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Examining the Value Proposition of Emerging Therapies and Treatment Models forObesityand Weight Management
Faculty
Robert F. Kushner, MD, MS, FACP
Professor of MedicineClinical Director
Northwestern Comprehensive Center on ObesityNorthwestern University Feinberg School of Medicine
Chicago, Illinois
William J. Cardarelli, PharmD
Director of Pharmacy Revenue and SupplyAtrius Health
Harvard Vanguard Medical AssociatesWatertown, Massachusetts
Dana T. Rey, MPH
Senior Health Care Analyst, Performance MeasurementNational Committee for Quality Assurance
Washington, DC
Learning Objectives
• Quantify the burden of obesity including the impact of cardiometabolic risks
• Discuss limitations of BMI-centric cost-effectiveness models in assessing new and emerging obesity treatment options
• Evaluate the safety, efficacy, and cost-effectiveness of newer and emerging obesity treatments
• Apply guidelines and evidence to the development of a complications-centric model for obesity management
• Implement appropriate HEDIS® measures for identifying and addressing obesity in children and adults
• Address gaps in complication-centric obesity management through the application of cardiometabolic risk-related HEDIS® measures and recognition programs
BMI = body mass index; HEDIS = Healthcare Effectiveness Data and Information Set.
Robert Kushner, MD, MS, FACP
Professor of MedicineNorthwestern University Feinberg School of MedicineChicago, Illinois
Tackling the Burden of Obesity
Outline• Medical and economic
burden of obesity
• Newer pharmacological agents
• Complications-centric model for obesity management
Trends inObesity and Overweight
among US Adults, 1960-2010
Obesity and Overweight Prevalence
Fryar C, et al. http://www.cdc.gov/nchs/data/hestat/obesity_adult_09_10/obesity_adult_09_10.pdf. Accessed February 19, 2014. Flegal KM, et al. JAMA. 2012;307(5):491-497.
Prevalence ofObesity and Overweight in US Adults, 2009-2010
20.4%
33.3%
30.8%
6.3%
9.2%
Overweight (BMI ≥25.0-29.9)
Normal / Underweight (BMI <25.0)
Obese Class 1 (BMI ≥30.0-34.9)
Obese Class 2 (BMI <≥35.0-39.9)
Obese Class 3 (BMI ≥40.0)
40
20
0
1960-1962
Pre
vale
nce
(%
) 30
10
Obese (BMI ≥30.0 kg/m2)
Obese Class 3 (BMI ≥40.0 kg/m2)
Overweight (BMI ≥25.0-29.9 kg/m2)
25
5
35
15
1971-1974
1976-1980
1988-1994
2001-2002
2005-2006
2009-2010
BMI and Mortality in 900,000 Adults: Collaborative Analysis of 57 Prospective Studies
CI = confidence interval.Whitlock G, et al. Lancet. 2009;373(9669):1083-1096.
34.7
91
146
28.2
26.0
20.5
16.9
15.314.5
15.8
18.4
26.4
15.1
10.5
9.58.9
9.2
10.4
11.4
13.0
14.7
17.0
19.2414
12193624
8052
1443714497
8920
2952
351
201
11943146
3995 3366
24151688
931
557
284
269
Yea
rly
Dea
ths
per
100
0(9
5% C
l)
Baseline BMI (kg/m2)
64
32
16
8
0 15 20 25 30 35 40 50
22.7
Female
Male
The Impact of Obesity on Health
Obesity burdenlargely driven byincreased risk of
• Cardiovascular diseases
• Type 2 diabetes
• Certain cancers
• Musculoskeletal pain
Centers for Disease Control and Prevention. http://www.cdc.gov/VitalSigns/AdultObesity/Risk-large.html#Complications. Accessed February 19, 2014. Singh-Manoux A, et al. Neurology. 2012;79(8):755-762. Guh DP, et al. BMC Public Health. 2009;9:88. Wang YC, et al. Lancet. 2011;378(9783):815-825.
Sleep apnea
Lung diseaseAsthmaPulmonary blood clots
Liver diseaseFatty liverCirrhosis
Gallstones
Urinary incontinence
Venous insufficiencyInflamed veins,often with blood clots
Peripheral edema
Stroke Cognitive decline
Pancreatitis
Chronic back pain
Infertility
Arthritis
Gout
Cancer Musculoskeletal pain
Diabetes
Heart diseaseAbnormal lipid profilesHigh blood pressure
Additional Yearly per Capita Healthcare andProductivity Costs Due to Obesity among
Full-Time US Employees ($2006)
All values significant (P<.05) compared to normal-weight workers.Finkelstein EA. J Occup Environ Med. 2010;52(10):971-976.
0
$2524
$4112
$7092
Ad
dit
ion
al Y
earl
y p
er C
apit
a C
ost
s ab
ove
No
rmal
-Wei
gh
t W
ork
ers
($)
ObeseClass 2
(BMI ≥35-39.9)
ObeseClass 3(BMI ≥40)
ObeseClass 1
(BMI ≥30-34.9)
Women
0
$1143
$2491
8,000
6,000
4,000
3,000
2,000
1,000
7,000
5,000
ObeseClass 2
(BMI ≥35-39.9)
ObeseClass 3(BMI ≥40)
ObeseClass 1
(BMI ≥30-34.9)
Men
$6087
8,000
6,000
4,000
3,000
2,000
1,000
7,000
5,000
Absenteeism
Healthcare
Presenteeism
Polling Question
It is predicted that by 2030, what percentage of US annual healthcare spending will be attributable to obesity?
1. 9.1%
2. 15.6%
3. 17.6%
4. 19.1%
US Healthcare Spending Attributable to Obesity
• By 2030, if trends in obesity rates continue, healthcare costs attributable to obesity will reach $956 billion
• This represents $1 in every $6 spent on healthcare
• The major driver of rising healthcare spending is the increased prevalence of obesity
Wang Y, et al. Obesity (Silver Spring). 2008;16(10):2323-2230.
Percentage of USAnnual Healthcare Spending
Attributable to Obesity by Year
Hea
lth
care
Sp
end
ing
(%
)
20
12
8
6
4
0
2
1998 2020 2030Projected
9.1
15.6
17.618
16
14
10
Overview of Weight LossTreatment Options
Treatment Options
BMI ≥25≥27 + Comorbidities
or ≥30
≥35 +Comorbidities or ≥40(laparoscopic oropen surgery)
Expected Efficacy4% to 10% of initial weight
Lack of long-term efficacy;weight regain without maintenance
therapy
5% to 11% of initial weight
Only ~3% of obese/overweight patients are prescribed
weight loss drugs
14% to 33% of initial weight
<1% of obese patientsundergo surgery due to perioperative risks and
potential long-termcomplications
Lifestyle Modification
Weight Loss Pharmacotherapy
ObesitySurgery
National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed February 21, 2014. FDA.gov. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm283455.htm. Accessed February 21, 2014. Sarwer DB, et al. Curr OpinEndocrinol Diabetes Obes. 2009;16(5):347-352. Nguyen N, et al. Obes Surg. 2012;22(6):956-966. ButrynML, et al. Psychiatr Clin North Am. 2011;34(4):841-859. Coleman E, et al. N Eng J Med. 2012;367(17): 1577-1579. Samaranayake NR et al. Ann Epidemiol. 2012;22(5):349-353. Sjöström L. J Intern Med. 2013;273(3):219-234.
Outline• Medical and economic
burden of obesity
• Newer pharmacological agents
• Complications-centric model for obesity management
Anti-Obesity Medications
• Drug approvals – 2012
– Phentermine/topiramate ER (Qsymia®)
– Lorcaserin (Belviq®)
• New Drug Application (NDA) submitted
– Naltrexone sustained release (SR) / Bupropion SR) (Contrave®) December 2013
– Liraglutide (Victoza®) December 2013
ER = extended release; SR = sustained release.FDA.gov. http://www.fda.gov. Accessed February 21, 2014.
Overview of Approved Medications
Agent Lorcaserin PHEN/TPM ER
Approval status Approved June 2012 Approved July 2012
Commercially available
June 27, 3013 September 18, 2012
Schedule IV IV
MechanismSelectively targets the 5-HT2C receptor
PHEN stimulates norepinephrinerelease from hypothalamic neurons; TPM anticonvulsant (GABA receptor modulation, carbonic anhydrase inhibition, glutamate antagonism)
Follow-up duration 52 (104) weeks 56 (108) weeks
Common adverse effects
• Headache• Dizziness• Nausea
• Dry mouth• Tingling• Constipation• Altered taste sensation
PHEN/TPM = phentermine/topiramate; IV = intravenous.FDA.gov. http://www.fda.gov. Accessed February 21, 2014.
PHEN/TPM56-Week Study (CONQUER) followed by
52-Week Extension (SEQUEL)
All patients participated in a lifestyle modification program
Placebon = 994
7.5 mg phentermine/ 46 mg topiramate(PHEN/TPM ER)
7.5/46n = 498
15 mg phentermine/ 92 mg topiramate(PHEN/TPM ER)
15/92n = 995
Patients with BMI 27-45 kg/m2 and≥2 Obesity-Related Comorbidities (N=2487)
Placebon = 227
7.5 mg phentermine/ 46 mg topiramate(PHEN/TPM ER)
7.5/46n = 153
15 mg phentermine/ 92 mg topiramate(PHEN/TPM ER)
15/92n = 295
Conducted between December 2008 and June 2010.Garvey WT, et al. Am J Clin Nutr. 2012;95(2):297-308.
Year 1
Year 2Year 2 Year 2
Garvey WT, et al. Am J Clin Nutr. 2012;95(2):297-308.
Effect of PHEN/TPM ER on Weight Loss in Obese Adults over 2 Years: SEQUEL Study
PHEN/TPM CR 7.5/46
Placebo
PHEN/TPM CR 15/92
0
-16
-14
-12
-10
-8
-6
-4
-2
0
8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108
LO
CF
LS
Mea
n W
eig
ht
Lo
ss (
%)
WeeksNumber
Placebo 227 227 227 208 197 227PHEN/TPM CR 7.5/46 153 1522 1532 1372 129 153PHEN/TPM CR 15/92 295 95 95 68 248 295
PHEN/TPM AchievingTarget Weight Loss at 1 Year
*Completers includes patients who had a 1-year evaluation within 7 days of their last medication dose; †P < .0001 vs lifestyle modification alone.Gadde KM, et al. Lancet. 2011;377(9774):1341-1352.
100
60
40
30
20
0
10
≥10% Weight Loss
10%
†
49%
†
64%
90
80
70
50
Per
cen
tag
e o
f P
atie
nts
(Co
mp
lete
rs*)
(%
)
100
60
40
30
20
0
10
≥5% Weight Loss
26%
†
75%
†
85%90
80
70
50
A significant proportion of patients on PHEN/TPMachieved ≥5% and ≥10% weight loss vs those on lifestyle modification alone
Phen/TPM Recommended Dose
Lifestyle Modification
Phen/TPM Top Dose
Non-High-DensityLipoprotein Cholesterol
Change in Lipid Panel inCONQUER Study
Davidson MH, et al. Am J Cardiol. 2103;111(8):1131-1138.
526436526
271222271
526364526
Weeks
15
10
5
0
-5
-10
LS
Mea
n
Pe
rce
nt
Ch
an
ge
(%
)
High-DensityLipoprotein Cholesterol
56 LOCF0 84 28 4016
Weeks
0
-2
-4
-8
-10
-12
-14
-16
LS
Mea
nP
erc
en
t C
ha
ng
e (
%)
56 LOCF0 84 28 4016
-6
Weeks
0
-5
-10
-15
-20
-25
-30
-35
LS
Mea
nP
erc
en
t C
ha
ng
e (
%)
Triglycerides
56 LOCF0 84 28 4016
PHEN/TPM ER 15/92
PHEN/TPM ER 7.5/46
Placebo
Weeks52443628201684
0
-2
-4
-6
-8
-10
-12
-14
LS
Mea
nW
eig
ht
Lo
ss (
%)
40 LOCF0 12 24 32 5648
403
206
338
Placebo
PHEN/TPM ER 7.5/46
PHEN/TPM ER 15/92
*
*
*
*
†
†
†
†
††
†
†
†
†
††
† †
† ††
†
† †
†
†
†
†
†
†
† †
† † † †
481624
Change in Blood Pressure in CONQUER Study
Davidson MH, et al. Am J Cardiol. 2103;111(8):1131-1138.
514422514
256210256
516368516
Weeks
-2
-4
-8
-10
-12
-14
LS
Mea
n C
han
ge
in B
P (
mm
Hg
)
Systolic Blood Pressure
56 LOCF0 168 32 48
-6
Weeks
0
-1
-2
-3
-4
-5
-6
-8
LS
Mea
n C
han
ge
in B
P (
mm
Hg
)
Diastolic Blood Pressure
56 LOCF0 248 4032
PHEN/TPM ER 15/92
PHEN/TPM ER 7.5/46
Placebo
Weeks52443628201684
0
-2
-4
-6
-8
-10
-12
-14
LS
Me
an
We
igh
t L
oss
(%
)
40 LOCF0 12 24 32 5648
400
194
346
-7
6
-4
-6
-8
-10
-12Per
cen
tag
e o
f P
arti
cip
ants
wit
h N
et C
han
ge
in C
on
com
itan
t A
nti
hyp
erte
nsi
ve M
edic
atio
ns
3.4
-10.5
-6.6
4
2
0
-2
Placebo
PHEN/TPM ER 7.5/46
PHEN/TPM ER 15/92
IncreasedMedication
DecreasedMedication
400
Impact on HbA1c and Antidiabetic Medications
*Hypoglycemia rates were comparable across all treatment groups; †LS mean was adjusted for baseline body weight and diabetic status; treatment difference from baseline following 1 year of treatment.HbA1c = glycosylated hemoglobin. Qsymia [prescribing information]. Mountain View, CA: VIVUS, Inc.; 2013.
Net Percentage of Subjects with Increase in
Antidiabetic Medications
Per
cen
t o
f S
ub
ject
s (%
)
14
6
2
0
12.1%
1.5%0.6%
12
10
8
4
-0.1
-0.4 -0.4
0
-0.2
-0.3
-0.4
-0.5
-0.1
LS
Mea
n†
Ch
ang
e fr
om
Bas
elin
e (%
)Mean Change in HbA1c Percentage
among Subjects withDiabetes at Baseline*
Phen/TPM Recommended Dose
Lifestyle Modification
Phen/TPM Top Dose
Mean Baseline HbA1c: 6.8%
PHEN/TPM ER* Prevents Progression to T2DM: SEQUEL Study
T2DM = type 2 diabetes mellitus; NS = not significant; CR = controlled release.*PHEN/TPM ER is not approved for the prevention of diabetes.Gadde KM, et al. Lancet. 2011;377:341-1352.
3.0
2.5
4.0
3.5
2.0
1.5
1.0
0.5
0
Placebo Phen/TPM CR7.5/46 mg
Phen/TPM CR15/92 mg
Pro
gre
sso
rsp
er Y
ear
(%)
3.7%
54%
0.9%
Annualized Incidence of T2DM
1.7%
P = .008
76%P = NS
PHEN/TPM ER: EQUIP and CONQUER ─Most Commonly Reported Treatment-Emergent Adverse Events
Adverse Events(N=3749)
PlaceboPHEN /TPM ER
Low
PHEN /TPM ER
Mid
PHEN /TPM ER
Top
Paresthesia 2.0 4.2 13.7 19.9
Dry mouth 2.9 6.7 13.5 19.5
Constipation 6.2 7.9 15.1 16.3
Upper respiratory tract infection 12.2 15.8 12.2 13.0
Headache 9.4 10.4 7.0 10.8
Dysgeusia 1.1 1.3 7.4 9.7
Nasopharyngitis 8.2 12.5 10.6 9.6
Insomnia 4.8 5.0 5.8 9.4
Dizziness 3.5 2.9 7.2 8.5
Sinusitis 6.3 7.5 6.8 8.1
Nausea 4.4 5.8 3.6 7.0
Back pain 5.0 5.4 5.6 6.6
Fatigue 4.4 5.0 4.4 6.0
Blurred vision 3.5 6.3 4.0 5.5
Diarrhea 4.7 5.0 6.4 5.4
?*Reported in >5% of subjects receiving PHEN/TPM ER 15/92.US FDA. Drugs@FDA. http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA. Accessed September 20, 2013.
Lorcaserin52-Week Study followed by 52-Week Extension (BLOOM)
BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management.Smith SR, et al. N Engl J Med. 2010;363(3):245-256.
All patients participated in a lifestyle modification program
Placebon = 1587
Lorcaserin10 mg BIDn = 1595
Patients with BMI 27-45 kg/m2 and≥1 Obesity-Related Comorbidities (N=3182)
Placebon = 697
Placebon = 283
Lorcaserin10 mg BID
n = 573
Year 1
Year 2Year 2 Year 2
Weight Change over 104 Weekswith Lorcaserin Therapy
Smith SR, et al. N Engl J Med. 2010;363(3):245-256.
Lorcaserin Year 1 / Placebo Year 2 = 3.8 kg (n=195)
Placebo Year 1 / Placebo Year 2 = 2.6 kg (n=507)
Lorcaserin Year 1 / Lorcaserin Year 2 = 6.0 kg (n=426)
BL
-10
-8
-6
-4
-2
0
4 8 12 24 36 52 60 72 84 96 104
LS
Mea
n (
SE
M)
Wei
gh
t C
han
ge
(kg
)
Study Week
Year 1 Randomized: Lorcaserin n = 1595, placebo n = 1587
Year 2 Randomized: Lorcaserin year 1 / lorcaserin year 2 ,n = 573; lorcaserin year 1 / placebo year 2, n = 283; placebo year 1 / placebo year 2, n = 697
Lorcaserin Categorical Weight Loss
Smith SR, et al. N Engl J Med. 2010;363(3):245-256.
50
60
40
30
20
10
0
Pro
gre
sso
rsp
er Y
ear
(%)
Weight Loss at 1 Year
P < .001
≥10% Weight Loss≥5% Weight Loss
P < .001
Placebo (N=1499)
Lorcaserin (N=1538)
Effect of Lorcaserin onMetabolic Measures
Data are presented from the intention-to-treat analysis with last-observation-carried forward imputation. Means ± SE.*P = .049; †P = .040; ‡P = .010; §P ≤ .001SBP = systolic blood pressure; DBP = diastolic blood pressure; TC = total cholesterol; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol. Smith SR, et al. N Engl J Med. 2010;363(3):245-256.
SBP DBP0
-1.0
-2.0
-1.6
-0.4
Ch
ang
e (m
m H
g)
†
‡
TC LDL-C6
2
-2
-4
-8
-6
4
Ch
ang
e (%
)
HDL-C Triglycerides
§
*
§
0
-0.6
-0.2
-0.8
-1.2
-1.4
-1.8
Lorcaserin 10 mg BID
Placebo
Effect of Lorcaserin* on Glycemia inType 2 Diabetes: BLOOM-DM Study
*Lorcaserin is not approved for the treatment of diabetes. †P < .001 vs placebo. ‡P = .087 vs placebo.BLOOM-DM = Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus.O’Neil PM et al. Obesity (Silver Spring). 2012;20(7):1426–1436.
Change in HbA1c Level
Placebo(n=248)
8.0
Lorcaserin10 mg bid
(n=251)8.1
Lorcaserin10 mg qd
(n=93)8.1
-0.4
-0.9† -1
†
0
-0.4
-0.6
-0.8
-1.2
-1.0
-0.2
Bas
elin
e L
S M
ean
∆A
1c (
%)
Change in Diabetes Medications
Pat
ien
ts I
ncr
easi
ng
Use
of
An
tid
iab
eti
cA
gen
ts (
%)
100
60
40
30
20
0
10
Placebo(n=248)
Lorcaserin10 mg bid
(n=251)
Lorcaserin10 mg qd
(n=95)
88.3 ‡
82.9 ‡
76.690
80
70
50
Lorcaserin Safety Data*
Lorcaserin10 mg BID (n=1593)
Year 1 n(%)
Lorcaserin10 mg BID (n=573)Years 1 and 2 n(%)
Placebo(n=1584)
Year 1 n(%)
Headache 287 (18.0) 41 (7.2) 175 (11.0)
Upper respiratory infection 235 (14.8) 83 (14.5) 189 (11.9)
Nasopharyngitis 213 (13.4) 94 (16.4) 190 (12.0)
Dizziness 130 (8.2) 10 (1.7) 60 (3.8)
Nausea 119 (7.5) 20 (3.5) 85 (5.4)
Sinusitis 114 (7.2) 49 (8.6) 130 (8.2)
Diarrhea 109 (6.8) 34 (5.9) 85 (5.4)
Urinary tract infection 106 (6.7) 41 (7.2) 96 (6.1)
Constipation 106 (6.7) 14 (2.4) 64 (4.0)
Back pain 99 (6.2) 34 (5.9) 89 (5.6)
Fatigue 95 (6.0) 15 (2.6) 48 (3.0)
Dry mouth 83 (5.2) 1 (0.2) 37 (2.3)
Gastroenteritis (viral cause) 79 (5.0) 18 (3.1) 64 (4.0)
Influenza 73 (4.6) 38 (6.6) 69 (4.4)
Arthralgia 70 (4.4) 38 (6.6) 75 (4.7)
*Population is all patients who received at least 1 dose of lorcaserin or placebo.Smith SR, et al. N Engl J Med. 2010;363(3):245-256.
Outline• Medical and economic
burden of obesity
• Newer pharmacological agents
• Complications-centric model for obesity management
BMI Category (kg/m2)
Treatment 25-26.9 27-29.9 30-34.9 35-39.9 ≥40
Diet, physical activity, and behavior
AppropriateNHLBI
guidelinesAppropriate Appropriate Appropriate Appropriate
Pharmacotherapy*Not
appropriateWith
comorbiditiesAppropriate Appropriate Appropriate
Surgery† Not appropriate
Not appropriate
With comorbidities
Appropriate
NHLBI Obesity Treatment Guidelines
CHD, coronary heart disease; NHLBI, National Heart, Lung, and Blood Institute.
*Risk factors for considering pharmacotherapy at BMI 27-29.9 kg/m2 are hypertension, dyslipidemia, coronary heart disease, T2DM, and sleep apnea; †Bariatric surgeries require lifestyle changes and medical follow-up; FDA approved laparoscopic adjustable gastric band surgery for patients with BMI ≥30 kg/m2 and 1 weight-related medical condition (February 2011).NHLBI = National Heart, Lung, and Blood Institute.National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed February 21, 2014. FDA.gov. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245617.htm. Accessed February 21, 2014.
A Guide to Selecting Treatment
Stage Cardiometabolic Mechanical/Functional
0 No risk factorsNo functional impairments or impairments in well-being
1“Sub-clinical risk factors”:Prediabetes, metabolic syndrome,NAFLD
Mild limitations and impairment of well-being
2End-Stage metabolic disease:T2DM, hypertension, sleep apnea
Moderate limitations and impairment of well-being
3End-Stage CVD:Myocardial infarction, heart failure, stroke
Significant limitations and impairment of well-being
4 End-Stage disabilitiesSevere limitations and impairment of well-being
Edmonton Obesity Staging System (EOSS)
NAFLD = nonalcoholic fatty liver disease; CVD = cardiovascular disease.Sharma AM, et al. Int J Obes (Lond). 2009;33(3):289-295. Padwal RS, et al. CMAJ. 2011;183(14):E1059-E1066.
EOSS Predicts Mortality in NHANES III
NHANES = National Health and Human Nutrition Examination Surveys; MEC = mobile examination center.Padwal RS, et al. CMAJ. 2011;183(14):E1059-E1066.
NHANES III (1988-1994)
50 100
0.8
0.7
1.0
0.9
0.6
0.5
0.4
0 150 200
Pro
po
rtio
n S
urv
ivin
g
Months since MEC Examination
NHANES III (1988-1994)
50 100
0.8
0.7
1.0
0.9
0.6
0.5
0.5
0 150 200P
rop
ort
ion
Su
rviv
ing
Months since MEC Examination
Zero
One
Two
Three
EOSS Stage
Overweight
Class I Obese
Class II Obese
Class III Obese
BMI Classification
Cardiometabolic Disease Staging
CVD = cardiovascular disease; HDL-C = high-density lipoprotein cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; T2DM = type 2 diabetes mellitus.Daniel S, et al. Curr Opin Endocrinol Diabetes Obes. 2013;20(5):377-388.
Stage Descriptor Criteria
0 Metabolicallyhealthy No risk factors
1 One or two risk factors
Have one or two of the following risk factors:a) High waist circumference (≥88 cm in women; ≥102 cm in men; and ≥80 cm in
south-east Asian women and ≥90 in south-east Asian men)b) Elevated blood pressure (systolic ≥130 mmHg and/or diastolic ≥85 mmHg) or on
hypertensive medicationc) Reduced serum HDL cholesterol (<1.0 mmol/l or 40 mg/dl in men; <1.3 mmol/l or
50 mg/dl in women)d) Elevated fasting serum triglycerides (≥1.7 mmol/l or 150 mg/dl)
2
Metabolic syndrome or prediabetes
Have only one of the following three conditions in isolation:a) Metabolic syndrome based on three or more of four risk factors: high waist circumference,
elevated blood pressure, reduced HDL-C, and elevated triglyceridesb) Impaired fasting glucose (fasting glucose ≥5.6 mmol/l or 100 mg/dl)c) Impaired glucose tolerance (2-h glucose ≥7.8 mmol/l or 140 mg/dl)
3
Metabolic syndrome and prediabetes
Have any two of the following three conditions:a) Metabolic syndromeb) IFGc) IGT
4T2DM and/or CVD
Have T2DM and/or CVD:a) T2DM (fasting glucose ≥126 mg/dl or 2-h glucose ≥200 mg/dl or on antidiabetic therapy)b) Active CVD (angina pectoris, or status after a CVD event such as acute coronary artery
syndrome, stent placement, coronary artery bypass, thrombotic stroke, nontraumaticamputation due to peripheral vascular disease)
AACE = American Association of Clinical Endocrinologists.Garber AJ, et al. Endocr Pract. 2013;19(2):327-336.
AACE Guidelines: Complications-Centric Model for Care of the Overweight/Obese Patient
Conclusions
• Obesity is associated with increased morbidity and mortality, and obesity increases healthcare costs
• Two new pharmacological agents are approved (PHEN/TPM ER and locaserin) that result in weight loss, improved cardiometabolic risk factors, and reduced need for concomitant medication
• We are moving away from a ‘BMI-centric model’ to a ‘cardiometabolic-centric model’ of care regarding treatment decisions
William J. Cardarelli
Director of Pharmacy Revenue and SupplyAtrius HealthHarvard Vanguard Medical AssociatesWatertown, Massachusetts
Examining the Value Proposition of Emerging Therapies and Treatment Models for Obesity andWeight Management
The Managed Care View
Adult Obesity
• More than one-third of US adults (35.7%) are obese
• Obesity-related conditions include heart disease, stroke, type 2 diabetes, and certain types of cancer, some of the leading causes of preventable death
• The estimated annual medical cost of obesity in the United States was $147 billion in 2008 US dollars; the medical costs for people who are obese were $1429 higher than those of normal weight
• Non-Hispanic blacks have the highest age-adjusted rates of obesity (49.5%) compared with Mexican Americans (40.4%), all Hispanics (39.1%), and non-Hispanic whites (34.3%)
Centers for Disease Control and Prevention. http://www.cdc.gov/obesity/data/adult.html. Accessed February 19, 2014.
Prevalence* of Self-Reported Obesity among US Adults
BRFSS, 2012
*Prevalence reflects BRFSS methodological changes in 2011, and these estimates should not be compared to those before 2011.BRFSS = Behavioral Risk Factor Surveillance SystemCenters for Disease Control and Prevention. http://www.cdc.gov/obesity/data/adult.html. Accessed February 19, 2014.
15% - <20%
20% - <25%
25% - <30%
30% - <35%
≥35%
Childhood Obesity
• Approximately 17% (or 12.5 million) of children and adolescents age 2-19 years are obese
• Since 1980, obesity prevalence among children and adolescents has almost tripled
• There are significant racial and ethnic disparities in obesity prevalence among US children and adolescents
– In 2007-2008, Hispanic boys, age 2-19 years, were significantly more likely to be obese than non-Hispanic white boys
– Non-Hispanic black girls were significantly more likely to be obese than non-Hispanic white girls
Centers for Disease Control and Prevention. http://www.cdc.gov/healthyyouth/obesity/facts.htm. Accessed February 19, 2014.
http://health-care-org.blogspot.com. Accessed January 30, 2014.
Economic Impact of Obesity
• Direct costs
– Preventative
– Diagnostic
– Treatment
• Indirect costs
– Morbidity
– Mortality
• 2008 national estimated cost of obesity
– $147 billion (2008 dollars)
– Medical costs for people who are obese were $1429 higher per year than those of normal weight
Centers for Disease Control and Prevention. http://www.cdc.gov/obesity/adult/causes/index.html. Accessed February 19, 2014.
Role of Managed Care
Renda A. http://kelley.iu.edu/CBLS/files/conferences/Renda,%20Curbing%20the%20Obesity%20 Epidemic%20-%20Managed%20Care%20Perspective%20-%20Renda.pdf. Accessed February 19, 2014.
Managed Care Considerations for Coverage of Weight Loss Medications
• Potential increases in drug utilization
• Comparative safety and efficacy of therapeutic agents
• Appropriate utilization management controls
– Ensure use in chronic medical conditions and not lifestyle therapy
• Impact on drug, medical, and overall healthcare costs
Kelly EM, et al. J Manag Care Pharm. 2013;19(8):642-654.
Polling Question
In which way does a complication-centric approach differ from a BMI-centric approach?
1. BMI calculations are considered less important
2. Comorbidities and their severity are the basis for treatment decisions and approach to care
3. Allows for more large-scale screening
4. Both 1 and 2
5. All of the above
Approaches to Obesity Treatment
BMI Approach
• Decisions based on BMI calculation
• Clear value at a societal level
• Allows for large scale screening
Complication-Centric Approach
• BMI less important
• Complications (comorbidities) and their severity are the basis for treatment decisions and approach to care
• Goal is to improve comorbidities via weight loss
Benefits to a Complication-Centric Model
• Identifies those patients who will most benefit from treatment
• Improves the benefit/risk ratio by prioritizing treatment
• May inform targeted therapy of obese/overweight patients with metabolic syndrome and prediabetes
• Should limit out of indication (off-label) use
Complication-Centric Model Patient Evaluation Guidelines
• Step 1 – Assess the patient for comorbidities
• Step 2 – Explore primary areas of concern
– CVD
– Type 2 diabetes
– Prediabetes
– Metabolic syndrome
– Dyslipidemia
– Hypertension
• Step 3 – Explore other areas of concern
– Sleep apnea
– Osteoarthritis
Garvey WT. Endocr Pract. 2013;19(5):864-874.
Cardiometabolic DiseaseStaging System
• 5 Stages – 0 through 4
– Stage 0 – Metabolically healthy but obese
– Stage 1 – 1 or 2 metabolic risk factors
– Stage 2 – Impaired fasting glucose or impaired glucose tolerance or metabolic syndrome
– Stage 3 – 2 of the above
– Stage 4 – Type 2 diabetes or CVD
Garvey WT. Endocr Pract. 2013;19(5):864-874.
EOSS
• 5 Stages – 0 through 4
– Stage 0 – Metabolically healthy but obese
– Stage 1 – Subclinical risk or mild symptoms
– Stage 2 – Established moderate comorbidities
– Stage 3 – Significant comorbidities
– Stage 4 – Severe comorbidities
Padwal RS, et al. CMAJ. 2011;183(14):E1059-E1066.
AACE Guideline
Garber AJ, et al. Endocr Pract. 2013;19(2):327-336.
Managed Care Formulary Management
• Objective is to provide high quality, effective, and safe medications to all patients
• Keeps the emphasis on
– Efficacy
– Safety
– Tolerability
– Place in therapy
• Promotes cost-effective treatments
Weight Loss GuidelineAdvantages for Managed Care
• Provides a framework for therapy
• Provides a cost-efficient approach
– Allows covered access to medications to most eligible patients
• Improvements in comorbidities yields return on investment and savings
– Weight loss lowers blood pressure, HbA1c levels, and improves lipids
Application Challengesfor Managed Care
• Using consensus guidelines to guide treatment
– Building successful pay-for-performance programs
• Understanding the patient challenges
– Cost, medical literacy, and lifestyle changes
• Improving therapy adherence
– Developing patient-centered solutions
• Improving information flow to clinicians
– Providing clinicians with tools to support consistent high-quality diabetes care
Opportunities for P&T Committee
• Increase committee’s knowledge of obesity therapies
– Both current and emerging therapies
• Develop evidence-based guidelines for earlier treatment intervention
– Work closely with thought leaders to adapt recommendations as best practices change
– Understand the value of early identification of eligible patients
• Explore opportunities for innovative strategies that maintain access while reducing costs
– Maximize adherence to lower overall costs and improve outcomes
– Consider formulary designs that reduce patient out-of-pocket spend
– Is this a place for the a collaborative team approach?
P&T = Pharmacy and Therapeutics.
Team-Based Approach in Obesity
• Physician, nurse, physician assistant, medical assistant, nutritionist, others……
– Collaborative obesity management using a team approach has been demonstrated to help patients achieve clinically meaningful weight loss
– In a recent study, physicians in collaboration with medical assistants helped obese patients lose 4.7% of their initial weight over 24 months
Wadden TA, et al. N Engl J Med. 2011;365(21):1969-1979. Tsai AG, et al. J Gen Intern Med. 2009;24(9):1073-1079.
P&T Committee Review Process
• Clinical review
– Efficacy
– Safety
– Bioavailability
– Approved indications
– Nonapproved indications
– Clinical Studies
• Expert testimony
• Financial review
• Committee vote
The Future Evolution ofFormulary Decision Making
• Focus on evidence-based medicine
– Comparative effectiveness
• Universal healthcare with standard benefit designs
• Accountable care organizations
– Patient-centered medical home
• Mandated benefits and restrictions
• Increased focus on adherence
– Improving adherence is projected to save $4.7 billion
Jah AK, et al. Health Aff (Millwood). 2012;31(8):1836-1846.
Conclusions
• Managed care organizations can contribute to improving the care of patients with obesity by developing evidence-based guidelines designed to provide treatment to those patients who would most benefit
• Successful initiatives assist clinicians by providing an infrastructure to acquire, sort, and display the types of cardiometabolic risk-related information that aids in selecting appropriate therapeutic choices
• These use of a complications-centric approach aligns the benefit language with the opportunity to provide cost-effective, high-quality care
Dana T. Rey, MPHSenior Health Care Analyst, Performance MeasurementNational Committee for Quality AssuranceWashington, DC
HEDIS®
Obesity Quality Measures
NCQA HEDIS® Obesity Measures
1. Adult BMI Assessment (ABA)
2. Weight Assessment and Counseling for Nutrition and Physical Activity for Children/Adolescents (WCC)
NCQA = National Committee for Quality Assurance.
Health Importance
• Obesity contributes to 1 in 10 deaths in the United States each year
• A rising number of US adults and children/adolescents are considered overweight and obese
– Over 66% of adults overweight; over 33% obese
– Over 33% of children/adolescents overweight; over 20% obese
Danaei G, et al. PLoS Med. 2009;6(4):e1000058. Centers for Disease Control and Prevention. http://www.cdc.gov/obesity/data/adult.html#Common. Accessed February 21, 2014. Weight-control Information Network. http://win.niddk.nih.gov/statistics/. Accessed February 21, 2014. Centers for Disease Control and Prevention. http://www.cdc.gov/healthyyouth/obesity/facts.htm. Accessed February 21, 2014. CDC. http://www.cdc.gov/obesity/data/childhood.html. Accessed February 21, 2014.
Polling Question
According to a recent study, keeping obesity rates from rising could save ___ in medical expenditures
1. Over $500 million
2. Nearly $250 billion
3. Nearly $550 billion
4. Over $1 trillion
Case for Improvement
• It is estimated that 51% of the US population will be obese by 2030
• According to a recent study, keeping obesity rates from rising could save nearly $550 billion in medical expenditures
• Annual direct medical costs of childhood obesity in the US are estimated to be at least $14.3 billion
• HEDIS® performance rates indicate there is an upward trend but room for improvement
RTI International. http://www.rti.org/newsroom/news.cfm?obj=27AAE8B0-5056-B100-31BFBF89933EC3D3. Accessed February 21, 2014. Finkelstein WA, et al. Am J Prev Med. 2012;42(6): 563-570. National Collaborative on Childhood Obesity Research. 2009. http://www.nccor.org/ downloads/ChildhoodObesity_020509.pdf. Accessed February 21, 2014. National League of Cities. http://www.healthycommunitieshealthyfuture.org/learn-the-facts/economic-costs-of-obesity/. Accessed February 21, 2014. Wang LY, et al. J Adolesc Health. 2008;42(5):512-518. Hammond RA, et al. Diabetes Metab Syndr Obes. 2010;3:285-295.
Why BMI over Other Measures?
• BMI is one of the best methods for population assessment of obesity
• BMI is a first step towards understanding a patient’s health needs
• Clinical guidelines for obesity encourage BMI screening for all adults and children/adolescents
Centers for Disease Control and Prevention. http://www.cdc.gov/healthyweight/assessing/ bmi/adult_bmi/index.html. Accessed February 21, 2014.
Considerations for Quality Measures
• Measure intent and importance
– Does each measure effectively target a gap in care?
• Feasibility
– Are data sources available? Can data be extracted without extreme burden?
• Progress
– Are we seeing improvement in performance? Are these measures still valuable?
Adult BMI Assessment
Measure Description
Percentage of members 18-74 years of age who had an outpatient visit and whose BMI was documented
Features
– Product lines: Commercial, Medicaid, Medicare
– Required benefit: Medical
– Continuous enrollment: 2 years
– Exclusion: Pregnancy
– Data collection method: Administrative, hybrid
ABA Performance 2009-2012
HMO = health maintenance organization; PPO = preferred provider organization. National Committee for Quality Assurance (NCQA). 2013. Improving Quality and Patient Experience: The State of Health Care Quality 2013. http://www.ncqa.org/Directories/HealthPlans/ StateofHealthCareQuality.aspx. Accessed February 10, 2014.
2011
2010
2009
201280
60
50
40
30
20
0
10
Per
cen
tag
e
CommercialHMO
MedicaidHMO
MedicarePPO
100
90
70
MedicareHMO
CommercialPPO
Weight Assessment and Counselingfor Nutrition and Physical Activity
Measure Description
Percentage of members 3-17 years of age who had an outpatient visit with a primary care physician or OB/GYN and evidence of the following
– BMI percentile documentation
– Counseling for nutrition
– Counseling for physical activity
Features– Product lines: Commercial, Medicaid
– Required benefits: Medical
– Continuous enrollment: 1 year
– Exclusion: Pregnancy
– Data collection method: Administrative, hybrid
WCC Performance 2009-2012
WCC – BMI Percentile
National Committee for Quality Assurance (NCQA). 2013. Improving Quality and Patient Experience: The State of Health Care Quality 2013. http://www.ncqa.org/Directories/HealthPlans/ StateofHealthCareQuality.aspx. Accessed February 10, 2014.
2011
2010
2009
2012
70
60
50
40
30
20
0
10
Per
cen
tag
e
Commercial HMO Commercial PPO Medicaid HMO
80
WCC Performance 2009-2012
National Committee for Quality Assurance (NCQA). 2013. Improving Quality and Patient Experience: The State of Health Care Quality 2013. http://www.ncqa.org/Directories/HealthPlans/ StateofHealthCareQuality.aspx. Accessed February 10, 2014.
WCC – Counseling for Nutrition
2011
2010
2009
2012
70
60
50
40
30
20
0
10
Per
cen
tag
e
Commercial HMO Commercial PPO Medicaid HMO
80
WCC Performance 2009-2012
National Committee for Quality Assurance (NCQA). 2013. Improving Quality and Patient Experience: The State of Health Care Quality 2013. http://www.ncqa.org/Directories/HealthPlans/ StateofHealthCareQuality.aspx. Accessed February 10, 2014.
WCC – Counseling for Physical Activity
2011
2010
2009
2012
70
60
50
40
30
20
0
10
Per
cen
tag
e
Commercial HMO Commercial PPO Medicaid HMO
80
Conclusions
• Monitoring BMI can help healthcare providers identify at-risk adults and children/adolescents
• Healthy eating and physical activity can lower the risk of becoming obese and developing related diseases
• Performance on obesity-related HEDIS® measures can be improved
Q&A Session