Philip S. Kim, M.D. Center for Interventional Pain Spine, LLC. [email protected].

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

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