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The Impact of Obesity and the Value of Treatment

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1 The Impact of Obesity and the Value of Treatment
Obesity is defined as a body mass index (BMI) of greater or equal to 30 kg/m2 in the National Institutes of Health (NIH) Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults—the evidence report. Body Mass Index (BMI) is a measure of an adult’s weight in relation to his or her height, specifically the adult’s weight in kilograms divided by the square of his or her height in meters.1 Note: LAP-BAND® is only approved in morbidly obese adults who have failed at previous weight loss attempts with a BMI >40kg/mg2, or 35 kg/m2 with one or more severe comorbid conditions, or those who are 100 pounds or more over their estimated ideal body weight, according to the 1983 Metropolitan Life Insurance Tables (using the midpoint for the medium frame). 2 References: 1. National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults—the evidence report. Obes Res 1998;6(suppl 2):51S–209S. 2. DHHS 2001 Report, Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity; available at or to the CDC presentation, Obesity Trends Among U.S. Adults, avail. at Trends Among U.S. Adults between 1985 and 2007 (Accessed February 24, 2009). 3. LAP-BAND DFU, Allergan

2 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

3 Prevalence and Trends BMI
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 Prevalence has more than doubled between 1980 and 2002 (13.3% to 32.2%)1,2 The prevalence of extreme obesity (BMI ≥40) in was: 2.8% in men and 6.9% in women1 In , 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 adults5 Normal Weight2 (BMI 18.5 to 24.9) Overweight2 (BMI 25 to 29.9) Obese3,4, (BMI 30 to 34.9) Moderate Obesity3,4,6 (BMI 35 to 39.9 ) Morbid Obesity3,4,6 (BMI 40 or more) Obesity, classified as a BMI > 30 is broken into 3 classifications, Class I (BMI of 30 to 34.9), Class II (BMI between 35 and 39.9) or Class III (BMI of 40 or greater). Overweight and obesity are at epidemic proportions in the United States.(1, 6) Between 1980 and 2002,obesity prevalence doubled in adults aged 20 years or older and overweight prevalence tripled in children and adolescents aged 6 to 19 years.3-5 In 2007, Ogden et al updated their prevalence data as follows: ► More than one-third of U.S. adults -– over 72 million people -- were obese in This includes 33.3 percent of men and 35.3 percent of women. ► Obesity rates have increased since the 1976–1980 survey period. There was no significant change in obesity prevalence, however ,between 2003–2004 when 31.1 percent of men were obese and 33.2 percent of women were obese and 2005–2006 percentages for either men or women. ► Adults aged had the highest obesity prevalence compared with other age groups. ►Recent data show racial and ethnic obesity disparities for women but not for men. Non-Hispanic black and Mexican-American women were more likely to be obese than non-Hispanic white women. ► Among obese adults, approximately two-thirds have ever been told by a health care provider that they are overweight.7 The reasons for this explosion in obesity are multifactorial and not easily remedied. However, for those that are already obese, there are treatments available that are effective. Given the high prevalence of obesity in children and adolescents, the epidemic is not going to lessen, but will likely continue to increase for the foreseeable future. Ogden et al Obesity Among Adults in the United States: No Statistically Significant Change Since (accessed 5/18/2009) Ogden, C. et al. Prevalence of Overweight and Obesity in the United States, JAMA 2006;295: Department of Health and Human Services - National Institutes of Health. BMI Categories. Accessed March 27, 2007. Practical Guide for the Identification, Evaluation, and Treatment of Overweight and Obesity in adults. (Accessed April 17, 2009.) 5. Department of Health and Human Services - National Institutes of Health. The Problem of Overweight Children and Adolescents. Accessed September 19, 2007. 6. Mechanick, 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 (AACE/TOS/ASMBS Guidelines). Surgery for Obes. & Rel. Diseases 4 (2008) S109-S184. Data source: *http://www.cdc.gov/nchs/data/databriefs/db01.pdf (accessed 6/23/09) Ogden CL, Desjardins E, Schwartz AL. Collaborating to combat childhood obesity. Health Aff (Millwood) 2007;26:567–571.  Sturm R. Increases in morbid obesity in the USA: 2000–2005. Public Health 2007;121:492–496.  Haslam DW, James WP. Obesity. Lancet 2005;366:1197–1209.  BMI Class I Obesity Class II Obesity Class III Obesity 1. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High Available at: Accessed 2. Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of overweight and obesity in the United States, JAMA. 2006; 295: 3. Caclulate Your Body Mass Index. Available at Accessed 4. National Insttitute of Health. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults Available at . Accessed 5. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity Available at: http//www.surgeongeneral.gov/topics/obesity/calltoaction/fact_adolescent.htm. Accessed 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

4 Obesity Trends* Among US Adults BRFSS† 1990, 1999, 2008
The slide is taken directly from the CDC presentation, Obesity Trends Among U.S. Adults, available at Trends Among U.S. Adults between 1985 and 2008 (Accessed Sept 9, 2009).Slide is from the CDC website In 1990, among states participating in the Behavioral Risk Factor Surveillance System, 10 states had a prevalence of obesity less than 10% and no states had prevalence equal to or greater than 15%. By 1998, no state had prevalence less than 10%, seven states had a prevalence of obesity between 20-24%, and no state had prevalence equal to or greater than 25%. In 2008, only one state (Colorado) had a prevalence of obesity less than 20%. Compared to 2007, the number of states with a prevalence equal to or greater than 30% has doubled, from 3 (Alabama, Mississippi and Tennessee) in 2007 to 6 in 2008. The data shown in these maps were collected through CDC’s Behavioral Risk Factor Surveillance System (BRFSS). Each year, state health departments use standard procedures to collect data through a series of monthly telephone interviews with U.S. adults. Prevalence estimates generated for the maps may vary slightly from those generated for the states by BRFSS (http://aps.nccd.cdc.gov/brfss) as slightly different analytic methods are used. 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: Accessed

5 Figure represents US adults aged 20-74 years
Changes in Distribution of Body Mass Index between and 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 and BMI Percent Source: CDC/NCHS, National Health and Nutrition Examination Survey (NHANES) 10 15 20 25 30 35 40 45 50 5 NHANES NHANES Changes in the prevalence of obesity do not present a complete picture of the trends in weight (measured by body mass index (BMI)) among U.S. adults. ● Changes in the prevalence of obesity do not present a complete picture of the trends in weight (measured by body mass index (BMI)) among U.S. adults. A more complete picture can be seen by comparing the distribution of BMI in 1976–1980 with the distribution in 2005–2006 for adults 20–74 years of age. Between 1976–1980 and 2005– 2006 the distribution of BMI shifted to the right but the shift was greatest at the upper percentiles of the distribution. This indicates that the entire adult population is heavier, and the heaviest have become much heavier since Ref: Ogden et al. Obesity Among Adults in the United States: No Statistically Significant Change Since (accessed 7/24/2009) Data Source: The National Health and Nutrition Examination Survey (NHANES) data were used for these analyses. NHANES is designed to monitor the health and nutritional status of the United States civilian, non-institutionalized population. The survey consists of interviews conducted in participants’ homes, standardized physical examinations conducted in mobile examination centers, and laboratory tests utilizing blood and urine specimens provided by participants during the physical examination. The NHANES sample is selected through a complex, multistage design that includes selection of primary sampling units (counties), household segments within the counties, and finally sample persons from selected households. The sample design includes oversampling in order to obtain reliable estimates of health and nutritional measures for population subgroups. In 2005–2006, African Americans, Mexican Americans, persons with low income, adolescents 12–19 years of age, and adults 60 years and older were oversampled. In 1999, NHANES became a continuous survey, fielded on an ongoing basis. Each year of data collection is based on a representative sample covering all ages of the civilian, noninstitutionalized population. Public-use data files are released in 2-year cycles. Figure represents US adults aged years 1. Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States--no statistically significant chance since NCHS Data Brief. 2007;1:1-8. 2. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High Available at: Accessed

6 Age-Adjusted Percentage of US Adults Who Were Obese or Who Had Diagnosed Diabetes
Risk factors for type 2 diabetes include older age, obesity, family history of diabetes, prior history of gestational diabetes, impaired glucose tolerance, physical inactivity, and race/ethnicity. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes. Risk factors are less well defined for type 1 diabetes than for type 2 diabetes, but autoimmune, genetic, and environmental factors are involved in developing this type of diabetes. Source: (accessed 5/18/09) The maps display the age-adjusted percentages of U.S. adults who were obese or had diagnosed diabetes in 1994, 2000 and 2007. In 1994, the percentage of adults who were obese was less than 18% in every state but two, and in no state was the percentage higher than 22%. In 2000, 13 states had less than 18% of adults who were obese, and 11 states had more than 22 percent. In 2007, no state had less than 18 percent who were obese and 45 states had more than 22%. Similarly, the percentage of adults with diagnosed diabetes was less than 6 percent in almost all states in In 2000, about half of the states had less than 6% of adults with diabetes. In 2007, three states had less than 6 percent of adults with diabetes and ten states had more than 9 percent Data Source and Methodology The percentage of U.S. adults who were obese or who had diagnosed diabetes was determined by using data from the Behavioral Risk Factor Surveillance System (BRFSS, available at An ongoing, yearly, state-based telephone survey of the non-institutionalized adult population in each state, the BRFSS provides state-specific information on behavioral risk factors for disease and on preventive health practices. Respondents who reported that a physician told them they had diabetes (other than during pregnancy) were considered to have diagnosed diabetes. Self reported weight and height were used to calculate body mass index (BMI): weight in kilograms divided by the square of height in meters. A BMI greater than or equal to 30 was considered to be obese. Rates were age-adjusted using the 2000 U.S. Standard Population. For additional information on overweight and obesity and for additional obesity trend data see: Source: (accessed 5/18/09) Maps of Diabetes and Obesity in 1994, 2000, and Available at: Accessed

7 Medical Complications Which May Be Associated With Obesity1
Pulmonary disease Abnormal function Obstructive sleep apnea Hypoventilation syndrome Idiopathic intracranial hypertension Stroke Cataracts Nonalcoholic fatty liver disease Steatosis Steatohepatitis Cirrhosis Coronary heart disease Diabetes Dyslipidemia Hypertension Gall bladder disease Severe pancreatitis Gynecologic abnormalities Abnormal menses Infertility Polycystic ovarian syndrome Cancer Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate Medical complications which MAY be Associated with obesity. Note: All the above diseases are NOT ALWAYS caused by obesity but certainly may be due to other causes. Slide accessible at: (accessed April 17, 2009) Ref: Bhoyrul S. JMCM (4):10-17 Journal of Managed Care Medicine-JMCM Osteoarthritis Phlebitis Venous stasis Skin Problems Gout 1. Bhoyrul S., Lashock J. The Physical and Fiscal Impact of the Obesity Epidemic: The Impact of Comorbid Conditions on Patients and Payers. .JMCM :11(4):

8 Body Mass Index vs Mortality
Exponential Increase in Risk 16 19 22 25 28 31 34 37 40 45 50 100 150 200 250 300 350 400 Relative Mortality Rate BMI (kg/m2) High risk Medium risk Low risk Visual evidence of the dramatic impact of obesity on the mortality rate. The relative mortality rate is defined as the ratio of the mortality rate at any selected BMI compared to a BMI of 24. Therefore, a relative mortality rate of 150 indicates a 50% increase in mortality over the reference case (BMI=24). The information was determined using a Cox regression model with mortality as the outcome. 1. Fontaine KR, et al. Years of life lost due to obesity. JAMA 2003;289: 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 1. Fontain KR, Redden DT, Wang C, et al. . Years of life lost due to obesity. JAMA. 2003;289:

9 Direct Cost of Chronic Diseases in the United States1,2
60 $53.2 $51.6 50 $38.7 40 Direct Cost ($ Billions) 30 $18.4 $18.1 20 Direct cost of chronic diseases in the United States It is estimated that obesity accounts for 6% of the nation’s total healthcare expenses, with $51.6 billion/year in direct costs and over $100 billion/year in both direct and indirect costs. Direct costs include the costs of personal health care, hospital care, physician services, allied health services, and medications. Indirect costs include the value of lost productivity from illness or premature mortality. The estimated direct cost of obesity is comparable to that of other prevalent, chronic diseases, such as type 2 diabetes and coronary heart disease, and is more costly than both hypertension and stroke. Moreover, obesity contributes to the development of other chronic diseases; it is estimated that 61% of the direct cost of type 2 diabetes, 17% of the direct cost of coronary heart disease, and 17% of the direct cost of hypertension are attributable to obesity. Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Obes Res. 1998;6: Hodgson TA, Cohen AJ. Medical care expenditures for selected circulatory diseases: opportunities for reducing national health expenditures. Med Care. 1999;37: 10 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 Mar;6: 2. Hodgson TA, Cohen AJ. Medical care expenditures for selected circulatory diseases: opportunities for reducing national health expenditures. Med Care. 1999;37:

10 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 These statistics demonstrate the extent to which obesity impacts society through increased medical costs and indirect costs. Note, these data are several years old and current data likely would show an increase in all of these estimates. Also, note that a great deal of the economic impact of obesity is due to increasing expenditures for the comorbidities related to obesity (e.g., diabetes, hyperlipidemia, and heart disease). Between 1987, when U.S> adult obesity averaged 14%, and 2001, when it was up to 31%, increases in spending on obese people relative to people of normal weight accounted for 27% of the rise in inflation adjusted per capita spending. Spending for diabetes accounted for 38% of that increase, hyperlipidemia for 22%, and heart disease for 41%. Increases in obesity prevalence alone accounted for 12% of the growth in health spending over the period. Overall, much of the increase in U.S. health spending over the past two decades — by some measures, 20% or more — is attributable to the risein obesity. If the prevalence of obesity were the same today as in 1987, health care spending in the U.S. 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, Accessed April 8, 2007. 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); *Data from 1997 and the 2005 Household Component to the Medical Expenditures Panel Survey (MEPS=HC). †The 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. 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); 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. 10

11 Weighty Matters: How Obesity Drives Poor Health and Health Spending in the US
This policy brief summarizes previous research and presents new evidence of the role obesity, which is defined in this study as a BMI > 30 kg/m2. Obesity plays in rising rates of chronic disease and health spending. The analysis uses data from the 1997 and the 2005 Household Component to the Medical Expenditure Panel Survey (MEPS-HC), collected by the Agency for Health Care Research and Quality (AHRQ). The authors conducted an analysis of the role rising obesity rates played in increasing chronic disease prevalence and health spending among working-age adults between 1997 and 2005. These annual surveys provide nationally representative estimates of health care spending, insurance status, utilization of medical services, sources of payment and disease prevalence, along with a broad set of socioeconomic characteristics, for the non-institutionalized civilian population in the U.S. Given the scope of the study, samples were restricted to non-pregnant adults aged 18 to 64 with valid body mass index (BMI) data, resulting in 16,476 observations in 1997, and 17,682 in 2005. Individuals were assigned into one of the four BMI categories using self-reported information on weight and height. BMI is calculated as weight in kilograms divided by the square of height in meters. CDC defines four BMI categories: obesity is a BMI of >30; overweight is BMI 25.0 to 29.9; normal weight is BMI between 18.5 and 24.9; and underweight is BMI <18.5. Persons with missing BMI data or implausible BMI values (e.g., under 10) were excluded from the analysis. *Note that LAP-BAND® is only approved in morbidly obese adults who have failed at previous weight loss attempts with a BMI ≥ 40 kg/m2, or 35 kg/m2 with one or more severe comorbid conditions, or those who are 100 pounds over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (using the midpoint for medium frame) Ref: Thorpe KE, Ogden L and Galactionova K. Weighty Matters: How Obesity Drives Poor Health and Spending in the U.S. National Business Group on Health (Feb 2009) (accessed 6/19/09) 1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed

12 Physical Costs of Obesity
Share in Condition Prevalence: 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% 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 In working-age adults, the prevalence of 11 chronic conditions associated with overweight and obesity grew percent from the study period, 1997 to 2005. 36.01% of new cases across all 11 chronic conditions can be contributed to obesity. 16.97% of new cases across all 11 chronic conditions can be contributed to overweight. Obesity alone contributed nearly 29 million additional chronic condition cases in 2005 over the 1997 level. For every condition, the obesity-associated share of prevalence (the far right column) was in double digits, with the exception of cancer (8.75% share) and kidney disease (7.48%). From 1997 to 2005, the overall average contribution of obesity across all 11 chronic conditions was 36.01%. The overall share attributable to overweight averaged roughly half that (16.97%). The burden of obesity is most marked in heart disease and diabetes, accounting for more than 70% of the growth in prevalence for these two conditions. Obesity accounted for 60% of the growth in hypertension and nearly 50% of the rise in arthritis. Of particular note for employers is the steep increase in overweight-associated back problems, which increased 578% from 1997 (1.18%) to 2005 (8%). Ref: Thorpe KE, Ogden L and Galactionova K. Weighty Matters: How Obesity Drives Poor Health and Spending in the U.S. National Business Group on Health (Feb 2009) (accessed 6/19/09) 1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed The prevalence of 11 chronic conditions associated with overweight and obesity grew 180%.

13 Physical Costs of Obesity
458% increase in pulmonary conditions 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 93% hyperlipidemia 35% hypertension 25% diabetes 1997 2005 Condition % 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% Hypertension 33.58% 45.40% Arthritis 17.04% 27.17% Diabetes 46.05% 57.60% Upper GI 8.59% 22.09% Kidney 18.53% 14.14% Hyperlipidemia 19.11% 36.96% Other increases of percent cases associated with obesity include: 458% increase in pulmonary conditions 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 93% hyperlipidemia 35% hypertension 25% diabetes 1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed

14 Physical Costs of Overweight and Obesity
Share in Condition Prevalence: 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 following increases in back problems were noted with overweight and obesity Overweight—578% increase Obesity—56% increase Of particular note for employers is the steep increase in overweight-associated back problems, which increased 578% from 1997 (1.18%) to 2005 (8%). The increase in obesity-associated back problems was smaller, 56%, but of concern. Low back pain is second only to upper respiratory illness as a reason for adults’ symptom-related physician visits, is the most common cause of work-related disability in people under 45 years of age, and is the most expensive cause of work-related disability, in terms of workers’ compensation and medical expenses. Ref: Thorpe KE, Ogden L and Galactionova K. Weighty Matters: How Obesity Drives Poor Health and Spending in the U.S. National Business Group on Health (Feb 2009) (accessed 6/19/09) 1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed

15 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 In 2005, condition specific health spending among adults age was roughly equivalent across BMI categories, excluding underweight adults , who accounted for under 2% (1.69%) of expenditures ($8.887million), a share equivalent to their proportion (1.71%) in the population. The other BMI categories accounted for about a third of total spending, although obese adults spent more in proportion of the population than did overweight or normal weight adults. Normal weight adults or 36.11% of population accounted for $160.6 million (32.45%) in spending, Overweight adults, or 35.36% of population accounted for $165.6 million (32.09%) in spending, and Obese adults which was 26.82% of the population accounted for $177.5 million which was 33.7% in spending. With the exception of the underweight BMI category, the key point of this slide is that healthcare expenditures for obese patients in 2005 was disproportionate to their percent of the overall adult population relative to those adults with BMIs in the under-, normal and over-weight BMI categories. Thorpe KE, Ogden L and Galactionova K. National Business Group on Health (Feb 2009) (accessed 6/19/09) 1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed Condition-Specific Health Spending Varies by BMI

16 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 Results: Regression-adjusted incremental direct medical costs associated with being overweight, obese, and severely obese were estimated to be Overweight—$147.11 Obese—$712.34 Severely Obese—$ Adjusted incremental indirect costs due to paid absence associated with being overweight, obese, and severely obese were estimated at Overweight—$ Obese—$ Severely Obese—$ 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:

17 % of Total Study Population
Durden et al: Prevalence of Conditions Within Selected Major Diagnostic Categories % of Total Study Population 5 10 15 20 25 30 35 40 Musculoskeletal Circulatory Endocrine, Nutritional, and Metabolic Diseases Respiratory Objective: To quantify the direct and indirect costs of obesity within a cohort of commercially insured employees in the United States. Method: Health plan claims, self-reported health risk assessment, and productivity data (Thomson MarketScan) from 2003 to 2005 were used to identify employees. Two-part regression models were used to compare body mass index (BMI) groups to estimate the incremental direct and indirect costs, conditional on expenditure, associated with elevated BMI. Results: Regression-adjusted incremental direct medical costs associated with being overweight, obese, and severely obese were estimated to be $147.11, $712.34, and $ , respectively. Adjusted incremental indirect costs due to paid absence associated with being overweight, obese, and severely obese were estimated at $ , $ , and $ , respectively. Conclusions: Overall adjusted direct and indirect costs were higher for workers with elevated BMI relative to those of normal weight. As shown in the above slide, the prevalence of a variety of conditions of major organ systems increases with increasing levels of BMI, including conditions of the musculoskeletal system, respiratory system, as well as endocrine, nutritional, and metabolic diseases and disorders. (The classes of conditions displayed represent chapters of the International Classification of Diseases, 9th revision—Clinical Modification (ICD-9-CM) manual. Claims histories of all patients were reviewed for the study period for the presence of any ICD-9-CM code contained in the reported chapters. (extracted from page of article) Reference: Durden et al. J Occup Environ Med. 2008;50: 991–997. Severely obese BMI ≥35 Obese 30≤ BMI <35 Overweight 25≤ BMI <30 Normal weight 18.5≤ BMI <25 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:

18 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 Authors provide estimates of the obesity costs for the U.S. across payers (Medicare, Medicaid, and private insurers), in separate categories for inpatient, non-inpatient, and prescription drug spending REF: 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 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

19 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 REF: 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 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

20 Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates
Authors’ Conclusions “The connection between rising rates of obesity and rising medical spending is undeniable. Given the current budget in most jurisdictions, the high public sector spending for obesity is a major cause for concern. However, if the motivation to prevent or treat obesity were solely based on cost, then only cost-saving obesity interventions would be implemented once all costs and benefits were taken into account. From a payer’s perspective, although there is increasing evidence suggesting that bariatric surgery may be cost saving, not all obesity treatments will meet this threshold (nor do most treatments for other conditions).” 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 The connection between rising rates of obesity and rising medical spending is undeniable. Given the current budget crisis in most jurisdictions, the high public-sector spending for obesity is a major cause for concern. However, if the motivation to prevent or treat obesity were solely based on cost, then only cost-saving obesity interventions would be implemented once all costs and benefits are taken into account. From a payer’s perspective, although there is increasing evidence suggesting that bariatric surgery may be cost saving2, not all obesity treatments will meet this threshold (nor do most treatments for other conditions). This is not to say that these treatments should or should not be offered, but the extent to which greater use of obesity treatments would reduce spending in either the short or the long run remains unknown. The same is true for prevention. Many successful obesity prevention efforts are likely to be cost-effective (that is, have a low cost effectiveness ratio) but not cost saving. From a public health perspective that focuses on identifying cost-effective strategies for improving the health of the population, these interventions may still be worth pursuing, even at significant cost. REF: 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 Ref:15. Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care 2008 Sep;14(9):589–96. 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

21 A Guide to Selecting Treatment
Diet Physical Activity Lifestyle Modification Pharmacotherapy Surgery Obesity treatment pyramid The clinical approach to obesity can be viewed as a pyramid consisting of several levels of therapeutic options. All patients should be involved in an effort to change their lifestyle behaviors to decrease energy intake and increase physical activity. Lifestyle modification also should be a component of all other levels of therapy. Pharmacotherapy can be a useful adjunctive measure for properly selected patients. Bariatric surgery is an option for patients with severe obesity, who have not responded to less-intensive interventions. As illustrated by the arrow at the right side of the pyramid, the number of obese patients who require a specific level of treatment decreases as one moves up the pyramid.

22 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 >40 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 BMI (kg/m²) >30 Medications >27 (5% to 10% EWL, on average, when used with lifestyle changes)2,3 The clinical approach to overweight and obesity can be viewed as a pyramid consisting of several levels of therapeutic options. Treatments offered to patients should be a function of how much extra weight they have, as shown in the slide. In general, life style changes are recommended to persons with BMIs in the 25 to < 27 kg/m2 range. Weight loss medications (pharmacotherapy) are indicated for individuals with BMIs of 27 and above, depending on coexisting comorbidities. For moderate obesity, pharmacotherapy, sibutramine (Meridia) and orlistat (Alli, Xenical) results in very modest weight loss.4 Lifestyle modification also should be a component of pharmacotherapy and surgery. Optimal and continuous application of a combination of dietary and drug therapy in association with increased exercise and behavioral modification can, at best, achieve and maintain a 5–10% loss of body weight. For severely obese individuals, this is insufficient to solve the problem.3 Bariatric surgery is an option for patients with severe obesity, who have not responded to less-intensive interventions. Surgery is indicated for people with BMIs > 40 if no comorbidities are present or when their BMIs are > 35 with coexisting comorbidities. Surgery is not an alternative to lifestyle therapy or medications and is not a quick fix. Surgery or medication has to be combined with lifestyle changes to be successful.4 The number of obese patients who require a specific level of treatment decreases as one moves up to the surgery treatment option. All patients should be involved in an effort to change their lifestyle behaviors to decrease energy intake and increase physical activity. A “malabsorptive procedure” is a “a procedure that interferes with ingested nutrient absorption” and “restrictive procedure” as “a procedure that restricts a person’s ability to eat” –Fisher, et al., Amer J. Surgery, 2002. Ref 2. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults Source: National Institutes of Health et al. Accessed May18, 2009 [provides a guideline for selecting treatment_ found on page 25} Ref 3, Dixon et al., Diabetes Care, 2002, reports that combined medications and lifestyle changes can, at best, achieve 5-10% EWL, but does not segregate the statistics. Ref 4. Bhoyrul S. JMCM (4):10-17 JMCM=Journal of Managed Care Medicine) Diet Exercise Behavior modification Comorbidity + - Lifestyle Changes (5% to 10% EWL, on average, when used with medication)1,2 National Institutes of Health et al. 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 ; 16: 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: 3. Wierzbicki A. Rimonabant: endocannabinoid inhibition for the metabolic syndrome. Int J Clin Pract. 2006; 60 (12): 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 :11(4):

23 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 You may be a candidate for surgery if you are an adult with:• A body mass index (BMI) of 40 or more (about 100 pounds overweight for men and 80 pounds for women) or a BMI between 35 and 39.9 and a serious obesity-related health problem such as type 2 diabetes, coronary heart disease, or severe sleep apnea (when breathing stops for short periods during sleep). • Acceptable operative risks. • An ability to participate in treatment and long-term follow-up. • An understanding of the operation and the lifestyle changes you will need to make.1 Ref 1: U.S. DHHS, NIH, and NIDDK. Bariatric Surgery for Severe Obesity. Pub. No , updated March 2008. Information for table taken from Mechancik 2008 SOARD AACE-TOS_ASMBS Guidelines –see Table 7 _Selection Criteria for Bariatric Surgery on page S118.2 Ref 2: Mechanick, 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 (AACE/TOS/ASMBS Guidelines). Surgery for Obes. & Rel. Diseases 4 (2008) S109-S184 You may be a candidate for surgery if you are an adult with:• A body mass index (BMI) of 40 or more (about 100 pounds overweight for men and 80 pounds for women) or a BMI between 35 and 39.9 and a serious obesity-related health problem such as type 2 diabetes, coronary heart disease, or severe sleep apnea (when breathing stops for short periods during sleep). • Acceptable operative risks. • An ability to participate in treatment and long-term follow-up. • An understanding of the operation and the lifestyle changes you will need to make. Note: LAP-BAND® is only approved in morbidly obese adults who have failed at previous weight loss attempts with a BMI >40kg/mg2, or 35 kg/m2 with one or more severe comorbid conditions, or those who are 100 pounds or more over their estimated ideal body weight, according to the 1983 Metropolitan Life Insurance Tables (using the midpoint for the medium frame), citing the LAP-BAND directions for use (DFU). 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 Weight Loss Surgery for Clinically Severe or Morbidly Obese Adults*1
Two main types of weight loss procedures Some procedures are a combination 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 At present, there are 3 broad categories of bariatric procedures: purely gastric restriction, gastric restriction with some malabsorption, as represented by the Roux-en-Y gastric bypass (RYGB), and gastric restriction with significant intestinal malabsorption which is the combination of both. Ref: Mechanick, 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 (AACE/TOS/ASMBS Guidelines). Surgery for Obes. & Rel. Diseases 4 (2008) S109-S184 *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 24 24

25 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. There are 4 types of operations that are commonly offered in the US: adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), gastric sleeve (GS), and biliopancreatic bypass with a duodenal switch (BPD). Each has its own benefits and risks. In determining the option that is best for the patient, both the patient and the physician will consider that operation’s benefits and risks along with many other factors, including BMI, eating behaviors, obesity-related health conditions, and previous operations. 1 Adjustable Gastric Banding (AGB) and Gastric Sleeve (GS) are restrictive bariatric procedures. The purposes of a gastric restriction procedure are to produce early satiety, limit food intake, and thus induce weight loss. RYGB is a combination of restriction and malabsorption.2 Adjustable Gastric Band AGB works primarily by decreasing food intake. Food intake is limited by placing a small bracelet-like band around the top of the stomach to produce a small pouch about the size of a thumb. The outlet size is controlled by a circular balloon inside the band that can be inflated or deflated with saline solution to meet the needs of the patient. 1 Roux-en-Y Gastric Bypass RYGB works by restricting food intake and by decreasing the absorption of food. Food intake is limited by a small pouch that is similar in size to the adjustable gastric band. In addition, absorption of food in the digestive tract is reduced by excluding most of the stomach, duodenum, and upper intestine from contact with food by routing food directly from the pouch into the small intestine. 1 Gastric Sleeve GS is usually performed as the first stage of biliopancreatic bypass with duodenal switch in patients who may be at high risk for complications from more extensive types of surgery. These patients’ high risk levels are due to body weight or medical conditions. A GS operation restricts food intake and does not lead to decreased absorption of food. However, most of the stomach is removed, which may decrease production of a hormone called ghrelin. 1 There are several evidence level 3 publications supporting a role for staged bariatric procedures involving an initial sleeve gastrectomy; nevertheless, the Gastric Sleeve operations remain investigational at the current time.2 (note to speaker, this ref was from a 2008 publication) Biliopancreatic Bypass With a Duodenal Switch (BPD) BPD, usually referred to as a “duodenal switch,” is a complex bariatric operation that includes removing the lower portion of the stomach and creating a gastric sleeve with the small pouch that remains. That pouch is connected directly to the small intestine, completely bypassing the duodenum and upper small intestine from contact with food. BPD produces significant weight loss. However, the mortality rate is higher than with other bariatric operations and there are more long-term complications because of decreased absorption of food, vitamins, and minerals. CMS found that RYGBP, LAGB, and BPD/DS improve health outcomes in Medicare beneficiaries who have T2DM and a BMI ≥ 35 and, as such, under these circumstances such surgeries may be reasonable and necessary (Medicare-coverable). See CMS Decision Memo for Surgery for Diabetes (CAG-00397N)(Feb. 12, 2009); avail. at (Accessed February 23, 2009). Additionally, Medicare will cover RYGBP, LAGB, and BPD/DS for Medicare beneficiaries who have a BMI >35, have at least one (1) co-morbidity related to obesity, and have previously been unsuccessful with medical treatment for obesity. Procedures must also be performed at qualified facilities. See CMS National Coverage Decision (NCD) Manual, Section See also NCD Manual Sections 100.8, Intestinal Bypass, and , Gastric Balloon. “The list of nationally-covered procedures now includes open and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and open and laparoscopic biliopancreatic diversion with duodenal switch.  Until other evidence is available, all other bariatric surgical procedures will be nationally non-covered. 3 Ref 1: Bariatric Surgery for Severe Obesity; NIH Publication No: , updated March 2008 DHHS: U.S. Department of Health and Human Services, NIH: National Institutes of Health, NIDDK: National Institute of Diabetes and Digestive Diseases and Kidney Diseases Ref 2: Mechanick, 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 (AACE/TOS/ASMBS Guidelines). Surgery for Obes. & Rel. Diseases 4 (2008) S109-S184 Ref 3: CMS National Coverage Decision (NCD) Manual, Section NCD Manual Sections 100.8, Intestinal Bypass, and , Gastric Balloon. CMS National Coverage Decision (NCD) Manual, Section NCD Manual Sections 100.8, Intestinal Bypass, and , Gastric Balloon Ref4 for CMS Nationally Non-Coverage Decisions National Coverage Decision (NCD) Manual, Section 100.1 Figure from Bariatric Surgery for Severe Obesity; NIH Publication No: , 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.

26 Commonly Performed Bariatric Procedures in the United States
Roux-en-Y Gastric Bypass Adjustable Gastric Banding Sleeve Gastrectomy RYGB works by restricting food intake and by decreasing the absorption of food. (Malabsorptive and restrictive) AGB works primarily by decreasing food intake. (Restrictive) Restricts food intake and usually requires a second procedure (Restrictive) Gastric banding and gastric bypass are the most common bariatric surgical procedures performed in the U.S. RYGB works by restricting food intake and by decreasing the absorption of food. Food intake is limited by a small pouch that is similar in size to the adjustable gastric band. In addition, absorption of food in the digestive tract is reduced by excluding most of the stomach, duodenum, and upper intestine from contact with food by routing food directly from the pouch into the small intestine. Currently, the LAGB has almost completely replaced the VBG because it is less invasive, is adjustable, and is reversible, and has better outcomes. LAGB works primarily by decreasing food intake. Food intake is limited by placing a small bracelet-like band around the top of the stomach to produce a small pouch about the size of a thumb. The outlet size is controlled by a circular balloon inside the band that can be inflated or deflated with saline solution to meet the needs of the patient. SLEEVE GASTRECTOMY The bariatric procedure commonly referred to as “sleeve gastrectomy” (SG) or “vertical gastrectomy” is a bariatric procedure involving subtotal gastric resection of the fundus and body to create a long, tubular gastric conduit along the lesser curve of the stomach. SG is the gastric component of the ASMBS-approved bariatric procedure of biliopancreatic diversion with duodenal switch. The mechanisms of weight loss and improvement in co-morbidities seen after SG might be related to gastric restriction, neurohumoral changes related to gastric resection or gastric emptying, or some other unidentified factor or factors. Bilio-pancreatic Bypass With a Duodenal Switch (BPD+ DS), usually referred to as a “duodenal switch,” is a complex bariatric operation that includes removing the lower portion of the stomach and creating a gastric sleeve with the small pouch that remains. That pouch is connected directly to the small intestine, completely bypassing the duodenum and upper small intestine from contact with food. BPD produces significant weight loss. However, the mortality rate is higher than with other bariatric operations and there are more long-term complications because of decreased absorption of food, vitamins, and minerals 2008 NIDDK/NIH/DHHS_Bariatric Surgery for Severe Obesity ASMBS Statistics RYBG More detailed description: In RYGB, the upper part of the stomach is transected; thus, a very small proximal gastric pouch, measuring 10 to 30 mL, is created. The gastric pouch is anastomosed to a Roux-en-Y proximal jejunal segment, bypassing the remaining stomach, duodenum, and a small portion of jejunum. The standard Roux (alimentary) limb length is about 50 to 100 cm, and the biliopancreatic limb is 15 to 50 cm. As a result, the RYGB limits food intake and induces some nutrient malabsorption. In procedures that result in much longer Roux limbs (“distal gastric bypass”) and a short common channel, macronutrient malabsorption can be significant. Another modification that has been used involves combining the gastric band with the RYGB (“banded RYGB”) Gastric restriction can be performed by the vertical banded gastroplasty (VBG) by means of (1) limiting the volume of an upper gastric pouch, into which the esophagus empties, to 15 to 45 mL and (2) limiting the pouch outlet to the remaining stomach to 10 to 11 mm. References Mechanick AACE/TOS/ASMBS Bariatric Surgery Guidelines Surgery for Obesity and Related Diseases; 2008;4: S109-S184 Updated Position Statement on Sleeve Gastrectomy as a Bariatric Procedure- Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery. SOARD 2009; (rapid communication, accepted for publication Nov 2009)

27 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 Available in many other countries, included most of Europe and Australia. Adjustable – correct volume is important for optimal performance. It is a closed loop system where the amount of saline can be increased or decreased depending on the patient’s needs. It is a semipermable membrane, so over time, some saline may loss over time. Laparoscopic procedure – Workshops, mentoring, advanced laparoscopic skills, minimum number of surgeries that will be done – 25 per year. Demonstrate advanced laparoscopic skills and suturing capabilities confirm that they have performed at least 25 Nissen fundoplication procedures. Confirm they have performed 25 bariatric procedures or completed bariatric surgery course that details the issues of patient selection, procedural options, perioperative care, and long-term management Confirmation that they have established a bariatric patient support program that includes: appropriate hospital facilities exercise and nutrition counseling support from psychological, general medicine, and radiology personnel 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 Confirm that they are willing and able to perform and support at least 25 procedures every year Be observed by qualified personnel during their first band placements Have previous experience in treating obese patients and have staff and commitment to comply with the long-term follow-up requirements of obesity procedures 27

28 The APS with 3 mL and 7 mL saline
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

29 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 The key benefit of the LAP-BAND is its adjustability, and optimal use of this feature is integral to success. The determinants of the need for adjustments are the rate of weight loss, the degree to which satiety has been induced,and the presence of symptoms that may suggest obstruction. Band adjustment is a critical component in the success of LAGB. Methods include simple filling of the band with saline without any radiologic guidance, the use of fluoroscopy, or the possibility of a combination of both.

30 The Green Zone Adjustment frequency, dependent on physician evaluation
Favretti: Patient management after LAP-BAND placement. American Journal of Surgery 184 (2002) 38S–41S Principles of adjustment The level of adjustment should be sufficient to achieve a prolonged sensation of satiety in the patient. Weight loss should be steady and progressive, with the early rate of weight loss ideally being 0.5 kg but 1 kg/week. Adjustment should induce no restrictive symptoms, ie, heartburn, vomiting, discomfort, excessive difficulty with eating a normal range of food. Loss of excess weight should be planned to occur gently over a period of 18 months to 3 years, depending on initial weight. Indicators for adjustment of the LAP-BAND in the office Consider adding fluid Adjustment not required Consider removing fluid Inadequate weight loss Adequate rate of weight loss Vomiting, heartburn, reflux into the mouth Rapid loss of satiety after meals Eating reasonable range of food Coughing spells, wheezing and choking, especially at night Increased volume of meals No negative symptoms Difficulty coping with broad range of foods Hunger between meals Maladaptive eating behavior* * Usually characterized by the consumption of high-calorie liquid or very soft foods, and is often induced by an overly tight band. Adjustment frequency, dependent on physician evaluation Year 1: every 4 to 6 weeks Year 3: every 6 months Year 2: every 3 to 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 Available at: Accessed

31 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 DFU:“Surgeons planning laparoscopic placement must have extensive advanced laparoscopic experience, i.e., fundoplications as well as previous experience in treating obese patients, and have the staff and commitment to comply with the long-term follow-up requirements “of obesity procedures.They should comply with the ASMBS & the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) joint “Guidelines for SurgicalTreatment of Morbid Obesity” and the SAGES “Guidelines for Framework for Post-Residency Surgical Education andTraining”. Surgeon participation in a training program authorized by INAMED (ALLERGAN) Health or by an authorized INAMED(ALLERGAN) Health distributor is required prior to use of the LAP-BAND® AP System. Info on Criteria for Bariatric Surgery Center of Excellence (COE) • Institutional commitment to follow credentialing guidelines for bariatric surgery staff and to have a designated physician medical director of bariatric surgery, who participates in decision making and provides program oversight. Expectation that the institution will perform min125 bariatric surgical cases/yr • Presence of written clinical standards and procedures that facilitate standardized quality care for all patients and include processes for managing the evaluation and correction of adverse events. • Comprehensive multidisciplinary approach to caring for patients before, during and after the procedure. • Proficiency in bariatric surgery, equipped with adequate facilities, furniture and instruments suitable for severely obese patients. The center should be staffed by bariatric surgery teams comprised of experienced skilled surgeons and physicians, nurses, specialty-educated nutritionists and anesthesiologists, all of whom complete periodic continuing education in the care of bariatric patients. • Qualified & comprehensive credentialing program that ensures bariatric surgeons have performed and continue to perform at least 50 bariatric surgeries/yr and have a history of having performed at least 125 bariatric surgery cases in the past. Ideally, the bariatric surgeon should be board certified (or in the process of certification) by the American Board of Surgery, the American Osteopathic Board of Surgery (AOBS) and/or the Royal College of Physicians and Surgeons of Canada (RCPSC). In addition, surgeons should acquire additional certification (e.g., completion of course requirement) for the particular type of bariatric surgery to be performed. • Immediate access−within 30 minutes−to needed specialists, such as cardiologists, pulmonologists, rehabilitation therapists, psychiatrists and support staff. Legally acceptable process for monitoring and outcomes follow-up for the majority of bariatric surgery recipients for 5 years post-intervention. Bariatric surgery COEs are certified by two organizations: the American College of Surgeons (ACS) and the American Society for Bariatric and Metabolic Surgery (ASBMS). CMS endorses covered bariatric surgeries only when conducted at facilities that are: (1)certified by the ACS as a Level 1 Bariatric Surgery Center (For more information, go to ACS’sWeb site at or (2) certified by the ASMBS as a Bariatric Surgery Center of Excellence (BSCOE). (Go to for additional information.) References: 1- LAP-BAND Directions for Use (DFU) 2- Pratt et al. Surgery for Obesity and Related Diseases 2006;2: 497–503 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:

32 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 Available at: Accessed

33 Clinical Impact of the LAP-BAND® System
LAP-BAND® System Results in Long-Term Weight Loss*1 70 64.3 62.0 60 52.9 50 62.0%  19% mean excess weight loss 3 years after surgery 40.5 40 % EWL 30 26.1 20 10 The LAP-BAND™ System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). In one study 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%). In Dr. Ponce’s study, 36- and 48-month data are 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). Possible risks and complications with the LAP-BAND™ System include but are not limited to infection, nausea, vomiting, band slippage and obstruction, and in rare cases, gastric perforation and reoperation. More detailed risk information is available at or Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg. 2005;201(4): 6 12 24 36 48 (n=812) (n=668) (n=240) (n=68)† (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: † 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 33

34 Clinical Impact of Weight Loss Following LAP-BAND® System Surgery
Key Outcomes from 4 studies: 100% 93% 93% 90% 90% 90% 59% 79% 26% 14% 80% 35% 70% 76% 60% 64% 50% 40% 44% 30% 34% 20% 21% One of the most important benefits associated with LAP-BAND™ System surgery (from clinical, QOL, and economic perspectives) is the impact on comorbidities. Key comorbidities are either mostly completely resolved (or improved) within a relatively short timeframe after surgery (1-2 years), but not all. Studies are based on data gathered from patients from 1996 – (1. Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after LAP-BAND surgery for morbid obesity. Obes Surg 1999;9(4): 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(2): Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity. Arch Intern Med 2001;161(1): Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of LAP-BAND placement. Obes Surg. 1999;9(6): ) Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after LAP-BAND surgery for morbid obesity. Obes Surg. 1999;9(4): 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(2): ***Only observed sleep apnea was reported. This study defined the term “sleep disturbance” to include patients who had significant sleep disturbance as evidenced by reported habitual snoring and (1) poor sleep quality, (2) an Epqorth Sleepiness Scale (ESS) score of greater than ten (10), or (3) observed sleep apnea. Chart above only includes sleep apnea, omitting habitual snoring and poor sleep quality comparisons. (3. Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity. Arch Intern Med. 2001;161(1): ) 4. Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of LAP-BAND placement. Obes Surg. 1999;9(6): Although weight loss tends to receive much of the attention and quantification in bariatric surgery trials and practice, a very important clinical consequence of weight loss is the improvement or resolution of costly (in clinical, economic, and QOL terms) comorbidities. 1,3 Some studies have demonstrated that serious comorbidities are completely resolved in the majority of patients within 1 year after LAP-BAND™ System surgery and that this resolution is long-lasting. 1,2,3 In addition, patients that are at risk for developing Type 2 diabetes (but do not currently have the condition at the time of LAP-BAND System surgery) may not develop the condition after the LAP-BAND™ System is implanted. In a series of studies resolution and improvement of serious conditions (not all studies provide data after year 1) such as Type 2 diabetes and hypertension after LAP-BAND® System surgery is observed in ~50%-80% of patients and has been demonstrated to be maintained over 4+ years2,5,7,8 Other studies have found different results (e.g., Ahroni et al., Obes Surg., 2005) reported that, at one (1) year post-op, 63.8% reported resolutions, 34% reported no difference, and 2.1% reported that the condition was slightly worse). 1. Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after LAP-BAND surgery for morbid obesity. Obes Surg 1999;9(4): 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(2): 3. Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity. Arch Intern Med 2001;161(1): 5. Frigg A, Peterli R, Peters T, Ackermann C, Tondelli P. Reduction in co-morbidities 4 years after laparoscopic adjustable gastric banding. Obes Surg 2004;14: 6. 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: 7. Pontiroli AE, Folli F, Pagnelli M, et al. Laparoscopic gastric banding prevents Type 2 diabetes and arterial hypertension and induces their remission in morbid obesity. Diabetes Care 2005;28: 8. Dixon J, O’Brien P. Weight loss following laparoscopic adjustable gastric band produces sustained improvements in fasting plasma glucose and indirect measures of insulin resistance. Diabetes 2003;52:75 [Abstract]. 9. Ahroni JH, Montgomery KF, Watkins BM. Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year. Obes Surg 2005;15: 10% 10% 6% 7% 7% 4% 0% Asthma1 1 Year Post-op (n=32) Hypertension2 1 Year Post-op (n=34) Type 2 Diabetes2 1 Year Post-op (n=50) Sleep Apnea3 1 Year Post-op (n=27) Gastroesophageal Reflux4 2 Years Post-op (n=48) Resolved No Change Improved 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: 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: 3.Dixon JB, Schachter LM, O'Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med ;161: 4. Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of lap-band placement. Obes Surg. 1999;9: 34 34

35 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 ( , n=53) preoperatively to 5.58 ( , n=15) at 2 years after surgery2 Dixon’s 2008 trail (graph on right depicts this study) Context Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes. Objective To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control. Design, Setting, and Participants Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI 30 and40) with recently diagnosed (2 years) type 2 diabetes. Interventions Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care. Main Outcome Measures Remission of type 2 diabetes (fasting glucose level 126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value 6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat. Results Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, ). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P.001). Remission of type 2 diabetes was related to weight loss (R2=0.46, P.001) and lower baseline HbA1c levels (combined R2=0.52, P.001). There were no serious complications in either group. Conclusions Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed. Ref: Dixon JB et al. Diabetes Care ;25: Ponce J et al. Obes Surg ;14: Dixon JB et al. JAMA ;299(3): Dixon et al. Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes. A Randomized Controlled Trial JAMA. 2008;299(3): 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: 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:

36 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† 2009 American Diabetes Association (ADA) Standards of Care published in 2009 the recommendations in this slide regarding bariatric surgery in pts with diabetes. Letters following the different recommendations reflect the levels of evidence. B= Supportive evidence from well-conducted cohort studies, including: ● Evidence from a well-conducted prospective cohort study or registry ● Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study E=Expert consensus or clinical experience Gastric reduction surgery, either gastric banding or procedures that involve bypassing or transposing sections of the small intestine, when part of a comprehensive team approach, can be an effective weight loss treatment for severe obesity, and national guidelines support its consideration for people with type 2 diabetes who have BMI at or exceeding 35 kg/m2. Bariatric surgery has been shown to lead to near or complete normalization of glycemia in 55–95% of patients with type 2 diabetes, depending on the surgica procedure. Buckwald’s meta-analysis of studies of bariatric surgery reported that 78% of individuals with type 2 diabetes had complete “resolution” of diabetes (normalization of blood glucose levels in the absence of medications), and that the resolution rates were sustained in studies that had follow-up exceeding 2 years . Resolution rates are lowest with procedures that only constrict the stomach and higher with those that bypass portions of the small intestine. Additionally, there is increasing evidence that intestinal bypass procedures may have glycemic effects that are independent of, and additive to, their effects on weight. Studies of the mechanisms of glycemic improvement, long-term benefits and risks, and cost-effectiveness of bariatric surgery in individuals with type 2 diabetes will require well-designed randomized clinical trials, with optimal medical and lifestyle therapy of diabetes and cardiovascular risk factors as the comparitor. Ref: Standards of Medical Care in Diabetes—2009 DIABETES CARE, VOLUME 32, SUPPLEMENT 1, JANUARY 2009 * 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.

37 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 In this meta-analysis, authors report on the 30-day and 30-day to 2-year mortality in 85,048 patients who underwent bariatric surgery from 478 treatment groups in 361 studies, published from January 1, 1990 to April 30, 2006.* They have focused on 5 areas of interest: mortality by procedure (laparoscopic gastric banding, open and laparoscopic gastroplasty, open and laparoscopic gastric bypass, open and laparoscopic BPD/DS, and revisions/reoperations); mortality by procedure type (restrictive, restrictive/ malabsorptive, malabsorptive); mortality by publication year; mortality by study design; and mortality for subgroups, such as males versus females, the elderly, and the superobese. Ref: Buchwald H, Estok R. Fahrbach K, Banel D, Sledge I. Trends in mortality in bariatric surgery: A systematic review and meta-analysis. Surgery 2007;142: 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:

38 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 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 In this meta-analysis, authors report on the 30-day and 30-day to 2-year mortality in 85,048 patients who underwent bariatric surgery from 478 treatment groups in 361 studies, published from January 1, 1990 to April 30, 2006.* They have focused on 5 areas of interest: mortality by procedure (laparoscopic gastric banding, open and laparoscopic gastroplasty, open and laparoscopic gastric bypass, open and laparoscopic BPD/DS, and revisions/reoperations); mortality by procedure type (restrictive, restrictive/ malabsorptive, alabsorptive); mortality by publication year; mortality by study design; and mortality for subgroups, such as males versus females, the elderly, and the superobese. Although a higher body-mass index has been shown to increase the risk of an adverse outcome after bypass procedures, this study showed that the body-mass index had a quadratic relationship to the predicted probability of the composite end point. The lowest predicted risk was found at a body-mass index of 53. The risk of the composite end point among patients with a body mass index of 75 was 61% higher than the risk among those with a body-mass index of 53 (odds ratio, 1.61; 95% CI, 1.04 to 2.48). The predicted risk of the composite end point among patients with a body-mass index of less than 53 was also higher than the risk among those with a BMI of 53, but the odds ratio did not differ significantly for any BMI below 53. The following slides focus solely on mortality by procedure. Other results can be found in the article, which is referenced on this slide. Ref: Buchwald H, Estok R. Fahrbach K, Banel D, Sledge I. Trends in mortality in bariatric surgery: A systematic review and meta-analysis. Surgery 2007;142: 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:

39 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:

40 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:

41 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 The judgment of whether or not a new treatment offers sufficient clinical benefits to justify its additional cost (and therefore warrants reimbursement and adoption) is often in the purview of centralized (or decentralized) organizations such as NICE (in the UK) or various bodies such as the BlueCross BlueShield Technology Evaluation Center in the US. These types of groups have reviewed the overall body of literature for bariatric surgeries (namely RYGBP and LAGB) and, based on these data, have made favorable policy recommendations for these procedures. Centers for Medicare and Medicaid Services. NCD for bariatric surgery for treatment of morbid obesity. Publication Number 100-3; Manual Section Number February 2006. Trust for America's Health 2008 report F as in Fat Survey published by Trust for American’s Health and the Robert Wood Johnson Foundation Agency for Healthcare Research and Quality (AHRQ). Pharmacological and Surgical Treatment of Obesity. AHRQ Publication no. 04-E028-2; July 2004. 4.National Institute for Health and Clinical Excellence. Obesity: the prevention, identification, assessment and management of overweigh and obesity in adults and children. NICE Clinical Guideline 43. Issue data: December 2006. BlueCross BlueShield Association Technology Evaluation Center (TEC). Laparoscopic adjustable gastric banding for morbid obesity Volume 21, No Accessed September 25, 2007. Surgery for Obesity and Related Diseases 4 (2008) S109-S184 1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections ) 2. F As In Fat. Available at Accessed . AHRQ. Pharmacological and Surgical Treatment of Obesity . Evidence Reprot/Technology Assessment. 2004; 103: 1-6. . NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and Children :1-84. . BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity 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 41

42 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 Abstract: extracted from page 996 In summary, obesity imposes a significant societal and employer burden, as indicated by the greater health care utilization, higher direct medical costs, and more time lost from work of those who are obese or severely obese. 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, including dyslipidemia and type 2 diabetes. Reductions in the prevalence of such conditions could prove beneficial to patients, employers, and insurers. These findings are the result of a retrospective data analysis based on information collected from health plan claims, self-reported health risk assessments, and productivity data (Thomson MarketScan) from 2003 through 2005. The present study finds similarities in health care and indirect costs of overweight and normal employees, but differences in costs that are pronounced at both ends of the BMI continuum Durden et al. JOEM 2008;50(9): 1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic costs of obesity to self-insured employers. J Occup Environ Med. 2008;50: 42

43 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 The judgment of whether or not a new treatment offers sufficient clinical benefits to justify its additional cost (and therefore warrants reimbursement and adoption) is often in the purview of centralized (or decentralized) organizations such as NICE (in the UK) or various bodies such as the BlueCross BlueShield Technology Evaluation Center in the US. These types of groups have reviewed the overall body of literature for bariatric surgeries (namely Gastric Bypass and Laparoscopic adjustable gastric banding) and, based on these data, have made favorable policy recommendations for these procedures. 1. Centers for Medicare and Medicaid Services. NCD for bariatric surgery for treatment of morbid obesity. Publication Number 100-3; Manual Section Number February 2006. 2. National Institute for Health and Clinical Excellence. Obesity: the prevention, identification, assessment and management of overweigh and obesity in adults and children. NICE Clinical Guideline 43. Issue data: December 2006. Boudreau R, Hodgson A. Laparoscopic adjustable gastric banding for weight loss in obese adults: clinical and economic review [Technology Report 90]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007. BlueCross BlueShield Association Technology Evaluation Center (TEC). Laparoscopic adjustable gastric banding for morbid obesity Volume 21, No Accessed September 25, 2007. 1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections ) 2. NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and Children :1-84. 3. CADTH . Laparoscopic Adjustable Banding for Weight Loss in Obese Adults: Clinical and Economic Report ; 90:1-38 4. . BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity 43 43

44 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 or 2009 Allergan, Inc., Irvine, CA ® Marks owned by Allergan, Inc. 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 44

45 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

46 Comorbidity Reactive Use Only

47 Systematic Reviews: Comorbidities
Buchwald et al. JAMA. 2004;292: 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: 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%). With respect to Buchwald et al., JAMA, 2004, the following may be noted: Review was based on 136 fully extracted studies with a total of 22,094 patients—the majority of whom were female (72.6%) with a mean age of 39 years and a baseline BMI of The review used a random effects model for the meta-analysis. More specifically, the review noted a 47.5% EWL, with respect to gastric banding; a 61.6% EWL, with respect to gastric bypass; a 68.2% EWL, with respect to gastroplasty; and a 70.1% EWL, with respect to BDP/DS. The review also reported an operative mortality rate of 0.1% for purely restrictive procedures, 0.5% for gastric bypass, and 1.1% for BDP/DS. With Respect to Buchwald et al. Am J Med. Published in 2009: This paper is the largest, current, comprehensive meta-analysis of this subject and includes all articles published in English from Jan 1, 1990 to April 30, The authors expanded the database from the 2004 meta-analysis to 621 studies with 888 treatment arms and 135,246 patients. At baseline, the mean age was 40.2 years, body mass index (BMI) was 47.9 kg/m2, 80% were female, and 10.5% had previous bariatric procedures. Meta-analysis of weight loss overall was 38.5 kg or 55.9% excess body weight loss. Overall, 78.1% of diabetic patients had complete resolution, and diabetes was improved or resolved in 86.6% of patients. Weight loss and diabetes resolution were greatest for patients undergoing biliopancreatic diversion/duodenal switch, followed by gastric bypass, and least for banding procedures. Insulin levels declined significantly postoperatively, as did hemoglobin A1c and fasting glucose values. For diabetic patients only, the total weight loss (all procedures) at the time point for which data are available for at least 50% of study patients was 40.6 kg or 64.4% of excess body weight loss. The weight loss results again appear to last more than 2 years, with a weight loss of 38.2 kg or 67.1% excess body weight at less than 2 years and 42.9 kg or 58.0% excess body weight at 2 years or more. The proportion of patients with diabetes resolution or improvement was fairly constant at time points less than 2 years and 2 years or more. (Weight and diabetes parameters showed little difference at less than 2 years and at 2 years or more. (The definition of diabetes at times varied among authors; as a rule, however, overt diabetes was defined as a fasting blood glucose greater than 125 mg/dL or an HgA1c greater than 7%) With respect to Maggard et al., Am. Coll of Phys., 2005, the following may be noted: Review was based on 147 studies and concluded that surgery is more effective than non-surgical treatment for weight loss and control of some comorbid conditions in patients with a BMI of 40 or greater. Bariatric procedures studies reviewed included RYGBP, LAGB, VBG, and BDP/DS. With respect to Sjostrom et al., NEJM, 2007, the following may be noted: See additional notes included on slide 39. The prospective, controlled study involved 4047 obese patients with 2010 undergoing bariatric surgery and 2037 receiving conventional treatment and reported mortality during an average of 10.9 years of follow-up. Mean weight loss was maximal after one (1) to two (2) years (gastric bypass, 32±8%; VBG, 25±9%; and banding 20±10%). After ten (10) years, the EWLs were 25±11%; 16±11%; and 14±14%, respectively, and after 15 years were 27±12%; 18±11%; and 13±14%, respectively. Unable to confirm some findings (i.e. dealing with comorbidities) based on the materials available. References: 1. Buchwald, et al. Bariatric surgery: a systematic review and meta-analysis JAMA 2004;292: 2. Buckwald, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. The American Journal of Medicine (2009) 122, 3. Maggard, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med 2005;142: 4. Sjostrom, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. NEJM 2007;357: 1. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA ;292: 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: e5. 47

48 Systematic Reviews: Comorbidities
Maggard et al. Ann Intern Med. 2005;142: Surgical treatment for obesity resulted in a 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: 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 With respect to Buchwald et al., JAMA, 2004, the following may be noted: Review was based on 136 fully extracted studies with a total of 22,094 patients—the majority of whom were female (72.6%) with a mean age of 39 years and a baseline BMI of The review used a random effects model for the meta-analysis. More specifically, the review noted a 47.5% EWL, with respect to gastric banding; a 61.6% EWL, with respect to gastric bypass; a 68.2% EWL, with respect to gastroplasty; and a 70.1% EWL, with respect to BDP/DS. The review also reported an operative mortality rate of 0.1% for purely restrictive procedures, 0.5% for gastric bypass, and 1.1% for BDP/DS. With Respect to Buchwald et al. Am J Med. Published in 2009: This paper is the largest, current, comprehensive meta-analysis of this subject and includes all articles published in English from Jan 1, 1990 to April 30, The authors expanded the database from the 2004 meta-analysis to 621 studies with 888 treatment arms and 135,246 patients. At baseline, the mean age was 40.2 years, body mass index (BMI) was 47.9 kg/m2, 80% were female, and 10.5% had previous bariatric procedures. Meta-analysis of weight loss overall was 38.5 kg or 55.9% excess body weight loss. Overall, 78.1% of diabetic patients had complete resolution, and diabetes was improved or resolved in 86.6% of patients. Weight loss and diabetes resolution were greatest for patients undergoing biliopancreatic diversion/duodenal switch, followed by gastric bypass, and least for banding procedures. Insulin levels declined significantly postoperatively, as did hemoglobin A1c and fasting glucose values. For diabetic patients only, the total weight loss (all procedures) at the time point for which data are available for at least 50% of study patients was 40.6 kg or 64.4% of excess body weight loss. The weight loss results again appear to last more than 2 years, with a weight loss of 38.2 kg or 67.1% excess body weight at less than 2 years and 42.9 kg or 58.0% excess body weight at 2 years or more. The proportion of patients with diabetes resolution or improvement was fairly constant at time points less than 2 years and 2 years or more. (Weight and diabetes parameters showed little difference at less than 2 years and at 2 years or more. (The definition of diabetes at times varied among authors; as a rule, however, overt diabetes was defined as a fasting blood glucose greater than 125 mg/dL or an HgA1c greater than 7%) With respect to Maggard et al., Am. Coll of Phys., 2005, the following may be noted: Review was based on 147 studies and concluded that surgery is more effective than non-surgical treatment for weight loss and control of some comorbid conditions in patients with a BMI of 40 or greater. Bariatric procedures studies reviewed included RYGBP, LAGB, VBG, and BDP/DS. With respect to Sjostrom et al., NEJM, 2007, the following may be noted: See additional notes included on slide 39. The prospective, controlled study involved 4047 obese patients with 2010 undergoing bariatric surgery and 2037 receiving conventional treatment and reported mortality during an average of 10.9 years of follow-up. Mean weight loss was maximal after one (1) to two (2) years (gastric bypass, 32±8%; VBG, 25±9%; and banding 20±10%). After ten (10) years, the EWLs were 25±11%; 16±11%; and 14±14%, respectively, and after 15 years were 27±12%; 18±11%; and 13±14%, respectively. Unable to confirm some findings (i.e. dealing with comorbidities) based on the materials available. References: 1. Buchwald, et al. Bariatric surgery: a systematic review and meta-analysis JAMA 2004;292: 2. Buckwald, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. The American Journal of Medicine (2009) 122, 3. Maggard, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med 2005;142: 4. Sjostrom, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. NEJM 2007;357: *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 ;142: 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: 48

49 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 AHRQ- specific 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 Morbid obesity represents a significant burden to the US workforce. This study demonstrates that employees DMO are at higher risk for a larger list of other conditions than has been previously shown. The authors’ objective was to find conditions with significantly different prevalence among employees diagnosed with morbid obesity (DMO). The effect of bariatric surgery on the prevalence of all categories of comorbid conditions after bariatric surgery was examined. A large employer retrospective database analysis used matching to create two cohorts: those diagnosed with morbid obesity and those without. . Even after controlling for differences in age, tenure, gender, marital status, race, exempt status, full-time/part-time status, salary, and geographic region, employees with a morbid obesity diagnosis have a significantly higher prevalence of many comorbid conditions when compared with employees without a morbid obesity diagnosis. Study Limitations identified by authors: 1) Data base used in study was an employee only database, and therefore, the results exclude the elderly and those who are unemployed for health or other reasons, 2) if an employee who is morbidly obese did not have the appropriate assigned ICD-9 code in the medical claims data, it could lead to having a morbidly obese employee in the control group. Thus, the differences in comorbidity prevalence between the DMO and control cohorts reported here may be understated, 3) ICD 9 codes for morbid obesity do not distinguish exact levels of BMI above 40, 4) certain factors could not be taken into account when matching the DMO cohort to the control group. These include company specific health plan policies and other company-specific benefits. 5) decreasing sample size for each subsequent 90 day period. At the final period, nearly 2 yrs after surgery, only 93 employees were enrolled in the final period. *Ref: 1. Kleinman NL, Melkonian A, Borden S 4th, Rohrbacker N, Lynch WD, Gardner HH.The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup Environ Med :51(2): 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:

50 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 Essential hypertension Diabetes millitis Asthma Osteoarthritis Hyperlipidemia Increases in prevalence at 2 years Anemia Surgical and medical care complications Nutritional deficiencies Headaches including migraines Other upper respiratory infections For long-term changes in comorbidity prevalence, of the 25 AHRQ specific categories, from 90 days before surgery to 2 yrs after surgery, those that showed the largest decrease decreases included: essential hypertension, diabetes, asthma, osteoarthritis, and hyperlipidemia. Some categories were associated with increases. Of these categories, the authors noted that most would be expected given the procedure that was performed. These categories are anemia, surgical and medical care complications, nutritional deficiencies, headaches including migraines, and other upper respiratory infections. Ref: 1. Kleinman NL, Melkonian A, Borden S 4th, Rohrbacker N, Lynch WD, Gardner HH.The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup Environ Med :51(2): *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:

51 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 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. Background Bariatric surgery leads to weight loss, but it is unclear whether surgery reduces conditions associated with obesity. This study explored this by assessing the change in use of medications to treat diabetes mellitus, hypertension, and hyperlipidemia in the year following surgery. Methods This is a cohort study using administrative data from 2002 to 2005 from seven Blue Cross/Blue Shield Plans. The study compared the mean number of medications at the time of surgery and in the subsequent year. Medication usage by surgical patients was also compared to usage by matched enrollees without surgery but with a propensity score suggesting obesity. With Poisson and logistic regression, we tested for statistical differences in usage, accounting for repeated measures and controlling for age, sex, and diabetes. Authors also evaluated medications expected to be less influenced by surgery (antidepressants, thyroid replacement, and antihistamines). *This study accessed claims data from seven Blue Cross Blue Shield health plans providing coverage in Western Pennsylvania, Philadelphia, South Dakota, Iowa, Hawaii, Michigan, North Carolina, and Tennessee. The data were de-identified in accordance with the Health Insurance Portability and Accountability Act’s definition of a limited data set. The data were used in accordance with federal standards for protecting the confidentiality of the personal health information of the enrollee. The Johns Hopkins Institutional Review Board deemed the study to be exempt from Federal regulations because the research activities were considered to be of minimal risk to subjects. Reference: Segal et al. OBES SURG 2009; 19:1646–1656 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 Prompt Reduction in Use of Medications for Comorbid Conditions After Bariatric Surgery
Results Bariatric study cohort, n= 6, 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 Results Study cohort included 6,235 enrollees with bariatric surgery. Their mean age was 44 years with 82% women; 34% had diabetes. Medication use declined significantly by 3 months. By 12 months after surgery, medication use for diabetes, hypertension, and hyperlipidemia had declined by 76%, 51%, and 59%, respectively. 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. Conclusions Medication use for three serious obesity associated conditions decreased promptly following surgery. The clinical and economic benefits of reduced medication requirements should be considered when making decisions about the effects of bariatric surgery. Authors concluded that bariatric surgery is effective for decreasing the use of medications for obesity-related diabetes, hypertension, and hyperlipidemia. Considerations: With using administrative data, the author acknowledged that “they could only know diagnoses based on diagnostic or procedural codes. There may have been more complete coding of diagnoses among the enrollees in the surgical group, as the presence of comorbid illness is needed to assure coverage of the procedure among those with lower body mass indexes. Indeed, virtually all patients undergoing surgery had a diagnosis code for obesity while few of the nonsurgical patients did. We expect, however, that the comparison group was indeed obese; obesity is consistently undercoded as a diagnosis. Administrative data are not adequate for describing the severity of individual conditions among enrollees; however, we used the well-validated ACG Case-Mix system for predicting the global burden of illness for an individual.” Authors also acknowledged that: “Our estimates of medication use were based on pharmacy claims. This only indicates that the prescription was filled; we cannot judge daily adherence to the medication. Additionally, we cannot definitively know the diagnosis for which the patient was taking a medication, particularly for those drugs with multiple indications (e.g., bupropion). For this analysis, however, filling the medication should be an adequate proxy for use of the medication because our primary interest is not a physiological measure but is the change in medication use over time. These enrollees were all privately insured patients, and we cannot conclude that the same changes in medication utilization would be observed in patients with coverage from Medicaid or Medicare.” Reference: Segal et al. OBES SURG 2009; 19:1646–1656 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.

53 Safety and Effectiveness
Reactive Use Only

54 Safety and Effectiveness
LABS N Engl J Med :5: If slides are presented to show a comparison with LRYGB, then they should be used only reactively  If slides are shown solely to present safety information for LAGB, they are OK to present proactively 

55 Reported Weight Loss as a Percentage of Excess Body Weight After Bariatric Surgery
Data taken from Table 4, pg S116 of the: AACE/TOS/ASMBS Bariatric Surgery Guidelines / Surgery for Obesity and Related Diseases 4 (2008) S109-S184 B References [156] Doherty (2001) [157] Polk (1983 [158] Van Dielen (2005) [159] Nocca (2007) [160] van Mastrigt (2006) C References: [11] Angrisani (2007) [55] Schauer (2001) [65] Sjöström (2007) [94] Himpens (2006) [161] O’Brien (2006) [162] Chapman (2004) [163] Puzziferri (2006) [164] Jan (2005) [165] Kim (2006) [166] Ren (2002) [167] Belachew (2002) [168] Melvin (2004) [169] Biertho (2005) [170] Ceelen (2003) [171] Dargent (2004) [172] Fox (2003) [173] Frigg (2004) [174] Greenslade (2004) [175] Holloway (2004) [176] Mittermair (2003) [177] Ponce (2004) [178] Steffen (2003) [179] Suter (2005) [180] Vertruyen (2002) [181] Victorzon (2002) [182] Weiner (2003) [183] Zinzindohoue (2003) [184] Naef (2007) [185] Lee (2006) [186] Parikh (2005) References correlating to b-h are provided within the AACE/TOS/ASMBS Bariatric Surgery Guidelines DS=duodenal switch D References [87] Regan (2003) [88] Almogy (2004) [90] Mognol (2006) [91] Hamoui (2006) [92] Cottam (2006) [94] Himpens (2006) [95] Milone (2005) E References [11] Angrisani (2007) [70] Sugerman (1987) [73] Capella (2002) [165] Kim (2006) [187] Sugerman (1989) [188] Smith (1997) [189] Nguyen (2001) [190] Brolin (1992) [191] Wittgrove (2000) [192] Olbers (2005) [193] Balsiger (2000) [194] Skroubis (2006) [195] Gleysteen (1987) [196] Higa (2001) [197] Jones (2000) [198] Linner (1982) [199] Oh (1997) [200] Rabkin (1998) [201] Alami (2005) [202] Inabnet (2005) [203] Lee (2005) [204] Nelson (2006) [205] Obeid (2005) F References [74] Fobi (2005) [75] White (2005) G References [72] Brolin (2002) [199] Oh (1997) [201] Alami (2005) [206] Choban (2002) H References 125, 194, [125] Scopinaro (1998) [194] Skroubis (2006) [207] Scopinaro (1996) [208] Dolan (2004) [209] Baltasar (2001) [210] Lagacé (1995) 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.

56 LAGB* vs LRYGB Surgery — Safety
Weight Loss Surgery LAGB* vs LRYGB Surgery — Safety Categories LAGB Gastric Bypass Total Complications†1 9% (n=480) 23% (n=235) Major Complications†1 (Grades III and IV) 0.2% 2.1% Postsurgical Mortality Rate2 (Short-term) 0.05%2 (n=5780) 0.5%2 (n=9258) In addition to similar long-term efficacy, LAGB is widely acknowledged to be a safer procedure than GBP—not only in terms of surgical mortality, but in major/total complications as well. These findings are based on data from studies published between 1988 and The term “complication” means “‘a documented deviation from the ideal post-operative course’ ranging from fever and atelectasis to mesenteric infarction and death. This term does not include sequelea (e.g., diarrhea, bloating, gallstone formation) and nutritional complications. Complications were compared using Fisher’s exact test or chi-square test. Grades were based on the 1992 Clavien and colleagues classification system Objective complication rating system (e.g., III or IV) vs. a subjective rating system (e.g., minor or major) focuses on the diagnostic tests and therapeutic procedures required to treat a complication rather than the complication itself, which tends to eliminate the subjective interpretation of severity and surgeons’ natural tendency to down-rate complications. Grade III complications means events with residual and lasting disability and/or requiring organ resection and includes, with respect to LAGB, rhabdomyloysis requiring debridement and sigmoid esophagus, and with respect to RYGB, revision of anastomosis and resection of the bowel. Grade IV complications means death as a result of any complication. Parikh study noted that one patient had a Grave IV complication, resulting in death as a result of RYGB. 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(2): 2.*LABS N Engl J Med 2009; 361(5): (laparoscopic comparison only shown above) * 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: 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: 56 56

57 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 In this meta-analysis, authors report on the 30-day and 30-day to 2-year mortality in 85,048 patients who underwent bariatric surgery from 478 treatment groups in 361 studies, published from January 1, 1990 to April 30, 2006.* They have focused on 5 areas of interest: mortality by procedure (laparoscopic gastric banding, open and laparoscopic gastroplasty, open and laparoscopic gastric bypass, open and laparoscopic BPD/DS, and revisions/reoperations); mortality by procedure type (restrictive, restrictive/ malabsorptive, malabsorptive); mortality by publication year; mortality by study design; and mortality for subgroups, such as males versus females, the elderly, and the superobese. Ref: Buchwald H, Estok R. Fahrbach K, Banel D, Sledge I. Trends in mortality in bariatric surgery: A systematic review and meta-analysis. Surgery 2007;142: 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:

58 Composite endpoint predictors
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 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 In this meta-analysis, authors report on the 30-day and 30-day to 2-year mortality in 85,048 patients who underwent bariatric surgery from 478 treatment groups in 361 studies, published from January 1, 1990 to April 30, 2006.* They have focused on 5 areas of interest: mortality by procedure (laparoscopic gastric banding, open and laparoscopic gastroplasty, open and laparoscopic gastric bypass, open and laparoscopic BPD/DS, and revisions/reoperations); mortality by procedure type (restrictive, restrictive/ malabsorptive, alabsorptive); mortality by publication year; mortality by study design; and mortality for subgroups, such as males versus females, the elderly, and the superobese. Although a higher body-mass index has been shown to increase the risk of an adverse outcome after bypass procedures, this study showed that the body-mass index had a quadratic relationship to the predicted probability of the composite end point. The lowest predicted risk was found at a body-mass index of 53. The risk of the composite end point among patients with a body mass index of 75 was 61% higher than the risk among those with a body-mass index of 53 (odds ratio, 1.61; 95% CI, 1.04 to 2.48). The predicted risk of the composite end point among patients with a body-mass index of less than 53 was also higher than the risk among those with a BMI of 53, but the odds ratio did not differ significantly for any BMI below 53. The following slides focus solely on mortality by procedure. Other results can be found in the article, which is referenced on this slide. Ref: Buchwald H, Estok R. Fahrbach K, Banel D, Sledge I. Trends in mortality in bariatric surgery: A systematic review and meta-analysis. Surgery 2007;142: 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:

59 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:

60 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:

61 Cost-Effectiveness Reactive Use Only

62 Recent Improvements in Bariatric Surgery Outcomes
Cost-Effective Recent Improvements in Bariatric Surgery Outcomes A study led by Senior Economist William E. Encinosa, PhD, from the Center for Healthcare Research and Quality (AHRQ), and funded by AHRQ compared six month complication rates among more than 9,500 patients under age 65 who underwent obesity surgery at 652 hospitals between 2001 and 2002 and between 2005 and The author examined insurance claims in 2001–2002 and 2005–2006 for 9582 bariatric surgeries, at 652 hospitals, among a population of 16 million nonelderly people. Outcomes and costs were risk-adjusted using multivariate regression methods with hospital fixed effects.1 The source of data is the MarketScan Commercial Claims and Encounter Database created by the Medstat Group, Inc., for 2001–2002 and 2005–2006. The original study by Encinosa et al used the 2001–2002 MarketScan data which contained about 6 million covered lives.2 The 2005–2006 data contains claims data for inpatient care and outpatient care for about 16 million enrollees under the age of 65 in employer-sponsored benefit plans for 45 large employers nationwide in 49 states. Overall, the MarketScan data consists of about 5% of the population with employer-sponsored health insurance coverage in the United States. The following should be noted: The results being reported are not specific to Laparoscopic Adjustable Gastric Banding (LAGB) and/or LAP-BAND.  Information on the sides relating to "banding" include both open and laparoscopic banding.  As the study data do not include/identify BMI, it is thus unclear how this population compares to population indicated for LAP-BAND A footnote in the 2009 Encinosa article stated that the views within the paper do not necessarily reflect the views or policies of AHRQ, nor the U.S. Department of Health and Human Services. Ref: Encinosa W, Bernard D, Dongyi D, Steiner C. Recent Improvements in Bariatric Surgery Outcomes. Medical Care 2009;47: Encinosa W, Bernard D, Chen C, et al. Healthcare utilization and outcomes after bariatric surgery. Medical Care 2006;44: 1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47: 62

63 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 , 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 were also more likely to have ≥2 comorbidities 20.91% ( ) vs 6.34% ( ) Despite the increase in patient health severity case mix, the 2009 study found that outcomes improved Between 2001 and 2006, the rate of bariatric surgery per 100,000 covered lives increased from 26.8 to 43.7 Compared with , 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 were also more likely to have > 2 co-morbidities Between 2001 and 2006, the rate of bariatric surgery per 100,000 covered lives increased from 26.8 to 43.7 Patients in were also more likely to have > 2 co-morbidities : 20.91% ( ) vs. 6.34% ( ) 1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47: 63

64 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 $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% Improved outcomes led to reduced costs. Image accessed at Key Findings: These improved outcomes led to reduced costs. Overall, risk-adjusted, inflation-adjusted hospital payments declined 6%, from $29,563 to $27,905, in 2006 dollars. Hospital payments for patients with complications declined from $41,807 to $38,175. Hospital payments for the most expensive patients—those who had to be readmitted because of complications—declined substantially from $80,001 to $69,960 Hospital payments for those patients without any readmissions also dropped, from $26,578 to $23,115. Use of laparoscopy, which increased from 9% to 71% during that time, reduced payments associated with bariatric procedures by 12% Gastric banding decreased 180 day hospital payments by 20% and reduced the odds ratio of having a complication by 30%. Limitations of the study noted by the authors’ include the following: Authors could not track death outside of the hospital. Thus, the low death rate was only for deaths observed in the hospital. The patient’s body mass index was not known. Patients with a higher body mass index may be at a greater risk of complications. Although the MarketScan data is national, the data is not nationally representative because it over-represents the South and under-represents the West. For example, although 36% of the US population resides in the South, 51% of the MarketScan population resides in the South. Also, authors could not track surgeons within and between hospitals to verify that the effect of within-hospital volume increases on outcomes was a result of surgeon learning-by-doing. Ref: Encinosa WE et al. Medical Care (2009) 47, * 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: 64

65 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.” According to Dr. Encinosa, the improvements are largely due to a combination of three factors—increased use of laparoscopy, a technology that allows physicians to operate through small incisions; increased use of banding procedures without gastric bypass, such as vertical-banded gastroplasty and lap band; and increased surgeon experience arising from the growth in the number of bariatric surgeries performed by hospitals. For example, laparoscopy reduced the odds of having a complication by 30 percent and drove down hospital payments by 12 percent, while banding reduced hospital payments by 20 percent. Improvements in bariatric outcomes and costs were due to a mix of within-hospital volume increases, a move to laparoscopic technique and an increase in banding without bypass. *Not noted if banding was performed open or laparascopically (internal note: move however to laparasopic procedures implies more use of LAGB vs Open AGB.) 1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47: 65

66 Average Cost Per 1,000 Patients
Healthcare Cost Savings Surgically Treated (RYGB and VGB) vs Conventional Therapy at 5 years N=1035 bariatric patients and 5746 match controls Average Cost Per 1,000 Patients for Hospitalization $ (Millions)* Bariatric cohort: Net reduction of >$5.7 million per 1,000 patients treated, within 5 years of surgery* Speaker notes: Study was sponsored by Ethicon This was an observational two-cohort study done at a single institute in Canada. It compared the direct health-care costs related to hospitalization of a cohort of morbidly obese patients treated with bariatric surgery to that of a matched morbidly obese controls treated with conventional therapy. A maximum of 6 controls were identified for each bariatric patient and followed for 5 years. Of 1118 patients who underwent bariatric surgery, 83 were excluded (final surgery N = 1035) because they were treated for one of the exclusion outcome conditions prior to their operation. Control cohort N = 5746. Patients were treated with RYGBP and VBG and study excluded patients who had been previously treated for certain conditions including diseases of the blood and blood-forming organs, cancer, cardiovascular and circulatory diseases, endocrinological diseases including diabetes, genitor-urinary diseases, infectious diseases, musculoskeletal disorders including arthritis, nervous system diseases, psychiatric and mental diseases, respiratory diseases, and skin diseases. Breakdown of procedures: open Roux-en-Y gastric bypass = 820 (79.2%) VBG = 194 (18.7%)… 35% were subsequently converted to open RYGBP because of complications. Laparoscopic Roux-en-Y gastric bypass = 21 (2.2%) Results: for the first 3.5 years, the cumulative average cost is higher for the bariatric cohort. In the next 1.5 years, the differences in costs was in favor of the bariatric surgery patients. After 3.5 years, the initial investment for the bariatric surgery and related hospital care was compensated by a reduction in total costs. Abstract: BACKGROUND: The treatment of obesity and related comorbidities are significant financial burdens and sources of resource expenditure. This study was conducted in order to assess the impact of weight-reduction surgery on health-related costs. METHODS: This was an observational two-cohort study. The treatment cohort included patients having undergone weight-reduction (bariatric) surgery at the McGill University Health Centre (MUHC) between 1986 and The control group included age and gender matched obese patients who had not undergone weight-reduction surgery from the Quebec provincial health insurance database (RAMQ). The cohorts were followed for a maximum of 5 years from inception. The primary outcome measure was overall direct healthcare costs. Secondary outcomes included cost analysis by diagnostic category for the treatment of new medical conditions following cohort inception. RESULTS: The cohorts were well-matched for age, gender and duration of follow-up. Patients having undergone bariatric surgery had significant reductions in mean percent initial excess weight loss (67.1%, P <0.001) and in percent change in initial body mass index (34.6%, P <0.001). Bariatric surgery patients had higher total costs for hospitalizations (per 1,000 patients) in the first year following cohort inception (surgery cohort = CDN 12,461,938 dollars; control cohort = CDN 3,609,680 dollars). At 5 years after cohort inception, average cumulative costs for operated patients were CDN 19,516,667 dollars versus CDN 25,264,608 dollars, for an absolute difference of almost CDN 6,000,000 dollars per 1,000 patients. CONCLUSION: Weight-reduction surgery in morbidly obese patients produces effective weight loss and decreases long-term direct health-care costs. The initial costs of surgery can be amortized over 3.5 years. Ref: Sampalis et al. Obes Surg Aug;14(7):939-47 * Canadian dollars, 5-year follow-up ( ). 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: 66

67 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 Gallagher et al. Obesity Surgery, 2003; 13, Average age was 52 yrs with a deviation of 2 years, mostly male (72%) with a BMI of 52 kg/m2 with a deviation of 2. Abstract Background: The economic burden of caring for veterans with clinically severe obesity and its comorbidities is straining the Veterans Administration (VA) healthcare system. The authors determined the cost of Roux-en-Y Gastric Bypass (RYGBP) in the VA’s single-payor healthcare system. Methods: The records of all 25 patients who underwent RYGBP from May 1999 to October 2001 were reviewed. All obesity-related health-care costs including hospitalizations as well as outpatient visits, medications and home health devices were calculated for 12 months before and after the RYGBP. Results: Age was 52±2 yr and preoperative BMI was 52±2 kg/m2; ASA score was III (21 patients) and II (4 patients). Mean follow-up was 18 months. Total cost of care for these patients preoperatively was $10,778± 2,460/patient (outpatient visits=$5,476±682, hospital admissions=$12,221±6,062, and home health devices=$1,383±349). Postoperative length of stay was 8±0.5 days. Cost of the gastric bypass was $8,976±497/pt (OR fixed ost=$1,900/patient + ICU and ward=$7,076±497/patient). For the first postoperative year, 6 patients had 12 admissions, but routine outpatient visits were significantly reduced from 55±6 to 18±2 postoperatively (P<0.001). The cost of all care excluding peri-operative charges for 1 year after gastric bypass was $2,840±622/patient (P=0.005 vs preop). Conclusions: Operative treatment of clinically severe obesity reduces obesity-related expenditures and utilization of healthcare resources. The cost of undertaking RYGBP at the VA is offset by reduction of health-care costs within the first year after surgery. Ref: Gallagher SF, et al. Impact of Bariatric Surgery on the Veteran’s Administration Healthcare System: A cost Analysis. Ob Surg 2003:13, The initial investment for bariatric surgery is approximately $26,000 for open surgery and $17,000 for laparoscopic surgery. After taking into account age, sex, and comorbidities, the initial investment is returned within 4 years for patients who undergo open surgery and within 2 years for patients who undergo laparoscopic surgery. Even ignoring potential quality-of-life and length-of-life benefits, as well as disability and work loss, third-party payers can rely on bariatric surgery paying for itself through decreased comorbidities within 2 to 4 years. Comments: It is important to realize that bariatric procedures should not be held to a different standard in comparison to other medical diseases/conditions. Allergan is happy to see the body of evidence growing on the cost effectiveness of bariatric surgery and gastric banding in particular. Using standard Health Outcomes measures, LAP-BAND® is cost-effective in the treatment of morbid obesity. Some studies indicate that LAP-BAND® is more cost-effective than gastric bypass due to fewer severe and more costly complications LAP-BAND® results in significant, rapid, and sustained improvement in health-related quality of life (HRQoL), resulting in levels comparable to community-based norms An important area of focus that is not included in an ROI analysis is the significant impact on presenteeism absenteeism, workers comp, etc. for obese employers before and after LAP-BAND® surgery. That being said, Allergan is pursuing studies that provide a more comprehensive societal and economic analysis of the effects of LAP-BAND® surgery than a simple ROI. Ultimately, LAP-BAND® should be covered and accessible to all patients who are at least 18 years old and a BMI ≥ 40 or a BMI of ≥ 35 with one or more comorbidities * Costs were reviewed from patient records from 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: 67

68 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 Laparoscopic adjustable gastric banding (LAGB) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the two most commonly performed bariatric procedures. Although both procedures likely reduce healthcare expenditures related to the resolution of co-morbid conditions, they have different rates of perioperative risks and different rates of associated weight loss. Previous studies have suggested that both procedures improve patients’ quality of life, reduce healthcare expenditures, and improve life expectancy. Given the differential risk and effectiveness of the procedures, the aim of this study was to evaluate the cost-effectiveness of surgical (LRYGB and LAGB) and nonoperative weight loss interventions. A model was designed a model to evaluate the incremental cost-effectiveness of these procedures compared with nonoperative weight loss interventions and with each other. Salem et al. Surg Obes Relat Dis 2008;4:26-32 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 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 cost- effective 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 Methods: A deterministic, payer-perspective model comparing the lifetime expected costs and outcomes of LAGB, LRYGB, and non-operative treatment. Major endpoints were: survival, health-related quality of life, weight loss. Life expectancy and lifetime medical costs were calculated across age, gender, and body mass index (BMI) strata from the Framingham Heart Study and Third National Health and Nutrition Examination Survey. In general, the model describes the possible pathways within the first 3 years to reach the age and body mass index (BMI) of survivors at the end of the 3-year period. The base-case scenarios included morbidly obese male and female patients without obesity-related comorbidities, with a BMI of 40, 50, and 60 kg/m2, and aged 35, 45, and 55 years. Patients not undergoing operative interventions were assumed to have a stable BMI over time (rather than gaining weight as is expected) to not overestimate the benefits of surgery. Surviving patients could require additional surgical interventions and might undergo band removal. Authors assumed that 3 years after the initial operation, the patient remained at the initial weight, had lost weight, or had died. Life expectancy and lifetime medical costs were calculated across age, gender, and BMI strata using previously published data. Results: For both men and women, LRYGB and LAGB were cost-effective at < $25,000/qualityadjusted 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 (ICER) 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. Ref: Salem et al. Surg Obes Relat Dis 2008;4:26-32 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
Probabilities and Cost for 3 Years¹ Variable LAGB LRYGB Cost %EWL* 55 % (38, 64) 71 % (59, 89) NA $16,200 † $27,560 † Operative Mortality (%) 0.05 (0.1) 1 (0.5-2) Band Adjustments 10 $150‡ LRYGB Revisional Surgery 5 (1-10) $10,000 LAGB Revisional Surgery 5 (2-7) $5,000 Evaluate cost-effectiveness of bariatric treatments using 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. RESULTS The major endpoints were survival and weight loss. Both LRYGB and LAGB were cost effective at <$25,000/QALY when evaluating the full range of BMI values and estimates of adverse outcomes, weight loss, and costs. The ICER (incremental cost-effectiveness ratio) for LAGB was lower than that of LRYGB for all base-cases and across the full range of variables tested: LAGB LRYGB Men (aged 35, BMI 40 kg/m2) $11,604 $18,543 Women (aged 35, BMI 40 kg/m2) $8,878 $14,680 When comparing the costs of surgical and non-surgical interventions, the surgical interventions resulted in cost savings. CONCLUSION The main elements influencing the cost effectiveness of these weight loss procedures is the associated weight loss and postoperative morbidity. Because these procedures have different rates of adverse events and outcomes, comparing them can be problematic. A CEA (cost-effectiveness analysis) is an ideal method to balance these two sets of outcomes. LAGB was found to be more cost-effective than LRYGB, with a lower ICER compared with the nonoperative interventions. The benefits of LAGB were related to its lower associated mortality rate and were dependent on it resulting in significant and sustained weight loss over time. When evaluating the survival benefits of obesity surgery, the mortality rate associated with the procedure is balanced against the long-term survival benefit. The 30-day mortality rate of gastric bypass in Washington State was nearly 2%, twice the greatest mortality rate previously reported. In contrast, LAGB has very low perioperative mortality: %. REF: Salem et al. Surg Obes Relat Dis 2008;4:26-32 *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. ‡H-CUP- Healthcare Costs and Utilization Project. 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

71 Cost-effectiveness of LAGB and LRYGB
Two-way sensitivity analysis of cost-effectiveness of LAGB and RYGB. For men and women, both LAGB and LRYGB are found as cost-effective at: <$25,000/QALY When evaluating the full range of BMI values and estimates of adverse outcomes, weight loss, and costs Benefit of higher excess weight loss of RYGB is outweighed by low rate of operative mortality of LAGB* Difference in cost-effectiveness of these procedures using base-case estimates Analysis based on the assumption of a 45-year-old female with BMI of 40 kg/m2 Fig. 3. Two-way sensitivity analysis of cost-effectiveness of LAGB and LRYGB. Diagram depicts difference in cost-effectiveness between LAGB and LRYGB with varying percentage of excess body weight loss (EBWL) achieved with these procedures for 45-year-old women with BMI of 40 kg/m2. CEA at <$25,000 when evaluating the full range of BMI values and estimates of adverse outcomes, weight loss and costs. Shaded area represents EBWL values for which difference in cost-effectiveness of surgical procedures favored LAGB. Line depicts scenarios in which LAGB and LRYGB yield same cost-effectiveness. Cross represents difference in cost-effectiveness of these procedures using base-case estimates. [Both LAGB and laparoscopic Roux-en-Y are found as cost-effective at <$25,000/QALY. Benefit of higher excess weight loss of RYGB is outweighed by low rate of operative mortality of LAGB.] More details available in article. Ref: Salem et al. Surg Obes Relat Dis. 2008;4:26-32 * 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

72 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 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 This slides cites some of the study’s limitations. The future costs, life expectancy, and quality of life were based on the areas reviewed. Ref: Salem et al. Surg Obes Relat Dis. 2008;4:26-32 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

73 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 Objective: To evaluate the private third-party payer return on investment for bariatric surgery in the United States. Study Design: Morbidly obese patients aged 18 years or older were identified in an employer claims database of more than 5 million beneficiaries ( ) using International Classification of Diseases, Ninth Revision, Clinical Modification code Each of 3651 patients who underwent bariatric surgery during this period was matched to a control subject who was morbidly obese and never underwent bariatric surgery. Bariatric surgery patients and controls were matched based on patient demographics, selected comorbidities, and costs. Methods: Total healthcare costs for bariatric surgery patients and their controls were recorded for 6 months before surgery through the end of their continuous enrollment. To account for potential differences in patient characteristics, we calculated the cost differential by estimating a Tobit model. A return on investment was estimated from the resulting coefficients. Costs were inflation adjusted to 2005 US dollars using the Consumer Price Index for Medical Care, and the cost savings were discounted by 3.07%, the 3-month Treasury bill rate during the same period. Results: The mean bariatric surgery investment ranged from approximately $17,000 to $26,000. After controlling for observable patient characteristics, we estimated all costs to have been recouped within 2 years for laparoscopic surgery patients and within 4 years for open surgery patients. Conclusions: Downstream savings associated with bariatric surgery are estimated to offset the initial costs in 2 to 4 years. Randomized or quasiexperimental studies would be useful to confirm this conclusion, as unobserved characteristics may influence the decision to undergo surgery and cannot be controlled for in this analysis. Ref: Cremieux et al. Am J Manag Care. 2008;14(9): The initial investment for bariatric surgery is approximately $26,000 for open surgery and $17,000 for laparoscopic surgery. After taking into account age, sex, and comorbidities, the initial investment is returned within 4 years for patients who undergo open surgery and within 2 years for patients who undergo laparoscopic surgery. Even ignoring potential quality-of-life and length-of-life benefits, as well as disability and work loss, third-party payers can rely on bariatric surgery paying for itself through decreased comorbidities within 2 to 4 years. Comments: It is important to realize that bariatric procedures should not be held to a different standard in comparison to other medical diseases/conditions. Allergan is happy to see the body of evidence growing on the cost effectiveness of bariatric surgery and gastric banding in particular. Using standard Health Outcomes measures, LAP-BAND® is cost-effective in the treatment of morbid obesity. Some studies indicate that LAP-BAND® is more cost-effective than gastric bypass due to fewer severe and more costly complications LAP-BAND® results in significant, rapid, and sustained improvement in health-related quality of life (HRQoL), resulting in levels comparable to community-based norms An important area of focus that is not included in an ROI analysis is the significant impact on presenteeism absenteeism, workers comp, etc. for obese employers before and after LAP-BAND® surgery. That being said, Allergan is pursuing studies that provide a more comprehensive societal and economic analysis of the effects of LAP-BAND® surgery than a simple ROI. Ultimately, LAP-BAND® should be covered and accessible to all patients who are at least 18 years old and a BMI ≥ 40 or a BMI of ≥ 35 with one or more comorbidities Open bariatric surgery average cost of $26,000 Laparoscopic bariatric surgery average cost of $17,000 49 Months * Based on 5 years of post-op cost data from 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: 73

74 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 or call Allergan Product Support at CAUTION: This device is restricted to sale by or on the order of a physician. APC81NQ10


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