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Learn more about NeuroStar TMS (transcranial magnetic stimulation) TherapyTRANSCRIPT
Advancing the Way In Treating Major Depression
MDD: A Large Patient Population That Is Currently Being
Underserved
2Kessler RC et al. JAMA. 2003;289(23):3095-3105.
14 Million US Adults with
MDD
•Inadequate response•Intolerant to side
effects
7.2 Million
Treated
4 Million Poorly Served
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This means every 20 MDD sufferers…
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…15 are not being adequately treated.
4
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Current Drug Treatment Paradigm for Depression
5Adapted from: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3rd Edition, APA (2010)
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Major DepressionCurrent Treatment Landscape
With each successive treatment failure, the landscape changes:
6Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am J Psychiatry
High
LowTreatmentResponsive
Treatment
ResistantDisease Staging (# of Tx
Failures)
Durability Likelihood of
long-term durability of benefit declines
Efficacy Likelihood of benefit from the next option diminishes
Efficacy, Adverse Events, and Durability Results With Each Successive Treatment Failure
Adverse
EventsIntolerance due to adverse events worsens
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STAR*D Study demonstrates that current treatment has limited effectiveness
7
Likelihood of achieving remission is limited and
Declines with each successive treatment attempt
Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am J Psychiatry
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Likelihood of discontinuing treatment increases with each new medication attempt
8
Systemic Drug Side Effects
Weight Gain
Constipation
Diarrhea
Nausea
Drowsiness
Insomnia
Decreased Libido
Nervous Anxiety
Increased Appetite
Decreased Appetite
Fatigue
Headache/Migraine
Abnormal Ejaculation
Impotence
Sweating
Tremor
Treatment Discontinuation Side Effects
Weakness
Dry Mouth
Dizziness
Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am J Psychiatry; Neuronetics, Inc. (data on file)
The Burden of Major Depression
99
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A Major Burden for Society Today:
Top 10 Causes of Disability
1. Lower Respiratory Infections
2. Diarrheal Diseases
3. UNIPOLAR MAJOR DEPRESSION 4. Ischemic Heart Disease
5. HIV/AIDS
6. Cerebrovascular Disease
7. Premature Birth
8. Birth Trauma
9. Road Traffic Accidents
10. Neonatal Infections
10The World Health Organization. The World Health Report 2004: Changing History, Annex Table 3: Burden of disease in DALYs by cause. Geneva: WHO, 2004.
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By 2030…Top 10 Causes of Disability
1. UNIPOLAR MAJOR DEPRESSION 2. Ischemic Heart Disease
3. Road Traffic Accidents
4. Cerebrovascular Disease
5. Chronic Obstructive Pulmonary Disease
6. Lower Respiratory Infections
7. War
8. HIV/AIDS
9. Diabetes
10. Neonatal Infections
11The World Health Organization. The World Health Report 2004: Changing History, Annex Table 3: Burden of disease in DALYs by cause. Geneva: WHO, 2004.
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Consumers want alternatives in overcoming Depression…
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NeuroStar TMS Therapy: An EffectiveTreatment for Depression
•A complete clinical system using a highly focused pulsed magnetic field to stimulate nerve cells in the area of the brain that controls mood.
•The first TMS system cleared by the US Food and Drug Administration (FDA) for the treatment of patients with major depression when initial antidepressant medication fails.
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NeuroStar TMS Session
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Mechanism of Action
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Major Depressive Disorder
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prefrontalcortex
amygdala
brainstem neurotransmitter centers
thalamus
striatum
anterior cingulate cortex
hippocampus
hypothalamusNeuroStar SYSTEM
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prefrontalcortex
In MDD, some
areas of the brain
are hypoactiv
e and others are hyperacti
ve.
amygdala
brainstem neurotransmitter centers
thalamus
striatum
anterior cingulate cortex
hippocampus
hypothalamus
LOW
HIGH
Neural Activity
Major Depressive Disorder
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Serotonin (5-HT) Dopamine (DA) Norepinephrine (NE)Monoamine Neurotransmitters
monoamine neurotransmitte
r projectionsRegions implicated in MDD
are connected to the brainstem via
monoaminergic circuits
Major Depressive DisorderCircuits and Neurotransmitters
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When there is an appropriate amount of
monoamine neurotransmitter activity, neuronal
activity throughout the brain functions
normally.
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concentrationpleasure/interests
guiltsuicidalityworthlessnessmood
sleepappetite
psychomotor fatigue (physical)pleasure/interests
psychomotor fatigue (mental)
guiltsuicidalityworthlessness
mood
• Monoamine dysfunction is linked to MDD
• Malfunctioning circuits lead to specific symptoms
Serotonin (5-HT) Dopamine (DA) Norepinephrine (NE)Monoamine Neurotransmitters
Major Depressive DisorderCircuits and Neurotransmitters
Chemical Antidepressants
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Antidepressant
Therapeutic Effects such as :
improved mood
increased concentratio
n
reduced feelings of guilt, suicidality, and worthlessness
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Chemical Antidepressants
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weight gainsexual
dysfunction
insomnia
nausea
GI distres
s
blood pressure changes
blurred vision
Antidepressant
Side Effects such as:
weight gain
insomnia
agitation dry mouth fatigue
Neuron
NeuroStar Directly Depolarizes Cortical Neurons
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Precise pulsed magnetic fields from NeuroStar:
Depolarization leads to action potentials in local neurons and thereby releases
neurotransmitters
Neurons are “electrochemical cells” and respond to either electrical or chemical stimulation
• elicit action potentials• cause the release of chemical neurotransmitters
• induce a local electric current in the cortex which depolarizes neurons
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NeuroStar Releases Neurotransmitters in the Brain
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Depolarization of neurons in the DLPFC causes local neurotransmitter release
Depolarization of pyramidal neurons in the DLPFC causes neurotransmitter release in deeper brain neurons
Activation of deeper brain neurons then exerts secondary effects on remaining portions of targeted mood circuits
Dorsolateral prefrontal
cortex
Cingulate cortex
Kito (2008) J Neuropsychiatry Clin Neurosci
These effects demonstrate
improvements in depressive symptoms
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Mechanism of Action Summary
NeuroStar TMS Therapy…• Specifically targets the underlying brain circuits
involved in mood regulation• Directly depolarizes cortical neurons and modulates
neurotransmitter release in the brain• Effects involve both the local and deep neural circuits in
the brain• Accomplishes these effects without unwanted systemic
adverse effects
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TMS Therapy is not ECT
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The NeuroStar TMS
Therapy System
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NeuroStar TMS in Clinical Practice
•Non-invasive•No anesthesia or sedation•Outpatient procedure easily performed in psychiatrists’ offices
•37-minute daily procedure (3000 pulses)
•4-6 week treatment course•Antidepressant medication monotherapy may be used for maintenance
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NeuroStar TMS Therapy System
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User Interface
Treatment Coil
Mobile Console
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Accurate, Repeatable Positioning
Patented 3D Coil Positioning System
Accurately uses external cranial landmarks for precise, targeted repeatable stimulation• Integrated laser facilitates accurate alignment of patient’s head within head support
•Maintains proper patient alignment throughout treatment
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Designed for Cortical Neuron Stimulation
Patented Precision Pulse TMS™ Technology• Proprietary coil design
increases efficiency and reduces heating to permit high patient throughput
• Focuses stimulation to the intended target tissue to maximize safety and efficacy
• Electromagnetic pulse duration designed to stimulate cortical neurons (<200 microseconds)
30
<
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NeuroStar SYSTEM
SenStar® Key Link to Consistent Treatment
31
SENSORY GUARDReduces magnetic field strength at the scalp
HYGIENE BARRIER
CONTACT SENSORConstantly monitors proper contact to ensure maximum therapy
SMART CHIPSignal processor remembers unique SenStar ID and monitors treatment status
Layered SenStar Illustration
SenStar Treatment Link
MAGNETIC FIELD DETECTORVerifies intensity of the magnetic field before every treatment
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SenStar Real Time Treatment Monitoring
Attached to coil, continuously communicates with the NeuroStar System, allowing the operator to:• Verify correct magnetic field strength
for each treatment
• Monitor coil/patient contact to ensure consistent stimulation of the cortex
• Ensure proper coil to head alignment32
SenStar Treatment Link
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Intuitive User Interface
NeuroStar TMS Therapy System Software• Complete software system easily
guides operator step-by-step through entire treatment workflow
• Controls therapeutic settings for safe and effective treatment
• Automatically stores and recalls individual patient data for subsequent treatments
• Aids compliance with NINDS Safety Guidelines*
33*Wassermann. Electroencephalography and clinical Neurophysiology, 1996.
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TMS TrakStar™ Simplifies Practice Management
TMS TrakStar™ Practice Data Management System
• Centralized patient database for single or multiple NeuroStar systems
• Tracks NeuroStar treatment history• Tracks clinical
outcomes• Produces reports
for patient records, reimbursement claims and communication to referring physicians
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Sample Outcomes Tracking Report
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TMS TrakStar™ Stores Data for Single or Multiple Systems
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Who Is Neuronetics?
•Founded in 2003•Highly experienced management and clinical team
•21 TMS patents•Significant support from top tier medical technology investors
36
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Who Is Neuronetics?
•Leader in TMS Therapy innovation, quality, clinical research, product development and support
•Pioneered TMS Therapy and made it a clinical reality in multiple practice settings
•Solely focused on the long term success of physicians and the health of their patients
37
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Clinical Data
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Agency for Healthcare Research and Quality Confirms Evidence Base for Efficacy of TMS
• Independent, Peer-reviewed• 15 TMS clinical trials involving nearly 500 patients
• Average HAM-D decrease in depressive symptoms >5 points vs. sham control
• Meets clinical significance threshold of 3 points on the HAM-D scale
• Response rate with active TMS was >3x higher than sham treatment
• Remission rate with active TMS was >6x higher than sham treatment
39
“High strength of evidence” for efficacy from well-controlled RCTs
Agency for Healthcare Research and Quality: Comparative Effectiveness Report on Non-Pharmacologic Treatments for Depression , October 2011
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Improved Durability of Effect
Study
Improved
A Rigorous Clinical Program to Prove Safety and Efficacy
40
NotImproved
Open-Label Extension
Study
NeuroStar Clinical Development Program
Acute Efficacy& Safety
Study (Double Blind, Sham Controlled)
These studies form the basis for FDA-clearance of the NeuroStar TMS Therapy System
O’Reardon, et al. (2007), Biological Psychiatry; Avery, et al. (2007), J Clin Psychiatry; Janicak, et al. (2010), Brain Stimulation
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A Randomized Controlled Trial Conducted
In a “Difficult to Treat” PopulationTMS monotherapy trial with wash-out period
• Primary diagnosis: DSM-IV Major Depressive Disorder
• Unipolar type, non-psychotic• Moderate to severe symptoms at baseline
Indicated patient population (164) had extensive prior antidepressant drug exposure• Average number of antidepressant medication trials in
current episode = 4 (range: 1 to 23 attempts)• Majority of treatment attempts were unable to achieve
adequate dose and duration of treatment due to intolerance
• Indicated patients had failed to achieve satisfactory benefit from one antidepressant medication at an adequate dose and duration in the current episode 41O’Reardon JP, et al. (2007). Biol Psychiatry 62(11):1208-1216.; Demitrack MA, Thase ME
(2009). Psychopharmacol Bull 42(2):5-38.
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There is evidence between Clear Separation Active and Sham Treatment
42Demitrack and Thase (2009), Psychopharm Bulletin
LOCF Analysis of intent-to-treat population
Greater Than 3 Times Reduction in Depressive Symptoms at Week 4
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UNMET NEEDSRandomized Controlled Trial Key Outcome Measure –
MADRS Change Score
Response and Remission Rates 2 to 3 Times Better – Active vs. Sham
43
Response = ≥50% improvement at end point compared to baseline scoreRemission = HAMD24 total score of <11 = P <0.05
Demitrack MA, Thase ME (2009). Psychopharmacol Bull 42(2):5-38.
Randomized Controlled Trial – Secondary Efficacy Outcomes Response and Remission Rates for NeuroStar TMS Therapy vs. Sham at 6 Weeks
*
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Significant Response and Remission Rates
44Demitrack MA, Thase ME (2009). Psychopharmacol Bull 42(2):5-38.
Week 2 Week 4 Week 6
Response Rate
60
50
40
30
20
10
0
7.0
23.318.6
37.232.6
53.3
Remission Rate
HAMD-24 Response and Remission Rates in the Group Transitioning from Sham to Active
Treatment MOA
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Less than 5% discontinuation rate due to adverse events
A Proven Safety and Patient Tolerability Profile
Most common adverse event related to TMS is localized pain or discomfort at or near the treatment area during active TMS
• No systemic side effects
• No adverse effect on cognition
Post marketing experience confirms a rare risk of seizure with TMS treatment
• No seizures reported during NeuroStar clinical studies (10,000 treatments)
• 0.003% per treatment, <0.1% per patient• Almost 250,000 treatments to date in post-marketing
experience
Long-term safety demonstrated in 6 months follow-up
46Janicak, et al. J Clin Psychiatry, 2008; Janicak, et al. Brain Stimulation, 2010.
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Independent Study Reinforces EfficacyOptimization of TMS (‘OPT-TMS’) Study
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Mark S. George, MD; Sarah H. Lisanby, MD; David Avery, MD; William M. McDonald, MD; Valerie Durkalski, PhD; Martina Pavlicova, Phd; Berry Anderson, Phd, RN; Ziad Nahas, MD; Peter Bulow, MD; Paul Zarkowski, MD; Paul E. Holtzheimer III, MD; Theresa Schwartz, MS; Harold A. Sackeim, PHD
• National Institute of Mental Health (NIMH) sponsored– Independent of industry
• Rigorous Randomized Controlled Trial– 190 patients treated at 4 premier academic sites
• Primary outcome measure: Percent Remission at 3 weeks
‒ Active 15% vs. Sham 4% (P = 0.015) George, Arch Gen Psychiatry,
2010
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NeuroStar TMS Therapy: Real World Outcomes
Treatment Utilization and Outcomes Study
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Naturalistic Study Demonstrates Acute Efficacy Outcomes in Real-World Clinical Practice
• Study goal was to define real world outcomes associated with NeuroStar TMS Therapy across a broad spectrum of patients and practitioners
• Examine acute phase response and one year patient outcomes
• Patient Population & Trial Sites• 307 evaluable unipolar, non-psychotic MDD patients in acute phase• 42 sites comprised of institutions and private practice
• Study Design Phases• Acute phase (treatment course driven by patient clinical response)• Long-term outcomes at 3, 6, 9 and 12 months
49Carpenter, Depression and Anxiety, 2012
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Patients in this study diagnosed with Major Depression
50Carpenter, Depression and Anxiety, 2012
Patient and Treatment Characteristics N (%) Female 205 (66.8)
Age in years, mean (SD) 48.6 (14.2)
Disease and Treatment History N(%)- Recurrent Major Depression- Comorbid Anxiety Disorder
285 (92.8)46 (15.0)
Psychiatric Treatment History N(%)- History of Inpatient Hospitalization- History of ECT Treatment
133 (43.3)15 (4.9)
Prior Antidepressant Medication Treatment mean (SD)- Average Number of Adequate Treatments in Current Episode
2.5 (2.3)
Mean (SD) Number of TMS Sessions During Acute Treatment 28 (10.1)
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Comparison of End of Acute Treatment Clinical Status: Clinician Assessed Outcomes
51Carpenter (2012), Depression and Anxiety
LOCF Analysis of intent-to-treat population
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LOCF Analysis of intent-to-treat population
Comparison of End of Acute Treatment Clinical Status: Patient-Assessed Outcomes
52Carpenter (2012), Depression and Anxiety
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Consistent Response & Remission Rates in a Difficult to Treat Population at end of Acute Phase
53Carpenter (2012), Depression and Anxiety
LOCF Analysis of intent-to-treat population
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Patient Disposition in Outcomes Study Through 1 Year Follow Up
54
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Long Term Phase Results at 12 Months
Outcomes measured for one year following end of acute treatment• Physician directed standard
of care• 36.2% of patients received
TMS reintroduction • Average number of TMS
treatment days equals 16
55
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Long term durability of effect has not been established in a controlled trial
LOCF Analysis; Neuronetics, Data on file, NCT 00104611
Largest Clinical Data Set of Any TMS Therapy in DepressionSix studies completed with 800 patients
• Two multisite, randomized controlled trials demonstrate clinically significant antidepressant effect of TMS
• Two open-label extension studies demonstrate consistent results
• One prospective, naturalistic study confirms results in real-world practice
• One open-label long term follow-up demonstrates safety
56O’Reardon, et al. (2007) Biological Psychiatry; Demitrack & Thase. (2009) Psychopharm Bull; George, Arch Gen Psychiatry, 2010; McDonald WM, et al. (2011) Depression and Anxiety; Carpenter (2012), Depression and Anxiety; Janicak, et al. (2010) Brain Stimulation; Janicak, et al. (2008) J Clin Psychiatry.
NeuroStar TMS Therapy consistently demonstrates significant response and remission rates in a difficult to treat population:
1 in 2 patients respond
1 in 3 patients achieved complete remission of
symptoms
Avoids many of the systemic side effects typically associated with antidepressant medications
Excellent safety profile and treatment adherence with less than 5% discontinuation rate due to adverse events
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NeuroStar TMS Therapy is an Established Therapy Beyond Clinical Trials
• Independent, Peer Review analysis (AHRQ) confirms efficacy in TMS class
• Included in the revised 2010 American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients With Major Depressive Disorder
• Several government and commercial payers have developed coverage policies for TMS
• Three CPT 1 codes established for TMS• Approximately 470+ NeuroStar Systems Installed• Over 11,000 patients safely treated with NeuroStar TMS Therapy
57Agency for Healthcare Research and Quality: Comparative Effectiveness Report on Non-Pharmacologic Treatments for Depression, October 2011; Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3 rd Edition (2010) American Psychiatric Association;
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Nearly all patients received multiple inadequate treatment attempts in current episode
(range: 1 to 23 attempts, avg: 4)
NeuroStar TMS Therapy: Indication for Use
58
The NeuroStar TMS System is indicated for the treatment of
adult patients with Major Depressive Disorder (MDD) who
have failed to receive satisfactory improvement from one prior
antidepressant medication at or above the minimal effective dose
and duration in the current episode…
Demitrack & Thase. (2009) Psychopharm Bull
”
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TMS is Included in Practice GuidelinesFollowing Failure of Initial Treatment
59Schlaepfer, et al. World J Biol Psychiatry (2009); Kennedy, et al J Aff Disorders (2009); American Psychiatric Association (2010)
Canadian Network for Mood and Anxiety Treatments (2009)
Guideline Sources
American Psychiatric Association (2010)
“…Acute phase treatment may include pharmacotherapy, depression-focused psychotherapy, the combination of medications and psychotherapy, or other somatic therapies such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or light therapy…”
World Federation of Societies for Biological
Psychiatry (2009)
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Top Psychiatry Facilities Provide NeuroStar TMS Therapy
• Johns Hopkins Hospital, Baltimore, Maryland• McLean Hospital, Belmont, Massachusetts• Sheppard and Enoch Pratt Hospital, Baltimore,
Maryland• Mayo Clinic, Rochester, Minnesota• UCLA, Los Angeles, California
60
Other notable hospitals and institutions include: Stanford Hospital, Alegent Health, Berenson-Allen Center for Noninvasive Brain Stimulation (Beth Israel DMC), Florida Hospital, University of Michigan, Butler Hospital/Brown University, Medical University of South Carolina, Rush University, Walter Reed, University of Florida, Loma Linda University, Boston University, University of South Florida and Southern Illinois University,
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Patient Experiences with NeuroStar
61
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Best Practices Treatment Guideline for DepressionBased on 2010 APA guidelines and NeuroStar TMS Therapy
62Adapted from: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3rd Edition, APA (2010)
SSRI
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Who is the NeuroStar TMS Therapy Patient?
• In a recurrent episode of depression• Has had many medication attempts, yet remains symptomatic
• Due to intolerance, patient has only been able to take one medication at adequate dose and duration
• Considering a complex multi-drug regimen but concerned about side effects:
• Adding another antidepressant medication• Stepping up to an atypical antipsychotic or patient has already failed to benefit from one
• Demonstrates motivation for change
63
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Who is a NeuroStar TMS Therapy Patient
64
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Sarah G. Age 37
65
Sarah G was first diagnosed with depression at age 20. This recurrent episode was precipitated by dealing with infertility. She tried an SSRI for eight weeks which worked in the past but not in this episode. She has added duloxetine and bupropion, but could not tolerate the side effects and remains symptomatic with difficulty sleeping. She is a school administrator, enjoys her job and loves the benefits of the school calendar. She really wants to get better so she and her husband can begin the adoption process and start a family.
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
George T. Age 52
66
George T is a computer programmer for a fast paced, high tech company. He loves his job and it makes him feel young at age 52. He has had depression for many years and good success with medications in the past. In this episode however, the drugs are just not working, even after many medication attempts, one of which was even for 8 weeks. He even tried an augmentation therapy with an atypical antipsychotic in this episode but had to stop due to weight gain and rising blood glucose levels. He has a family history of diabetes. He is highly motivated to pursue new treatment options because he wants to be in the game at the office.
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Julie A. Age 49
67
Julie A is a classic middle aged mom, chasing her teenagers andworrying about her elderly parents. She is teaching her 17 year-old son to drive a car and wonders how she ever got to be age 49! She was first diagnosed with MDD in her early thirties along with generalized anxiety. In this recurrent episode, she has tried many medications but was only able to stay on one for 6 weeks at the right dose. And after all that work to stay on the medication,it just did not make her feel better. The other medications left her in a fog. Julie is motivated to get well because she wants to remain engaged with her busy family and to be there when her son passes his driver’s test.
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar TMS Therapy Summary
NeuroStar TMS Therapy is:• An effective, proven treatment for major depression when initial drug treatment fails
• Included in APA Practice Guidelines
•A valuable treatment for patients with depression who want to reduce medications and their side effect burden
68
MOA
NeuroStar SYSTEM
PRACTICE SUCCESS PROGRAM
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar TMS Therapy
Practice Success Program
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar Practice Success ProgramPurpose: Accelerate integration of Neurostar TMS Therapy into a psychiatric practice utilizing a structured six stage process.
70
Through a focused six stage process, each with clear milestones, the practice is given a roadmap toward creating a successful NeuroStar TMS clinic.
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Practice Success Program Resources
•Neuronetics TMS Specialist: Assigned to the practice to drive the process
•Practice resources: Physician, TMS Coordinator and practice staff align on roles and practice goals
•PSP tool set: From clinical training through NeuroStar TMS consultations to tips on marketing the practice
71
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 1 – Planning and Installation
•Your TMS Specialist will partner with you from the very beginning
•You’ll benefit from our experience as you plan the integration of your NeuroStar System into your practice
72
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
StarGuard® Field Service
•“Turn-key” installation process
•24/7 hotline to our fast, responsive local service
•Service representatives located throughout the U.S.
•Always have access to the latest NeuroStar TMS technology for your patients
73
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 2 – Online and Staff Training
• Build a strong foundation for your NeuroStar practice through comprehensive staff training, including training on patient finance resources
• Understand best practices for identifying NeuroStar patients and developing a TMS intake process
• Begin online clinical training through NeuroStar University
74
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 3 – Consult Training
• Understand the dynamics of a NeuroStar TMS consultation
• Complete review of NeuroStar patient education materials
75
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Patient Education
• Wide range of patient-friendly educational materials
• Provide your patients the knowledge they need to understand NeuroStar TMS Therapy
76
• Help facilitate patient decision-making about choosing NeuroStar TMS Therapy with your guidance
• Assist family members in understanding NeuroStar TMS Therapy
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Patient Financing Options
• Financing is available for NeuroStar TMS Therapy which meets the individual needs
• Creates greater access to your practice, reduces the barriers to treatment
• Allows consumers to bring the benefits of NeuroStar to more patients
77
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 4 – Clinical Training
• Master the use of the NeuroStar System through our on-site Clinical Training
• Performed right in your office with actual NeuroStar patients
78
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar University Clinical Training & Support
•Deliver NeuroStar TMS Therapy to your patients knowing you have received top quality training
•Provide the highest quality clinical care toyour patients
•Position yourself as a leader in the emerging new field of “interventional psychiatry”
79
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 5 – Outcome Analysis
•Utilize TMS TrakStar™ Practice Data Management Software to track your outcomes as you prepare to educate your community about NeuroStar TMS Therapy
•Track your outcomes for patient, referring physician and reimbursement purposes
80
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Stage 6 – Increasing Awareness
•Grow your NeuroStar practice by increasing TMS awareness in your community
•Utilize tools and resources to educate referring physicians and reach new patients
81
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Public Relations & Local Outreach
• Neuronetics works in many geographic areas to obtain local TV and newspaper articles about NeuroStar TMS Therapy
• Your NeuroStar practice can benefit from our media outreach and community awareness
• Enhance your reputation in the community as a mental health treatment expert
82
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar in the News
83
http://neurostar.com/hcp/news-events-exhibits/recent-press-coverage/
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar In The News
84
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
NeuroStar Practice Success Program
•Neuronetics team is available to you 24/7 for service and support whenever you need it
•We are your partner in helping you to build a successful NeuroStar TMS Therapy practice
•We support you every step of the way with a variety of programs, services and tools
85
MOA
NeuroStar SYSTEM
CLINICAL DATA
REIMBURSE-
MENT
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Reimbursement Support Services
• Insurance Reimbursement is a complex process• The Neuronetics Reimbursement Team is committed to providing support in all areas:
86
Reimbursement Managers
PROVIDER FOCUSED SUPPORT
Provides education and individual office support
Provides general coding, billing, prior authorization and appeals assistance
Health Policy TeamPAYER
FACING SUPPORTWorks with
Payers to obtain coverage policies
Works with the Provider to develop Payer Advocates
NeuroStar Reimbursement Support (NRS)
SUPPORT SERVICES HOTLINE
Team who provides general reimbursement support services Conducts insurance Benefits Investigation in your officeO’Reardon JP, et al. (2007). Biol Psychiatry 62(11):1208-1216.; Demitrack MA, Thase ME
(2009). Psychopharmacol Bull 42(2):5-38.
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
CPT Category I Codes
87
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
Progress Toward Broader Coverage
• Tremendous momentum with both commercial and government payers issuing coverage policies for NeuroStar TMS Therapy
• Neuronetics works closely with interested NeuroStar providers to educate insurers in their region
88
Neuronetics provides no guarantee of insurance coverage. Coverage guidelines vary with each payer according to the patient’s individual benefits plan, medical necessity and local reimbursement policies. It is the responsibility of the physician or facility to contact each carrier regarding the plan’s specific guidelines and policies.
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
What does NRS do?
89
NeuroStar Reimbursement Services Provides These Basic Services
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
The Value of NeuroStar
90
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
OTHER
UNMET NEEDS
REIMBURSE-
MENT
Financial Overview
91
*Maximum System Capacity = 8 patients/day = 8 patients/month. **Neuronetics, Inc. does not determine the reimbursement or revenue per treatment for TMS Therapy. These ranges of revenue per treatment session are not definitive, are based on limited information, and may not apply to a particular provider or patient. Neuronetics does not endorse or advocate for any particular pricing or reimbursement structure with our customers and we are not able to advise on the reimbursement rates providers will receive in particular cases.
Specific Treatment Volumes, Revenues and Expenses Are Hypothetical Examples Only and Neuronetics Makes No Representation or Warranty That These Examples Will Apply
In Your Circumstances
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
OTHER
UNMET NEEDS
REIMBURSE-
MENT
Flexible Financing
•Flexible equipment leasing options are available from financial groups who work with psychiatrists
•Easy monthly payments improve cash flow
•Offer the benefits of NeuroStar TMS Therapy to your patients without the financial burden of a capital equipment purchase
92
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
OTHER
UNMET NEEDS
REIMBURSE-
MENT
NeuroStar System Investment
NeuroStar TMS Therapy System
• Mobile console w/touch screen graphical user interface
• Precision Pulse™ TMS Technology• Adjustable, ergonomic patient chair
• 3D Coil positioning system• NeuroStar TMS Therapy System Software
• TMS TrakStar™ Patient Data Management System
• Installation and two-year limited warranty
• Neuronetics Service & Support
93
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
OTHER
UNMET NEEDS
REIMBURSE-
MENT
Summary
• The NeuroStar TMS Therapy System is the first FDA-cleared non-systemic and non-invasive TMS device for the treatment of Major Depression
• NeuroStar is demonstrated to be effective and safe in the treatment of patients with MDD who had failed to benefit from initial antidepressant medication
• Neuronetics partners with you and provides our complete wraparound services to successfully integrate NeuroStar TMS Therapy into your practice
94
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
OTHER
UNMET NEEDS
REIMBURSE-
MENT
Prescribing and Safety Information
• Refer to www.NeuroStar.com for complete prescribing and product safety information
• NeuroStar TMS Therapy is contraindicated in patients that have non-removable conductive metal in or near the head.
• Patients treated with TMS Therapy should be monitored for symptoms of worsening depression
• There is a rare risk of seizure with TMS Therapy (0.1% of acute treatment course)
• NeuroStar TMS Therapy has not been studied in patients who have not received initial antidepressant treatment and has not been shown to be effective in patients outside the indicated population for use
• NeuroStar TMS Therapy is not appropriate for all patients with depression; patients should be evaluated by their physician to determine if TMS Therapy is an appropriate treatment option
• NeuroStar TMS Therapy is available by prescription only95
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
REIMBURSE-
MENT
96
Thank You
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
OTHER
UNMET NEEDS
REIMBURSE-
MENT
Competitive Review
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
UNMET NEEDS
REIMBURSE-
MENT
Brainsway Offers Minimal Increase in Magnetic Field Depth
• Brainsway device uses a variation of research air-cooled coil technology, known as a Hesed coil (H-Coil)
• Vastly different than the first to market patented solid ferromagnetic coil technology used by the NeuroStar System.
• Coil uses multiple magnets to produce a diffuse magnetic field
• Brainsway coil stimulates greater volume of braintissue and reaches approximately 0.5 cm deeper
98Neuronetics, Data on File.
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
UNMET NEEDS
REIMBURSE-
MENT
Brainsway Offers Minimal Increase in Magnetic Field Depth
• Brainsway’s claim to reach deeper brain structures is misleading
• Majority of tissue stimulated is not associated with relevantdeep-brain structures thought to be involved in mood regulation(i.e. the limbic system)
99
NeuroStar Depth
Brainsway Depth
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
UNMET NEEDS
REIMBURSE-
MENT
NeuroStar TMS Therapy: A Targeted Mechanism of Action
• Precise pulsed magnetic fields induce small electric currents in the prefrontal cortex of the brain
• Local neurons depolarize which leads to activation of deep brain structures via trans-synaptic pathways
• Activation of these pathways in the limbic system leads to the release of neurotransmitters
• Blood flow and glucose metabolism rise in the activated regions, which is thought to result in improved mood
100
Patented solid ferromagnetic coil technology used by the NeuroStar System allows targeted stimulation of cortical neurons in brain structures associated with mood.
Kito (2008), Journal of Neuopsychiatry and Clinical Neuroscience.
MOA
NeuroStar SYSTEM
CLINICAL DATA
PRACTICE SUCCESS PROGRAM
VALUE OF A
NeuroStar
UNMET NEEDS
REIMBURSE-
MENT