Philip S. Kim, M.D. Center for Interventional Pain Spine, LLC.

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 OCD 1 Depression 2 Epilepsy 2 Migraine Headache Pain 3 Nonopioid Chronic Pain 4 Fecal Incontinence 2 Parkinson’s Disease Essential Tremor Chronic Pain Gastroparesis 1 Urinary Incontinence and Retention Dystonia 1 Severe Spasticity COMMERCIAL IN DEVELOPMENT 1,300, ,000 1,200,000 Patient #’s = US Net Prevalence (indicated, addressable population) 1,400, , ,000 patients 245, , ,000 3,500,000 80,000 1 Humanitarian 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

C onditions Numbers (Millions) Chronic pain 76.2 Diabetes20.8 Coronary heart disease and stroke 18.7 Cancer1.4 Taken form AAPM Facts and Figures and Pain. Assessed 3/8/10

 Large patient population Often under-diagnosed and under-treated 1 1.5–8% of general population 2,3.  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 management 4,5. 1.Taylor RS. Pain Practice, Torrance N et al. J Pain, Hall et al. Pain, Finnerup N et al. Pain, Attal N et al. Eur J Neurol, North et al. Neurosurgery 2005

ConditionsNumber of Cases Painful diabetic neuropathy600,000 Postherpetic neuralgia500,000 Cancer associated200,000 Spinal cord injury120,000 Causalgia and CRPS100,000 Multiple Sclerosis50,000 Phantom Limb Pain50,000 Poststroke30,000 HIV-associated15,000 Trigeminal Neuralgia15,000 Low Back Pain -associated2,100,000 Total (excluding back Pain)1,680,000 Total ( including back Pain)3,780,000 Adapted from Bennett GJ. Hosp Pract. 1998; 33:

 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= #.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 Intraspinal Catheter Pump

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 Neurostimulation Intrathecal Drug Delivery Neuroablation Diagnosis Establish Therapy Goals Oral Medications Active Physical Rehabilitation Therapeutic Nerve Blocks Psychological Therapy Oral Opioids Krames E. J Pain Symp Manage 1996;11(6): 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 Patients Positive Ways to Present Negative 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 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