Transcript Practice Guidelines

THANK YOU
SINCERELY
Joshua Prager and Ali Rezai
Ben Pless and Salim Hayek
Tom Tefft, Michael Demane
Mona Patel, Brad Maruca
GOALS and RULES
• Let’s bring industry and stake holders an event
to provide a platform to discuss the relevant
issues for the INVIGORATION of the field of
Neuromodulation. (BE POSITIVE)
• Each moderators should set the stage for the
need, showcase some emerging technologies,
and the panel will THOUGHTFULLY discuss
opportunities, challenges.
GOALS
•
•
•
•
•
•
•
Technology
Spinal Cord Stimulation
Regulatory and Economics
Study Designs
Peripheral Nerve Stimulation
Intrathecal therapy
Wrap-up
TRANSFORMATIVE technology changes the practice of medicine?
•
•
•
•
•
•
20
NeuroNavigation
Endovascular Surgery
Minimally invasive Spinal Neurosurgery
Bone Morphogenic Protein
Endscopic Neursorgery
Hemostatic Agents
• Deep Brain Stimulation/ NEUROMODULATION
1997
15
NEUROMODULATION
2011 Market
Revenue
($ millions)
2011
Market
Units
(estimate)
Spinal Cord Stimulation (SCS)
$1,286
60,643
Deep Brain Stimulation (DBS)
$393
24,104
Sacral Neuromodulation (SNM)
$386
41,233
Vagal Nerve Stimulation (VNS)
$211
8,612
Targeted Drug Delivery
$340
29,565
$2,616
164,158
(Intrathecal Pain & Spasticity)
Global Neuromodulation Market
Market revenue source: Dodds, Matthew. Citi Research, A Division of Citigroup Global
Markets, Inc. Neuromodulation Market Model, September 17, 2012
Approved
• VNS for Epilepsy,
Depression
• DBS for PD, ET, OCD,
Dystonia
• SCS for limb and
body pain
• IT for pain, spasticity
• PNS for Urge
incontinence
10
5
Horizon
+5
NEUROMODULATION
• DBS for Depression,
REMAINS
Epilepsy
QUITE EXCITING • SCS for CHF
• RNS for Epilepsy
ROBUST
• PNS for Headache,
asthma, GI
TECHNOLOGY
PENETRATION
OP Ed
Remember – that we are treating patients who have the worst of the worst problem…
The Creative
Destruction of
Medicine
7 billion people
>3 million doctors
>10,000 hospitals
>6000 prescription drugs
>4000 procedures & operations
Supplements, herbs, alternative
treatments
In the Future …
SPINAL CARE IS
FRAGMENTED
Motrin/ Medications
Physical Therapy
Accupuncture
Chiropractor
Epidural Steroid Injection
Spinal Surgeries
Neurostimulation
Who gets what where
when why?
• Define Patient Needs
(DISEASE MANAGEMENT)
• Practice Guidelines
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
In the Future …
SPINAL CARE IS
FRAGMENTED
Motrin/ Medications
Physical Therapy
Accupuncture
Neurostimulation
Chiropractor
Epidural Steroid Injection
Spinal Surgeries
Who gets what where
when why?
• Define Patient Needs
(DISEASE MANAGEMENT)
• Practice Guidelines
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
Choosing the Right Patient
In the Future …
Who gets what where
when why?
(Practice Guidelines)
I don’t want
no WIRE in my
back!
• Define Patient Needs
(DISEASE MANAGEMENT)
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
Equipment
•
•
•
•
Familiarity
Device Complications
Minimal Invasiveness
Ease of use
Navigation
MRI Guidance
INTRA OP MER?
SPINAL Flouroscopy/ XRT?
Wires running around the body
Ease of Programming
Device Comfort
Healing
- programming
How do we make
people good and
WANT to FEEL
BIONIC?
In the Future …
Who gets what where
when why?
(Practice Guidelines)
• Define Patient Needs
(DISEASE MANAGEMENT)
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
Practice of Medicine is Evolving
Neurosurgery (General)
Vascular
Tumor
Functional
Epilepsy
Spine
Pediatric
Neurology, hematology
Medical and Radiation onc
Movement Disorder Neurology
Epilepsy neurology, Neuropsych
Pain, PM&R
Pediatrics
Maybe an Opportunity in the field of Internventional Headache
and Epilepsy Management
Defining Role of Device Development
• CONVERGENCE – CARDIAC
– Manufacturing IPG
– Lead design and material (2-16/20)
– Sensing (rhythm, closed loop, posture, LFP)
– Home/ Remote monitoring
– Diagnostics
– Health care IT systems
– Objectification of patient symptoms
In the Future …
HEADACHE
LIFE TRANSFORMING
Who gets what where
when why?
(Practice Guidelines)
How do we get the Patients
involved to let their voices get
heard?
• Define Patient Needs
(DISEASE MANAGEMENT)
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
“Medicine is a science of uncertainty and an art of probability.”
Studies - DESIGN
• Effectiveness - The extent to which a
treatment achieves its intended purpose
• Efficacy - The extent to which a specific
intervention, procedure, regimen, or service
produces a beneficial result under ideal
conditions
In the Future …
Who gets what where
when why?
(Practice Guidelines)
• Define Patient Needs
(DISEASE MANAGEMENT)
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
SCS
INDICATIONS:
Heart Failure
Refractory Angina
Peripheral Vascular Disease
Peripheral Neuropathy
In the Future …
Who gets what where
when why?
(Practice Guidelines)
• Define Patient Needs
(DISEASE MANAGEMENT)
• Define Success
• Define Technology GAPS
• Advance Understanding of
the disease
TRIALS
•
•
•
•
•
Occipital Stimulation for Headaches
Deep Brain Stimulation for Depression
Cortical Stimulation for Stroke
DBS and RNS for Epilepsy
VNS for Obesity
“What have we learned about
the disease and science?”
- Brian Kopell
Disruptive Forces
EASY TO USE, EASY TO CONSUME
Pharmaceutical Challenges
• R&D
1995 - $15billion
2010 - $85billion
• Approved drugs 1996 – 56
2010 – 21
• 100,000 sales reps for 700,000
physicians
• 250,000 defibrillators
implanted on the rise
Pharmaceutical Challenges
• Dendreon – vaccine for
Prostrate revs up immune
system, costs $93,000, four
month survival advantage
• Rheumatoid Arthritis - $14
billion, remicade, Enbrel,
humira – half effective
• 10% actually active and
beneficial
• How many drugs are wasted?
Costs of medications
•
•
•
•
Avinza 90mg Qday
Percocet 5/325 Qid
Oxycontin 40mg Bid
Neurontin 600mg Tid
•A typical regimen for
chronic pain might include
a sustained release drug,
Oxycontin, a breakthrough
drug, Percocet and a
Neuromodulator,
Neurontin which cost
over $1000/month
$338/month ($4056)
$465/month ($5580)
$421/month ($5052)
$375/month ($4500)
Cost neutrality is reached within
5 years following SCS implant
Budd K. Spinal Cord Stimulation: CostBenefit Study.Neuromodulation
2002;5:75-78
OUR ADVANTAGES
• Compliance
• Gains in the Costs of unused medications
– Low risk, low rewards (medications)
– Higher risk, higher rewards (intervention)
• Take it for the rest of my life (medicine)
• When does it work, how well does it work
(medicine)
• Opiod Abuse – SCS Study
• Defining role for intervention for spine surgeries
OPPORTUNITY
NANS Foundation
SOCIETY TO TAKE UPON A
TRANSFORMATIVE APPROACH
REGISTRIES
GUIDELINES
POSITION STATEMENT
DEFINE THE TECHNOLOGICAL GAPS
OPPORTUNITY
Care more particularly for the individual patient
than the special features of the disease.
- Sir William Osler 1899
COLLABORATION
PATIENTS
PHYSICIANS
SOCIETY
INDUSTRY
REGULATORY
Conclusion
• White Papers & Neuromodoulation
• Consider a Neuromodulation community
forum
• Survey the membership to define the gaps
Email – ideas, collaboration, new thoughts
[email protected]