The Cost of The Cost of Type 2 Diabetes Prevention Type 2 Diabetes Prevention

in the USAin the USA

Michael M. EngelgauMichael M. Engelgau

Division of Diabetes TranslationDivision of Diabetes Translation

CDCCDC

Symposium on Diabetes EconomicsSão Paulo, Brazil, 27 September 2004

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Never have doctors known so much about how to prevent and control this disease, yet the epidemic keeps on raging ….

Christine GormanTime 30 November 2003

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TIMETIME

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How can we stop (or slow down) the diabetes

??

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Rationale for Rationale for Primary PreventionPrimary Prevention

ScientificScientific

EconomicsEconomics

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Genetic predisposition

Preclinical state

Normal IGT

DisabilityDeath

Clinical disease

Type 2 DM

DisabilityDeath

Complications

Complications

Primary Secondary Tertiaryprevention prevention prevention

Stages in the Natural History of Type 2 diabetes

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What is theWhat is the ??

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Major StudiesMajor Studies Da Qing IGT and Diabetes StudyDa Qing IGT and Diabetes Study (China) (China)

Diabetes Prevention Study Diabetes Prevention Study (Finland) (Finland)

Diabetes Prevention Program Diabetes Prevention Program (USA)(USA)

STOP NIDDM STOP NIDDM (Europe, (Europe, Canada)Canada)

Troglitazone in the Prevention of Diabetes Troglitazone in the Prevention of Diabetes (TRIPOD) (TRIPOD) (USA)(USA)

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BenefitsBenefitsStudy Study Reduction in risk (%) Reduction in risk (%)

LifestyleLifestyle DrugDrug

Da QingDa Qing 31–46 31–46

DPSDPS 58 58

DPPDPP 58 58 31 31

Stop NIDDMStop NIDDM 25 25

TRIPODTRIPOD 55 55

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Primary prevention

works!!!!

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EconomicsEconomics

$$$$$$$$$$$$$$$$$$

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Medical Costs of DPP Interventions(per participant)

▲- Placebo

3-Yr. Cost

+2,701+2,463-

2,780 2,54279

LifestyleMetforminPlacebo

DPP Research Group, Diabetes Care 2003.

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Is it cost effective?Is it cost effective?

Societal judgement and is not absoluteSocietal judgement and is not absolute

Expert panels in developed countries Expert panels in developed countries suggest:suggest:

<$20,000/QALY<$20,000/QALY ready uptakeready uptake

$20-100,000/QALY$20-100,000/QALY considerconsider

>$100,000/QALY>$100,000/QALY less attractiveless attractive

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CE of Primary Prevention DPP* CE of Primary Prevention DPP* (USA)(USA) Within Group LS/Within Group LS/

DPP Generic Met DPP Generic Met

Cost/QALY Cost/QALY US$ US$ US$ US$

Lifestyle vs PlaceboLifestyle vs Placebo 51,600 27,10051,600 27,100

Metformin vs Placebo 99,200 35,000Metformin vs Placebo 99,200 35,000

*Societal perspectiveDPP Research Group, Diabetes Care 2003.

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Who should we target?Who should we target?High-Risk vs Entire PopulationHigh-Risk vs Entire Population

EpidemiologyEpidemiology

PreDM (IGT/IFG) have 10 fold higher risk than NGTPreDM (IGT/IFG) have 10 fold higher risk than NGT

Only 10% have IGT/IFG but yield 40-50% new DMOnly 10% have IGT/IFG but yield 40-50% new DM

PathophysiologyPathophysiology

Clinical trials in populations with preDMClinical trials in populations with preDM

Human behaviorHuman behavior

Health belief model – risk and benefitHealth belief model – risk and benefit

Narayan et al., BMJ 2002; 325:403.

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ParticipantsParticipants

EligibilityEligibility StudyStudy

criteriacriteria DaQing DPS DPP Stop TRIPOD DaQing DPS DPP Stop TRIPOD

NIDDMNIDDM

Glucose (mg/dl)Glucose (mg/dl)

FastingFasting none none none 95-125 100-140 none none 95-125 100-140 none

2-hr OGTT2-hr OGTT 140-199 140-199 140-199 140-199 none 140-199 140-199 140-199 140-199 none

5 OGTT sum5 OGTT sum >=625 >=625

Age (yrs)Age (yrs) >25 40-65 >25 40-65 >=25 40-70 >=25 40-70 >=18>=18

BMI (kg/m2)BMI (kg/m2) none none >=24 >=25 25-40 none >=24 >=25 25-40 none

History GDMHistory GDM ++

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What are the gaps from What are the gaps from RCTs? RCTs?

Isolated IFG not studiedIsolated IFG not studied

Only one study examined Only one study examined non-overweight persons with IGTnon-overweight persons with IGT

What is the risk of developing What is the risk of developing diabetes in these groups? diabetes in these groups?

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International Diabetes Federation IGT/IFG International Diabetes Federation IGT/IFG Consensus Statement: Consensus Statement:

Report of an Expert Consensus WorkshopReport of an Expert Consensus Workshop

Combined IGT and IFG have highest riskCombined IGT and IFG have highest risk

Isolated IFG and IGT have about the same riskIsolated IFG and IGT have about the same risk

Isolated IGT is more commonIsolated IGT is more common

About a third who develop diabetes have About a third who develop diabetes have “normal” glucose tolerance at baseline “normal” glucose tolerance at baseline (dependent on length of follow-up)(dependent on length of follow-up)

Unwin N et al., Diabetic Medicine 2002; 19: 708.

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What are the current policy What are the current policy recommendations? recommendations? American Diabetes AssociationAmerican Diabetes Association

Pre-diabetes:Pre-diabetes:

Opportunistic screening for IGT or IFG:Opportunistic screening for IGT or IFG:

>= 45 yrs>= 45 yrs

Emphasis in those with BMI >25 Emphasis in those with BMI >25

Consider others if are overweight with Consider others if are overweight with risk factorsrisk factors

ADA Position Statement, Diabetes Care 2004; 27: S47.

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What are the current policy What are the current policy recommendations? recommendations?

IDF IGT/IFG Consensus Statement:IDF IGT/IFG Consensus Statement:Report of an Expert Consensus WorkshopReport of an Expert Consensus Workshop

e IGT or IFG should receive lifestyle adviceIGT or IFG should receive lifestyle adviced If lifestyle fails, consider drugsIf lifestyle fails, consider drugsl Target those at highest risk for DM and Target those at highest risk for DM and

CVD.CVD.

Unwin N et al., Diabetic Medicine 2002; 19: 708.

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What are the current policy What are the current policy recommendations? recommendations?

Finnish National PolicyFinnish National Policy

Prediction models for future riskPrediction models for future risk

s Use fewer screening testsUse fewer screening tests

i Tailor to the individuals level of riskTailor to the individuals level of risk

Lindstrom J, Diabetes Care 2003; 26: 725.

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How do we do find the at-risk population?

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CDC WorkshopCDC Workshop

National and International researchersNational and International researchers

QuestionsQuestionsM What populations not studiedWhat populations not studied Health policy for those not studiedHealth policy for those not studiedr Detection strategiesDetection strategiesg Further studyFurther study

Diabetes Therapeutics and Treatments 2004 (in press).

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How do we detect targeted How do we detect targeted populations? populations? Two general approaches:Two general approaches:

3.3. Measure glucose levels directlyMeasure glucose levels directly• Use clinical and demographic charaterisitics to Use clinical and demographic charaterisitics to

target testtarget test• Determine current glycemic statusDetermine current glycemic status

5.5. Use individual characteristics (clinical, demographic)Use individual characteristics (clinical, demographic)

• Predict future risk for diabetesPredict future risk for diabetes• Current glycemic status unknownCurrent glycemic status unknown

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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly

Three approaches*Three approaches*

Combinations of risk factors with Combinations of risk factors with various cutpointsvarious cutpoints

Statistical models with risk factors Statistical models with risk factors

Risk scores Risk scores

*NHANES (3 studies), Framingham, SAHS, AusDiab, NUDS India, INTER-99, Ely Study, Diabetes in Egypt, ARIC

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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly

Risk factorsRisk factors

DemographicsDemographics

Self-report clinical historySelf-report clinical history

Current clinical measuresCurrent clinical measures

Administrative dataAdministrative data

Laboratory dataLaboratory data

Metabolic syndrome criteriaMetabolic syndrome criteria

CombinationsCombinations

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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly

Performance Performance

Moderately effectiveModerately effective

AUC 0.60-0.80AUC 0.60-0.80

Sensitivity 60-80%; Sensitivity 60-80%; Specificity 70-90%Specificity 70-90%

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Detection Strategies:Detection Strategies:Prediction of Future Risk of Diabetes Prediction of Future Risk of Diabetes

Method* Method*

5-10 year risk of diabetes 5-10 year risk of diabetes

Risk score or “clinical” modelRisk score or “clinical” model

Risk factors Risk factors

Demographic, clinical Demographic, clinical

Glucose measures not requiredGlucose measures not required

ResultsResults

0.60-0.85 AUC0.60-0.85 AUC

Age-dependent performanceAge-dependent performance

*Finrisk-87, JACDS-Seattle, SAHS

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EconomicsEconomics

$$$$$$$$$$$$$$$$$$

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Random Capillary Blood Glucose TestRandom Capillary Blood Glucose Test

All

Low-risk populatione.g., age < 45

RCBG positive

High-risk populatione.g., age e 45

RCBG negative

IFG or IGT or DM OGTT & FPG negative

OGTT

RCBG test

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50

250

450

650

850

75 85 95 105 115 125 135 145Cutoff value (mg/dl)

Co

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ca

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($

)Screening for pre-diabetes & diabetesScreening for diabetes alone

Cost per Case of Undiagnosed Diabetes or Pre-Diabetes Identified by Random Capillary Glucose Test

Zhang et al ADA 2004

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Cost per Case Identified at the Most Efficient Cost per Case Identified at the Most Efficient Cutoff PointCutoff Point (single-payer perspective)(single-payer perspective)

5.0%

100 mg/dl

100 mg/dl

Cutoff point

Screening for pre-diabetes & diabetes

$153

$127

$125

$/case $/caseCutoff point

$578110 mg/dlFPG

$5905.7%A1C

$392120 mg/dlRCBG

Screening for diabetes alone

Test

Zhang et al ADA 2004

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Follow-up Report on the Diagnosis of Diabetes Mellitus

The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus

Diabetes Care 2003; 26: 3160.

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Criteria for Diabetes and Pre-Diabetes Criteria for Diabetes and Pre-Diabetes

Fasting glucose

2-hour glucose

Cutpointloweredto >=100

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Fasting Glucose Distribution

Glucose level (mg/dl)

Nu

mb

er

100 110 126

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Pre-Diabetes in the US population 40–74 years of Age by Old and New Criteria, 2000

Total = 20 million Total = 41 million

Benjamin et al., CDC unpublished; CDC National Diabetes Fact Sheet.

13 M (4 M) 15 M 35 M (5 M) 16 M

OLD NEW

IFG IGT & IGT IFG

IFG IFG & IGT IGT

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Detection IssuesDetection IssuesSensitivity, specificity trade-offsSensitivity, specificity trade-offs

Program goalsProgram goals

Use of resourcesUse of resources

Targeted populationTargeted population

New IFG criteria* (adding 100-110 mg/dl)New IFG criteria* (adding 100-110 mg/dl)

* Benefit unknown/small Benefit unknown/small

s 89% w 100-109 have other indication for LS89% w 100-109 have other indication for LS

v ““False positive” and label side-effectFalse positive” and label side-effect

Schriger and LorberSchriger and Lorber Diabetes Care Diabetes Care 2004; 27: 598.2004; 27: 598.

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TIMETIME

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TomorrowTomorrowTodayToday

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Knowing it not enough; Knowing it not enough; we must apply.we must apply.

Willing is not enough; Willing is not enough; we must do.we must do.

- Goethe

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