Lifetime Benefits and Costs of DCCT Intensive Therapy DCCT References: Diabetes Care, 1995...

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Lifetime Benefits and Costs of DCCT Intensive Therapy

References:

Diabetes Care, 1995 18:1468-78.

JAMA, 1996 276: 1409-15.

References:

Diabetes Care, 1995 18:1468-78.

JAMA, 1996 276: 1409-15.

The DCCT Study Group

Study Chair: Oscar Crofford

The DCCT Coordinating Center (GWU BSC): John Lachin, Patricia Cleary, and many others

The NIDDK, NIH: Richard Eastman, Carolyn Siebert

29 Clinical Centers in the US and Canada

7 Central Laboratories, Reading Units

The DCCT Economic Evaluation Study Group

Study Chair: Oscar Crofford

The DCCT Coordinating Center (GWU BSC): John Lachin, Patricia Cleary, Desmond Thompson

The NIDDK, NIH: Richard Eastman, Carolyn Siebert

The CDC, Collaborators William Herman, Erik Dasbach, Jonathon Javitt, Thomas Songer

Objectives

• Assess the benefits over a lifetime of intensive versus conventional therapy

complications and mortality

years and quality adjusted years saved

• Assess the costs of therapy and the costs of treatment of complications and adverse effects

Objectives (cont.)

• Assess whether intensive therapy is preferable from the perspective of the health care system

Costs• the annual cost of treatment

- intensive treatment

- conventional treatment

• the annual cost of treating side effects (e.g. hypoglycemia)

• the annual cost of treating diabetic complications

• Health care system perspective only

Direct medical costs only (not indirect)

• 1994 USD

• Discounted at 3%/year for the costs of:therapy complications (benefits)adverse effects (hypoglycemia)

Approaches to Identifying Direct CostsApproaches to Identifying Direct Costs

• Hospital– gather billing records from acct. dept.

• Physician Services– salary information or prevailing fees

• Laboratory Tests– identify govt. reimbursement fees

• Drugs, Supplies– identify wholesale costs

Benefits

• Years free from complications

• Years of life

• Quality of life

• Quality-adjusted life years (QALYs)

Quality-Adjusted Life Years (QALYs)

Reduce the value of a year of life associated with concurrent illness

1.0 When free of major illness

0.69 for blindness

0.61 for End Stage Renal Disease (ESRD)

0.80 for lower extremity amputation (LEA)

0.0 for deathDCCT

What are the Costs of DCCT Therapy?

Increased Use of Primary Diabetes Care

Physician Time Nurse/Educator TimeDietician TimeBehavioral Scientist TimeSelf Blood Glucose MonitoringInsulin InjectionsLaboratory TestsTelephone Follow-up

The Treatment Team & Outpatient Visits

Annual minutes per patient

Doctor Nurse Ed Dietician Behav Sci0

700 IntensiveConventional

The Costs of Annual Therapy

Dollars

CSII MDI Conventional0

Costs Used In Simulation ModelCosts Used In Simulation ModelConventional Intensive

Initiation of therapy -- 2848

Annual Therapy 1666/y 4545/y

Photocoagulation 948

Renal evaluation 1080

Neurologic evaluation 124

ACE Inhibition therapy 725/y

Blindness 1911/y

End-stage renal disease 46,207/y

Lower extremityamputation

31,225

Added years of life 1855DCCT

Research Question

Given that intensive therapy uses more resources than conventional therapy, is intensive therapy cost-effective?

Costs and Effects of Intensive Therapy

Increased use of primarydiabetes care

Increased hypoglycemia

Increased weight gain

Lower incidence ofmicrovascular complications

Health care savings whencomplications are delayedor prevented

Costs Effects

Methods

Determine the costs associated withdiabetes treatment

Model the long-term impact ofdiabetes treatment

Monte CarloSimulationModel

cohort

microvasculardisease model

mortalitymodel

End of Simulation DCCT

cohort

mortalitymodel

End of Simulation

selectpatient

Cohort of Patients in the Model

• 120,000 individuals with IDDM in the USA who have clinical and demographic characteristics which meet the eligibility criteria for enrollment in the DCCT

• 17% of the US IDDM population37% of these Primary patients

73% Secondary

cohort

mortalitymodel

End of Simulation

advancedisease

Microvascular Disease Model

retinopathy model model model

nephropathy neuropathy

Assessment of Disease Status

Dependent upon.…• Type of Treatment• Previous stage of disease• Duration of IDDM

Early Stages: DCCT based Weibull hazard rates

Advanced Stages:

Clinical trial & epidemiologic dataDCCT

Nephropathy Model

• Urinary albumin excretion rates less than or equal to 40 mg/24 hours

• microalbuminuria

• clinical nephropathy (albuminuria)

• End Stage Renal Disease (ESRD)

Health states include ...

Transitions between Disease Stages

Diabetic Nephropathy

Normal

micro-albuminuria

clinicalnephropathy

DCCTdata

Epidemiologicdata

Nephropathy Transition ProbabilitiesNephropathy Transition Probabilities

Conventional IntensiveMicroabluminuria

Primary = 1.512 = 0.014

= 1.123 = 0.018

Secondary = 1.260 = 0.036

= 1.093 = 0.030

NephropathyPrimary 0.06/y 0.02/y

Secondary 0.03/y 0.03/y

ESRD 0.05/y 0.05/y

Diabetic Nephropathy

Normal

micro-albuminuria

nephropathy

0.06 conventional0.02 intensive

Primary: =1.5, =0.014 conv. =1.1, =0.018 int.

clinical

Retinopathy Model

• no retinopathy

• background retinopathy

• proliferative retinopathy (PDR) with HRC

• clinically significant macular edema (CSME)

• visual acuity worse than 20/200 (better eye)

Retinopathy Transition ProbabilitiesRetinopathy Transition Probabilities

Conventional Intensive

BackgroundRetinopathy (PDR)

= 2.486 = 0.008

= 1.487 = 0.018

ProliferativeRetinopathy

= 1.898 = 0.004

= 1.165 = 0.007

Macular Edema(CSME)

0.03/y 0.02/y

BlindnessFrom PDR 0.01/y 0.01/y

From CSME 0.03/y 0.03/yDCCT

Neuropathy Model

• No neuropathy

• Clinically significant neuropathy

• Lower extremity amputation (LEA)

cohort

mortalitymodel

End of Simulation

determinemortalitystatus

Mortality Model• Risk dependent upon age and severity of

nephropathy

• normal albumin:

1.2x US age-specific mortality

• microalbuminuria:

• Clinical nephropathy (albuminuria):

Cumulative Incidence of ComplicationsAt Age 70

Conventional IntensiveProliferative Retinopathy 70 30Macular Edema 56 35Blindness 34 20Microalbuminuria 86 64Albuminuria 46 15End-stage renal disease 24 7Neuropathy 57 31Lower extremity amputation 7 4

Cumulative Incidence of Proliferative Retinopathy by Treatment Group

19 29 39 49 59 69 79 89 99

ConventionalConventional

IntensiveIntensive

Cumulative Incidence of Clinical Nephropathy (Albuminuria) by Treatment Group

19 29 39 49 59 69

Age (years)Age (years)

IntensiveIntensive

Life-Expectancy by Treatment Group

12 22 32 42 52 62 72 82 92 1000

Percentsurviving

Age (years)DCCT

IntensiveIntensive

Average Number of Years Living Without ...Average Number of Years Living Without ...

Conventional Intensive Difference

Proliferative Retin. 39.1 53.9 14.8

Macular Edema 44.7 52.9 8.2

Visual Acuity Loss 49.1 56.8 7.7

Overt Nephrop. 49.7 59.5 9.8

ESRD 55.6 61.3 5.8

LE Amputation 55.2 60.9 5.7

1st major comp. 37.0 52.2 15.2

Benefit Implications of DCCT

Intensive therapy will provide

– 920,000 more years free from blindness

– 691,000 more years free from ESRD

– 678,000 more years free from LE Amputation

– 611,000 additional years of life

For the 120,000 persons in the United States who meet the DCCT eligibility criteria:

Annual Cost of TherapyAnnual Cost of Therapy

• Conventional

• Intensive

- $1,666 per year

- includes side effects

- $4,545 per year

- includes MDI/CSII patients andside effects

Cost of End-Stage ComplicationsCost of End-Stage Complications

• ESRD - $46,207 per year

• Blindness - $1,911 per year

• Lower Extremity Amputation - $31,225

Type of Health Care Costs by Treatment Group

Intensive Conventional

Treatment Side Effects Complications

Treatment Duration

100000

150000

200000

250000

$300000

1 5 10 15 20 25 30 35 40 45 50

Conventional

Intensive

Cumulative Actual Cost of Conventional vs. Intensive Therapy by Treatment Duration

Not Discounted

Discounted Average Lifetime Costs

$99,822

$66,076

$0 $20,000 $40,000 $60,000 $80,000 $100,000

Intensive

Conventional

U.S. Dollars

Annual costs of therapy + costs of complications

Cost Implications of DCCT

Intensive therapy will cost about $4 billion more than standard therapy over a lifetime

For the 120,000 persons in the United States who meet the DCCT eligibility criteria:

• Intensive therapy yields 5.1 additional years of life at a cost of $28,661 per year of life gained.

• Intensive therapy markedly improves the quality of life at a cost of $19,987 per quality adjusted life year gained.

Mortality Cost-Benefit of Intensive Therapy

Sensitivity Analysis

• Incidence of Complications

• Annual Cost of Therapy

• Discount Rate

• Health State Utilities

• Compliance to Intensive Therapy

• Mortality rate

Sensitivity AnalysisSensitivity Analysis

AssumptionAssumption Cost per lifeyear gainedCost per lifeyear gained

Best Estimate $28,661

Incidence of microalbuminuria $79,883

50% lower in conventional group

5% Discount Rate $50,925

Intensive Treatment Cost 50% Lower Cost savings

Mortality hazard (50%) higher $30,973

Remaining IssuesRemaining Issues

• Health Policy Decisions

• Generalizability of the Models

• Availability to Treatment

• Extensions to Patients with NIDDM

Costs of Therapy in the DCCT

Annual Therapy

MDI CSII ConventionalInpatient 127 155 58

Outpatient 1,243 1,244 513

Case-management 548 554 116

Self-care 1,866 3,621 909

Side-effects of therapy 210 210 70

TOTAL $4,014 $5,784 $1,666

Costs of Complications ofType 1 Diabetes

laser therapy $948 / episode

ACE inhibitor $725 / yr

blindness $1,911 / yr

renal failure $46,207 / yr

amputation $31,225 / episode

Discounting

• Even in a world of zero inflation, there are advantages to receiving benefits earlier and incurring costs later.

• Discounting adjusts future costs and benefits to current value.

Cost Saving Health Care Interventions(Cost < 0$ per life-year saved)

• prenatal care• PKU screening in newborns• thyroid screening in newborns• childhood immunizations• heparin and stockings to prevent venous

thrombosis• smoking cessation advice

Cost per Life-year Saved Estimates for Health Care Interventions ($1993)

Intervention n median cost / life-yearprenatal care 12 <$0-blockers following MI 4 $2,000anti hypertensive rx 6 $15,000cronary bypass surgery 8 $26,000DCCT Intensive therapy 1 $28,661hormone replacement 13 $42,000renal dialysis 20 $46,000cholesterol lowering therapy 19 $154,000

Intensive therapy represents good value for money

Impact of The DCCT and UKPDS

• UKPDS (1998) shows equivalent benefits in type II diabetes (NIDDM)

• Intensive therapy is not universally accepted by the health care system

• Intensive therapy is not available to the majority of patients with diabetes mellitus, either type I or II

Lifetime Benefits and Costs of DCCT Intensive Therapy DCCT References: Diabetes Care, 1995...

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