1 The Impact of Obesity and the Value of Treatment

1

The Impact of Obesity andthe Value of Treatment

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

3

Prevalence and Trends

· More than 1/3 of adults ≥20 years of age, or over 72 million people, were obese with a body mass index (BMI) ≥30 kg/m2 in 2005-20061

– Prevalence has more than doubled between 1980 and 2002 (13.3% to 32.2%)1,2

· The prevalence of extreme obesity (BMI ≥40) in 2003-2004 was:– 2.8% in men and 6.9% in women1

· In 2003-2004, 17.1% of children and adolescents age 2-19 years were overweight2,5

– Prevalence of overweight has tripled in children 6-19 years2

– Overweight adolescents have a 70% chance of becoming overweight/obese adults5

Moderate Obesity3,4,6 (BMI 35 to 39.9 )

Morbid Obesity3,4,6

(BMI 40 or more)Normal Weight2 (BMI 18.5 to 24.9)

Obese3,4,6 (BMI 30

to 34.9)

Overweight2

(BMI 25 to 29.9)

1. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High. 2007. Available at: http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm. Accessed 6-23-092. Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006; 295:1549-1555.3. Caclulate Your Body Mass Index. Available at http://www.nhlbisupport.com/bmi. Accessed 10-29-094. National Insttitute of Health. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults . 2000. Available at http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf . Accessed 12-15-095. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity. 2007. Available at: http//www.surgeongeneral.gov/topics/obesity/calltoaction/fact_adolescent.htm. Accessed12-15-096. 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.

Class I Obesity

Class II Obesity

Class III ObesityBMI

http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm.%20Accessed%206-23-09

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ogden%20CL%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Carroll%20MD%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Curtin%20LR%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.nhlbisupport.com/bmi

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mechanick%20JI%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kushner%20RF%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sugerman%20HJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sugerman%20HJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

4

1999

2008

1990

No Data <10% 10%-14% 15%-19% 20%-24% 25%-29% ≥30%

*BMI ≥30, or about 30 lb overweight for 5’4” person.† BRFSS=CDC’s Behavioral Risk Factor Surveillance System.U.S. Obesity Trends--Trends by State 1985–2008. Available at: http://www.cdc.gov/NCCDPHP/dnpa/obesity/trend/maps/index.htm. Accessed 12-8-09.

Obesity Trends* Among US AdultsBRFSS† 1990, 1999, 2008

http://www.cdc.gov/NCCDPHP/dnpa/obesity/trend/maps/index.htm

5

Changes in Distribution of Body Mass Index between 1976-1980 and 2005-2006

· Changes in the prevalence of obesity do not present a complete picture of the trends in weight as measured by BMI1

Figure represents US adults aged 20-74 years

BMI

Per

cen

t

Source: CDC/NCHS, National Health and Nutrition Examination Survey (NHANES)

10 15 20 25 30 35 40 45 500

5

10

15

20

NHANES 1976-1980

NHANES 2005-2006

1. Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States--no statistically significant chance since 2003-2004. NCHS Data Brief. 2007;1:1-8.2. New CDC Study Finds No Increase in Obesity Among Adults; But Levels Still High. 2007. Available at: http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm. Accessed 6-23-09

Changes in BMI distribution between 1976-1980 and 2005-20061

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ogden%20CL%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Carroll%20MD%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McDowell%20MA%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Flegal%20KM%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.cdc.gov/nchs/pressroom/07newsreleases/obesity.htm

6

Age-Adjusted Percentage of US Adults Who Were Obese or Who Had Diagnosed Diabetes

Maps of Diabetes and Obesity in 1994, 2000, and 2008. 2009. Available at: http://www.cdc.gov/diabetes/statistics/slides/maps_diabetesobesity94.pdf. Accessed 5-18-09.

http://www.cdc.gov/diabetes/statistics/slides/maps_diabetesobesity94.pdf

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Medical Complications Which May Be Associated With Obesity1

Severe pancreatitis

Pulmonary disease• Abnormal function• Obstructive sleep apnea• Hypoventilation syndrome

Nonalcoholic fatty liver disease• Steatosis• Steatohepatitis• Cirrhosis

Coronary heart disease

Diabetes Dyslipidemia Hypertension

Gynecologic abnormalities• Abnormal menses• Infertility• Polycystic ovarian

syndrome

Osteoarthritis

Skin Problems

Gall bladder disease

Cancer• Breast, uterus, cervix,

colon, esophagus, pancreas, kidney, prostate

Phlebitis• Venous stasis

Gout

Idiopathic intracranial hypertension

Stroke

Cataracts

1. Bhoyrul S., Lashock J. The Physical and Fiscal Impact of the Obesity Epidemic: The Impact of Comorbid Conditions on Patients and Payers. . JMCM. 2008 :11(4): 10-17.

8

Body Mass Index vs Mortality

16 19 22 25 28 31 34 37 40 45

0

50

100

150

200

250

300

350

400

Rel

ativ

e M

orta

lity

Rat

e

BMI (kg/m2)

Exponential Increase in Risk

For adults with a BMI above 45, life expectancy decreases by up to 20 years.

High risk

Medium risk

Low risk

Data based on BMI distribution from the Third National Health and Nutrition Examination Survey (NHANES II)—a 6-year study from 1988-1994.

1. Fontain KR, Redden DT, Wang C, et al. . Years of life lost due to obesity. JAMA. 2003;289:187-193.

9

0

10

20

30

40

50

60

Direct Cost of Chronic Diseases in the United States1,2

Dir

ect

Cos

t ($

Bil

lion

s)

Type 2 Diabetes

Obesity CoronaryHeart Disease

Hypertension Stroke

$18.1$18.4

$38.7

$51.6$53.2

Adjusted to 1995 dollars.1. Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Res. 1998 Mar;6:97-106.2. Hodgson TA, Cohen AJ. Medical care expenditures for selected circulatory diseases: opportunities for reducing national health expenditures. Med Care. 1999;37:994-1012.

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Economic Impact—Annual Expenditures Attributable to Obesity and Overweight in the United States

· Based on data from 1998 through 2000, approximately– 5.7% of total adult medical expenditures1 – 6.8% of total Medicare expenditures1

– 10.6% of total Medicaid expenditures1

· Between 1987 and 2001 (obesity average 14% and 31% respectively), increases in spending on obese people relative to people of normal weight accounted for 27% of the rise in inflation-adjusted per capita spending2

– Obesity trends account for a large proportion of the increased spending growth for diabetes (38%), hyperlipidemia (22%), and heart disease (41%)*2

· $93 billion in direct medical costs†

– Relates to total medical costs attributable to obesity and overweight at $78.5 billion, which was projected to be equivalent to $92.6 billion in 2002 dollars3

· $117 billion in total costs (direct and indirect; $2001)3

· Estimated to have risen to $147 billion per year by 20084

*Data from 1997 and the 2005 Household Component to the Medical Expenditures Panel Survey (MEPS=HC).†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. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.480. Accessed April 8, 2007.3. Finkelstein EA, Fiebelkorn IC, Wang G. National medical spending attributable to overweight and obesity: how much, and who’s paying? Health Affairs 2003;W3(Suppl Web Exclusives);219-226.4. Finkelstein EA, Trogdon JG, Cohen JW, Diestz W. Annual medical spedning attributable to obesity: payer-and service-specific estimates. Heallth Aff (Millwodd). 2009; 28:w822-w831.

11

Weighty Matters:How Obesity Drives Poor

Health and Health Spending in the US

1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed 12-8-2009.

https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf

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Physical Costs of Obesity

· 36.01% of new cases across all 11 chronic conditions can be attributed to obesity

· 16.97% of new cases across all 11 chronic conditions can be attributed to overweight

· The burden of obesity is most marked in heart disease and diabetes, accounting for more than 70% of the growth in prevalence for these 2 conditions

· Obesity accounted for 60% of the growth in hypertension and nearly 50% of the rise in arthritis

The prevalence of 11 chronic conditions associated with overweight and obesity grew 180%.1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed 12-8-2009.

Share in Condition Prevalence: 1997-2005

Condition Overweight Obesity

Mental Disorders 7.43% 16.22%

Heart Disease 7.21% 71.64%

Cancer 6.34% 8.75%

Back Problems 20.09% 17.55%

Pulmonary Conditions -0.07% 20.07%

Hypertension 31.29% 59.90%

Arthritis 15.76% 48.74%

Diabetes 28.87% 70.95%

Upper GI 27.30% 30.54%

Kidney -3.12% 7.48%

Hyperlipidemia 35.57% 44.24%

Average Share of Cases 16.97% 36.01%


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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

% Cases Associated with Obesity



Cancer 3.25% 4.70%


Pulmonary Conditions 0.92% 5.13%


Arthritis 17.04% 27.17%

Diabetes 46.05% 57.60%

Upper GI 8.59% 22.09%

Kidney 18.53% 14.14%



14

Physical Costs of Overweight and Obesity

· The following increases in back problems were noted with overweight and obesity

– Overweight—578% increase

– Obesity—56% increase


Share in Condition Prevalence: 1997-2005

Condition Overweight Obesity



Cancer 6.34% 8.75%


Pulmonary Conditions -0.07% 20.07%


Arthritis 15.76% 48.74%

Diabetes 28.87% 70.95%

Upper GI 27.30% 30.54%

Kidney -3.12% 7.48%


Average share of cases 16.97% 36.01%


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Financial Costs of Obesity

· In 2005, condition-specific health expenditures among adults across BMI categories were

– Underweight: $8.887 million

– Normal weight: $170.6 million

– Overweight: $168.6 million

– Obese: $177.5 million

· Obese adults spent more in proportion to their share of the population than any other BMI category examined

Condition-Specific Health Spending Varies by BMI1. Weighty Matters: How Obesity Drives Poor Health and Health Spending in the U.S. 2009. Available at: https://www.businessgrouphealth.org/pdfs/NBGH%20WeightyMatters_Final.pdf. Accessed 12-8-2009.


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Economic Costs of Obesity and Overweightto Self-Insured Employers

· Objective: To quantify direct and indirect costs of obesity within a cohort of commercially insured employees in the United States

· Method: Review of health plan claims, self-reported health risk assessment, and productivity data from 2003-2005

· Results: Regression-adjusted incremental direct medical costs associated with being overweight, obese, and severely obese were estimated to be

– Overweight—$147.11

– Obese—$712.34

– Severely Obese—$1977.43

· Adjusted incremental indirect costs due to paid absence associated with being overweight, obese, and severely obese were estimated at

– Overweight—$1403.81

– Obese—$1511.24

– Severely Obese—$1414.09

· Conclusions: Overall adjusted direct and indirect costs were higher for workers with elevated BMI relative to those of normal weight

1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic Costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997.

17

Durden et al: Prevalence of Conditions Within Selected Major Diagnostic Categories

% o

f T

otal

Stu

dy

Pop

ula

tion

0

5

10

15

20

25

30

35

40

Musculoskeletal Circulatory Endocrine, Nutritional, and Metabolic Diseases

Respiratory

Severely obeseBMI ≥35

Obese30≤ BMI <35

Overweight25≤ BMI <30

Normal weight18.5≤ BMI <25

UnderweightBMI <18

Table is based on data examined from 2003 to 2005.1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic Costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997

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

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


· 2006 payer-specific estimates by type of service—inpatient, noninpatient, or prescription drug spending—to identify the cost drivers attributable to obesity

· Results suggest spending within these categories for each obese beneficiary was more than $600 per year higher than for a normal-weight beneficiary in 2006

· Estimates for all payers combined range between $420 (inpatient) and $568 (prescription drugs)

· In percentage terms, the increases for all payers combined range from 27% (noninpatient) to 80% (prescription drugs) from 1998 to 2006

Finkelstein EA, Trogdon JG, Cohen JW, Dietz W, Annual Medical Spending Attributable To Obesity: Payer- And Service-Specific Estimates. Health Affairs 2009;28(5): w822–w831

20


· 2006 payer-specific estimates by type of service—inpatient, noninpatient, or prescription drug spending—to identify the cost drivers attributable to obesity

· Results suggest spending within these categories for each obese beneficiary was more than $600 per year higher than for a normal-weight beneficiary in 2006

· Estimates for all payers combined range between $420 (inpatient) and $568 (prescription drugs)

· In percentage terms, the increases for all payers combined range from 27% (noninpatient) to 80% (prescription drugs) from 1998 to 2006

Finkelstein EA, Trogdon JG, Cohen JW, Dietz W, Annual Medical Spending Attributable To Obesity: Payer- And Service-Specific Estimates. Health Affairs 2009;28(5): w822–w831

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).”

21

Diet Physical Activity

Lifestyle Modification

Pharmacotherapy

Surgery

A Guide to Selecting Treatment

22

• Diet• Exercise• Behavior modification

Lifestyle Changes

Medications

BMI (kg/m

²)

Surgery

(5% to 10% EWL, on average, when used with medication)1,2

(5% to 10% EWL, on average, when used with lifestyle changes)2,3

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

A Guide to Selecting Treatment

Malabsorptive procedures: Jejunoileal BypassRestrictive procedures: Gastric Banding, Sleeve GastrectomyCombination procedures: Roux-en Y Gastric Bypass (RYGB),

Biliopancreatic Diversion/Duodenal Switch

25-26.9

>27

Comorbidity

+-

27-29.9

>30

35-39.9

>40

National Institutes of Health et al. http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed May 18, 20091. O’Brien PE, Mc Phail T, Chaston TB, et al. Systematic Review of Medium-Term Weight Loss after Bariatric Operations. Obes Surg . 2006; 16:1032-1040.2. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.3. Wierzbicki A. Rimonabant: endocannabinoid inhibition for the metabolic syndrome. Int J Clin Pract. 2006; 60 (12): 1697-1706.4. Fisher BL, Schauer P. Medical and Surgical Options in the Treatment of Severe Obesity. The Amer Journ of Surg. 2002; 184 (6B): 9S-16SImages taken from: Bhoyrul S., Lashock J. The Physical and Fiscal Impact of the Obesity Epidemic: The Impact of Comorbid Conditions on Patients and Payers. . JMCM. 2008 :11(4): 10-17.

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

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.

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Weight Loss Surgery for Clinically Severe or Morbidly Obese Adults*1

· Two main types of weight loss procedures

· Some procedures are a combination

MalabsorptiveProcedures

Reduce the absorption of calories (along with

proteins and other nutrients)

RestrictiveProcedures

Decreasefood intake and

promote a feeling of fullness (satiety) after

eating

*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.

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Common Types of Bariatric Surgical Options1

· AGB=adjustable gastric banding· RYGB=Roux-en-Y gastric bypass· GS=gastric sleeve· BPD=biliopancreatic diversion with

a duodenal switch

Diagram of Surgical Options*Image credit: Walter Pories, MD, FACS.

Figure from Bariatric Surgery for Severe Obesity; NIH Publication No: 08-4006, updated March 2008: 1-6.

DHHS=US Department of Health and Human Services.

NIH=National Institutes of Health.

NIDDK=National Institute of Diabetes and Digestive Diseases and Kidney Diseases.*Surgical options can be performed open or laparoscopically.

26

Commonly Performed Bariatric Procedures in the United States

Adjustable Gastric Banding

RYGB works by restricting food intake and by decreasing the absorption of food.

(Malabsorptive and restrictive)

AGB works primarily by decreasing food intake.

(Restrictive)

Roux-en-Y Gastric Bypass

Restricts food intake and usually requires a second procedure

(Restrictive)

Sleeve Gastrectomy

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The LAP-BAND® System

· Approved by the FDA in 2001· Approved for adults and over· Indicated for use in weight reduction for severely obese patients with

– A BMI ≥40 or a BMI ≥35 with one or more severe comorbid conditions, or

– Those who are 100 pounds or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame)

· The LAP-BAND® System is indicated for use only in severely obese adult patients who

– Have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior-modification programs

· Bariatric surgery eligibility criteria: patients with a BMI ≥40 or a BMI ≥35 with one or more severe comorbid conditions

– 1998 NIH Overweight and Obesity Guidelines

– 2004 ASMBS Consensus Statement

– 2008 AACE-TOS-ASMBS Metabolic and Bariatric Surgery Medical Guidelines

28

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

30

Adjustment frequency, dependent on physician evaluationYear 1: every 4 to 6 weeks Year 3: every 6 monthsYear 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. 2009. Available at: http://www.lapband.com/life_after_surgery/optimizing_your_weight_loss/#greenzone. Accessed 12-8-2009

The Green Zone

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

1. Data on file, Allergan, Inc. December 2009.2. Pratt GM, McLees B, Pories WJ. The ASBS Bariatric Surgery Centers of Excellence program: a blueprint for quality improvement. Surg Obes Relat Dis. 2006;2:497-503.

32

Bariatric Surgery – Measure of EfficacyPercent 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 InsuranceHeight & Weight Table for Women Height & Weight Table for Men

1. About the "Metropolitan Life" tables of height and weight. 2008. Available at: http://www.halls.md/ideal-weight/met.htm. Accessed 8-19-09.

33

1. Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg. 2005;201:529-535.† Based on a chart review of 1,014 consecutive cases of patients undergoing LAP-BAND ® System surgery at a single center. Follow-up data were available for relatively few patients at 36 months (68 of 77) and

at 48 months (12 of 14).

Clinical Impact of the LAP-BAND® System

LAP-BAND® System Results inLong-Term Weight Loss*1

(n=812) (n=668) (n=240) (n=68)† (n=12)†

% E

WL

26.1

40.5

52.9

62.064.3

0

10

20

30

40

50

60

70

6 12 24 36 48

Time After Surgery (Months)

62.0% 19% mean excessweight loss 3 yearsafter surgery

*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%).

34

Clinical Impact of Weight Loss Following LAP-BAND® System Surgery

Resolved No Change

93%

79%

90%93%

90%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Asthma1

1 Year Post-op(n=32)

Hypertension2


Type 2 Diabetes2


Sleep Apnea3


Gastroesophageal Reflux4

2 Years Post-op(n=48)

59%

34%

35%

44%

26%

64%

14%

76%

7%

21%

10%7%

6%4%

Medications or other aids may still be required for certain conditions, and percentages are rounded up to whole numbers.Other studies have found different results in resolution and reduction rates (eg, Ahroni et al, 2005)

1.Dixon JB, Chapman L, O'Brien P. Marked improvement in asthma after Lap-Band surgery for morbid obesity. Obes Surg. 1999;9:385-389. 2. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.3.Dixon JB, Schachter LM, O'Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med. 2001 8;161:102-106.4. Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of lap-band placement. Obes Surg. 1999;9:527-31.

Improved

Declined

Key Outcomes from 4 studies:

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 (5.6-11.0, n=53) preoperatively to 5.58 (5.0-6.2, n=15) at 2 years after surgery2

1. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.

2. Ponce J, Haynes B, Paynter S, et al. Effect of Lap-Band-induced weight loss on type 2 diabetes mellitus and hypertension. Obes Surg. 2004;14:1335-1342.

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†

*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

1. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.

38



· Results: Of 4476 patients, more than half had >2 coexisting conditions

– 30-day rate of death among patients was 0.3% (RNY and LAGB)

– A total of 4.3% of patients had at least 1 major adverse event

· Composite endpoint predictors– History of deep vein thrombosis(DVT) or

pulomonary embolus (PE), diagnosis of obstructive sleep apnea (OSA), and impaired functional status were each independently associated with an ↑ risk of the composite endpoint

– Extreme values of BMI


39




40



LABS ConclusionOverall risk of death and AE after bariatric surgery was low and varied

considerably according to patient characteristics


41

The Overall Value of BariatricSurgery and the LAP-BAND® System

Government agencies and professional organizations assess the value of new treatments and consider both clinical and economic data to ensure access to therapies and procedures with a favorable balance of incremental costs and benefits· Review of bariatric surgery in general, or adjustable gastric banding specifically,

has resulted in favorable policy recommendations1-6

– CMS implemented national coverage decision in 20061

– 45 states cover bariatric surgery for Medicaid patients2

– AHRQ 2004 technology assessment concluded for patients with BMI ≥40, surgical therapy is superior to existing pharmaceutical and diet therapy3

– National Institute for Health and Clinical Excellence (NICE) recommends bariatric surgery for certain obese adults in the UK in 20064

– BlueCross® BlueShield® Association publishes positive Technology Evaluation Center (TEC) assessment for LAGB in 20075

– AACE/TOS/ASMBS 2008 Bariatric Surgery Guidelines6

1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections 90-160.25) 2. F As In Fat. Available at http://healthyamericans.org/reports/obesity2008/Obesity2008Report.pdf. Accessed 12-15-09 3. . AHRQ. Pharmacological and Surgical Treatment of Obesity . Evidence Reprot/Technology Assessment. 2004; 103: 1-6.4. . NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and Children.. 2006. 43:1-84.5. . BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity. 2007. 1-50.6. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical

Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient . Surg Obes Relat Dis. 2008;4:S109-S184.

http://healthyamericans.org/reports/obesity2008/Obesity2008Report.pdf

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

1. Durden ED, Huse D, Ben-Joseph R, Chu BC. Economic costs of obesity to self-insured employers. J Occup Environ Med. 2008;50:991-997.

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

1. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Chapter 1, Part 2 (Sections 90-160.25) 2. NHS. Obesity Guidance on the Prevention, Identification, Assessment, and Management of Overweight and Obesity in Adults and

Children.. 2006. 43:1-84.3. CADTH . Laparoscopic Adjustable Banding for Weight Loss in Obese Adults: Clinical and Economic Report . 2007; 90:1-384. . BCBS. Laparoscopic Adjustable Gastric Banding for Morbid Obesity. 2007. 1-50.

http://www.cms.hhs.gov/

http://cadth.ca/index.php/en/home

http://www.bcbs.com/

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 www.lapbandcentral.com or 1-800-624-4261.2009 Allergan, Inc., Irvine, CA 92612. ® Marks owned by Allergan, Inc. www.allergan.com TOPS, eDiets, Optifast, Health Management Resources Weight Watchers, Blue Cross, and Blue Shield are the property of their respective trademark owners.

LBTP/3476/09

http://www.lapbandcentral.com/

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

ComorbidityReactive Use Only

47

Systematic Reviews: Comorbidities· Buchwald et al. JAMA. 2004;292:1724-17371

– 2004 meta-analysis of all types of bariatric surgery • Average 61% EWL (n=10,172)*• Improvements in T2DM, hypertension, sleep apnea, and hyperlipidemia in most

patients

· Buchwald et al. Am J Med. 2009;122:248-2562 – 2009 meta-analysis of bariatric surgeries and diabetes

– Includes all English articles studying biliopancreatic diversion/duodenal switch, gastric bypass, and gastric banding from 1/1/1990-4/30/2005

• 55.9% EWL (n=34,329), weight loss overall was 38.5 kg*• 78.1% patients had complete resolution of type 2 diabetes • 86.6% improvement or resolution of type 2 diabetes in patients


1. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 13;292:1724-1737.2. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009;122:248-256.e5.

48

Systematic Reviews: Comorbidities· Maggard et al. Ann Intern Med. 2005;142:547-5591

– Surgical treatment for obesity resulted in a 20-30 kg weight loss maintained up to 10 years in association with*:

• Reduction in some comorbidities and an overall mortality rate <1%

– Benefits were conclusive for those patients with BMI• ≥40 but not <40 kg/m2

· Sjostrom et al. NEJM. 2004;357:741-7522

– Nonrandomized, prospective, controlled study involved obese subjects who underwent surgical procedures (mostly gastroplasties and nonadjustable bands) and contemporaneously matched, obese control subjects treated conventionally

– 2- and 10-year improvement rates in T2DM, hypertriglyceridemia, low levels of HDL density lipoprotein, and hyperuricemia:

• Were more favorable in surgically treated vs the control group

– Recovery from hypercholesterolemia and hypertension did not differ between groups at 10 years

1 Maggard MA, Shugarman LR, Suttorp M, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 5;142:547-559.3. Sjöström L, Gummesson A, Sjöström CD,et al. Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial. Lancet

Oncol. 2009;10:653-662.

*Results are inclusive of all types of bariatric surgery

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

1. Kleinman NL, Melkonian A, Borden S 4th, et al. The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup Environ Med. 2009;51:170-179.

50

Long-term Changes in Comorbidity Prevalence—From 90 Days Before to 2 Years After Surgery

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

Long-term results of select AHRQ condition categories (out of 106 eligible categories)*

1. Kleinman NL, Melkonian A, Borden S 4th, et al. The impact of morbid obesity and bariatric surgery on comorbid conditions: a comprehensive examination of comorbidities in an employed population. J Occup Environ Med. 2009;51:170-179.

*Results are inclusive of all types of bariatric surgery

51

Prompt Reduction in Use of Medications for ComorbidConditions After Bariatric Surgery

Comparison of relationship between bariatric surgery and comorbidities by assessing change in use of medications in the year following bariatric surgery

Methods· Cohort study, administrative claims data from 2002 -

2005 from 7 BCBS Plans. Evaluated mean number of medications at time of bariatric surgery and 1 year post surgery.

– Medication usage by surgical patients was also compared to usage by matched enrollees without surgery but with a propensity score suggesting obesity.

– Statistical differences in usage, accounting for repeated measures and controlling for age, sex, and diabetes tested for using Poisson and logistic regression.

1. Segal JB, Clark JM, Shore AD, et al.. Prompt Reduction in Use of Medications for Comorbid Conditionsla After Bariatric Surgery. Obes Surg. 2009; 19:1646–1656.

52

Prompt Reduction in Use of Medications for ComorbidConditions After Bariatric Surgery

· Results

– Bariatric study cohort, n= 6,235 mean age = 44 years , 82% women; 34% diabetes

– By 12 months after surgery, medication use had declined for diabetes (76%), hypertension (51%), and hyperlipidemia( 59%)

– In contrast, thyroid hormone, antihistamine, and antidepressant use decreased by only 6%, 15%, and 9%, respectively.

– Enrollees without surgery had a modest increase in medications for diabetes, hypertension, and hyperlipidemia of 4%, 8%, and 20%, respectively

· Conclusion Authors concluded that bariatric surgery is effective for decreasing the use of medications for obesity-related diabetes, hypertension, and hyperlipidemia

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.

Estimates of medication use were based on pharmacy claims. This only indicates that the prescription was filled.

53

Safety and EffectivenessReactive Use Only

54

Safety and Effectiveness

· LABS N Engl J Med. 2009 361:5: 445-454– If slides 54-57 are presented to show a comparison with

LRYGB, then they should be used only reactively

– If slides 54-57 are shown solely to present safety information for LAGB, they are OK to present proactively

55

Reported Weight Loss as a Percentage of Excess Body Weight After Bariatric Surgery

References correlating to b-h are provided within the AACE/TOS/ASMBS Bariatric Surgery Guidelines

DS=duodenal switch

1. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4:S109-S184.

56

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%

(n=480)2.1%

(n=235)Postsurgical Mortality Rate2

(Short-term)0.05%2

(n=5780)0.5%2

(n=9258)

*Includes the LAP-BAND® System and other adjustable gastric banding systems. † Published complication rates vary depending upon the institution and how the surgeon diagnoses and defines a particular complication.1. Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg. 2006;202:252-261.2. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445-454.

57



· 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


58



· Results: Of 4476 patients, more than half had >2 coexisting conditions

– 30-day rate of death among pts was 0.3% (RYGB and LAGB)

– A total of 4.3% of patients had at least 1 major adverse event

· Composite endpoint predictors– History of deep vein thrombosis (DVT) or

pulmonary embolus (PE), diagnosis of obstructive sleep apnea (OSA), and impaired functional status were each independently associated with an ↑ risk of the composite endpoint

– Extreme values of BMI


59




60



LABS ConclusionOverall risk of death and AE after bariatric surgery was low and varied

considerably according to patient characteristics


61

Cost-EffectivenessReactive Use Only

62

Recent Improvements in Bariatric Surgery

Outcomes

1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.

Cost-Effective

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 2001-2002, patients with higher severity case

mix underwent bariatric surgery between 2005 and 2006· Between the 2 periods, patient age increased, with a greater

proportion being over age 50 (44% vs 28%)· Patients in 2005-2006 were also more likely to have ≥2

comorbidities – 20.91% (2005-2006) vs 6.34% (2001-2002)

· Despite the increase in patient health severity case mix, the 2009 study found that outcomes improved


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.

*Not noted if banding was performed open or laparascopically.1. Encinosa WE, Bernard DM, Du D, Steiner CA. Recent improvements in bariatric surgery outcomes. Med Care. 2009;47:531-535.

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.”


66

Healthcare Cost Savings Surgically Treated (RYGB and VGB) vs

Conventional Therapy at 5 years A

vera

ge C

ost

Per

1,0

00 P

atie

nts

for

Hos

pit

aliz

atio

n$

(Mil

lion

s)*

N=1035 bariatric patients and 5746 match controls

Bariatric cohort: Net reduction of >$5.7 million per 1,000 patients treated, within 5 years of surgery*

*Canadian dollars, 5-year follow-up (1986-2002). McGill University Heath Center, Montreal. 1. Sampalis JS, Liberman M, Auger S, Christou NV. The impact of weight reduction surgery on health-care costs in morbidly obese patients. Obes Surg. 2004;14:939-947.

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

*Costs were reviewed from patient records from 1999-2001.1. Gallagher SF, Banasiak M, Gonzalvo JP, et al. The impact of bariatric surgery on the Veterans Administration healthcare system: a cost analysis. Obes Surg. 2003;13:245-248.

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

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


70

Cost-effectiveness of LAGB and LRYGB

· 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.

Probabilities and Cost for 3 Years¹Variable LAGB LRYGB Cost%EWL* 55 % (38, 64) 71 % (59, 89) NALAGB NA NA $16,200 † LRYGB NA NA $27,560 † Operative Mortality (%) 0.05 (0.1) 1 (0.5-2) Band Adjustments 10 NA $150‡

LRYGB Revisional Surgery NA 5 (1-10) $10,000LAGB Revisional Surgery 5 (2-7) NA $5,000

† 2004 US dollars, adjusted for inflation, based on public data sources QALY=Quality–adjusted-life years. ‡H-CUP- Healthcare Costs and Utilization Project.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


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*

Analysis based on the assumption of a 45-year-old female with BMI of 40 kg/m2

Difference in cost-effectiveness of these procedures using base-case estimates

*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.

72


· Study limitations– Data from the Third National Health and Nutrition Evaluation Survey and the

Framingham Heart Study used to estimate life expectancy, future costs, and quality of life

– Studies included data on patients with a BMI ≤37.5 kg/m2 • Assumed a linear correlation between BMI and these parameters for BMIs of 40-60 kg/m2 • Data support linear relationship, but data for BMI >45 kg/m2 is limited

– Probabilities (perioperative mortality, revisional surgery, and weight loss) and costs associated with those states that underlie the model were not BMI- or age-specific, because few reports have suggested that the probabilities and costs are related to BMI or age

– Obesity’s relationship with 5 chronic conditions (hypertension, hypercholesterolemia, type 2 diabetes mellitus, coronary heart disease, and stroke) were considered, which accounted for ~85% of total economic burden of obesity

– Although the model incorporated the complications of surgery in the usual care cost calculation, the rates of these complications could vary between sites and would be difficult to assess accurately in a modeled analysis


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

25 Months

• First ROI evidence using actual claims records for bariatric surgery

• 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 1999-2005 from Ingenix private insurer claims database. † Cohort sample of nonsurgery patients were based on patient demographics, selected comorbidities, and cost.‡ Estimate based on surgeries performed between 2004 and 2005 for laparoscopic surgeries and between 2003 and 2005 for open surgeries.1. Cremieux PY, Buchwald H, Shikora SA, et al. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008;14:589-596.

http://www.ncbi.nlm.nih.gov/pubmed/18778174?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2

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 www.lapband.com or call Allergan Product Support at 1-800-624-4261.

CAUTION: This device is restricted to sale by or on the order of a physician.APC81NQ10

http://www.lapband.com/

Documents

1 The Impact of Obesity and the Value of Treatment