Transcript Experiences with Sacral Neuromodulation for Urinary Control and Bowel Control Agenda • Prevalence & Impact of Overactive Bladder • Prevalence & Impact of Chronic Fecal Incontinence •

Experiences with
Sacral Neuromodulation
for Urinary Control and Bowel
Control
Agenda
• Prevalence & Impact of Overactive Bladder
• Prevalence & Impact of Chronic Fecal Incontinence
• InterStim Therapy for Urinary Control and Bowel Control
– Efficacy & Safety Information
– Test Procedure & System Overview
– Medtronic Support
• Q&A
Overactive Bladder: Prevalence & Impact
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OAB 1
OAB
Asthma 2
Asthma
Diabetes 3
Diabetes
Osteoporosis 4
Osteoporosis
Alzheimer's 5
Alzheimer’s
• 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. Urology.2004;63(3):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
OAB medications in the California Medicaid Program1
6- Month Persistence & Adherence
100%
Discontinue + no restart
Discontinue + restart
80%
77%
60%
82%
73%
40%
• > 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
20%
0%
Tolterodine
Oxybutynin ER
Oxybutynin
(n = 1093)
(n = 524)
(n = 812)
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
Pharmacotherapy Persistence & Adherence
OAB medications compared to those for several other
chronic conditions
Persistent at 6 months
OAB
Medications
Prostaglandins
Analogs
Bisphosphonates
Statins
ARBs
(osteoporosis)
(hyperlipidemia)
(hypertension)
(indicated for glaucoma)
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•
•
Persistent at 1 year
Oral
antidiabetics
(Type II)
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
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.
Fecal IncontinenceMore Common Than You Might Think
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OAB1,2
OAB
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5.
6.
7.
Asthma 3
Asthma
Diabetes 4
Diabetes
FI 5
FI
Osteoporosis
Osteoporosis6
Alzheimer's 7
Alzheimer’s
It is estimated that more than 18 million adults in the United States
– 1 in 12 – suffer from fecal incontinence (FI)5
FI is nearly as prevalent as many other chronic diseases and more prevalent
than other illnesses well-known to impact many Americans.1-4,6-7
Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20:327-336
Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801.
Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010.
National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010.
Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:512-517.
National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010.
Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.
FI Impacts Quality of Life
Fecal Incontinence Quality of Life Scale (FIQOL) Scores
Note: Higher scores translate to higher quality of life
Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P080025.
Patient Education Needed
Studies suggest that only 15%– 45% of FI patients seek
treatment1,2.
Consider the following statistics that support the claim that
fecal incontinence is a hidden condition:
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For 84% of patients with FI, the physician was unaware of the patient’s
disorder1
54% of patients with FI had not discussed the problem with a professional2
65% of patients with severe or major FI which had an impact on the quality of
life wanted help with their symptoms3
1. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. Gastroenterol Clin Biol.
2006;30(1):37-43
2. Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6):503-7
3. Perry S, Shaw C, McGrother C, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut.
2002;50(4):480-484.
InterStim Therapy for Urinary Control and
Bowel Control
An established therapy that expands your
treatment options for patients with:
• urge incontinence,
• urgency-frequency,
• non-obstructive urinary retention,
• chronic fecal incontinence
who do not benefit from more
conservative treatments.
More than 100,000 patients worldwide
have received InterStim Therapy
InterStim Delivers Clinical Efficacy
12-month clinical success for Urinary Control1
79% of urge incontinence
patients achieved clinical success
• 45% remained completely dry
• An additional 34% experienced 50%
reduction in leaking
64% of urgency-frequency
patients achieved clinical success
Urge
Incontinence
UrgencyFrequency
Urinary
Retention
(n=38)
(n=33)
(n=38)
1. Medtronic-sponsored research : InterStim
Therapy - Clinical Summary, 2011.
• 31% returned to normal voids
(4 to 7 voids/day)
• An additional 33% experienced 50%
reduction in number of voids
77% of urinary retention
patients achieved clinical success
• 61% eliminated use of catheters
• An additional 16% experienced 50%
reduction in catheterized urine volume
InterStim Therapy for Urinary Control
Lasting Efficacy - Proven in a 5-year Clinical Trial
Urge Incontinence1
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
• 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)
1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011.
InterStim Therapy for Urinary Control
Lasting Efficacy - Proven in a 5-year Clinical Trial
Urgency-Frequency1
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
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, 2011.
InterStim Therapy for Urinary Control
Lasting Efficacy - Proven in a 5-year Clinical Trial
Urinary Retention1
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
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, 2011.
InterStim Therapy for Bowel Control
Clinical Efficacy: Reduction in Episodes
Mean Number of Weekly
Incontinent Episodes
InterStim Therapy Bowel Control Study
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9.4
9.2
3.1
Modified
Worst Case
(MWC)
(n=120)
1.9
Per-protocol
(completers)
(n=106)
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
2. Medtronic-sponsored research. InterStim Therapy Clinical Summary - 2011.
InterStim Therapy for Bowel Control
Percent of Patients with a 100%
Reduction in Accidents at 12 Months
Clinical Efficacy: Complete Continence
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InterStim Therapy
Bowel Control Study1,2
47%
40
30
Tjandra RCT3
41%
36%
20
10
0
MWC
(n=120)
Per-protocol
(n=106)
SNS group
(n=53)
1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.
2. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011.
3. Tjandra JJ et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal
incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008;51(5):494-502.
InterStim Therapy for Bowel Control
Clinical Efficacy: Quality of Life
InterStim Therapy Bowel Control Study1
Mean FIQOL Score
(Completers Analysis)
4.0
3.5
3.0
2.5
2.0
1.5
1.0
Baseline
(n=119)
3-Months
(n=116)
6-Months
(n=109)
12-Months
(n=107)
24-Months
(n=68)
36-Months
(n=30)
Scale 1 - Lifestyle
2.31
3.22
3.26
3.36
3.32
3.52
Scale 2 - Coping/Behavior
1.49
2.64
2.69
2.77
2.69
2.7
Scale 3 - Depression/SelfPerception
2.53
3.33
3.48
3.54
3.58
3.77
Scale 4 - Embarrassment
1.6
2.73
2.75
2.81
2.76
2.95
1. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence:
results of a 120-patient prospective multicenter study. Ann Surg. Mar 2010;251(3):441-449.
Adverse Events
The most common adverse events experienced
during clinical studies included:
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Pain at implant sites
New pain
Lead migration
Infection
Technical or device problems
Adverse change in bowel or voiding function
Undesirable stimulation or sensations
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.
Test for Potential Success
Basic Evaluation
• A temporary lead is placed during a simple
in-office procedure and connected to an external
stimulator
• You and your patient assess therapy effects in
as few as 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
advance evaluation via the staged test is
recommended
Test for Potential Success
Advanced Evaluation
• Utilizes a tined lead that anchors in place
• Placed in the OR during an outpatient procedure
• You and your patient assess therapy effects for
up to 14 days
• 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.
Complete InterStim System
1. Tined lead is placed
parallel to the sacral
(S2, S3, or S4) nerve.
3
2
2
1
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.
The Pelvic Floor
• S3, the most distal
common point of
innervation for the
bladder
• InterStim Therapy
stimulates S3 or S4
InterStim Therapy for Urinary Control
Evaluating for InterStim: Treatment Algorithm
Urge Incontinence & Urgency-Frequency
Initial Screening
Voiding Diary
Urodynamic
Work-up
Behavioral Techniques
Interventional Techniques
Medications
+
Continue as
Appropriate
InterStim Therapy
Test Stimulation
InterStim Therapy for Urinary Control
Evaluating for InterStim: Treatment Algorithm
Urinary Retention
Initial Screening
Voiding Diary
Urodynamic
Work-up
Rule Out Obstruction
Medications and/or
Catheterization
+
Continue as
Appropriate
InterStim Therapy
Test Stimulation
InterStim Therapy for Bowel Control
Evaluating for InterStim: Treatment Algorithm
Fecal Incontinence
Initial Evaluation
Conservative Treatment
•Diet Modification
•Medication
•Behavioral Therapy
InterStim Therapy
Test Evaluation
+
2nd
Test Evaluation
+
Continue as
Appropriate
-
InterStim Implant
Other Surgical
Treatment
InterStim Therapy for Urinary Control
Coverage
• 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.
InterStim Therapy for Bowel Control
Coverage
• The coverage profile for sacral nerve stimulation
for fecal incontinence is developing:
– Medicare Local Coverage Determinations (emerging)
– Many commercial payers have coverage policies in place
• Diagnosis code used:
– 787.60 fecal incontinence
• Same procedural codes (CPTs) used as for urinary
control
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
• Fecal incontinence is a hidden condition that can
severely impact quality of life
• 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 Information
InterStim 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.
The following Warning applies only to InterStim Therapy for Urinary Control:
Warning: This therapy is not intended for patients with mechanical obstruction such as benign
prostatic hypertrophy, cancer, or urethral stricture.
InterStim® Therapy for Bowel Control is indicated for the treatment of chronic fecal incontinence in
patients who have failed or are not candidates for more conservative treatments.
Contraindications for Urinary Control and for Bowel Control: Diathermy. Patients who have not
demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Precautions/Adverse Events:
For Urinary Control: 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.
For Bowel Control: Safety and effectiveness have not been established for bilateral stimulation;
pregnancy, unborn fetus, and delivery; pediatric use under the age of 18; or for patients with progressive,
systemic neurological diseases.
For Urinary Control and for Bowel Control: 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
Questions?
To take the next step:
• Contact your local Medtronic Representative or
• Call the clinician services line: 800-633-8766