philip s. kim, m.d. center for interventional pain spine, llc. [email protected]
TRANSCRIPT
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
Neurodegenerative Diseases (drug-device)3
OCD1
Depression2
Epilepsy2
Migraine Headache Pain3
Nonopioid Chronic Pain4
Fecal Incontinence2
Parkinson’s Disease
Essential Tremor
Chronic Pain
Gastroparesis1
Urinary Incontinence and Retention
Dystonia1
Severe Spasticity
COMMERCIALIN DEVELOPMENT
1,300,000
216,000
1,200,000
Patient #’s = US Net Prevalence (indicated, addressable population)
1,400,000
653,000
775,000 patients
245,000
904,000
692,000
3,500,000
80,000
1Humanitarian Device Exemption (HDE), 2 Investigational Use Only (IDE)
3 Research, 4 Investigational New Drug
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.
FY95 FY08
$1.3B+
$190 M
Medtronic Neuromodulation Revenue
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
18.7
Cancer 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. Taylor RS. Pain Practice, 2006. 2. Torrance N et al. J Pain, 2006.
3. Hall et al. Pain, 2006.
4. Finnerup N et al. Pain, 2005.5. Attal N et al. Eur J Neurol, 20066. 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-painkillers-record-number-americans-pain-medication/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
Direct drug delivery
Spasticity
Pain
IntraspinalIntraspinalCatheterCatheter
PumpPump
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?
Advanced Pain Therapies
NeurostimulationIntrathecal Drug Delivery
Neuroablation
DiagnosisEstablish Therapy Goals
Oral MedicationsActive Physical Rehabilitation
Therapeutic Nerve Blocks
Psychological Therapy
Oral Opioids
Krames E. J Pain Symp Manage 1996;11(6):333-352.
Surgery
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: Potential for Center of Excellence in pain management Enhanced reputation, utilization of radiology, physical
therapy, labs
Review billing and coding procedures. 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
COST: Saving. Is it worth it?
ANALGESIA: scale and percentage
ACTIVITIES: quality of life, functional scales
MEDICATIONS: Reduction in use
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 PatientsPresenting Device Therapy to Patients
• 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
• May reduce pain significantly
• Therapy is established - not new or experimental
• An alternative way to control your pain
• Will completely eliminate the need for drugs
• Will eliminate your pain
• Will cure you
• Invasive procedure
• A last resort
Patient Therapy Introduction Market Research Data on file, Medtronic, 2009
Going too far….
Not a TENS UNIT
Thank you for your time