migraine and botox 2013

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BoTox for BoTox for Migraines 2013 Migraines 2013 Rex Moulton-Barrett, MD Plastic & Reconstructive Surgery Alameda and Evidence Based Medicine: Often Disregarded by Insurance Carriers’

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Page 1: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Migraines BoTox for Migraines 2013 2013

Rex Moulton-Barrett, MD Plastic & Reconstructive Surgery Alameda and Brentwood Ca

‘Evidence Based Medicine: Often Disregarded by Insurance Carriers’

Page 2: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

• Does It Work : Evidence based medicine• Physiology• Techniques• Controversy• Nerve Blocks, Steroid and Surgery• Treatment Algorithms

Page 3: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

Botulinum Toxin Type A for Treatment of Migraine

‘incidental finding’

Dr. William Binder, in 1992, injected botulinum toxin type A into patient’s forehead to treat wrinkles

Several months later, patients reported a lessening of migraine symptoms

First correlation between use of botulinum toxin & reduction in headache severity

Page 4: Migraine and BoTox  2013

Single Dose 25/75U Randomized Single Dose 25/75U Randomized Double Double Blind Placebo Controlled Study, Blind Placebo Controlled Study, 20002000• N=123 N=123

• 25 or 75 Unit multiple pericranial muscles25 or 75 Unit multiple pericranial muscles

• Assessments: 1, 2, 3 months laterAssessments: 1, 2, 3 months later

• No statistical significance between either group No statistical significance between either group

Silberstein, SD. Neurology 2000; 55(60).754-762 Silberstein, SD. Neurology 2000; 55(60).754-762

Page 5: Migraine and BoTox  2013

Am Acad Neurology 2009: Am Acad Neurology 2009: Assessment on the Use of BoTox for Assessment on the Use of BoTox for Migriane andMigriane and Chronic Tension Type Headaches Chronic Tension Type Headaches

• No conclusive evidence in preventing No conclusive evidence in preventing chronic daily headacheschronic daily headaches

• Probably ineffective in episodic migraineProbably ineffective in episodic migraine

Page 6: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

271 pt study 2006 Blumenfeld Elkind A. H., O'Carroll P., Blumenfeld A., DeGryse R., Dimitrova R. ; BoNTA-024-026- 036 Study Group. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006 Oct;7(10):688-96.

• 30 injections/ treatment• treated every three months• minimum of 2 treatments

• maximum of 5 treatments • 80% (217) head pain were less frequent,

less intense or both • 60.5% (164) excellent pain relief • 19.5% (53) some pain relief • 20% (54) reported no relief

Page 7: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

95% no side effectsside effects 4-5%:eyelid drooping (1%)neck muscle weakness (1%)flu-like symptoms (< 1%) head pain (2%)

Page 8: Migraine and BoTox  2013

PPhase III hase III ReReseacrh seacrh EEvaluating valuating MMigraine igraine PProphylaxis rophylaxis TTherapherapyy 11 ( (PREEMPT 1 & 2 TrialsPREEMPT 1 & 2 Trials) 2010: ) 2010: FDA FDA clearanceclearance • 24 wk, double blind • 24 wk, double blind • followed by 32 week open label use • followed by 32 week open label use

• injections every 12 weeks: • injections every 12 weeks: 155-195 U155-195 U • pooled 2 studies n= 1384 pts • pooled 2 studies n= 1384 pts• decrease:decrease:

•• frequency headaches: p< 0.001 frequency headaches: p< 0.001 •• disabilitydisability

• did not decrease did not decrease • • medication consumed during acute medication consumed during acute

episodeepisode Dodick DW, et al, 2010. Onabotulinumtoxin A for treatment of chronic migraine: Pooled results From a double-blind, randomized placebo-controlled phases of the PREEMPT clinical program. Headache 2010; 50(6): 793-803.

Page 9: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

History of Botox Clostridium botulinum (Purified Neurotoxin Complex)

• 1895 - C. botulinum first identified - 7 serotypes (A, B, C, D, E, F, G)• 1920 - Type “A ” first isolated• 1950s - Type “A ” shown to block release of Acetylcholine• 1973 - Therapeutic potential to relax extraocular muscles investigated by Dr. Alan Scott (San Francisco, CA)• 1978 - FDA approves type A (Oculinum) for human testing• 1989 - Allergan leads Oculinum through FDA testing & receives approval for Strabismus & Blepharospasm• 1991 - Allergan acquires rights to Oculinum - name changed to Botox®• 2000 - FDA approves Botox® for treatment of Cervical Dystonia• 2002 - FDA approves Botox Cosmetic® for Glabellar Lines• 2004 - FDA approves Botox for Axillary Hyperhidrosis• 2010 - FDA approves for Migraine Headaches

Page 10: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Headaches BoTox for Headaches 2011 2011

Pharmacology of Botulinum Toxin

7 distinct antigenic types (serotypes): A, B, C, D, E, F, G A - OnabotulinumtoxinA:BoTox - Reloxin/Dysport ( FDA 4/2009 ) - IncobotulintoxinA: Xeomin ( FDA 10/2010 ) B - Rimabotulinumtioxin:Myoblock Serotypes differ:

• Biochemical structure• molecular weight• Potency (ED50)• Intracellular target

Page 11: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Mechanism of Nerve Action Potential & Muscle Mechanism of Nerve Action Potential & Muscle

ContractionContraction

Kiss-and-Run Exocytosis

Axon surface K+ positivity leads to muscle surface positivity:Ca2+

Neuromuscular Junction

Pre-Synaptic Bulb

Page 12: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox Prevents SNARE Complex BoTox Prevents SNARE Complex

formationformation

Page 13: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

• Paresis occurs after 4 - 5 days

• Lasts for 2-3 months before gradually it wear off • The paresis produces a reduction in the diameter of the targeted hyperactive muscle, or

• It will normalize the diameter of a hypertrophic muscle

Effects of BoTox- botulinum toxin A

Page 14: Migraine and BoTox  2013
Page 15: Migraine and BoTox  2013

• Cholinergic neuromuscular junctions are found between motor neurons & the extrafusal fibers+intrafusal fibers

( extrafusal fibers= motor contraction, intrafusal fibers= sensory to pressure )

• Botulinum toxin injection blocks extrafusal & intrafusal release of acetylcholine: a. reduces I & II aafferent signal from muscle spindle organs b. this reduces muscle tone by reflex inhibition

• This anti-dystonic effect, therefore, is caused not only by target

muscle paresis, but also by spinal reflex inhibition.

• Prolonged botulinum toxin leads to true muscle atrophy

• Muscle atrophy occurs in: extrafusal & intrafusal muscle fibers

Page 16: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Mechanism of Action of Mechanism of Action of BoToxBoTox

Muscle• Alpha motorneuron inhibition• Gamma motorneuron inhibition• Ia afferent reduction

Decrease Nociceptors/pain pathways:• C and A delta fibers (group III and IV)• Mechano- and chemo-nociceptors• Substance P • Calcitonin Gene Related Peptid (CGRP) • glutamate release

Page 17: Migraine and BoTox  2013

Mechanism of ActionMechanism of Action

• Reduction of nerve entrapment alone Reduction of nerve entrapment alone ??

• Reduction of spinal Ia afferents Reduction of spinal Ia afferents ??

• Reduction of Nociceptive afferents Reduction of Nociceptive afferents ??

• Reduction of Substance P Reduction of Substance P ??

Page 18: Migraine and BoTox  2013

YES TO BOTOXYES TO BOTOX

• • Tension Type Headache Tension Type Headache SymptomSymptom

• • Temple HeadachesTemple Headaches

• • Daily HeadachesDaily Headaches

• • Headache OccipitalHeadache Occipital

• • Headache in the Back of HeadHeadache in the Back of Head

• • Headache on the Top of HeadHeadache on the Top of Head

• • HeadachesHeadaches with with Neck PainNeck Pain

• • Sex HeadachesSex Headaches

NO TO BOTOXNO TO BOTOX

High Blood Pressure High Blood Pressure

Menstrual HeadachesMenstrual Headaches

Vestibular HeadachesVestibular Headaches

Headache Rebound Headache Rebound

Middle Turbinate Middle Turbinate ‘‘SinusSinus’’ HeadacheHeadache

Headache Behind the EyesHeadache Behind the Eyes

Dehydration HeadacheDehydration Headache

Barometric Pressure &Barometric Pressure & HeadacheHeadache

Page 19: Migraine and BoTox  2013

Principles BoTox for MigrainePrinciples BoTox for Migraine

IndividualizedIndividualizedPalpate muscle spasm ( trigger point )Palpate muscle spasm ( trigger point )Consider nerve block if unsure of siteConsider nerve block if unsure of siteOnset of benefit 2-4 weeksOnset of benefit 2-4 weeksIncreased duration with repeat Increased duration with repeat

injections (80%)injections (80%)

Page 20: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Migraine: BoTox for Migraine: TechniquesTechniques

3 different types of injection protocols:

• fixed site approach

• follow-the-pain approach

• combination of both

Page 21: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox Fixed Site BoTox Fixed Site Technique Technique

SupraTrochlear/ Orbital Nerve: Corrugators

ZTN:Temporalis

Greater Occipital Nerve: Semi-Spinalis Capitis

5.0 units/side 12.5U units/side

12.5 units/site• •• •• •

Lesser Occipital Nerve: Sternocleidomastoid

Page 22: Migraine and BoTox  2013

Fixed Site Fixed Site ApproachApproach

• migraine-type headaches• fixed symmetrical injection sites: pre-determined 12.5U/site except Corrugators 5

U/side • patients injected unilaterally for a unilateral headache • may develop headaches on the contra-lateral side

Page 23: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Temporal BoTox for Temporal

MigraineMigraine

• •• •

ZygomaticoTemporal (ZT) Branch of Maxillary Trigeminal nerve

ZT•• 12.5 Units / 4 pointsUsing 4 ml=100units1/2ml / 4 points= 0.125ml/point

Landmark for Nerve: 1.5 cm ( 1.5-1.7 cm ) lateral to lateral canthus & 0.6 cm ( 0.4-1.1 cm ) superior to this point

nose

temple 12. 5 U

Page 24: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Greater Occipital NerveBoTox for Greater Occipital Nerve Entrapment Tension Type Entrapment Tension Type Headache Headache

Landmarks: 3.0 cm ( +/- 7mm ) inferior to Occipital Prominence, 1.5cm ( +/- 4 mm ) lateral to midline 2.5cm deep ( 8-9 mm deep to Semispinalis Capitus )

Page 25: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Greater Occipital BoTox for Greater Occipital NerveNerve Entrapment Tension Type Entrapment Tension Type Headache Headache

12.5U = 1/2 ml ( 100U = 4 ml )

Landmarks: 3.0 cm ( +/- 7mm ) inferior to Occipital Prominence, 1.5cm ( +/- 4 mm ) lateral to midline 2.5cm deep ( 8-9 mm deep to Semispinalis Capitus )

*Occipital Prominence

Page 26: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

BoTox for Suprorbital BoTox for Suprorbital Migraine Migraine

100U=4ml, 5U/side ie place 2 injections of 0.1ml each

Innervation of Corrugator Muscle: 40% deep to muscle 34% deep and superficial 22% from above 4% superficial

Janis, et al, 2008 PRS 121(1), 233-40

Corrugator arises laterally from undersurface of frontalisCorrugator passes between orbital and palpabral orbicularisInserts in a medial & downward direction into the skin

Page 27: Migraine and BoTox  2013

Patient Care Patient Care ConsiderationsConsiderations

Avoid the orbit: Avoid the orbit: ptosisptosisAvoid periosteumAvoid periosteum: painful: painfulAvoid Superficial Temporal Avoid Superficial Temporal

VesselsVesselsAvoid Avoid Sentinel VeinSentinel Vein

Page 28: Migraine and BoTox  2013

Combination of fixed point & follow the pain techniques:

1. refractory to fixed point or2. exact site of the pain may be non - specific3. Site of pain not over 3 usual sites, ie:a. SCM: lesser occipital nerveb. Trapezius: lateral neck no name nervec. Medial Para-scapular: rhomboids no name nerved. Superior Medial Para-scapular: Levator Scapulae

Page 29: Migraine and BoTox  2013

Follow The Pain Technique

Individualized; large persons take Individualized; large persons take MOREMORE

Frontal HA Only: 30-60 UnitsFrontal HA Only: 30-60 Units

Posterior HA Only: 70-100 UnitsPosterior HA Only: 70-100 Units

Front and Back: 100-160 UnitsFront and Back: 100-160 Units

Upper back injections 40-60 UnitsUpper back injections 40-60 Units

Page 30: Migraine and BoTox  2013

Follow The Pain Approach

Indications ( Trott, 2002 ) :Indications ( Trott, 2002 ) :

Intractable headacheIntractable headache807 Patient Injections 807 Patient Injections 295 Patients295 PatientsFrontal Headache : 70% betterFrontal Headache : 70% betterChronic Daily Headache: Posterior-Neck HA:Chronic Daily Headache: Posterior-Neck HA: 87% better 87% betterSide Effects: minor bleeding, Side Effects: minor bleeding, rare burning sensationrare burning sensation

Page 31: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Follow the Pain Follow the Pain Approach Approach

Trapezius SternocleidomastoidSemispinalis Capitis

Erb’s point

Page 32: Migraine and BoTox  2013

• SCM is an anterior neck flexor

• Botox causes temporary neck flexion weakness

• Compensary recruitment from other muscle groups, may lead to altered posture: subsequent pain

Sternocleidomastoid Muscle Botox

Arch Otolatryngol Hand N Surg 2002128: 956-959 • post XRT painful neck spasm• 20-25 U BoTox/muscle• EMG guided for maximum signal• 4/6 benefited from the treatment

Page 33: Migraine and BoTox  2013

• • •••

•• • • •

35 Units each Trapezius

Page 34: Migraine and BoTox  2013

Rhomboids BoTox Rhomboids BoTox injectionsinjections

Palpate the Muscle Spasm a.k.a. trigger point

5-15 units per site

5-15 Units per injection site: up to 3 sites per side

Page 35: Migraine and BoTox  2013

Levator ScapulaeLevator Scapulae

Page 36: Migraine and BoTox  2013

• 9% neck pain• 5% headaches• 4% eyelid ptosis• 4% muscular weakness• 4% muscular stiffness• 3% bronchitis• 3% injection site pain• 3% musculoskeletal pain• 3% myalgia• 2% facial paresis• 2% hypertension• 2% muscle spasms

Overall Complications with BOTOX for Chronic Migraines

Page 37: Migraine and BoTox  2013

Rex Moulton-Barrett, MDRex Moulton-Barrett, MDPlastic & Reconstructive SurgeryPlastic & Reconstructive Surgery

San Leandro Surgery CenterSan Leandro Surgery Center

Criteria of Success

Decrease frequency & intensity of headache

Improve function & decrease disability

Reduce medication usage for headaches

Increase efficacy of acute headache medications

Happiness = Reality / Expectation

Page 38: Migraine and BoTox  2013

INDICATIONS: BoTox for chronic INDICATIONS: BoTox for chronic

migraine for prophylaxis in migraine for prophylaxis in

adultadult • Allergan:Allergan: •• Frequency: => 15 days / month, Frequency: => 15 days / month, •• Duration: => 4 hrs / dayDuration: => 4 hrs / day•• AetnaAetna + tried => 3/5 classes of migraine + tried => 3/5 classes of migraine

prophylaxis drugs for at least 60 daysprophylaxis drugs for at least 60 days • • ACE inhibitors, ie lisiniprilACE inhibitors, ie lisinipril

• • Antidepressants, ie nortryptilineAntidepressants, ie nortryptiline • • Antiepileptic drug, ie gabapentinAntiepileptic drug, ie gabapentin • • Beta blockers, ie atenololBeta blockers, ie atenolol • • Ca channel blocker, ie dlitiazemCa channel blocker, ie dlitiazem

Page 39: Migraine and BoTox  2013

Insurance Criteria: BoTox for Insurance Criteria: BoTox for chronicchronic migraine for prophylaxis in migraine for prophylaxis in

adultsadults • Blue CrossBlue Cross: : ““Recent clinical data Recent clinical data does notdoes not support support the use of BoTox in the treatment of migrainethe use of BoTox in the treatment of migraine””

• Blue ShieldBlue Shield: + 2/6 migraine : + 2/6 migraine IHC-2IHC-2 criteria criteria >= 15 days /month, >= 4hrs >= 15 days /month, >= 4hrs

> 3 consecutive months> 3 consecutive months

failed failed ‘‘adequateadequate’’ trials >= 2 agents trials >= 2 agents

• • 6 6 ( 4C1+( 4C1+2C22C2 ) ) International Headache Classification-2International Headache Classification-2 criteria:criteria:

4: unilateral, pusatile, mod/severe, aggravated routine activity4: unilateral, pusatile, mod/severe, aggravated routine activity

2: nausea/vomiting, photophobia2: nausea/vomiting, photophobia

Page 40: Migraine and BoTox  2013

Insurance Criteria: BoTox for Insurance Criteria: BoTox for chronicchronic migraine for prophylaxis in migraine for prophylaxis in

adultsadults • United Health CareUnited Health Care: : Must fulfill IHC-2 for chronic migraine as defined:Must fulfill IHC-2 for chronic migraine as defined:• >=15 days/month, >=15 days/month, • >=3 consecutive months,>=3 consecutive months,• >= 5 attacks without aura/month, >= 5 attacks without aura/month, • >=8 days per month 2/4 criteria: >=8 days per month 2/4 criteria: unilateral, pusatile, unilateral, pusatile,

mod/severe, aggravated by routine activitymod/severe, aggravated by routine activity

• and or 1/2 criteria:and or 1/2 criteria:nausea/vomiting, photophobianausea/vomiting, photophobia

• Responds to tripans and or ergotsResponds to tripans and or ergots• no medication overuseno medication overuse• Failed trials of all preventive anti-migraine medication Failed trials of all preventive anti-migraine medication

after titration to maximum tolerated doses after titration to maximum tolerated doses

Page 41: Migraine and BoTox  2013

Insurance Criteria: BoTox for Insurance Criteria: BoTox for chronicchronic migraine for prophylaxis in migraine for prophylaxis in

adultsadults • Medicare:Medicare:• ““Unresponsive to conventional methods of treatment Unresponsive to conventional methods of treatment • • medicationmedication • • physical therapyphysical therapy”” • • Primary treatment tension &/or migraine: Primary treatment tension &/or migraine: not not

coveredcovered• Requires Requires physician letter supporting medical

necessity: number of units, concentrations, map of sites, supporting literature

• 1 injection per site, maximum of 31 sites / patient1 injection per site, maximum of 31 sites / patient• 3 vials maximum per patient3 vials maximum per patient• If vial not split bill for full vial regardless if not usedIf vial not split bill for full vial regardless if not used• If split between > 1 pt must bill for exact unitsIf split between > 1 pt must bill for exact units

Page 42: Migraine and BoTox  2013

BoTox Billing CodesBoTox Billing Codes

Code346.70 chronic migraine without aura, without mention of

intractable migraine, without mention of status migrainous

346.71 no aura, + intractable migraine, no status migrainous

346.72 no aura, not intractable with + status migrarainous

346.73 no aura, +intractable, + status migainous

350.1 Trigeminal neuralgia

NEVER USE with the word “HEADACHE” when coding

Page 43: Migraine and BoTox  2013

Medicare Guidelines for BoTox UseageMedicare Guidelines for BoTox Useage

• • Code J0585, Trade Name Code J0585, Trade Name ‘‘BoToxBoTox’’, , • • use code use code ‘‘Botulinum toxin type A, per [Allergan] unit’

• • Recommend change from ‘BoTox’ to ‘Onabotulinatoxin’

• If change USAN then for code J0585, should read: ‘Onabotulinatoxin’, per unit’.

Page 44: Migraine and BoTox  2013

BoTox Billing CodesBoTox Billing Codes

Code Description

C9278 Injection, incobotulinumtoxinA, 1 unit

J0585 ( 100 units= $530 ) Injection, onabotulinumtoxinA, 1 unit

J0586 Injection, abobotulinumtoxinA, 5 units

64612 = $150 ( Medicare, 10%more PPO) either / or: 64613 = $200 ( Medicare, 10% more PPO)

Chemodenervation facial nerve muscles

Chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia)

64614 Chemodenervation of muscle(s); extremity(s) and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)

67345 Chemodenervation of extraocular muscle

64650 Chemodenervation of eccrine glands; both axillae

64653 Chemodenervation of eccrine glands; other area(s) (eg, scalp, face, neck), per day

Xeomin = incobotulinumAMyoblock = rimabotulinumABoTox = onabotulinumA

Page 45: Migraine and BoTox  2013

BoTox Assistance BoTox Assistance ProgramProgram

Allergan, Inc. donates BOTOX® vials for qualifying patients at no charge Cash payments are not involved

Provider and patient must complete the following steps: • Sponsor/MD signs the certification and consent statement • patient signs the certification and consent statement • patient must submit an acceptable form of the patient’s (or guardian’s) • • income documentation:• 1040, 1040A or • 1099 from the most recent tax year • W-2 • Social Security Statement

call 1-800-44-BOTOX (Option 6) between 9:00AM and 8:00PM EST or email at [email protected].

Page 46: Migraine and BoTox  2013

Consent for BoTox for Headache Procedure

RISKS AND COMPLICATIONS OF PROCEDUREThe following is a list of possible complications in your proposed procedure. Though some complications are more rare than others, they could occur. In any human endeavor, there are many unknowns. Hence, it is impossible to have a complete list of possible complications. If you are not satisfied with any explanation, please feel free to postpone the procedure until you believe that the potential benefit of the procedure outweighs the risks. If you would like, we encourage you to obtain a second opinion. If you have concerns or desire further explanation, please do not hesitate to ask. Understand that BOTOX injection has certain expected, but temporary side effects. Understand that BOTOX treatment is only temporary. It is not considered permanent treatment for any type of condition. BOTOX used will either be fresh or frozen. It is also understood that no injection is guaranteed to be perfect each time and that there may be variation in outcome with each injection. Several injections may need to be performed over time before the appropriate amount for a good effect can be determined for a given patient.

BOTOX Injection for Headache1. Pain at injection site2. Infection3. Bleeding (Hematoma)4. No noticeable effect5. Droopy eyelids6. Allergic reaction to medicine or material7. Headache8. Rash9. Itching10. Flu-like symptoms11. Dry mouth12. Hoarseness13. Bruising14. Temporal hollowing15. Weakness to the back of the head

I have read the above and am willing to accept the risks of surgery and I believe that the potential benefits outweigh the potential risks.________________________________Name of Patient Signature of Patient or Guardian___________________________Date

Page 47: Migraine and BoTox  2013

Nerve Blocks: safe test for Nerve Blocks: safe test for determiningdetermining fixed site injection efficacy fixed site injection efficacy• Nerve Block: Nerve Block: • • 1/4 ml 1% Lidocaine with 1:200,000 1/4 ml 1% Lidocaine with 1:200,000

epinephrine & 1/4 ml marcaine with 1:200,000 epinephrine & 1/4 ml marcaine with 1:200,000 epinephrineepinephrine

• Total = 1/2 ml ie. = volume injected with BoToxTotal = 1/2 ml ie. = volume injected with BoTox

Page 48: Migraine and BoTox  2013

Steroid Blocks: alternative to Steroid Blocks: alternative to BoTox or to determine efficacy for BoTox or to determine efficacy for first BoTox treatment: first BoTox treatment: neck onlyneck only

• When in doubt 1/4 ml kenalog 40 with When in doubt 1/4 ml kenalog 40 with 1/4 ml of 1/2 % Marcaine and 1/4 ml of 1/2 % Marcaine and 1:200,000 epinephrine can be injected1:200,000 epinephrine can be injected

• Avoid near eye and near Avoid near eye and near communicating vessels to orbit, ie communicating vessels to orbit, ie neck onlyneck only

Page 49: Migraine and BoTox  2013

Surgery for Chronic Surgery for Chronic MigraineMigraine

3 sites: • Endoscopic Corrugator resection, 3 sites: • Endoscopic Corrugator resection, • • Endoscopic ZT Nerve divisionEndoscopic ZT Nerve division • • Open division Third Occipital NerveOpen division Third Occipital Nerve release Greater Occipital Nerverelease Greater Occipital Nerve

80-90 % success rate at > 1 yr if BoTox responder80-90 % success rate at > 1 yr if BoTox responder

Page 50: Migraine and BoTox  2013

Migraine Treatment AlgorithmsMigraine Treatment Algorithms

• Nerve BlockNerve Block when in doubt when in doubt

• Steroid injectionsSteroid injections by MD to the neck only: alternative or to by MD to the neck only: alternative or to preceed BoToxpreceed BoTox

• BotoxBotox fixed site protocol based on history of site of pain and fixed site protocol based on history of site of pain and palpable trigger point, MD for follow the painpalpable trigger point, MD for follow the pain

• SurgerySurgery for BoTox responder who wants permanent for BoTox responder who wants permanent correctioncorrection

Page 51: Migraine and BoTox  2013

Thanks for your time