440 likes | 669 Views
The Cost of Type 2 Diabetes Prevention in the USA. Michael M. Engelgau Division of Diabetes Translation CDC. Symposium on Diabetes Economics São Paulo, Brazil, 27 September 2004. Never have doctors known so much about how to prevent and control this disease, yet the epidemic
E N D
The Cost of Type 2 Diabetes Prevention in the USA Michael M. Engelgau Division of Diabetes Translation CDC Symposium on Diabetes Economics São Paulo, Brazil, 27 September 2004
Never have doctors known so much about how to prevent and control this disease, yet the epidemic keeps on raging …. Christine Gorman Time 30 November 2003
Burden of Diabetes TIME Today
How can we stop (or slow down) the diabetes ? Epidemic
Rationale for Primary Prevention • Scientific • Economics
Stages in the Natural History of Type 2 diabetes Disability Death Type 2 DM Normal IGT Complications Genetic predisposition Preclinical state Clinical disease Disability Death Complications Primary Secondary Tertiary prevention prevention prevention
Evidence ? What is the No Yes
Major Studies • Da Qing IGT and Diabetes Study (China) • Diabetes Prevention Study (Finland) • Diabetes Prevention Program (USA) • STOP NIDDM (Europe, Canada) • Troglitazone in the Prevention of Diabetes (TRIPOD) (USA)
Benefits Study Reduction in risk (%) Lifestyle Drug Da Qing 31–46 DPS 58 DPP 58 31 Stop NIDDM 25 TRIPOD 55
Primary prevention works!!!!
Economics $$$$$$$$$
Medical Costs of DPP Interventions(per participant) DPP Research Group, Diabetes Care 2003.
Is it cost effective? • Societal judgement and is not absolute • Expert panels in developed countries suggest: • <$20,000/QALY ready uptake • $20-100,000/QALY consider • >$100,000/QALY less attractive
CE of Primary Prevention DPP* (USA) Within Group LS/ DPP Generic Met Cost/QALY US$ US$ Lifestyle vs Placebo 51,600 27,100 Metformin vs Placebo 99,200 35,000 *Societalperspective DPP Research Group, Diabetes Care 2003.
Who should we target?High-Risk vs Entire Population • Epidemiology PreDM (IGT/IFG) have 10 fold higher risk than NGT Only 10% have IGT/IFG but yield 40-50% new DM • Pathophysiology Clinical trials in populations with preDM • Human behavior Health belief model – risk and benefit Narayan et al., BMJ 2002; 325:403.
Participants EligibilityStudy criteria DaQing DPS DPP Stop TRIPOD NIDDM Glucose (mg/dl) Fasting none none 95-125 100-140 none 2-hr OGTT 140-199 140-199 140-199 140-199 none 5 OGTT sum >=625 Age (yrs) >25 40-65 >=25 40-70 >=18 BMI (kg/m2) none >=24 >=25 25-40 none History GDM +
What are the gaps from RCTs? • Isolated IFG not studied • Only one study examined non-overweight persons with IGT What is the risk of developing diabetes in these groups?
International Diabetes Federation IGT/IFG Consensus Statement: Report of an Expert Consensus Workshop • Combined IGT and IFG have highest risk • Isolated IFG and IGT have about the same risk • Isolated IGT is more common • About a third who develop diabetes have “normal” glucose tolerance at baseline (dependent on length of follow-up) Unwin N et al., Diabetic Medicine 2002; 19: 708.
What are the current policy recommendations? American Diabetes Association Pre-diabetes: Opportunistic screening for IGT or IFG: >= 45 yrs Emphasis in those with BMI >25 Consider others if are overweight with risk factors ADA Position Statement, Diabetes Care 2004; 27: S47.
What are the current policy recommendations? IDF IGT/IFG Consensus Statement:Report of an Expert Consensus Workshop • IGT or IFG should receive lifestyle advice • If lifestyle fails, consider drugs • Target those at highest risk for DM and CVD. Unwin N et al., Diabetic Medicine 2002; 19: 708.
What are the current policy recommendations? Finnish National Policy • Prediction models for future risk • Use fewer screening tests • Tailor to the individuals level of risk Lindstrom J, Diabetes Care 2003; 26: 725.
How do we do find the at-risk population?
CDC Workshop • National and International researchers • Questions • What populations not studied • Health policy for those not studied • Detection strategies • Further study Diabetes Therapeutics and Treatments 2004 (in press).
How do we detect targeted populations? Two general approaches: • Measure glucose levels directly • Use clinical and demographic charaterisitics to target test • Determine current glycemic status • Use individual characteristics (clinical, demographic) • Predict future risk for diabetes • Current glycemic status unknown
Detection Strategies:Measuring Glucose Directly Three approaches* • Combinations of risk factors with various cutpoints • Statistical models with risk factors • Risk scores *NHANES (3 studies), Framingham, SAHS, AusDiab, NUDS India, INTER-99, Ely Study, Diabetes in Egypt, ARIC
Detection Strategies:Measuring Glucose Directly Risk factors • Demographics • Self-report clinical history • Current clinical measures • Administrative data • Laboratory data • Metabolic syndrome criteria • Combinations
Detection Strategies:Measuring Glucose Directly Performance • Moderately effective • AUC 0.60-0.80 • Sensitivity 60-80%; Specificity 70-90%
Detection Strategies:Prediction of Future Risk of Diabetes Method* 5-10 year risk of diabetes Risk score or “clinical” model Risk factors Demographic, clinical Glucose measures not required Results 0.60-0.85 AUC Age-dependent performance *Finrisk-87, JACDS-Seattle, SAHS
Economics $$$$$$$$$
Random Capillary Blood Glucose Test RCBG test All Low-risk population e.g., age <45 High-risk population e.g., age 45 RCBG positive RCBG negative OGTT IFG or IGT or DM OGTT & FPG negative
Cost per Case of Undiagnosed Diabetes or Pre-Diabetes Identified by Random Capillary Glucose Test Zhang et al ADA 2004
Cost per Case Identified at the Most Efficient Cutoff Point(single-payer perspective) Zhang et al ADA 2004
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.
Criteria for Diabetes and Pre-Diabetes Cutpoint lowered to >=100 2-hour glucose Fasting glucose
Number 100 110 126 Glucose level (mg/dl) Fasting Glucose Distribution
Pre-Diabetes in the US population 40–74 years of Age by Old and New Criteria, 2000 OLD NEW IFG IGT & IGT IFG IFG IFG & IGT IGT 13 M (4 M) 15 M 35 M (5 M) 16 M Total = 41 million Total = 20 million Benjamin et al., CDC unpublished; CDC National Diabetes Fact Sheet.
Detection Issues • Sensitivity, specificity trade-offs • Program goals • Use of resources • Targeted population • New IFG criteria* (adding 100-110 mg/dl) • Benefit unknown/small • 89% w 100-109 have other indication for LS • “False positive” and label side-effect Schriger and Lorber Diabetes Care 2004; 27: 598.
Burden of Diabetes TIME Today Tomorrow
Knowing it not enough; we must apply.Willing is not enough; we must do. - Goethe