Experiences with Sacral Neuromodulation for Urinary Control

Agenda

• Prevalence & Impact of Overactive Bladder

• InterStim Therapy for Urinary Control

– Efficacy & Safety Information

– Test Procedure & System Overview

– Medtronic Support

• Q&A

Overactive Bladder: Prevalence & Impact

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OAB Asthma Diabetes Osteoporosis Alzheimer'sOAB1 Asthma2 Diabetes3 Osteoporosis4 Alzheimer’s5

• It is estimated that overactive bladder (OAB) affects more than 33 million people in the U.S.1

• OAB is more prevalent than many well-known diseases.2-5

• The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars).6

1. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801.2. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010.3. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010.4. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010.5. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.6. Hu, TW et al. Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study.j.urology.2003:10.037:461-465.

Patient Survey Data*

• NAFC survey data found OAB patients seek treatment for the following reasons:– Frustration from living with the symptoms (78%)– Embarrassment (42%)– Physical discomfort (38%)

• 74% of surveyed OAB patients said they waited longer than they should have to seek treatment

• Only 20% of surveyed OAB patients are extremely satisfied with their current treatment

* Source: Survey for the National Association for Continence (NAFC), sponsored by Medtronic, Inc. and conducted by Kelton Research. April 2009. The online survey was conducted using an email invitation. Respondents were 611 nationally representative American women ages 40-65 with overactive bladder.

Pharmacotherapy Persistence & Adherence

• > 70% discontinuation of prescribed therapy within 6 months

• > 80% discontinuation of prescribed therapy within 1 year

• > 50% chose not to restart their therapy after discontinuation

0%

20%

40%

60%

80%

100%

Tolterodine Oxybutynin ER Oxybutynin

Discontinue + no restart Discontinue + restart

(n = 1093) (n = 524) (n = 812)

77%73%

82%

OAB medications in the California Medicaid Program1

1. Yu YF, Nichol MB, Yu AP, et al. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Value in Health. 2005;8(4):495-505.11

1. Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009;15:724-736.

• Only 28% of patients on OAB medications remained persistent at 6 months• Only 18% of patients on OAB medications remained persistent at 1 year• Patients were less likely to remain on OAB medications than on any other

drug class assessed

Pharmacotherapy Persistence & Adherence OAB medications compared to those for several other

chronic conditions

OABMedications

ProstaglandinsAnalogs

(indicated for glaucoma)

Bisphosphonates(osteoporosis)

Statins(hyperlipidemia)

ARBs(hypertension)

Oral antidiabetics

(Type II)

Persistent at 6 months Persistent at 1 year

Discussion Slide

Do these adherence & persistence data reflect what you see in your practice?

InterStim Therapy for Urinary Control

An established therapy that expands your treatment options for patients with:

• urge incontinence,

• urgency-frequency and

• non-obstructive urinary retention

who have failed or could not tolerate more conservative treatments.

More than 85,000 patients worldwide have received InterStim Therapy

1. Medtronic-sponsored research. InterStim Therapy

Clinical Summary Insert, 2006.

79% of urge incontinence patients achieved clinical success

• 45% remained completely dry • An additional 34% experienced 50%

reduction in leaking

• 31% returned to normal voids (4 to 7 voids/day)

• An additional 33% experienced 50% reduction in number of voids

• 61% eliminated use of catheters

• An additional 16% experienced 50% reduction in catheterized urine volume

64% of urgency-frequency patients achieved clinical success

77% of urinary retention patients achieved clinical success

12-month clinical success1

InterStim Delivers Clinical Efficacy

UrgeIncontinence

(n=38)

Urgency-Frequency

(n=33)

UrinaryRetention

(n=38)

1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

Urge Incontinence1

Lasting Efficacy - Proven in a 5-year Clinical Trial

• 59% of urge incontinent patients achieved 50% reduction in leaks/day*

• 71% of those urge incontinent patients who reported heavy leaks at baseline achieved 50% reduction in leaks per day†

* 59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96)† 71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84)

Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available

Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline

Urgency-Frequency1

56% of urgency-frequency patients achieved 50% increase

in volume voided/void and improved degree of urgency** 56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)

1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available

Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline

Lasting Efficacy - Proven in a 5-year Clinical Trial

Urinary Retention1

78% of urinary retention patients achieved 50% reduction in volume/catheterization*

* 78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31)

1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available

Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline

Lasting Efficacy - Proven in a 5-year Clinical Trial

Adverse Events

• Pain at implant sites• New pain• Lead migration• Infection• Technical or device problems• Adverse change in bowel or voiding function• Undesirable stimulation or sensations

The most common adverse events experienced during clinical studies included:

Any of these may require additional surgery or cause return of symptoms. For additional safety information, please refer to the Important Safety Information on the last slide of this presentation.

Discussion Slide

What level of efficacy do you look for when considering adoption of a new therapy?

Test for Potential SuccessIn-office Test

• A temporary lead is placed during a simple in-office procedure and connected to an external stimulator

• You and your patient assess therapy effects for 3-7 days

• If successful, patient may proceed directly to long-term lead and device implant through an outpatient procedure

• If test is inconclusive or unsuccessful, the staged test is recommended

Test for Potential Success

• Utilizes a tined lead to reduce migration

• Placed in the OR during an outpatient procedure

• With successful test results, the lead remains in place and the device & lead extension (if applicable) are implanted

Complications can occur with the test procedure, including movement of the wire, technical problems with the device, and some temporary pain.

Staged Test

Complete InterStim System

1. Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve.

2. Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes.

3. Clinician and patient programmers are used to set the parameters of the electrical pulses.

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2

3

2

The Pelvic Floor

• S3, the most distalcommon point ofinnervation for the bladder

• InterStim Therapystimulates S3 or S4

Evaluating for InterStim: Treatment AlgorithmUrge Incontinence & Urgency-Frequency

Initial Screening

Voiding Diary

UrodynamicWork-up

Behavioral TechniquesInterventional Techniques

Medications

Continue as Appropriate

InterStim TherapyTest Stimulation

+ -

Evaluating for InterStim: Treatment AlgorithmUrinary Retention

Initial Screening

Voiding Diary

UrodynamicWork-up

Rule Out Obstruction

Continue as Appropriate

InterStim TherapyTest Stimulation

Medications and/or Catheterization

+ -

Discussion Slide

Do you believe your patients would be willing to try the temporary test procedure even if they feel unsure about the idea of the long-term implant?

Coverage for InterStim Therapy

• The coverage profile for sacral nerve stimulation is strong:– Medicare National Coverage Determination– Medicare Local Coverage Determinations (many retired)– Most commercial payers have coverage policies in place

• Common diagnoses include:– 788.20 - Retention of urine, unspecified– 788.21 - Incomplete bladder emptying– 788.29 - Other specified retention of urine– 788.31 - Urge incontinence– 788.41 - Urinary frequency

Medtronic provides this information for your convenience only. It is not intended as a recommendation regarding clinical practice. It is always the provider’s responsibility to determine coverage and submit appropriate codes, modifiers, and charges for the services that were rendered. This document provides assistance for FDA approved or cleared indications. Where reimbursement is requested for a use of a product that may be inconsistent with, or not expressly specified in, the FDA cleared or approved labeling (e.g., instructions for use, operator’s manual or package insert) consult with your billing advisors or payers for advice on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related service. Contact your Medicare contractor or other payer for interpretation of coverage, coding, and payment policies.

Coding: CPT* Unique codes included on the 2010 Medicare Physician Fee

Schedule for placement of electrodes on the sacral nerve:• CPT 64561: Percutaneous implantation of neurostimulator electrodes; sacral nerve

(transforaminal placement) (2010 Medicare Physician Payment National Average: Non Facility Setting: $1,046/Facility Setting: $417)

• CPT 64581: Incision for implantation of of neurostimulator electrodes; sacral nerve (transforaminal placement) (2010 Medicare Physician Payment National Average: Facility Setting: $826)

• CPT 64590: Insertion or replacement of peripheral neurostimulator pulse generator or receiver, direct or inductive coupling (2010 Medicare Physician Payment National Average: Facility Setting: $177)

• CPT 95972: Complex spinal cord or peripheral (except cranial nerve) neurostimulator pulse generator transmitter with intraoperative or subsequent reprogramming, first hour(2010 Medicare Physician Payment National Average: Non Facility Setting: $108/Facility Setting: $79)

*CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is a copyright 2009 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

Medicare payment is determined by multiplying the sum of the three RVUs (work, practice expense and malpractice) by the conversion factor. The conversion factor for CY 2010 is $36.8729. On June 25, 2010 the President signed into law HR 3962. This provides a 2.2% increase to the Physician Medicare Fee Schedule from June 1, 2010 through November 30, 2010. The bill may be found at: http://www.govtrack.us/congress/bill.xpd?bill=h111-3962. National average Medicare rates are shown here. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown. Multiple surgical procedure reductions may apply and are not calculated here.

Medtronic Reimbursement Resources Medtronic has resources available to assist your practice

with coding and reimbursement considerations:

• Field Based Health Economics Managers (available for coding and reimbursement education, claims reviews, appeal assistance, meetings with facilities, etc.)

• Coding Sheets (Procedural and Diagnosis)

• Financial/Coding Models

• Dictation Guides

• Prior Authorization Guides and Sample Letters of Medical Necessity

Additional Resources for Physicians

• Training & Education• Patient Awareness & Education Resources• Therapy Integration Consultation

Summary• The condition of OAB is common and persistence

and adherence with medication therapy is suboptimal

• InterStim is an established therapy with proven long-term clinical efficacy

• A simple test procedure initiated in the office helps determine whether InterStim Therapy may help restore control over symptoms

• Reimbursement for InterStim is generally favorable

• Medtronic offers comprehensive support

Important Safety InformationInterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Contraindications: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.

Precautions/Adverse Events:

Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins such as multiple sclerosis. The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. Product technical manual must be reviewed prior to use for detailed disclosure.

USA Rx Only. Rev 0409

Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

Questions?

To take the next step:• Contact your local Medtronic Representative or

• Call the clinician services line: 800-633-8766