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Philip S. Kim, M.D.
Center for Interventional Pain Spine, LLC.
[email protected]
Consultant
Medtronic
Stryker
Azur
Define Neuromodulation
Is there a need?
What role should I play?
How do you market neuromodulation?
Modification of neural transmission to achieve
change in function and symptoms
electrical or chemical
central nervous system
Neuromodulation Therapies: Present &
Future OCD
1
Depression2
Parkinson’s Disease
775,000 patients
216,000
Essential Tremor
Epilepsy2
245,000
80,000
Dystonia1
Neurodegenerative
Diseases (drug-device)3
3,500,000
Severe Spasticity
1,200,000
Migraine Headache Pain3
904,000
Chronic Pain
1,300,000
Nonopioid Chronic Pain4
653,000
Gastroparesis1
Urinary Incontinence
and Retention
1,400,000
COMMERCIAL
1Humanitarian
3
Device Exemption (HDE), 2 Investigational Use Only (IDE)
Research, 4 Investigational New Drug
Fecal Incontinence2
692,000
IN DEVELOPMENT
Patient #’s = US Net Prevalence (indicated,
addressable population)
Medtronic invests in neuromodulation therapy research to
deliver new treatment options and future product innovation.
•
Neuromodulation spends approximately $35 million
annually conducting 20 to 25 different clinical trials.
•
Neuromodulation invests 15% of revenue in R&D annually.
$1.3B+
$190 M
FY95
Medtronic Neuromodulation Revenue
FY08
Medical Device Industry
Incidence of Chronic pain
Prevalence of Neuropathic pain
Opioid consumption
Conditions
Numbers
(Millions)
Chronic pain
76.2
Diabetes
20.8
Coronary heart disease
and stroke
Cancer
18.7
1.4
Taken form AAPM Facts and Figures and Pain.
www.painmed.org/patients/facts.html. Assessed 3/8/10
Large patient population
Often under-diagnosed and under-treated1
1.5–8% of general population2,3.
Low quality of life
The quality of life of neuropathic pain patients is comparable
to that experienced by patients suffering from cancer or
chronic heart failure.
Unmet medical need
Drug refractory patients
Only a proportion (maximum 50%) of neuropathic pain
patients get substantial pain relief (> 50%) with conventional
pharmacological management4,5.
1.
2.
Taylor RS. Pain Practice, 2006.
Torrance N et al. J Pain, 2006.
3.
Hall et al. Pain, 2006.
4.
5.
6.
Finnerup N et al. Pain, 2005.
Attal N et al. Eur J Neurol, 2006
North et al. Neurosurgery 2005
Conditions
Number of Cases
Painful diabetic neuropathy
600,000
Postherpetic neuralgia
500,000
Cancer associated
200,000
Spinal cord injury
120,000
Causalgia and CRPS
100,000
Multiple Sclerosis
50,000
Phantom Limb Pain
50,000
Poststroke
30,000
HIV-associated
15,000
Trigeminal Neuralgia
15,000
Low Back Pain -associated
2,100,000
Total (excluding back Pain)
1,680,000
Total ( including back Pain)
3,780,000
Adapted from Bennett GJ. Hosp Pract. 1998; 33: 95-110
4.6% of world population
80% consumption of all opioids produced in
world
99% of hydrocodone
consumption.
abcnews.go.com/US/prescription-painkillersrecord-number-americans-painmedication/story?id=13421828#.T_7AQaAp_G4
Delivery of low-voltage
electrical stimulation to the
spinal cord to inhibit or
mask the sensation of
pain.
Treats chronic intractable
neuropathic pain which
results from injury to
neural tissue that is
involved in the
transduction, modulation,
transmission or perception
of pain
Intraspinal
Catheter
Pump
Direct drug delivery
Spasticity
Pain
Philip S. Kim, M.D.
Director
Center for Pain Medicine
It exists
occipital nerve stimulation
inguinal nerve stimulation
Lumbar sympathetic chain
Median, ulnar nerve stimulation
sacral nerve stimulation
retrograde
Transforaminal
Field Stimulation?
Moniker?
Diagnosis
Establish Therapy Goals
Oral Medications
Active Physical Rehabilitation
Therapeutic Nerve Blocks
Psychological Therapy
Oral Opioids
Advanced Pain Therapies
Neurostimulation
Intrathecal Drug Delivery
Neuroablation
Krames E. J Pain Symp Manage 1996;11(6):333-352.
Physical facilities
Practice structure
Key team members
Critical mass of patients
Key partnerships
“Starting a Medical Practice” AMA
Building A Successful Pain Management Practice, Linda Van Horn
Hospital and Facilities administration
Referring providers
Physicians
Nurse Practitioners
Chiropractors
Physical Therapists
Physical Trainers
Podiatrists
Payors
Explain the potential benefits of the therapy:
Review billing and coding procedures.
Potential for Center of Excellence in pain management
Enhanced reputation, utilization of radiology, physical therapy,
labs
Payor contracts
Develop specific protocols for pain patients.
Educational and Administrative services
What are you offering?
Access and availability ?
Keep them informed, and call up
directly.
Quality assurance
Understand the coverage policies for your area.
Having an excellent billing service is critical to
a new practice.
Typical reasons for coverage refusals include:
Not convinced of the need in your particular patient
Diagnosis is not covered
DOCUMENTATION
Benefits include:
Data to show payors that the therapy works
Improve patient care and satisfaction
Document cost-effectiveness, safety
Expand referral base
Improve relationship with hospital
Distinguish practice as a Center of Excellence
CAAM
COST: Saving. Is it worth it?
ANALGESIA:
ACTIVITIES:
MEDICATIONS: Reduction in use
scale and percentage
quality of life, functional scales
Patients
Referring Physicians
Payors
Communicate regularly with patients.
Conduct community education programs.
Involvement in Health care fairs
Website
Internet: You Tube or Facebook
Printed material
Patient advocates
Improve referral patterns (ACTIVE) :
Educate referring physicians.
Attend and present at medical societies.
Conduct Grand Rounds.
Invite referring physicians to observe procedures.
Tailor mailings by specialty to help physicians select
the patients most likely to benefit from the therapies
Business cards, pamphlets, referral cards.
Invitation to dinner, lunch, breakfast, coffee
Participate in insurance roundtables.
Establish contacts with managed care.
Conduct educational programs for nurse case
managers and medical staff.
Building a critical mass of patients and
ensuring their satisfaction is essential.
Requires:
Identifying, attracting, and retaining patients
Educating patients and setting appropriate
expectations.
Quality assurance assessment.
Biggest Marketing Efforts
Fear of infection, allergic reaction, overdose (IDD) or having a
foreign object in body
Fear that it won’t work, will limit their activities, or is generally
unsafe
Reluctance to accept that therapy isn’t a cure
Some associate risks of back surgery with neurostimulation or
pump placement
Underutilization of current networking systems available to patient
CommGeniX, LLC. Medtronic Patient Acceptance Advisory Council Executive Summary. Tampa,
FL Data on file, Medtronic, Inc.; April 2010.
Present the risks and benefits of the therapy, devices, and
procedures in ways that the patient will understand
Quantify risks of infection at your center
Compare activity constraints due to implant with current activity levels
Compare devices to other implanted devices with which people are
most familiar and comfortable
Define clear expectations
Introduce patients to resources such as American Chronic Pain Association
or the American Pain Foundation.
CommGeniX, LLC. Medtronic Patient Acceptance Advisory Council Executive Summary. Tampa, FL Data on file,
Medtronic, Inc.; April 2010.
Presenting Device Therapy to Patients
Positive Ways to Present
• The therapies are safe and effective
• A trial is performed to assess your
response to the therapy
• The therapies are surgically reversible
and can be discontinued at the
discretion of the physician
• May reduce oral opioids
Negative Ways to Present
• Will completely eliminate the need for
drugs
• Will eliminate your pain
• Will cure you
• Invasive procedure
• A last resort
• May reduce pain significantly
• Therapy is established - not new or
experimental
• An alternative way to control your pain
Patient Therapy Introduction Market Research Data on file, Medtronic, 2009
•
Device Companies Resources
•
American Chronic Pain Association
www.theacpa.org/
•
American Pain Foundation
www.painfoundation.org/
Going
far….
Not
a
TENS
UNIT
too
Thank
you for
your time