Migraine and BoTox 2013

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Migraine and BoTox 2013

  1. 1. BoTox for Migraines 2013BoTox for Migraines 2013 Rex Moulton-Barrett, MD Plastic & Reconstructive Surgery Alameda and Brentwood Ca ‘Evidence Based Medicine: Often Disregarded by Insurance Carriers’
  2. 2. BoTox for Headaches 2011BoTox for Headaches 2011 • Does It Work : Evidence based medicine • Physiology • Techniques • Controversy • Nerve Blocks, Steroid and Surgery • Treatment Algorithms
  3. 3. BoTox for Headaches 2011BoTox for Headaches 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
  4. 4. Single Dose 25/75U RandomizedSingle Dose 25/75U Randomized DoubleDouble Blind Placebo Controlled Study, 2000Blind Placebo Controlled Study, 2000 • N=123N=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 groupNo statistical significance between either group Silberstein, SD. Neurology 2000; 55(60).754-762Silberstein, SD. Neurology 2000; 55(60).754-762
  5. 5. Am Acad Neurology 2009:Am Acad Neurology 2009: Assessment on the Use of BoTox for MigrianeAssessment on the Use of BoTox for Migriane andand Chronic Tension Type HeadachesChronic Tension Type Headaches • No conclusive evidence in preventingNo conclusive evidence in preventing chronic daily headacheschronic daily headaches • Probably ineffective in episodic migraineProbably ineffective in episodic migraine
  6. 6. BoTox for Headaches 2011BoTox for Headaches 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
  7. 7. BoTox for Headaches 2011BoTox for Headaches 2011 95% no side effects side effects 4-5%: eyelid drooping (1%) neck muscle weakness (1%) flu-like symptoms (< 1%) head pain (2%)
  8. 8. PPhase IIIhase III ReReseacrhseacrh EEvaluatingvaluating MMigraineigraine PProphylaxisrophylaxis TTherapherapyy 11 ((PREEMPT 1 & 2 TrialsPREEMPT 1 & 2 Trials) 2010:) 2010: FDA clearanceFDA clearance • 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< 0.001frequency headaches: p< 0.001 •• disabilitydisability • did not decreasedid not decrease •• medication consumed during acute episodemedication consumed during acute episode 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.
  9. 9. BoTox for Headaches 2011BoTox for Headaches 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
  10. 10. BoTox for Headaches 2011BoTox for Headaches 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
  11. 11. Mechanism of Nerve Action Potential & MuscleMechanism 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
  12. 12. BoTox Prevents SNARE ComplexBoTox Prevents SNARE Complex formationformation
  13. 13. • 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
  14. 14. • 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
  15. 15. Mechanism of Action of BoToxMechanism of Action of BoTox 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
  16. 16. Mechanism of ActionMechanism of Action • Reduction of nerve entrapment aloneReduction of nerve entrapment alone ?? • Reduction of spinal Ia afferentsReduction of spinal Ia afferents ?? • Reduction of Nociceptive afferentsReduction of Nociceptive afferents ?? • Reduction of Substance PReduction of Substance P ??
  17. 17. YES TO BOTOXYES TO BOTOX •• Tension Type Headache SymptomTension Type Headache Symptom •• 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 withwith Neck PainNeck Pain •• Sex HeadachesSex Headaches NO TO BOTOXNO TO BOTOX High Blood PressureHigh Blood Pressure Menstrual HeadachesMenstrual Headaches Vestibular HeadachesVestibular Headaches Headache ReboundHeadache Rebound Middle TurbinateMiddle Turbinate ‘‘SinusSinus’’ HeadacheHeadache Headache Behind the EyesHeadache Behind the Eyes Dehydration HeadacheDehydration Headache Barometric Pressure &Barometric Pressure & HeadacheHeadache
  18. 18. Principles BoTox for MigrainePrinciples BoTox for Migraine ♦♦ IndividualizedIndividualized ♦♦ Palpate muscle spasm ( trigger point )Palpate muscle spasm ( trigger point ) ♦♦ Consider nerve block if unsure of siteConsider nerve block if unsure of site ♦♦ Onset of benefit 2-4 weeksOnset of benefit 2-4 weeks ♦♦ Increased duration with repeat injections (80%)Increased duration with repeat injections (80%)
  19. 19. BoTox for Migraine: TechniquesBoTox for Migraine: Techniques 3 different types of injection protocols: • fixed site approach • follow-the-pain approach • combination of both
  20. 20. BoTox Fixed Site TechniqueBoTox Fixed Site 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
  21. 21. Fixed Site ApproachFixed Site Approach • 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
  22. 22. BoTox for Temporal MigraineBoTox for Temporal Migraine • • • • ZygomaticoTemporal (ZT) Branch of Maxillary Trigeminal nerve ZT•• 12.5 Units / 4 points Using 4 ml=100units 1/2ml / 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
  23. 23. BoTox for Greater Occipital NerveBoTox for Greater Occipital Nerve Entrapment Tension Type HeadacheEntrapment Tension Type 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 )
  24. 24. BoTox for Greater Occipital NerveBoTox for Greater Occipital Nerve Entrapment Tension Type HeadacheEntrapment Tension Type 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
  25. 25. BoTox for Suprorbital MigraineBoTox for Suprorbital 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 frontalis Corrugator passes between orbital and palpabral orbicularis Inserts in a medial & downward direction into the skin
  26. 26. Patient Care ConsiderationsPatient Care Considerations ♦♦Avoid the orbit:Avoid the orbit: ptosisptosis ♦♦Avoid periosteumAvoid periosteum: painful: painful ♦♦Avoid Superficial Temporal VesselsAvoid Superficial Temporal Vessels ♦♦AvoidAvoid Sentinel VeinSentinel Vein •
  27. 27. Combination of fixed point & follow the pain techniques: 1. refractory to fixed point or 2. exact site of the pain may be non - specific 3. Site of pain not over 3 usual sites, ie: a. SCM: lesser occipital nerve b. Trapezius: lateral neck no name nerve c. Medial Para-scapular: rhomboids no name nerve d. Superior Medial Para-scapular: Levator Scapulae
  28. 28. Follow The Pain Technique ♦♦ Individualized; large persons take MOREIndividualized; large persons take MORE ♦♦ 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
  29. 29. Follow The Pain Approach Indications ( Trott, 2002 ) :Indications ( Trott, 2002 ) : ♦♦Intractable headacheIntractable headache ♦♦807 Patient Injections807 Patient Injections ♦♦295 Patients295 Patients ♦♦Frontal Headache : 70% betterFrontal Headache : 70% better ♦♦Chronic Daily Headache: Posterior-Neck HA:Chronic Daily Headache: Posterior-Neck HA: 87% better87% better ♦♦Side Effects: minor bleeding,Side Effects: minor bleeding, rare burning sensationrare burning sensation
  30. 30. Follow the Pain ApproachFollow the Pain Approach Trapezius SternocleidomastoidSemispinalis Capitis Erb’s point
  31. 31. • 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 2002 128: 956-959 • post XRT painful neck spasm • 20-25 U BoTox/muscle • EMG guided for maximum signal • 4/6 benefited from the treatment
  32. 32. • • • •• • • • • • • • 35 Units each Trapezius •
  33. 33. Rhomboids BoToxRhomboids 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
  34. 34. Levator ScapulaeLevator Scapulae
  35. 35. • 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
  36. 36. 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
  37. 37. INDICATIONS: BoTox for chronicINDICATIONS: BoTox for chronic migraine for prophylaxis in adultmigraine for prophylaxis in adult • 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
  38. 38. Insurance Criteria: BoTox for chronicInsurance Criteria: BoTox for chronic migraine for prophylaxis in adultsmigraine for prophylaxis in adults • Blue CrossBlue Cross:: ““Recent clinical dataRecent clinical data does notdoes not support thesupport the use of BoTox in the treatment of migraineuse of BoTox in the treatment of migraine”” • Blue ShieldBlue Shield: + 2/6 migraine: + 2/6 migraine IHC-2IHC-2 criteriacriteria >= 15 days /month, >= 4hrs>= 15 days /month, >= 4hrs > 3 consecutive months> 3 consecutive months failedfailed ‘‘adequateadequate’’ trials >= 2 agentstrials >= 2 agents •• 66 ( 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
  39. 39. Insurance Criteria: BoTox for chronicInsurance Criteria: BoTox for chronic migraine for prophylaxis in adultsmigraine for prophylaxis in adults • 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 medicationFailed trials of all preventive anti-migraine medication after titration to maximum tolerated dosesafter titration to maximum tolerated doses
  40. 40. Insurance Criteria: BoTox for chronicInsurance Criteria: BoTox for chronic migraine for prophylaxis in adultsmigraine for prophylaxis in adults • Medicare:Medicare: • ““Unresponsive to conventional methods of treatmentUnresponsive to conventional methods of treatment •• medicationmedication •• physical therapyphysical therapy”” •• Primary treatment tension &/or migraine:Primary treatment tension &/or migraine: not coverednot covered • RequiresRequires 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
  41. 41. BoTox Billing CodesBoTox Billing Codes Code 346.70 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
  42. 42. Medicare Guidelines for BoTox UseageMedicare Guidelines for BoTox Useage •• Code J0585, Trade NameCode J0585, Trade Name ‘‘BoToxBoTox’’,, •• use codeuse 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’.
  43. 43. 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 = incobotulinumA Myoblock = rimabotulinumA BoTox = onabotulinumA
  44. 44. BoTox Assistance ProgramBoTox Assistance Program 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 PatientAssistance@BOTOX.com.
  45. 45. Consent for BoTox for Headache Procedure RISKS AND COMPLICATIONS OF PROCEDURE The 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 Headache 1. Pain at injection site 2. Infection 3. Bleeding (Hematoma) 4. No noticeable effect 5. Droopy eyelids 6. Allergic reaction to medicine or material 7. Headache 8. Rash 9. Itching 10. Flu-like symptoms 11. Dry mouth 12. Hoarseness 13. Bruising 14. Temporal hollowing 15. 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
  46. 46. Nerve Blocks: safe test for determiningNerve Blocks: safe test for determining fixed site injection efficacyfixed site injection efficacy • Nerve Block:Nerve Block: •• 1/4 ml 1% Lidocaine with 1:200,000 epinephrine &1/4 ml 1% Lidocaine with 1:200,000 epinephrine & 1/4 ml marcaine with 1:200,000 epinephrine1/4 ml marcaine with 1:200,000 epinephrine • Total = 1/2 ml ie. = volume injected with BoToxTotal = 1/2 ml ie. = volume injected with BoTox
  47. 47. Steroid Blocks: alternative to BoTox orSteroid Blocks: alternative to BoTox or to determine efficacy for first BoToxto determine efficacy for first BoTox treatment:treatment: neck onlyneck only • When in doubt 1/4 ml kenalog 40 with 1/4When in doubt 1/4 ml kenalog 40 with 1/4 ml of 1/2 % Marcaine and 1:200,000ml of 1/2 % Marcaine and 1:200,000 epinephrine can be injectedepinephrine can be injected • Avoid near eye and near communicatingAvoid near eye and near communicating vessels to orbit, ie neck onlyvessels to orbit, ie neck only
  48. 48. Surgery for Chronic MigraineSurgery for Chronic Migraine 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
  49. 49. Migraine Treatment AlgorithmsMigraine Treatment Algorithms • Nerve BlockNerve Block when in doubtwhen in doubt • Steroid injectionsSteroid injections by MD to the neck only: alternative or toby MD to the neck only: alternative or to preceed BoToxpreceed BoTox • BotoxBotox fixed site protocol based on history of site of painfixed site protocol based on history of site of pain and palpable trigger point, MD for follow the painand palpable trigger point, MD for follow the pain • SurgerySurgery for BoTox responder who wants permanentfor BoTox responder who wants permanent correctioncorrection
  50. 50. Thanks for your time

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