Lifetime Benefits and Costs of DCCT Intensive Therapy DCCT References: Diabetes Care, 1995...
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Transcript of Lifetime Benefits and Costs of DCCT Intensive Therapy DCCT References: Diabetes Care, 1995...
Lifetime Benefits and Costs of DCCT Intensive Therapy
Lifetime Benefits and Costs of DCCT Intensive Therapy
DCCT
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
DCCT
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
DCCT
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
DCCT
Objectives (cont.)
• Assess whether intensive therapy is preferable from the perspective of the health care system
DCCT
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
DCCT
Costs
• 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)
DCCT
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
DCCT
Benefits
• Years free from complications
• Years of life
• Quality of life
• Quality-adjusted life years (QALYs)
DCCT
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?
DCCT
Increased Use of Primary Diabetes Care
Physician Time Nurse/Educator TimeDietician TimeBehavioral Scientist TimeSelf Blood Glucose MonitoringInsulin InjectionsLaboratory TestsTelephone Follow-up
DCCT
The Treatment Team & Outpatient Visits
Annual minutes per patient
Doctor Nurse Ed Dietician Behav Sci0
100
200
300
400
500
600
700 IntensiveConventional
DCCT
The Costs of Annual Therapy
Dollars
CSII MDI Conventional0
2000
4000
6000
8000
DCCT
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?
DCCT
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
DCCT
Costs Effects
Methods
Determine the costs associated withdiabetes treatment
Model the long-term impact ofdiabetes treatment
DCCT
Monte CarloSimulationModel
cohort
microvasculardisease model
mortalitymodel
End of Simulation DCCT
Monte CarloSimulationModel
cohort
mortalitymodel
End of Simulation
microvasculardisease model
selectpatient
DCCT
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
DCCT
Monte CarloSimulationModel
cohort
microvasculardisease model
mortalitymodel
End of Simulation
advancedisease
DCCT
Microvascular Disease Model
retinopathy model model model
nephropathy neuropathy
DCCT
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 ...
DCCT
Transitions between Disease Stages
Diabetic Nephropathy
ESRD
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
DCCT
Diabetic Nephropathy
ESRD
Normal
micro-albuminuria
nephropathy
0.05
0.95
0.06 conventional0.02 intensive
.94
.98
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)
Health states include ...
DCCT
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)
Health states include ...
DCCT
Monte CarloSimulationModel
cohort
microvasculardisease model
mortalitymodel
End of Simulation
determinemortalitystatus
DCCT
Mortality Model• Risk dependent upon age and severity of
nephropathy
• normal albumin:
1.2x US age-specific mortality
• microalbuminuria:
1.4x US age-specific mortality
• Clinical nephropathy (albuminuria):
1.7x US age-specific mortality
DCCT
Cumulative Incidence of ComplicationsAt Age 70
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
DCCT
Cumulative Incidence of Proliferative Retinopathy by Treatment Group
Age
Per
cent
19 29 39 49 59 69 79 89 99
0
20
40
60
80
100
ConventionalConventional
IntensiveIntensive
Cumulative Incidence of Clinical Nephropathy (Albuminuria) by Treatment Group
Cumulative Incidence of Clinical Nephropathy (Albuminuria) by Treatment Group
0
20
40
60
80
100
19 29 39 49 59 69
Age (years)Age (years)
Per
cent
Per
cent
IntensiveIntensive
ConventionalConventional
DCCT
Life-Expectancy by Treatment Group
12 22 32 42 52 62 72 82 92 1000
20
40
60
80
100
Percentsurviving
Age (years)DCCT
ConventionalConventional
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
DCCT
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:
DCCT
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
DCCT
Cost of End-Stage ComplicationsCost of End-Stage Complications
• ESRD - $46,207 per year
• Blindness - $1,911 per year
• Lower Extremity Amputation - $31,225
DCCT
Type of Health Care Costs by Treatment Group
Intensive Conventional
Treatment Side Effects Complications
DCCT
Treatment Duration
U.S
. D
oll
ars
0
50000
100000
150000
200000
250000
$300000
1 5 10 15 20 25 30 35 40 45 50
Conventional
Intensive
DCCT
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
DCCT
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:
DCCT
• 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
DCCT
Sensitivity Analysis
• Incidence of Complications
• Annual Cost of Therapy
• Discount Rate
• Health State Utilities
• Compliance to Intensive Therapy
• Mortality rate
DCCT
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
DCCT
Remaining IssuesRemaining Issues
• Health Policy Decisions
• Generalizability of the Models
• Availability to Treatment
• Extensions to Patients with NIDDM
DCCT
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
DCCT
Costs of Complications ofType 1 Diabetes
laser therapy $948 / episode
ACE inhibitor $725 / yr
blindness $1,911 / yr
renal failure $46,207 / yr
amputation $31,225 / episode
DCCT
Discounting
• Even in a world of zero inflation, there are advantages to receiving benefits earlier and incurring costs later.
• Discounting adjusts future costs and benefits to current value.
DCCT
Cost Saving Health Care Interventions(Cost < 0$ 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
DCCT
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
DCCT
Intensive therapy represents good value for money
Intensive therapy represents good value for money
DCCT
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
DCCT