman B. Simpson LL. So Y. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 70(19):1691-8, 2008 May Simpson DM. Treatment of spasticity with botulinum toxin. Muscle Nerve 2000; 23: Smith SJ, Ellis E, White S, Moore AP. A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000;14:5 13. Botulinum Toxin Injection for Page 8 of 9

9 109. Snow BJ, Tsui JK, Bhatt MH, Varelas M, Hashimoto SA, Calne DB. Treatment of spasticity with botulinum toxin: a double-blind study. Ann Neurol 1990;28: Stahl JS, Averbuch HL, Remler BF, Leigh RJ. Clinical evidence of extraocular muscle fiber-type specificity of botulinum toxin. Neurology 1998; 51: Suputtitada A, Suwanwela NC. The lowest effective dose of botulinum A toxin in adult patients with upper limb spasticity. Disabil Rehabil 2005;27: Tilton AH. Injectable neuromuscular blockade in the treatment of spasticity and movement disorders. Journal of Child Neurology. 18 Suppl 1:S50-66, 2003 Sep Tsui JK, Eisen A, Mak E, Carruthers J, Scott A, Calne DB. A pilot study on the use of botulinum toxin in spasmodic torticollis. Can J Neurol Sci 1985; 12: Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child 2000;83: Wang HC, Hsieh LF, Chi WC, et al. Effect of intramuscular botulinum toxin injection on upper limb spasticity in stroke patients. Am J Phys Med Rehab 2002; 81: Ward AB. Spasticity treatment with botulinum toxins. Journal of Neural Transmission. 115(4):607-16, Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal, myofascial pain syndrome. Spine 1998; 23: Wheeler AH. Botulinum toxin A, adjunctive therapy for refractory headaches associated with pericranial muscle tension. Headache 1998; 38: Wheeler JSJ, Walter JS, Chintam RS, Rao S. Botulinum toxin injections for voiding dysfunction following SCI. Journal of Spinal Cord Medicine 1998; 21: Wissel J, Heinen F, Schenkel A, et al. Botulinum toxin A in the management of spastic gait disorders in children and young adults with cerebral palsy: a randomized, double-blind study of high-dose versus lowdose treatment. Neuropediatrics 1999;30: Wissel J, Müller J, Dressnandt J, et al. Management of spasticity associated pain with botulinum toxin A. J Pain Sympt Manag 2000; 20: Wong V, Ng A, Sit P. Open-label study of botulinum toxin for upper limb spasticity in cerebral palsy. J Child Neurol 2002; 17: Yablon AS, Agana BT, Ivanhoe CB, et al. Botulinum toxin in severe upper extremity spasticity among patients with traumatic brain injury: An open-labeled trial. Neurology 1996;47: YaJie W. BaoQin G. Botulinum toxin A injection for children with spastic cerebral palsy. Developmental Medicine & Child Neurology. 50(8):640, 2008 Aug Yoshimura DM, Aminoff MJ, Olney RK. Botulinum toxin therapy for limb dystonias. Neurology 1992; 42: Zwart JA, Bovim G, Sand T, Sjaastad O. Tension headache: botulinum toxin paralysis of temporal muscles. Headache 1994; 34: Botulinum Toxin Injection for Page 9 of 9

10 ************ FOR INTERNAL SWHP USE ONLY ************ FULL HAYES RATINGS August, 2013 D1 C D2 D2 D2 B B B C D D For botulinum toxin A (BTX-A) as a treatment for chronic tension-type headache (CTTH). This Rating reflects the negative results from the majority of randomized controlled trials of BTX-A for the treatment of CTTH. For local anesthetic injection therapies for cervicogenic headache and occipital neuralgia. For local Botox injection therapy for cervicogenic headache and occipital neuralgia. For cervical radiofrequency lesions for cervicogenic headache and occipital neuralgia. For discectomy for cervicogenic headache and occipital neuralgia. For botulinum toxin type A (BTX-A) treatment of cervical dystonia. For botulinum toxin type B (BTX-B) treatment of cervical dystonia. For BTX-A treatment of blepharospasm. For BTX-A treatment of hemifacial spasm; Meige s syndrome, oromandibular dystonia; hand dystonias such as writer s cramp, stenographer s cramp, and musician s cramp; laryngeal dystonia; and as an adjunct to surgery or as an alternative to reoperation in patients with infantile esotropia or concomitant strabismus, when interference with normal visual system development is likely to occur and when spontaneous recovery is unlikely. For patients with conditions that are considered specific contraindications to BTX treatment. This Rating reflects concerns regarding the safety and/or efficacy of BTX in these patient populations. For gastroparesis Hyperhydrosis B Botulinum toxin type A (BTX-A) for treatment of axillary hyperhidrosis that is refractory to topical and pharmacological therapies. C BTX-A for treatment of palmar hyperhidrosis that is refractory to topical and pharmacological therapies. D BTX-A for digital hyperhidrosis, facial and scalp hyperhidrosis, frontal hyperhidrosis, Frey s syndrome (gustatory sweating), and plantar hyperhidrosis. D Botulinum toxin type B (BTX-B) for all forms of hyperhidrosis. Detrusor overactivity C For onabotulinumtoxina (onabtx-a) as a treatment for idiopathic or neurogenic detrusor overactivity in adults who do not have contraindications to this treatment and who cannot tolerate or have an inadequate response to management and anticholinergic medications. This Rating is based on the finding that although onabtx-a may reduce the symptoms of detrusor overactivity, the treatment is associated with several risks, the need for repeated treatments is not well characterized, and little is known about how onabtx-a compares with other current invasive treatments for detrusor overactivity. D1 For onabtx-a as a treatment for detrusor overactivity in patients who have contraindications to this treatment, including hypersensitivity to botulinum toxin type A (BTX-A) or a component in its formulation, acute urinary retention, or acute urinary tract infection. This Rating reflects concerns regarding the safety of BTX-A treatment in patients who have these conditions. D2 For abobotulinumtoxina (abobtx-a) as a treatment for idiopathic or neurogenic detrusor overactivity. This Rating is based on the small number and size of high-quality studies evaluating abobtx-a for these indications. Botulinum Toxin Injection for Page 10 of 9

11 D2 For BTX-B as a treatment for idiopathic or neurogenic detrusor overactivity. This Rating is based on the absence of randomized clinical trials evaluating this BTX serotype for these indications. B D D For botulinum toxin type A (BTX-A) treatment in adult patients with chronic anal fissures of at least 2 months duration that are refractory to conservative therapy. For BTX-A treatment in pediatric patients, due to the lack of information on efficacy or safety. For BTX-A treatment in patients with secondary anal fissures, due to the lack of information on efficacy or safety. Botulinum Toxin Injection for Page 11 of 9