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Prior Authorization Protocol
BOTOXR (onabotulinumtoxin A), DYSPORTR (abobotulinumtoxin A),
XEOMIN
R (incobotulinumtoxin A), MYOBLOCR (rimabotulinum toxin type-B)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Botox:
    • Treatment of strabismus in patients 12 years and older
    • Treatment of blepharospasm associated with dystonia in patients 12 years and older
    • Treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia
    • Treatment of severe primary axillary hyperhidrosis that is inadequately managed by topical agents in adult patients
    • Treatment of upper limb spasticity in adult patients
    • To prevent headaches in adult patients with chronic migraine (15 or more days per month with headache lasting 4 hours a day or longer)
    • Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
    • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
    Dysport:
    • Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naove and previously treated patients
    • The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients <65 years of age
    • Treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors
    Xeomin:
    • Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naove and previously treated patients
    • Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox)
    • Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
    • Treatment of upper limb spasticity in adult patients
    Myobloc:
    • For the treatment of adults with cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD
  2. Health Net Approved Indications and Usage Guidelines:
    For all requests:
    • Condition for which the toxin will be used
    AND
    • Anticipated frequency of injection
    AND
    • Total dose per visit
    AND
    • Previous therapies tried

    AND

    Diagnosis of one of the following:

    • Strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older
    • Hemifacial spasm
    • Facial spasm
    • Jaw-closing oromandibular dystonia
    • Spasmodic dysphonia (laryngeal dystonia, lingual dystonia, laryngeal spasm)
    • Spasmodic Torticollis (cervical dystonia)
    • Focal task-specific dystonia
    • Head and neck tremor
    • Dynamic muscle contractions in pediatric cerebral palsy
    • Limb spasticity
    • Frey's Syndrome (gustatory sweating) secondary to parotid surgery
    • Sialorrhea in Parkinson's Disease
    • Detrussor sphincter dyssynergia (lower urinary tract dysfunction)

    OR

    • Overactive bladder or urinary incontinence due to detrusor overactivity associated with a neurologic condition
    AND
      • The patient has had an inadequate response to or clinically significant adverse reaction to at least two anticholinergic agents (oxybutynin immediate and extended release tabs, OxytrolR patch, GelniqueR gel, tolteridine immediate and extended release, ToviazR, EnablexR, VesicareR, trospium immediate and extended release).

    OR

    • Focal hand dystonias (organic writer's cramp) when incapacitating and refractive to medical treatment including oral medications

    AND

      • Documentation of functional limitations

    AND

      • The patient has failed or had a clinically significant adverse reaction to oral medications (baclofen, beta-blockers and benzodiazepines)

    OR

    • Symptomatic patients with primary, idiopathic esophageal achalasia
    • AND

      • The patient has failed or had a clinically significant adverse reaction to conventional therapy (nitrates or calcium channel blockers)

    OR

      • The patient is ineligible for surgical treatment due to advance age or multiple co-morbidities (poor surgical risk

    OR

      • The patient is at high risk of complications of pneumatic dilation or surgical myotom

    OR

      • Failure of prior myotomy or dilatio

    OR

      • The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the ristk of dilation-induced perforation

    OR

    • Focal, primary axillary or palmar hyperhidrosis

    AND

      • The patient has failed or had a clinically significant adverse reaction to topical antiperspirants (e.g., Drysol)

    AND

      • Condition creates a significant disruption to patients daily life and ability to work/function or patient has recurrent or chronic irritations and/or infections, dermatitis, skin macerations

    OR

    • Chronic anal fissure

    AND

      • The patient has failed or had a clinically significant adverse reaction to topical nitroglycerin or a topical calcium channel blocker

    OR

    • Diagnosis of internal anal sphincter (IAS) achalasia
    AND
      • The patient has not responded to treatment with laxatives
    AND
      • The patient has not responded to or is not a candidate for anal sphincter myectomy

    OR

    • Chronic migraine headache
    AND
      • The patient has a persistent history of chronic, debilitating migraine headaches with frequent attacks on 15 or more days per month for longer than 3 months
    AND
      • A neurologist has thoroughly evaluated the patient and has established a diagnosis of chronic migraine headaches
    AND
      • There is documentation of significant functional disability (e.g., work absenteeism, multiple emergency department visits)
    AND
      • The patient has failed or had a clinically significant adverse reaction to abortive treatment with at least three (3) different therapy classes listed below
    AND
      • The patient has failed or had a clinically significant adverse reaction to prophylactic therapy from at least two (2) different therapy classes listed below
  3. Coverage is Not Authorized For:
    • Cosmetic treatment of hyperfunctional wrinkles of the upper face including glabellar frown lines, deep forehead wrinkles and periorbital wrinkles (crow's feet)
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
  4. General Information:
    Medications for Abortive Migraine Treatment

    Class
    Commonly Used Examples
    Dose/Limit/Maximum Dose
    Triptans*
    ImitrexR (sumitriptan), MaxaltR (rizatriptan), Zomigb (zolmitriptan), AmergeR (naratriptan), AxertR (almotriptan), FrovaR (frovatriptan), RelpaxR (eletriptan)
    Varies according to the agent used
    Ergot derivatives
    CafergotR (ergotamine/caffeine), D.H.E.-45R (dihydroergotamine)
    Varies according to the agent used
    Analgesics*
    aspirin, acetaminophen, opioids (morphine, oxycodone), opioid combinations (APAP/codeine, APAP hydrocodone)
    Varies according to the agent used
    Non-steroidal anti-inflammatory agents (NSAIDs)
    MotrinR (ibuprofen), NaprosynR (naproxen), RelafenR (nabumetone), VoltarenR (diclofenac), OrudisR (ketoprofen), ClinorilR (sulindac), ToradolR (ketorolac)
    Varies according to the agent used
    Combination products
    MidrinR (isometheptene/APAP), FiorinalR (butalbital/aspirin), FioricetR (butalbital/APAP)
    Varies according to the agent used

    Medications for Prophylaxis Migraine Treatment

    Class
    Commonly Used Examples
    Dose/Limit/Maximum Dose
    Anticonvulsants*
    divalproex (DepakoteR), topiramate (TopamaxR)
    Varies according to the agent used
    Beta blockers
    propranolol (InderalR), metoprolol (LopressorR), atenolol (TenorminR)
    Varies according to the agent used
    Antidepressants/
    Tricyclic antidepressants
    amitriptyline (ElavilR), venlafaxine (EffexorR)
    Varies according to the agent used
    Non steroidal anti-inflammatory drugs (NSAIDs)
    Fenoprofen (NalfonR), ibuprofen (MotrinR), ketoprofen (OrudisR), naproxen (NaprosynR)
    Varies according to the agent used

    * Check the members benefits; some agents may require prior authorization.
    • All botulinum toxin products have a black box warning which cautions patients that the effects of the drug may spread from the area of injection and cause symptoms similar to botulism, including potentially life-threatening swallowing and breathing difficulty.
    • The potency Units of botulinum toxin products are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of one product cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
    • Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) and is a Class 2b recommendation in Micromedex
    • Safety and effectiveness have not been established for the treatment of all headache types except migraine as outlined above.
    • For detrusor overactivity associated with a neurologic condition there was no additional benefit of Botox 300 Units over 200 Units.
    • Safety and effectiveness have not been uniformly established for the treatment of temporomandibular disorders (TMD). Use of botulinumtoxin for this indication is a Class IIb recommendation in Micromedex based on a single study from 1999. A review of two clinical studies (from 2002 and 2011) (15 and 21 patients) found no significant differences in pain reduction between botulinumtoxin and placebo. Other small studies (from 2005 - Italy and 2008 - Turkey) have been performed and showed improvement in objective measures of pain (20 patients and 26 patients). The most common total dose of BTX-A used in the studies was 25u for each temporalis muscle and 50u for each masseter muscle. The studies did not repeat the dosing, but measured efficacy at 16 weeks post dose. The 2003 Guidelines for diagnosis and management of disorders involving the temporomandibular joint and related musculoskeletal structures mention Botox as a possible treatment option for TMJ based on its mechanism of action and the pathophysiology of TMD.
    • TMD "gold standard" treatment continues to be: 1) TMJ intraoral orthotic; 2) Muscle relaxants by mouth; and 3) Home muscle relaxation exercises/techniques.
    • Myobloc appears to be effective in the treatment of cervical dystonia in patients who have developed tolerance to or who are not responsive to botulinum toxin type A (BotoxR). Experience with Myobloc in patients who have not previously received Botox is limited. There is limited data supporting the use of Myobloc in blepharospasm, spasmodic dysphonia, axillary hyperhidrosis, plantar/palmar hyperhidrosis, gustatory sweating, sialorrhea, upper-limb spasticity due to stroke, anal fissure, detrusor hyperreflexia due to multiple sclerosis and myofascial pain syndrome.
    • Limb spasticity may be caused by Heredity spastic paraplegia; multiple sclerosis or other demyelinating diseases of the central nervous system; Spastic hemiplegia; Infantile cerebral palsy; stroke.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Various

    Depending on patient's diagnosis and previous therapy

    This field intentionally left blank.

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Botox

    Botox (onabotulinumtoxin A) Dose Chart
    Condition
    Average Duration of Effect
    Average Dose
    Blepharospasm
    12.5 weeks
    5 units per site
    Strabismus
    6-8 weeks to 6-12 months
    2.5 to 5 units per muscle (max 25 units)
    Cervical dystonia
    4 weeks to 3 months
    200 to 300 units divided among affected muscles
    Overactive bladder
    12 weeks
    Total dose 100 Units, as 0.5 mL (5 Units) injections across 20 sites into the detrusor; repeat doses should be 12 weeks apart
    Axillary Hyperhidrosis
    4-12 months
    50 units per axilla
    Migraines
    3-4 months
    155 total units given in 5 to 40 units/site
    Neurogenic bladder
    8-12 months
    200 units given in multiple sites
    Upper Limb Spasticity
    12 weeks
    12.5 Units-50 Units in one site

    6 months or to member's renewal period, whichever is sooner.

    Botox

    *Unlabelled uses

    Botox (onabotulinumtoxin A) Dose Chart
    Condition
    Average Duration of Effect
    Average Dose
    Oromandibular dystonia*
    10 to 14 weeks
    25 to 50 units per masseter muscle, 5 to 40 units per temporalis
    Spasmodic dysphonia*
    3-6 months
    0.031 to 10 units per vocal cord. 5 to 30 units in abductor muscle
    Spastic muscle contracture of pediatric cerebral palsy*
    1-6 months
    3 to 6 units/kg (maximum 12 units/kg). total dose 82 to 220 units divided among affected muscles
    Childhood myoclonus following failure of Baclofen, benzodiazepines, and antiseizure medications*
    4-8 months
    8 to 80 units/kg
    Chronic anal fissure*
    Single Injection
    20 units both sides
    Gustatory sweating (Frey's syndrome)*
    6 months
    15 to 75 units per injection
    Internal anal sphincter achalasia*Single treatment. Patient may require repeat treatment. Adults or children15 units to 25 units in each quadrant or up to 50 units on either side of IAS
    Plantar/palmar hyperhidrosis*
    4-12 months
    100 to 165 units per palm

    6 months or to member's renewal period, whichever is sooner.

    Dysport

    Cervical dystonia:
    Initial dose is 500 units IM as a divided dose among the affected muscles.
    Re-treatment every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms.
    Upper Limb Spasticity:
    As clinically appropriate
    6 months or to member's renewal period, whichever is sooner.

    Xeomin

    Cervical dystonia:
    The usual starting dose is 120 units per treatment session, doses up to 300 units may be used in treatment-experienced patients.
    Dose, number, and location of injection sites should be based on the number and location of muscles involved, severity of dystonia, and response to any previous botulinum toxin injections.
    Blepharospasm:
    When initiating Xeomin therapy, the dose, number, and location of injections should be based on the previous dosing of Botox.
    If the previous dose of Botox is not known, the recommended starting dose is 1.25-2.5 units per injection site.

    Upper limb spasticity:
    Dosing varies based on location of muscles to be treated (refer to dosing chart in the prescribing information). The recommended maximum cumulative dose is 400 units.

    Other diagnoses:
    As clinicaly appropriate

    6 months or to member's renewal period, whichever is sooner.

    Myobloc

    Cervical dystonia:
    The initial dose of Myobloc for patients with a history of tolerating botulinum
    toxin injections is 2500 to 5000 U divided among affected muscles.
    Give patients without a history of tolerating botulinum toxin injections a lower initial dose.

    Optimize subsequent dosing according to the patient's individual response.
    The duration of effect has been observed in studies to be
    between 12 and 16 weeks at doses of 5000 U or 10,000 U.

    6 months or to member's renewal period,
    whichever is sooner

  7. Product Availability:
    Botox: Powder for injection (lyophilized) 100 units, or 200 units of Clostridium botulinum toxin type A per vial
    Dysport: Powder for injection 500 unit vial; powder for injection 300 unit vial
    Xeomin: lyophilized powder for injection 50 units, 100 units, or 200 units
    Myobloc: 2,500, 5,000 and 10,000 units of rimabotulinum toxin type B per vial
  8. References:
    1. MICROMEDEXR, http://www.thomsonhc.com/. Accessed June 10, 2015.
    2. Maria G, Cassetta E, Gui D, et al., A Comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N Engl J Med. 1998; 338(4): 217-220.
    3. Mosby-Year Book, Inc., Mosby's GenRx: The Complete Reference for Generic and Brand Drugs, 8th Ed. St. Louis, MO: Mosby, 1999.
    4. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 2015.
    5. Biglan AW, et al. Management of strabismus with botulinum A toxin. Ophthalmology 1989;96(7): 935-943.
    6. Biglan AW, et al., Management of facial spasm with Clostridium botulinum toxin type A (Oculinum). Arch Otolaryngol Head Neck Surg. 1998; 114(12): 1407-1412.
    7. Kalra HK, et al., Side effects of the use of botulinum toxin for treatment of benign essential blepharospasm and hemifacial spasm. Ophthalmic Surg. 1990;21(5): 335-338.
    8. Brisinda et al., A comparison of injections of botulinum toxin and topical hitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med 1999; 341: 65-69.
    9. Schulte-Mattler WJ, Wieser T, Zierez S. Treatment of tension-type headache with botulinum toxin: a pilot study. Eur J Med Res. 1999; 4(5): 183-186.
    10. Wheeler A.H., Botulinum toxin A. adjunctive therapy for refractory headaches associated with pericranical muscle tension. Headache. 1998;38(6):468-471.
    11. Domzal TM. Botulinum toxin in the treatment of pain. Neurol Neurochir Pol. 1998;32 Suppl 1:57-60.
    12. Hobson DE, Gladish DF. Botulinum toxin injection for cervicogenic headache. Headache. 1997:37(4):253-255.
    13. Zwart JA, Bovim G, Sand T, Sjaastad O. Tension headache: botulinum toxin paralysis of temporal muscles. Headache. 1994; 34 (8): 458-462.
    14. Karamfilov T, Konrad H, Karte K, et al., Lower relapse rate of botulinum toxin A therapy for axiallary hyperhidrosis by dose increase. Arch Dermatol. 2000; 136(4): 487-490.
    15. 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.
    16. Heckmann M, Breit S, Ceballos-Baumann A, et al., Side-controlled intradermal injection of botulinum toxin A in recalcitrant axillary hyperhidrosis. J Am Acad Dermatol. 1999; 41(6): 987-990.
    17. Odderson IR. Hyperhidrosis treated by botulinum A exotoxin. Dermatol Surg. 1998; 24(11): 1237-1241.
    18. Solomon BA, Hayman R. Botulinum toxin type A therapy for palmar and digital hyperhidrosis. J Am Acad Dermatol. 2000; 42(6):1026-1029.
    19. USP DI R Drug Information for the Health Care Professional. 20th ed. B Monographs. Botulinum Toxin Type A (Parenteral-Local); 2000. STAT! Ref (Accessed June 30, 2000).
    20. Sedano MJ, Trejo JM, Macarron JL, Polo JM, Berciano J, Calleja J. Continuous facial myokymia in multiple sclerosis: treatment with botulinum toxin. Eur Neurol. 2000; 43(3): 137-40.
    21. Boghen Dr. Disorders of facial motor function. Curr Opin Ophthalmol. 1996 Dec;7(6): 48-52.
    22. Lou JS, Pleninger P, Kurlan R. Botulinum toxin A is effective in treating trismus associated with postradiation myokymia and muscle spasm. Mov Disord. 1995 Sep; 10(5): 680-681.
    23. Ruusuvaara P, Setala K. Long term treatment of involuntary facial spasms using botulinum toxin. Acta Ophthalmol (Copenh). 1990 Jun; 68(3): 331-8.
    24. Jordan DR, Anderson RL, Thiese SM. Intractable orbicularis myokymia: treatment alternatives. Ophthalmic Surg. 1989; 20(4): 280-283.
    25. Freund B, Schwartz M, Symington JM. Botulinum toxin: new treatment for temporomandibular disorders. Br J Oral Maxillofac Surg. 2000; 38(5): 466-471.
    26. Freund B, Schwartz M, Symington JM. The use of botulinum toxin for the treatmetn of temporomandibular disorders: preliminary findings. J Oral Maxillofac Surg. 1999; 57(8): 916-921.
    27. Freund B, Schwartz M. The use of botulinum toxin for the treatment of temporomandibular disorder. Oral Health. 1998; 88(2):32-37.
    28. Moore AP, Wood GD. Medical treatment of recurrent temporomandibular joint dislocation using botulinum toxin A., Br Dent J. 1997; 183(11-12): 415-417.
    29. Daelen B, Thorwirth V, Koch A. Treatment of recurrent dislocation of the temporomandibular joint with type A botulinum toxin. Int J Oral Maxillofac Surg. 1997; 26(6): 458-460.
    30. 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): S29-35.
    31. Munchau A, Bhatia KP. Uses of botulinum toxin injection in medicine today. BMJ. 2000;320:161-165.
    32. Brashear A, Lew MF, Dykstra DD, et al., Safety and efficacy of NeuroBloc (botolinum toxin type B) in type A-responsive cervical dystonia. Neurology. 1999; 53(7): 1439-1446.
    33. 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(7): 1431-1438.
    34. Cullis PA, OBrien CF, Truong DD, et al., Botulinum toxin type B: an open-label, dose-escalation, safety and preliminary efficacy study in cervical dystonia patients. Adv Neurol. 1998;78: 227-230.
    35. Pasricha PJ, Ravich WJ, Henrix TR, et al., Intraspincteric botulinum toxin for the treatment of achalasia. N Engl J Med 1995;322: 774-78.
    36. Pasricha PJ, Rai R, Ravich WJ, et al., Botulinum toxin for achalasia: Long term outcome and predictors of response. Gastroenterol 1996; 110: 1410-1415.
    37. Vaezi MF, Richter JE, Wilcox M, et al., Botulinum toxin versus pneumatic dilation in the treatment of achalasia: A randomized trial. Gut 1999, 44: 231-239.
    38. Prakash C, Freedland KE, Chan MF, et al., Botulinum toxin injections for achalasia symptoms can approximate the short-term efficacy of a single pneumatic dilation: A survival analysis approach. Am J Gastroenterol 1999; 94: 328-333.
    39. Gordon JMI, Eager ELY. Prospective study of esophageal botulinum toxin in high-risk achalasia patients. Am J Gastroenterol; 1997; 92: 1812-1817.
    40. Richter MF. American College of Gastroenterology Practice. Diagnosis and Management of Achalasia. Practice Guidelines. Am J of Gastroenterol 1999; 94(12): 3406-3412.
    41. Kolbasnik J, Waterfall WE, Fachnie B, Chen Y, et al., Long term efficacy of botulinum toxin in classical achalasia: a prospective study. Am J Gastroenterol 1999; 94(12): 3434-39.
    42. Muehldorfer SM, Schneider TH, et al., Esophageal achalasia: intrasphincteric injection of botulinum toxin, A versus balloon dilation. Endoscopy 1999; 31(7): 231-34.
    43. Dysport [Prescribing Information] Wrexham, UK, Ipsen Biopharm Ltd.; July 2015.
    44. Botox [Prescribing Information] Irvine, CA , Allergan; April 2015.
    45. Myobloc [package insert] South San Francisco, CA; Solstice Neurosciences: June 2012.
    46. Mathew NT et al. A double-blind comparison of onabotulinumtoxin A (Botox) and topiramate (Topamax) for the prophylactic treatment of chronic migraine: A pilot study. Headache November 2009 49:1466-1478.
    47. Blumenfeld AM et al. Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Headache February 2008 48:210-220.
    48. Petri S et al. Botulinum toxin as preventative treatment for migraine: A randomized double-blind study. Euro Neurol 2009 62:204-211.
    49. Aurora SK et al. Botulinum toxin type A as prophylactic treatment of episodic migraine headache: A randomized, placebo controlled, exploratory trial. Headache April 2007 47:486-499.
    50. Xeomin [Prescribing Information] Franksville, WI. Merz Pharmaceuticals; December 2015.
    51. American Society of Temporomandibular Joint Surgeons. Guidelines for diagnosis and management of disorders involving the temporomandibular joint and related musculoskeletal structures. Accessed at http://astmjs.org/guidelines.html
    52. Hoque A, McAndrew M. Use of Botulinum Toxin in Dentistry. NY State Dent J, 2009; 75(6):52-5.
    53. Nixdorf DR, Heo G, Major PW. Randomized controlled trial of botulinum toxin A for chronic myogenous orofacial pain. Pain, 2002; 99:465-73.
    54. Ernberg M, Hedenberg-Magnusson B, List T, Svensson P. Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: a randomized, controlled, double-blind multicenter study. Pain, 2011; 152:1988-96.
    55. Guarda-Nardini L, Manfredini D, Salamone M, et al. TMD Clinic, Cranio. 2008 Apr;26(2):126-35.
    56. Karacalar A, Yilmaz N, Bilgici A, Bas B, Akan H. Botulinum toxin for the treatment of temporomandibular joint disk disfigurement: clinical experience. J Craniofac Surg. 2005 May;16(3):476-81.
    57. Friedmacher F and Puri P. Comparison of posterior internal anal sphincter myectomy and intrasphincteric botulinum toxin injection for treatment of internal anal sphincter achalasia: a meta-analysis. Pediatr Surg Int. Aug 2012 28;8: 765-771.
    58. Doodnath R and Puri P. Long-term outcome of internal sphincter myectomy in patients with internal anal sphincter achalasia. Pediatr Surg Int October 2009 25;10: 869-871.
    59. Estemalik E and Tepper S. Preventive treatment in migraine and the new US guidelines. Neuropsychiatric Disease and Treatment 2013;9:709-20.
    60. Silberstein SD, Holland S, Freitag F et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Neurology 2012;78:1337-45.
    61. Perry WB, Dykes SL, Buie WD et al. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum 2010;53:1110-15.
    62. Benecke R, Jost WH, Kanovsky P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005;64(11):1949-1951.
    63. Fernandez HH, Pagan F, Danisi F, Greeley D, Jankovic J, Verma A, Sethi K, Pappert EJ; XCiDaBLE Study Group. Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 subjects with Cervical Dystonia. Tremor and Other Hyperkinet Mov. 2013;17(3). pii:tre-03-139-2924-1. Print 2013.
    64. Dressler D. Routine use of Xeomin in patients previously treated with Botox: long term results. Eur J Neurol. Dec 2009;16 Suppl 2:2-5.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.