Transcript The Impact of Obesity and the Value of Treatment

The Impact of Obesity and
the Value of Treatment
1
Contents
 Review prevalence and overall impact of obesity in adults
 Discuss safety and efficacy of bariatric surgery
 Review obesity-related costs
 Assess economic benefit from bariatric surgery in adults
2
Prevalence and Trends
 More than 1/3 of adults ≥20 years of age, or over 72 million people, were obese with a body
mass index (BMI) ≥30 kg/m2 in 2005-20061
–
Prevalence has more than doubled between 1980 and 2002 (13.3% to 32.2%) 1,2
 The prevalence of extreme obesity (BMI ≥40) in 2003-2004 was:
–
2.8% in men and 6.9% in women1
 In 2003-2004, 17.1% of children and adolescents age 2-19 years were overweight2,5
–
Prevalence of overweight has tripled in children 6-19 years2
– Overweight adolescents have a 70% chance of becoming overweight/obese adults 5
Moderate Obesity3,4,6
Morbid Obesity3,4,6
Normal Weight2
Overweight2
Obese3,4,6
(BMI 18.5 to 24.9)
BMI
(BMI 25 to 29.9)
(BMI 30 to 34.9)
Class I
Obesity
(BMI 35 to 39.9 )
Class II
Obesity
(BMI 40 or more)
Class III
Obesity
1. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High. 2007. Available at: http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm. Accessed 6-23-09
2. Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006; 295:1549-1555.
3. Caclulate Your Body Mass Index. Available at http://www.nhlbisupport.com/bmi. Accessed 10-29-09
4. National Insttitute of Health. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults . 2000. Available at
http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf . Accessed 12-15-09
5. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity. 2007. Available at: http//www.surgeongeneral.gov/topics/obesity/calltoaction/fact_adolescent.htm.
Accessed12-15-09
6. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical
Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.
3
Obesity Trends* Among US Adults
BRFSS† 1990, 1999, 2008
1990
1999
2008
No Data
<10%
10%-14%
15%-19%
20%-24%
25%-29%
≥30%
*BMI ≥30, or about 30 lb overweight for 5’4” person.
† BRFSS=CDC’s Behavioral Risk Factor Surveillance System.
U.S. Obesity Trends--Trends by State 1985–2008. Available at: http://www.cdc.gov/NCCDPHP/dnpa/obesity/trend/maps/index.htm. Accessed 12-8-09.
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Changes in Distribution of Body Mass
Index between 1976-1980 and 2005-2006
 Changes in the prevalence of obesity do not present a complete picture of
the trends in weight as measured by BMI1
Changes in BMI distribution between 1976-1980 and 2005-20061
20
Percent
15
NHANES 1976-1980
10
5
NHANES 2005-2006
0
10
15
20
25
30
35
40
45
50
BMI
Source: CDC/NCHS, National Health and Nutrition Examination Survey (NHANES)
Figure represents US adults aged 20-74 years
1. Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States--no statistically significant chance since 2003-2004. NCHS Data Brief. 2007;1:1-8.
2. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High. 2007. Available at: http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm. Accessed 623-09
5
Age-Adjusted Percentage of US Adults Who
Were Obese or Who Had Diagnosed Diabetes
Maps of Diabetes and Obesity in 1994, 2000, and 2008. 2009. Available at: http://www.cdc.gov/diabetes/statistics/slides/maps_diabetesobesity94.pdf. Accessed 5-18-09.
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Medical Complications Which May Be
Associated With Obesity1
Pulmonary disease
• Abnormal function
• Obstructive sleep apnea
• Hypoventilation syndrome
Nonalcoholic fatty
liver disease
• Steatosis
• Steatohepatitis
• Cirrhosis
Idiopathic intracranial
hypertension
Stroke
Cataracts
Coronary heart disease
Diabetes
Dyslipidemia
Hypertension
Gall bladder disease
Severe pancreatitis
Gynecologic abnormalities
• Abnormal menses
• Infertility
• Polycystic ovarian
syndrome
Osteoarthritis
Skin Problems
Gout
Cancer
• Breast, uterus, cervix,
colon, esophagus, pancreas,
kidney, prostate
Phlebitis
• Venous stasis
1. Bhoyrul S., Lashock J. The Physical and Fiscal Impact of the Obesity Epidemic: The Impact of Comorbid Conditions on Patients and Payers. .JMCM. 2008 :11(4): 10-17.
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Body Mass Index vs Mortality
Exponential Increase in Risk
Relative Mortality Rate
400
350
300
250
High risk
200
Medium risk
150
Low risk
100
50
0
16
19
22
25
28
31
34
37
40
45
BMI (kg/m2)
For adults with a BMI above 45, life expectancy decreases by up to 20 years.
Data based on BMI distribution from the Third National Health and Nutrition Examination Survey (NHANES II)—a 6-year study from
1988-1994.
1. Fontain KR, Redden DT, Wang C, et al. . Years of life lost due to obesity. JAMA. 2003;289:187-193.
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Direct Cost of Chronic Diseases
in the United States1,2
60
$53.2
$51.6
Direct Cost ($ Billions)
50
$38.7
40
30
$18.4
20
$18.1
10
0
Type 2
Diabetes
Obesity
Coronary
Heart Disease
Hypertension
Stroke
Adjusted to 1995 dollars.
1. Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Res. 1998 Mar;6:97-106.
2. Hodgson TA, Cohen AJ. Medical care expenditures for selected circulatory diseases: opportunities for reducing national health expenditures. Med Care. 1999;37:994-1012.
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Economic Impact—Annual Expenditures Attributable to
Obesity and Overweight in the United States
 Based on data from 1998 through 2000, approximately
– 5.7% of total adult medical expenditures1
– 6.8% of total Medicare expenditures1
– 10.6% of total Medicaid expenditures1
 Between 1987 and 2001 (obesity average 14% and 31% respectively), increases
in spending on obese people relative to people of normal weight accounted for
27% of the rise in inflation-adjusted per capita spending2
– Obesity trends account for a large proportion of the increased spending growth for
diabetes (38%), hyperlipidemia (22%), and heart disease (41%)*2
 $93 billion in direct medical costs†
– Relates to total medical costs attributable to obesity and overweight at $78.5 billion,
which was projected to be equivalent to $92.6 billion in 2002 dollars3
 $117 billion in total costs (direct and indirect; $2001)3
 Estimated to have risen to $147 billion per year by 20084
*Data
from 1997 and the 2005 Household Component to the Medical Expenditures Panel Survey (MEPS=HC).
information was based on data from 1998 Medical Expenditures Panel Survey merged with the 1996 and 1997 National Health Interview Surveys.
Figures have been rounded to the nearest whole number.
1. Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res. 2004;12(1):18-24.
2. Thorpe KE, Florence CS, Howard DH, Joski P. The impact of obesity on rising medical spending. Health Affairs, October 20,2004.
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.480. Accessed April 8, 2007.
3. Finkelstein EA, Fiebelkorn IC, Wang G. National medical spending attributable to overweight and obesity: how much, and who’s paying? Health Affairs 2003;W3(Suppl Web Exclusives);219-226.
4. Finkelstein EA, Trogdon JG, Cohen JW, Diestz W. Annual medical spedning attributable to obesity: payer-and service-specific estimates. Heallth Aff (Millwodd). 2009; 28:w822-w831.
†The
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Weighty Matters:
How Obesity Drives Poor
Health and Health
Spending in the US
1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed
12-8-2009.
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Physical Costs of Obesity
 36.01% of new cases across all 11
chronic conditions can be attributed
to obesity
 16.97% of new cases across all 11
chronic conditions can be attributed
to overweight
 The burden of obesity is most
marked in heart disease and
diabetes, accounting for more than
70% of the growth in prevalence for
these 2 conditions
 Obesity accounted for 60% of the
growth in hypertension and nearly
50% of the rise in arthritis
Share in Condition
Prevalence: 1997-2005
Condition
Overweight
Obesity
Mental Disorders
7.43%
16.22%
Heart Disease
7.21%
71.64%
Cancer
6.34%
8.75%
Back Problems
20.09%
17.55%
Pulmonary Conditions
-0.07%
20.07%
Hypertension
31.29%
59.90%
Arthritis
15.76%
48.74%
Diabetes
28.87%
70.95%
Upper GI
27.30%
30.54%
Kidney
-3.12%
7.48%
Hyperlipidemia
35.57%
44.24%
Average Share of Cases
16.97%
36.01%
The prevalence of 11 chronic conditions associated with overweight and obesity grew 180%.
1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf.
Accessed 12-8-2009.
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Physical Costs of Obesity
 458% increase in pulmonary
conditions
1997
2005
Condition
% Cases
Associated
with
Obesity
% Cases
Associated
with
Obesity
Mental Disorders
7.18%
11.60%
Heart Disease
16.16%
24.13%
Cancer
3.25%
4.70%
Back Problems
6.88%
10.73%
Pulmonary Conditions
0.92%
5.13%
– 93% hyperlipidemia
Hypertension
33.58%
45.40%
– 35% hypertension
Arthritis
17.04%
27.17%
– 25% diabetes
Diabetes
46.05%
57.60%
Upper GI
8.59%
22.09%
Kidney
18.53%
14.14%
Hyperlipidemia
19.11%
36.96%
– 0.92% (1997) to 5.13% (2005)
 156% increase in gastrointestinal
ailments
– 8.59% (1997) to 22.09% (2005)
 Significant increase in trio of
conditions associated with metabolic
syndrome
1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf.
Accessed 12-8-2009.
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Physical Costs of Overweight and Obesity
 The following increases in
back problems were noted
with overweight and
obesity
– Overweight—578%
increase
– Obesity—56% increase
Share in Condition
Prevalence: 1997-2005
Condition
Overweight
Obesity
Mental Disorders
7.43%
16.22%
Heart Disease
7.21%
71.64%
Cancer
6.34%
8.75%
Back Problems
20.09%
17.55%
Pulmonary Conditions
-0.07%
20.07%
Hypertension
31.29%
59.90%
Arthritis
15.76%
48.74%
Diabetes
28.87%
70.95%
Upper GI
27.30%
30.54%
Kidney
-3.12%
7.48%
Hyperlipidemia
35.57%
44.24%
Average share of cases
16.97%
36.01%
1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf.
Accessed 12-8-2009.
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Financial Costs of Obesity
 In 2005, condition-specific
health expenditures among
adults across BMI categories
were
– Underweight: $8.887 million
– Normal weight: $170.6 million
– Overweight: $168.6 million
– Obese: $177.5 million
 Obese adults spent more in
proportion to their share of the
population than any other
BMI category examined
Condition-Specific Health Spending Varies by BMI
1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf.
Accessed 12-8-2009.
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Economic Costs of Obesity and Overweight
to Self-Insured Employers
 Objective: To quantify direct and indirect costs of obesity
within a cohort of commercially insured employees in the
United States
 Method: Review of health plan claims, self-reported health
risk assessment, and productivity data from 2003-2005
 Results: Regression-adjusted incremental direct medical
costs associated with being overweight, obese, and severely
obese were estimated to be
–
Overweight—$147.11
–
Obese—$712.34
–
Severely Obese—$1977.43
 Adjusted incremental indirect costs due to paid absence
associated with being overweight, obese, and severely
obese were estimated at
–
Overweight—$1403.81
–
Obese—$1511.24
–
Severely Obese—$1414.09
 Conclusions: Overall adjusted direct and indirect costs
were higher for workers with elevated BMI relative to
those of normal weight
1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic Costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997.
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Durden et al: Prevalence of Conditions Within
Selected Major Diagnostic Categories
% of Total Study Population
40
35
30
25
20
15
10
5
0
Musculoskeletal
Severely obese
BMI ≥35
Circulatory
Obese
30≤ BMI <35
Overweight
25≤ BMI <30
Endocrine, Nutritional,
and Metabolic Diseases
Normal weight
18.5≤ BMI <25
Respiratory
Underweight
BMI <18
Table is based on data examined from 2003 to 2005.
1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic Costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997
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Annual Medical Spending Attributable to
Obesity: Payer- and Service-Specific Estimates
Study updates on earlier analysis by
Finkelstein and colleagues.
 In 1998, medical costs of obesity were
estimated to be as high as $78.5 billion (with
roughly half financed by Medicare and
Medicaid)
 Using 2006 data, authors estimate that in 2008
the medical costs of obesity could be as high as
$147 billion
 The increased prevalence of obesity is
responsible for almost $40 billion of increased
medical spending through 2006, including
$7 billion in Medicare prescription drug costs
1. Finkelstein EA, Trogdon JG, Cohen JW, Dietz W, Annual Medical Spending Attributable To Obesity: Payer- And Service-Specific Estimates. Health Affairs 2009;28(5): w822–
w831
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Annual Medical Spending Attributable to Obesity:
Payer- and Service-Specific Estimates
 2006 payer-specific estimates by
type of service—inpatient,
noninpatient, or prescription drug
spending—to identify the cost
drivers attributable to obesity
 Results suggest spending within
these categories for each obese
beneficiary was more than $600 per
year higher than for a normal-weight
beneficiary in 2006
 Estimates for all payers combined
range between $420 (inpatient) and
$568 (prescription drugs)
 In percentage terms, the increases
for all payers combined range from
27% (noninpatient) to 80%
(prescription drugs) from 1998 to
2006
Finkelstein EA, Trogdon JG, Cohen JW, Dietz W, Annual Medical Spending Attributable To Obesity: Payer- And Service-Specific Estimates. Health Affairs 2009;28(5): w822–w831
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Annual Medical Spending Attributable to Obesity:
Payer- and Service-Specific Estimates
 2006 payer-specific estimates by
type of service—inpatient,
noninpatient, or prescription drug
Authors’ Conclusions
spending—to identify the cost
drivers attributable
to obesity between rising rates of obesity and
“The connection
risingwithin
medical spending is undeniable.
 Results suggest spending
these categoriesGiven
for each
theobese
current budget in most jurisdictions,
beneficiary
was more
thanspending
$600 per for obesity is a major cause for concern.
the high public
sector
year higher than for a normal-weight
However,
motivation to prevent or treat obesity were solely based on
beneficiaryifinthe
2006
cost, then only cost-saving obesity interventions would be implemented
 Estimates for all payers combined
once
all(inpatient)
costs andand
benefits were taken into account.
range between
$420
a payer’s
perspective, although there is increasing evidence
$568From
(prescription
drugs)
suggesting
bariatric surgery may be cost saving,
 In percentage
terms, the that
increases
all obesity
will meet this threshold
for all payers not
combined
rangetreatments
from
27% (noninpatient)
(nor to
do80%
most treatments for other conditions).”
(prescription drugs) from 1998 to
2006
Finkelstein EA, Trogdon JG, Cohen JW, Dietz W, Annual Medical Spending Attributable To Obesity: Payer- And Service-Specific Estimates. Health Affairs 2009;28(5): w822–w831
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A Guide to Selecting Treatment
Surgery
Pharmacotherapy
Lifestyle Modification
Diet
Physical Activity
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A Guide to Selecting Treatment
Malabsorptive procedures: Jejunoileal Bypass
Restrictive procedures:
Gastric Banding, Sleeve Gastrectomy
Combination procedures: Roux-en Y Gastric Bypass (RYGB),
Biliopancreatic Diversion/Duodenal Switch
Surgery
Effective over time
RYGB: One study showed up to ≥52%
EWL at 10 years1
LAGB: One study showed up to 59% EWL
at 8 years1
Medications
(5% to 10% EWL, on average, when used with lifestyle changes) 2,3
Lifestyle
Changes
• Diet
• Exercise
• Behavior modification
(5% to 10% EWL, on average, when used with medication)1,2
National Institutes of Health et al. http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed May 18, 2009
1. O’Brien PE, Mc Phail T, Chaston TB, et al. Systematic Review of Medium-Term Weight Loss after Bariatric Operations. Obes Surg . 2006; 16:1032-1040.
2. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.
3. Wierzbicki A. Rimonabant: endocannabinoid inhibition for the metabolic syndrome. Int J Clin Pract. 2006; 60 (12): 1697-1706.
4. Fisher BL, Schauer P. Medical and Surgical Options in the Treatment of Severe Obesity. The Amer Journ of Surg. 2002; 184 (6B): 9S-16S
Images taken from: Bhoyrul S., Lashock J. The Physical and Fiscal Impact of the Obesity Epidemic: The Impact of Comorbid Conditions on Patients and Payers. .JMCM. 2008 :11(4): 10-17.
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Selection Criteria for Bariatric Surgery
in Adults1
Factor
Criteria
Weight (adults)
• BMI >40 kg/m2 with no comorbidities
• BMI >35 kg/m2 with obesity-associated comorbidity
Weight loss history
• Failure of previous nonsurgical attempts at weight reduction,
including nonprofessional programs (for example,
WeightWatchers®)
Commitment
•
•
•
•
Expectation that patient will adhere to postoperative care
Follow-up visits with physician(s) and team members
Recommended medical management
Instructions regarding any recommended procedures or tests
Exclusion
•
•
•
•
Reversible endocrine disorders or other disorders that cause obesity
Current drug or alcohol abuse
Uncontrolled, severe psychiatric illness
Lack of comprehension of
– Risks, benefits, expected outcomes, alternatives, and required lifestyle
changes
– This is not a complete list of exclusion criteria for bariatric surgery
1. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical
Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.
23
Weight Loss Surgery for Clinically Severe
or Morbidly Obese Adults*1
 Two main types of weight loss procedures
Malabsorptive
Procedures
Reduce the absorption
of calories (along with
proteins and other
nutrients)
Restrictive
Procedures
Decrease
food intake and
promote a feeling of
fullness (satiety) after
eating
 Some procedures are a combination
*Surgery is applicable only when nonsurgical options have been attempted and failed.
1. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for
Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric
surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.
24
Common Types of Bariatric Surgical
Options1
 AGB=adjustable gastric banding
 RYGB=Roux-en-Y gastric bypass
 GS=gastric sleeve
 BPD=biliopancreatic diversion with
a duodenal switch
Diagram of Surgical Options*
Image credit: Walter Pories, MD, FACS.
Figure from Bariatric Surgery for Severe Obesity; NIH Publication No: 08-4006, updated March 2008: 1-6.
DHHS=US Department of Health and Human Services.
NIH=National Institutes of Health.
NIDDK=National Institute of Diabetes and Digestive Diseases and Kidney Diseases.
*Surgical options can be performed open or laparoscopically.
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Commonly Performed Bariatric
Procedures in the United States
Roux-en-Y Gastric Bypass
RYGB works by restricting
food intake and by
decreasing the absorption
of food.
Adjustable Gastric Banding
AGB works primarily by
decreasing food intake.
(Restrictive)
Sleeve Gastrectomy
Restricts food intake and
usually requires a second
procedure
(Restrictive)
(Malabsorptive and
restrictive)
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The LAP-BAND® System
 Approved by the FDA in 2001
 Approved for adults and over
 Indicated for use in weight reduction for severely obese patients with
– A BMI ≥40 or a BMI ≥35 with one or more severe comorbid conditions, or
– Those who are 100 pounds or more over their estimated ideal weight according to
the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame)
 The LAP-BAND® System is indicated for use only in severely obese adult
patients who
– Have failed more conservative weight-reduction alternatives, such as supervised
diet, exercise, and behavior-modification programs
 Bariatric surgery eligibility criteria: patients with a BMI ≥40 or a BMI ≥35
with one or more severe comorbid conditions
– 1998 NIH Overweight and Obesity Guidelines
– 2004 ASMBS Consensus Statement
– 2008 AACE-TOS-ASMBS Metabolic and Bariatric Surgery Medical Guidelines
27
LAP-BAND® AP—2007
 The silicone band around the stomach is hollow
 It is filled with a saline solution
 By adding or removing the saline, the band can be made
tighter or looser
 Adjustments are made to meet individual weight loss
needs
The APS with 3 mL and 7 mL saline
28
Goals of Proper Adjustment
 Key benefit of the LAP-BAND® System is its
adjustability
– Determinants are the rate loss, degree to which satiety has
been induced, and presence of symptoms
 A properly adjusted band induces a feeling of satiety or
fullness while permitting compliance with eating
guidelines
 The ability to eat solid foods is a key to success
– Solid foods induce satiety which persists with a properly
adjusted band
29
The Green Zone
Adjustment frequency, dependent on physician evaluation
Year 1: every 4 to 6 weeks
Year 2: every 3 to 6 months
Year 3: every 6 months
Year 5: annually
1. Favretti F, O'Brien PE, Dixon JB. Patient management after LAP-BAND placement. Am J Surg. 2002;184:38S-41S.
2. Optimizing your weight loss though adjustments. 2009. Available at: http://www.lapband.com/life_after_surgery/optimizing_your_weight_loss/#greenzone. Accessed 12-8-2009
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Eligibility for LAP-BAND® System
Training and Certification
 Physician certification process
– FDA label (DFU): Surgeon participation in a training program authorized by Allergan or
by an authorized Allergan Health distributor is required prior to use.1
 Physicians must:
– Participate in a comprehensive workshop or one-on-one training on patient selection,
patient support, complication management, and procedural information specific to the
LAP-BAND® Adjustable Gastric Banding System 1
– Confirm that they are willing and able to perform and support at least 50 procedures in
the next 12 months2
– Be observed by qualified personnel during their first band placements1
– Have previous experience in treating obese patients and have staff and commitment to
comply with the long-term follow-up requirements of obesity procedures2
– Confirm establishment of a bariatric patient support program that includes: 2
• Appropriate hospital facilities
• Exercise and nutrition counseling
• Support from psychological, general medicine, and radiology personnel
1. Data on file, Allergan, Inc. December 2009.
2. Pratt GM, McLees B, Pories WJ. The ASBS Bariatric Surgery Centers of Excellence program: a blueprint for quality improvement. Surg Obes Relat
Dis. 2006;2:497-503.
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Bariatric Surgery – Measure of Efficacy
Percent Excess Weight Loss
 % EWL is defined as
– The difference in the baseline and post-surgery weight divided by the
difference in baseline weight and ideal body weight, multiplied by 100
– Ideal body weight is determined using the upper limit value of the
medium-frame range from the 1983 Metropolitan Tables for Life
Insurance
Height & Weight Table for Women
Height & Weight Table for Men
1. About the "Metropolitan Life" tables of height and weight. 2008. Available at: http://www.halls.md/ideal-weight/met.htm. Accessed 8-19-09.
32
Clinical Impact of the LAP-BAND® System
LAP-BAND® System Results in
Long-Term Weight Loss*1
70
62.0
60
64.3
52.9
% EWL
50
62.0%
40.5
40
30
 19% mean excess
weight loss 3 years
after surgery
26.1
20
10
0
6
12
24
(n=812)
(n=668)
(n=240)
36
(n=68)†
48
(n=12)†
Time After Surgery (Months)
*The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study
(N=299). Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24
months (37.8%), and 36 months (36.2%).
1. Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg. 2005;201:529-535.
† Based on a chart review of 1,014 consecutive cases of patients undergoing LAP-BAND® System surgery at a single center. Follow-up data were available for relatively few patients at 36 months (68 of 77) and at
48 months (12 of 14).
33
Clinical Impact of Weight Loss Following
LAP-BAND® System Surgery
Key Outcomes from 4 studies:
100%
90%
93%
93%
90%
59%
79%
90%
14%
26%
80%
35%
70%
76%
60%
64%
50%
40%
30%
44%
34%
20%
21%
10%
0%
10%
7%
Asthma1
1 Year Post-op
(n=32)
Hypertension2
1 Year Post-op
(n=34)
Resolved
Type 2 Diabetes2
1 Year Post-op
(n=50)
Improved
7%
Sleep Apnea3
1 Year Post-op
(n=27)
No Change
6%
4%
Gastroesophageal Reflux4
2 Years Post-op
(n=48)
Declined
Medications or other aids may still be required for certain conditions, and percentages are rounded up to whole numbers.
Other studies have found different results in resolution and reduction rates (eg, Ahroni et al, 2005)
1.Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after Lap-Band surgery for morbid obesity. Obes Surg. 1999;9:385-389.
2. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.
3.Dixon JB, Schachter LM, O'Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med. 2001 8;161:102-106.
4. Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of lap-band placement. Obes Surg. 1999;9:527-31.
34
Remission of Diabetes After Weight Loss
 Type 2 diabetes remission in 64% to 80% of patients within ~1 to 2 years1,2
– Normalization of blood glucose in 1 to 4 weeks1
– Improved insulin sensitivity1
– Improved beta-cell function1
– HbA1c drop from 7.25 (5.6-11.0, n=53)
preoperatively to 5.58 (5.0-6.2, n=15)
at 2 years after surgery2
1. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding.
Diabetes Care. 2002;25:358-363.
2. Ponce J, Haynes B, Paynter S, et al. Effect of Lap-Band-induced weight loss on type 2 diabetes mellitus and hypertension. Obes Surg.
2004;14:1335-1342.
35
American Diabetes Association (ADA)
2009 Standards of Medical Care in Diabetes
ADA 2009 Recommendations Regarding Approaches to
Diabetes Treatment: Bariatric Surgery
 Bariatric surgery should be considered for adults with BMI ≥35 kg/m2 and
type 2 diabetes, especially if the diabetes is difficult to control with lifestyle
and pharmacologic therapy. Evidence Level B*
 Patients with type 2 diabetes who have undergone bariatric surgery need
lifelong lifestyle support and medical monitoring. Evidence Level E†
 Although small trials have shown glycemic benefit of bariatric surgery in
patients with type 2 diabetes and BMI of 30 kg/m2 to 35 kg/m2, there is
currently insufficient evidence to generally recommend surgery in patients
with BMI <35 kg/m2 outside of a research protocol. Evidence Level E†
 Long-term benefits, cost-effectiveness, and risks of bariatric surgery in
individuals with type 2 diabetes should be studied in well-designed,
randomized, controlled trials with optimal medical and lifestyle therapy as
the comparator. Evidence Level E†
*B=Supportive evidence from well-conducted cohort studies.
† E=Expert consensus or clinical experience.
1. Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management education. Diabetes Care. 2009;32 Suppl 1:S87-S94.
36
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
 Background: To improve decision making in the
treatment of severe obesity, the risks of bariatric
surgery require further characterization
 Methods: US prospective, multicenter,
observational study of 30-day outcomes in
consecutive patients undergoing bariatric surgery
 Primary outcome was a composite endpoint of
any of the following within 30-days after first-time
bariatric surgery
 Major adverse outcomes including
– Death
– Venous thromboembolism
– Percutaneous, endoscopic, or operative
reintervention
– Failure to be discharged from the hospital
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.
37
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
 Results: Of 4476 patients, more than half
had >2 coexisting conditions
– 30-day rate of death among patients was
0.3% (RNY and LAGB)
– A total of 4.3% of patients had at least
1 major adverse event
 Composite endpoint predictors
– History of deep vein thrombosis(DVT) or
pulomonary embolus (PE), diagnosis of
obstructive sleep apnea (OSA), and
impaired functional status were each
independently associated with an ↑ risk of
the composite endpoint
– Extreme values of BMI
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.
38
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.
39
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
LABS Conclusion
Overall risk of death and AE after bariatric surgery was low and varied
considerably according to patient characteristics
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.
40
The Overall Value of Bariatric
Surgery and the LAP-BAND® System
Government agencies and professional organizations assess the value of new
treatments and consider both clinical and economic data to ensure access to
therapies and procedures with a favorable balance of incremental costs and
benefits
 Review of bariatric surgery in general, or adjustable gastric banding specifically, has
resulted in favorable policy recommendations1-6
– CMS implemented national coverage decision in 20061
– 45 states cover bariatric surgery for Medicaid patients2
– AHRQ 2004 technology assessment concluded for patients with BMI ≥40, surgical
therapy is superior to existing pharmaceutical and diet therapy3
– National Institute for Health and Clinical Excellence (NICE) recommends bariatric
surgery for certain obese adults in the UK in 20064
– BlueCross® BlueShield® Association publishes positive Technology Evaluation Center
(TEC) assessment for LAGB in 20075
– AACE/TOS/ASMBS 2008 Bariatric Surgery Guidelines6
1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections 90-160.25)
2. F As In Fat. Available at http://healthyamericans.org/reports/obesity2008/Obesity2008Report.pdf. Accessed 12-15-09
3.. AHRQ. Pharmacological and Surgical Treatment of Obesity . Evidence Reprot/Technology Assessment. 2004; 103: 1-6.
4.. NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and Children.. 2006. 43:1-84.
5.. BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity. 2007. 1-50.
6. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical
Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.
41
Costs of Obesity
 Summary
– Obesity imposes a significant societal and employer
burden, as indicated by
• Greater healthcare utilization
• Higher direct medical costs
• More time lost from work
– Given the multiple links between obesity and a range of
chronic health problems, interventions that reduce the
prevalence of obesity are likely to simultaneously reduce
the prevalence of its comorbid conditions
– Reductions in the prevalence of such conditions could
prove beneficial to patients, employers, and insurers
1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997.
42
The Overall Value of Bariatric Surgery
and the LAP-BAND® System
 Many countries (including the United States) task
organizations with assessing the value of new treatments
 Considering clinical and economic data, these
organizations help to ensure access to therapies and
procedures that have a favorable balance of incremental
costs and benefits
 Several such bodies have reviewed bariatric surgery in
general, or adjustable gastric banding specifically, and
have made favorable policy recommendations1-4
1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections 90-160.25)
2. NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and
Children.. 2006. 43:1-84.
3. CADTH . Laparoscopic Adjustable Banding for Weight Loss in Obese Adults: Clinical and Economic Report . 2007; 90:1-38
4. . BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity. 2007. 1-50.
43
Important LAP-BAND® System Safety
Information
Indications: The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with
a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or
those who are 100 lbs. or more over their estimated ideal weight.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with
conditions that may make them poor surgical candidates or increase the risk of poor results, who are unwilling
or unable to comply with the required dietary restrictions, or who currently are or may become pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required
at some time. Patients who become pregnant or severely ill, or who require more extensive nutrition may require
deflation of their bands. Patients should not expect to lose weight as fast as gastric bypass patients, and band
inflation should proceed in small increments. Anti-inflammatory agents, such as aspirin, should be used with
caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can
occur. Possible complications include the risks associated with the medications and methods used during
surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object
implanted in the body.
Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, infection, or nausea
and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may
alleviate excessively rapid weight loss or esophageal dilation.
Not all contraindications, warnings, or adverse events are included in this brief description. More detailed risk
information is available at www.lapbandcentral.com or 1-800-624-4261.
2009 Allergan, Inc., Irvine, CA 92612. ® Marks owned by Allergan, Inc. www.allergan.com TOPS, eDiets, Optifast, Health Management Resources
Weight Watchers, Blue Cross, and Blue Shield are the property of their respective trademark owners.
LBTP/3476/09
44
Slides for Reactive Use Only
 The following slides are to be used only when a customer
specifically requests information on the following topics
– Cost-Effectiveness
– Safety/Efficacy
– Comorbidities
45
Comorbidity
Reactive Use Only
46
Systematic Reviews: Comorbidities
 Buchwald et al. JAMA. 2004;292:1724-17371
– 2004 meta-analysis of all types of bariatric surgery
• Average 61% EWL (n=10,172)*
• Improvements in T2DM, hypertension, sleep apnea, and hyperlipidemia in most
patients
 Buchwald et al. Am J Med. 2009;122:248-2562
– 2009 meta-analysis of bariatric surgeries and diabetes
– Includes all English articles studying biliopancreatic diversion/duodenal
switch, gastric bypass, and gastric banding from 1/1/1990-4/30/2005
• 55.9% EWL (n=34,329), weight loss overall was 38.5 kg*
• 78.1% patients had complete resolution of type 2 diabetes
• 86.6% improvement or resolution of type 2 diabetes in patients
*The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299).
Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%),
and 36 months (36.2%).
1. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 13;292:1724-1737.
2. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009;122:248-256.e5.
47
Systematic Reviews: Comorbidities
 Maggard et al. Ann Intern Med. 2005;142:547-5591
– Surgical treatment for obesity resulted in a 20-30 kg weight loss maintained up to 10 years in
association with*:
• Reduction in some comorbidities and an overall mortality rate <1%
– Benefits were conclusive for those patients with BMI
• ≥40 but not <40 kg/m2
 Sjostrom et al. NEJM. 2004;357:741-7522
– Nonrandomized, prospective, controlled study involved obese subjects who underwent
surgical procedures (mostly gastroplasties and nonadjustable bands) and contemporaneously
matched, obese control subjects treated conventionally
– 2- and 10-year improvement rates in T2DM, hypertriglyceridemia, low levels of HDL density
lipoprotein, and hyperuricemia:
• Were more favorable in surgically treated vs the control group
– Recovery from hypercholesterolemia and hypertension did not differ between groups at 10
years
*Results are inclusive of all types of bariatric surgery
1 Maggard MA, Shugarman LR, Suttorp M, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 5;142:547-559.
3. Sjöström L, Gummesson A, Sjöström CD,et al. Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial. Lancet
Oncol. 2009;10:653-662.
48
Impact of Morbid Obesity and Bariatric Surgery on
Comorbid Conditions: A Comprehensive Examination of
Comorbidities in an Employed Population
 Objective
–
–
Find conditions with significantly different prevalence
among employees diagnosed with morbid obesity (DMO)
Examine effects of bariatric surgery on prevalence of all
categories of comorbid conditions
 Methods
–
Large employer retrospective database analysis—2 matched
cohorts:
•
Those with DMO and those without DMO
 Results
–
–
–
DMO cohort had higher diagnosis rates in every AHRQ
major diagnostic category except pregnancy
Significantly higher prevalence in 147 of 261 AHRQspecific categories
Bariatric surgery patients experienced significant decreases
in prevalence in 26 of 261 specific categories
 Conclusion
–
–
Employees with DMO are at higher risk for many serious
diseases
Bariatric surgery has been effective in promoting weight loss
and decreasing the rates of many serious comorbidities
1. Kleinman NL, Melkonian A, Borden S 4th, et al. The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup
Environ Med. 2009;51:170-179.
49
Long-term Changes in Comorbidity Prevalence—
From 90 Days Before to 2 Years After Surgery
Long-term results of select AHRQ condition categories
(out of 106 eligible categories)*
Decreases in prevalence at 2 years
Increases in prevalence at 2 years
 Essential hypertension
 Anemia
 Diabetes millitis
 Surgical and medical care
complications
 Asthma
 Osteoarthritis
 Hyperlipidemia
 Nutritional deficiencies
 Headaches including migraines
 Other upper respiratory infections
*Results are inclusive of all types of bariatric surgery
1. Kleinman NL, Melkonian A, Borden S 4th, et al. The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup
Environ Med. 2009;51:170-179.
50
Prompt Reduction in Use of Medications for Comorbid
Conditions After Bariatric Surgery
Comparison of relationship between bariatric
surgery and comorbidities by assessing change in
use of medications in the year following bariatric
surgery
Methods
 Cohort study, administrative claims data from 2002 2005 from 7 BCBS Plans. Evaluated mean number
of medications at time of bariatric surgery and 1 year
post surgery.
– Medication usage by surgical patients was also
compared to usage by matched enrollees
without surgery but with a propensity score
suggesting obesity.
– Statistical differences in usage, accounting for
repeated measures and controlling for age, sex,
and diabetes tested for using Poisson and
logistic regression.
1. Segal JB, Clark JM, Shore AD, et al.. Prompt Reduction in Use of Medications for Comorbid Conditionsla After Bariatric Surgery. Obes Surg. 2009; 19:1646–1656.
51
Prompt Reduction in Use of Medications for Comorbid
Conditions After Bariatric Surgery
 Results
– Bariatric study cohort, n= 6,235
mean age = 44 years , 82% women; 34%
diabetes
– By 12 months after surgery, medication use
had declined for diabetes (76%), hypertension
(51%), and hyperlipidemia( 59%)
– In contrast, thyroid hormone, antihistamine,
and antidepressant use decreased by only 6%,
15%, and 9%, respectively.
– Enrollees without surgery had a modest
increase in medications for diabetes,
hypertension, and hyperlipidemia of 4%, 8%,
and 20%, respectively
 Conclusion Authors concluded that bariatric
surgery is effective for decreasing the use of
medications for obesity-related diabetes,
hypertension, and hyperlipidemia
Estimates of medication use were based on pharmacy claims. This
only indicates that the prescription was filled.
1. Segal JB, Clark JM, Shore AD, et al.. Prompt Reduction in Use of Medications for Comorbid Conditionsla After Bariatric Surgery. Obes Surg. 2009; 19:1646–1656.
52
Safety and Effectiveness
Reactive Use Only
53
Safety and Effectiveness
 LABS N Engl J Med. 2009 361:5: 445-454
– If slides 54-57 are presented to show a comparison with
LRYGB, then they should be used only reactively
– If slides 54-57 are shown solely to present safety
information for LAGB, they are OK to present proactively
54
Reported Weight Loss as a Percentage of
Excess Body Weight After Bariatric Surgery
References correlating to b-h are provided within the AACE/TOS/ASMBS
Bariatric Surgery Guidelines
DS=duodenal switch
1. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical
Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.
55
Weight Loss Surgery
LAGB* vs LRYGB Surgery — Safety
Categories
Total Complications†1
Major Complications†1
(Grades III and IV)
Postsurgical Mortality Rate2
(Short-term)
LAGB
9%
(n=480)
0.2%
(n=480)
0.05%2
(n=5780)
Gastric Bypass
23%
(n=235)
2.1%
(n=235)
0.5%2
(n=9258)
*Includes the LAP-BAND® System and other adjustable gastric banding systems.
† Published complication rates vary depending upon the institution and how the surgeon diagnoses and defines a particular complication.
1. Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg. 2006;202:252-261.
2. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.
56
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
 Background: To improve decision making in
the treatment of severe obesity, the risks of
bariatric surgery require further characterization
 Methods: US prospective, multicenter,
observational study of 30-day outcomes in
consecutive patients undergoing bariatric
surgery
 Primary outcome was a composite endpoint
of any of the following within 30 days after
first-time bariatric surgery
– Major adverse outcomes including
• Death
• Venous thromboembolism
• Percutaneous, endoscopic, or operative
reintervention
• Failure to be discharged from the hospital
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med.
2009;361:445-454.
57
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
 Results: Of 4476 patients, more than
half had >2 coexisting conditions
– 30-day rate of death among pts was 0.3%
(RYGB and LAGB)
– A total of 4.3% of patients had at least
1 major adverse event
 Composite endpoint predictors
– History of deep vein thrombosis (DVT) or
pulmonary embolus (PE), diagnosis of
obstructive sleep apnea (OSA), and
impaired functional status were each
independently associated with an ↑ risk of
the composite endpoint
– Extreme values of BMI
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med.
2009;361:445-454.
58
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med.
2009;361:445-454.
59
Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery: The Longitudinal Assessment of Bariatric
Surgery (LABS) Consortium
LABS Conclusion
Overall risk of death and AE after bariatric surgery was low and varied
considerably according to patient characteristics
1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med.
2009;361:445-454.
60
Cost-Effectiveness
Reactive Use Only
61
Cost-Effective
Recent Improvements
in Bariatric Surgery
Outcomes
1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.
62
Recent Improvements in Bariatric
Surgery Outcomes
Key findings
 Between 2001 and 2006, the rate of bariatric surgery per
100,000 covered lives increased from 26.8 to 43.7
 Compared with 2001-2002, patients with higher severity case
mix underwent bariatric surgery between 2005 and 2006
 Between the 2 periods, patient age increased, with a greater
proportion being over age 50 (44% vs 28%)
 Patients in 2005-2006 were also more likely to have ≥2
comorbidities
– 20.91% (2005-2006) vs 6.34% (2001-2002)
 Despite the increase in patient health severity case mix, the
2009 study found that outcomes improved
1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.
63
Recent Improvements in Bariatric Surgery
Outcomes (Costs)
Key findings
 Overall, risk-adjusted, inflation-adjusted hospital payments
declined 6%
–
$29,563 to $27,905 in 2006 dollars
 Hospital payments for patients with complications declined
–
Improved outcomes led
to reduced costs.
$41,807 to $38,175
 Total hospital payments for those with the most expensive
outcomes and readmissions also declined substantially
–
$80,001 to $69,960
 Hospital payments for those patients without any
readmissions also dropped
–
$26,578 to $23,115
 Use of laparoscopy, which increased from 9% to 71% during
that time, reduced 180-day payments associated with
bariatric procedures by 12%
 Banding reduced 180-day payments by 20%
*Not noted if banding was performed open or laparascopically.
1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.
64
Recent Improvements in Bariatric
Surgery Outcomes
Authors’ conclusions
“Improvements in bariatric outcomes and costs were
due to mix of within-hospital volume increases,
a move to a laparoscopic technique, and
an increase in banding without bypass.”
1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.
65
Healthcare Cost Savings
Surgically Treated (RYGB and VGB) vs
Conventional Therapy at 5 years
Average Cost Per 1,000 Patients
for Hospitalization
$ (Millions)*
N=1035 bariatric patients and 5746 match controls
Bariatric cohort: Net
reduction of >$5.7
million per 1,000
patients treated,
within 5 years of
surgery*
*Canadian dollars, 5-year follow-up (1986-2002). McGill University Heath Center, Montreal.
1. Sampalis JS, Liberman M, Auger S, Christou NV. The impact of weight reduction surgery on health-care costs in morbidly obese patients. Obes Surg. 2004;14:939-947.
66
Impact of Bariatric Surgery on the Veterans
Administration Healthcare System: A Cost Analysis
 All obesity-related healthcare costs for 25 RYGB patients were determined
in the Veterans Administration (VA) single-payor healthcare system.*
Costs included
• Hospitalizations
• Outpatient visits
• Medications
• Home health devices
– Total costs of care per patient preoperatively
• $10,778 ± $2,460
– Total costs of care per patient for 1 year postbypass
• $2,840 ± $622
 Operative treatment of clinically severe obesity reduces obesity-related
expenditures and utilization of healthcare resources
 The cost of undertaking RYGB at the VA was offset by reduction of
healthcare costs within the first year after surgery
*Costs were reviewed from patient records from 1999-2001.
1. Gallagher SF, Banasiak M, Gonzalvo JP, et al. The impact of bariatric surgery on the Veterans Administration healthcare system: a cost analysis. Obes Surg. 2003;13:245-248.
67
Cost-effectiveness Analysis of Laparoscopic Gastric Bypass,
Adjustable Gastric Banding LAGB, and Nonoperative
Weight Loss Interventions
 Background
– Laparoscopic adjustable gastric banding
(LAGB) and laparoscopic Roux-en-Ygastric
bypass (LRYGB) are the two most commonly
performed bariatric procedures
– Although both procedures likely reduce
healthcare expenditures related to the
resolution of comorbid conditions, they have
different rates of perioperative risks and
different rates of associated weight loss
– A model was designed to evaluate the
incremental cost-effectiveness of these
procedures compared with nonoperative
weight loss interventions and with each other
1. Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight loss interventions. Surg Obes
Relat Dis. 2008;4:26-32.
68
Cost-effectiveness analysis of Laparoscopic Gastric Bypass,
Adjustable Gastric Banding LAGB, and Nonoperative
Weight Loss Interventions
 Methods
–
–
A deterministic, payer-perspective model comparing the
lifetime expected costs and outcomes of LAGB, LRYGB,
and nonoperative treatment
Major endpoints were:
•
•
•
–
Survival
Weight loss
Health-related quality of life
Life expectancy and lifetime medical costs were calculated
across age, gender, and body mass index (BMI) strata using
data from the Framingham Heart Study and Third National
Health and Nutrition Examination Survey
 Results
–
For both men and women, LRYGB and LAGB were costeffective at <$25,000/quality adjusted life-year (QALY)
•
•
•
Even when evaluating the full range of baseline BMI and
estimates of adverse outcomes, weight loss, and costs
For base-case scenarios in men (age 35 y, BMI 40 kg/m2), the
incremental cost-effectiveness was $11,604/QALY for LAGB
compared with $18,543/QALY for LRYGB
For base-case scenarios in women (age 35 y, BMI 40 kg/m2), the
incremental cost-effectiveness was $8878/QALY for LAGB
compared with $14,680/QALY for LRYGB
1. Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight loss interventions. Surg Obes Relat
Dis. 2008;4:26-32.
69
Cost-effectiveness of LAGB and
LRYGB
Probabilities and Cost for 3 Years¹
Variable
%EWL*
LAGB
LRYGB
Operative Mortality (%)
Band Adjustments
LAGB
55 % (38, 64)
NA
NA
0.05 (0.1)
10
LRYGB
71 % (59, 89)
NA
NA
1 (0.5-2)
NA
Cost
NA
$16,200 †
$27,560 †
5 (1-10)
NA
$10,000
$5,000
LRYGB Revisional Surgery
NA
LAGB Revisional Surgery
5 (2-7)
 Evaluate cost-effectiveness of bariatric treatments using
–
–
–
–
–

$150‡
Procedure effectiveness in terms of %EWL
Initial treatment costs (eg, H-CUP‡) and expert opinion§
Costs of complications/sequelae, based on public data sources (eg, H-CUP) and expert opinion
BMI-specific utilities
Major endpoints: survival, health-related quality of life, weight loss
Conclusion:
–
The modeled cost-effectiveness analysis showed that both operative interventions for morbid obesity, LAGB and
LRYGB, were cost-effective at $25,000 and that LAGB was more cost-effective than LRYGB for all base-case
scenarios.
*The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess
weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).
† 2004
US dollars, adjusted for inflation, based on public data sources QALY=Quality–adjusted-life years.
Healthcare Costs and Utilization Project.
‡H-CUP-
1.
Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight
loss interventions. Surg Obes Relat Dis. 2008;4:26-32.
70
Cost-effectiveness of LAGB and LRYGB
Two-way sensitivity analysis of
cost-effectiveness of LAGB
and RYGB.
Difference in cost-effectiveness of these
procedures using base-case estimates
 For men and women, both LAGB
and LRYGB are found as costeffective at: <$25,000/QALY
 When evaluating the full range of
BMI values and estimates of
adverse outcomes, weight loss, and
costs
Analysis based on
the assumption
of a 45-year-old
female with BMI
of 40 kg/m2
 Benefit of higher excess weight
loss of RYGB is outweighed by
low rate of operative mortality of
LAGB*
*If weight loss from LAGB is significant and sustained over time.
1. Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight loss interventions. Surg Obes Relat
Dis. 2008;4:26-32.
71
Cost-effectiveness of LAGB and LRYGB
 Study limitations
– Data from the Third National Health and Nutrition Evaluation Survey and the
Framingham Heart Study used to estimate life expectancy, future costs, and
quality of life
– Studies included data on patients with a BMI ≤37.5 kg/m2
• Assumed a linear correlation between BMI and these parameters for BMIs of 40-60 kg/m2
• Data support linear relationship, but data for BMI >45 kg/m2 is limited
– Probabilities (perioperative mortality, revisional surgery, and weight loss) and costs
associated with those states that underlie the model were not BMI- or age-specific,
because few reports have suggested that the probabilities and costs are related to BMI
or age
– Obesity’s relationship with 5 chronic conditions (hypertension, hypercholesterolemia,
type 2 diabetes mellitus, coronary heart disease, and stroke) were considered, which
accounted for ~85% of total economic burden of obesity
– Although the model incorporated the complications of surgery in the usual care cost
calculation, the rates of these complications could vary between sites and would be
difficult to assess accurately in a modeled analysis
1. Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight loss interventions. Surg Obes Relat
Dis. 2008;4:26-32.
72
Cremieux Study Demonstrates
Return on Investment (ROI) Data1
A Study on the Economic Impact of Surgery*
Purpose
Evaluate private third-party payer ROI for bariatric surgery in treatment of morbid obesity
Study Design
Retrospective claims analysis with matched cohort sample of nonsurgery patients†
Results
ROI within approximately 4 years for open bariatric surgery and approximately 2 years for laparoscopic bariatric
surgery
Conclusion
Downstream savings associated with bariatric surgery are estimated to offset the initial costs in 2 to 4 years
Limitations
ROI estimates are driven more by the rising costs in matched control group rather than reduction in costs
postsurgery
• First ROI evidence using actual
claims records for bariatric
surgery
25 Months
49 Months
• Open bariatric surgery average
cost of $26,000
• Laparoscopic bariatric surgery
average cost of $17,000
*Based on 5 years of post-op cost data from 1999-2005 from Ingenix private insurer claims database.
† Cohort sample of nonsurgery patients were based on patient demographics, selected comorbidities, and cost.
‡ Estimate based on surgeries performed between 2004 and 2005 for laparoscopic surgeries and between 2003 and 2005 for open surgeries.
1. Cremieux PY, Buchwald H, Shikora SA, et al. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008;14:589-596.
73
IMPORTANT LAP-BAND® SYSTEM
SAFETY INFORMATION
Indications: The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body
Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are
100 lbs. or more over their estimated ideal weight. The LAP-BAND is indicated for use only in severely obese adult
patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior
modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes
in their eating habits for the rest of their lives.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that
may make them poor surgical candidates or increase the risk of poor results, (e.g., inflammatory or cardiopulmonary
diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis), who are unwilling or unable to
comply with the required dietary restrictions, who have alcohol or drug addictions, or who currently are or may be
pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required at some
time. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their
bands. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in
small increments. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an
increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur.
Possible complications include the risks associated with the medications and methods used during surgery, the risks
associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea
and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in malnutrition, anemia, or other complications that may require additional surgery.
Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Important: For full safety information please visit www.lapband.com or call Allergan Product Support at 1-800-6244261.
CAUTION: This device is restricted to sale by or on the order of a physician.
APC81NQ10
74