examining thevalue proposition of emerging therapies and ...€¦ · examining thevalue proposition...

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.


burden of obesity



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


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


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.


burden of obesity



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 – Counseling for Nutrition

2011

2010

2009

2012

70

60

50

40

30

20

0

10

Per

cen

tag

e


80



WCC – Counseling for Physical Activity

2011

2010

2009

2012

70

60

50

40

30

20

0

10

Per

cen

tag

e


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

examining thevalue proposition of emerging therapies and ...€¦ · examining thevalue proposition...

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