Lifetime Benefits and Costs of DCCT

Intensive Therapy

References:
Diabetes Care, 1995 18:1468-78.
JAMA, 1996 276: 1409-15.
DCCT

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 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 death

DCCT

What are the Costs of

DCCT Therapy?

DCCT

Increased Use of Primary Diabetes Care

Physician Time
Nurse/Educator Time
Dietician Time
Behavioral Scientist Time
Self Blood Glucose Monitoring
Insulin Injections
Laboratory Tests
Telephone Follow-up
DCCT

The Treatment Team & Outpatient Visits

Annual minutes
per patient
Intensive
Conventional

700
600
500
400
300
200
100
0

Doctor

Nurse Ed

Dietician

Behav Sci

DCCT

The Costs of Annual Therapy

Dollars
8000
6000
4000
2000
0

CSII

MDI

Conventional
DCCT

Costs Used In Simulation Model

Conventional Intensive
Initiation of therapy
Annual Therapy

--

2848

1666/y

4545/y

Photocoagulation

948

Renal evaluation

1080

Neurologic evaluation

124

ACE Inhibition therapy

725/y

Blindness

1911/y

End-stage renal disease

Lower extremity
amputation
Added years of life

46,207/y
31,225
1855

DCCT

Research Question
Given that intensive therapy uses
more resources than conventional
therapy, is intensive therapy costeffective?

DCCT

Costs and Effects of Intensive Therapy

Costs

Effects

Increased use of primary

diabetes care

Lower incidence of
microvascular complications

Increased hypoglycemia

Health care savings when

complications are delayed
or prevented

Increased weight gain

DCCT

Methods
Determine the costs associated with
diabetes treatment
Model the long-term impact of
diabetes treatment
DCCT

Monte Carlo
Simulation
Model

cohort

microvascular
disease model

mortality
model
End of Simulation

DCCT

Monte Carlo
Simulation
Model

cohort

select
patient

microvascular
disease model

mortality
model
End of Simulation

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 population
37% of these Primary patients
73% Secondary
DCCT

Monte Carlo
Simulation
Model

cohort

microvascular advance
disease model disease

mortality
model
End of Simulation

DCCT

Microvascular Disease Model

retinopath
y model

nephropathy
mode
l

neuropath
y mode
l

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 data

DCCT

Nephropathy Model
Health states include ...
Urinary albumin excretion rates less
than or equal to 40 mg/24 hours
microalbuminuria
clinical nephropathy (albuminuria)
End Stage Renal Disease (ESRD)
DCCT

Transitions between Disease Stages

Diabetic Nephropathy
Epidemiologic
data

Normal
microalbuminuria

DCCT
data

clinical
nephropathy
ESRD

Nephropathy Transition Probabilities

Conventional

Intensive

= 1.512
= 0.014

= 1.123
= 0.018

= 1.260
= 0.036

= 1.093
= 0.030

Nephropathy
Primary

0.06/y

0.02/y

Secondary

0.03/y

0.03/y

0.05/y

0.05/y

Microabluminuria
Primary
Secondary

ESRD

DCCT

Diabetic Nephropathy
.94
.98

0.06 conventional
0.02 intensive

Normal
0.95

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

clinical
nephropathy

0.05

ESRD

Retinopathy Model
Health states include ...

no retinopathy
background retinopathy
proliferative retinopathy (PDR) with HRC
clinically significant macular edema (CSME)
visual acuity worse than 20/200 (better eye)
DCCT

Retinopathy Transition Probabilities

Conventional

Intensive

Background
Retinopathy (PDR)

= 2.486
= 0.008

= 1.487
= 0.018

Proliferative
Retinopathy

= 1.898
= 0.004

= 1.165
= 0.007

0.03/y

0.02/y

0.01/y

0.01/y

0.03/y

0.03/y

Macular Edema
(CSME)
Blindness
From PDR
From CSME

DCCT

Neuropathy Model
Health states include ...
No neuropathy
Clinically significant neuropathy
Lower extremity amputation (LEA)

DCCT

Monte Carlo
Simulation
Model

cohort

microvascular
disease model

mortality
model
DCCT

End of Simulation

determine
mortality
status

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 Complications

At Age 70
Proliferative Retinopathy
Macular Edema
Blindness
Microalbuminuria
Albuminuria
End-stage renal disease
Neuropathy
Lower extremity amputation

Conventional
70
56
34
86
46
24
57
7

Intensive
30
35
20
64
15
7
31
4
DCCT

Cumulative Incidence of Proliferative

Retinopathy by Treatment Group
100

Percent

80
60

Conventional

40
20

Intensive

0
19

29

39

49

59
Age

69

79

89

99

Cumulative Incidence of Clinical Nephropathy

(Albuminuria) by Treatment Group
100

Percent

80

Conventional

60
40

Intensive

20
0

19

29

39

49

Age (years)

59

69

DCCT

Life-Expectancy by Treatment Group

Percent
surviving
100
80
Intensive

60
40
Conventional

20
0
12

22

32

42

52

62

72

82

92

100

Age (years)
DCCT

Average Number of Years Living Without ...

Conventional
Proliferative Retin.
Macular Edema
Visual Acuity Loss
Overt Nephrop.
ESRD
LE Amputation
1st major comp.

39.1
44.7
49.1
49.7
55.6
55.2
37.0

Intensive Difference
53.9
52.9
56.8
59.5
61.3
60.9
52.2

14.8
8.2
7.7
9.8
5.8
5.7
15.2
DCCT

Benefit Implications of DCCT

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

Annual Cost of Therapy

Conventional
- $1,666 per year
- includes side effects

Intensive
- $4,545 per year
- includes MDI/CSII patients and
side effects
DCCT

Cost 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

DCCT
Treatment

Side Effects

Complications

Cumulative Actual Cost of Conventional vs.

Intensive Therapy by Treatment Duration
Not Discounted
$300000

Conventional

U.S.
Dollars

250000
200000
150000

Intensive

100000
50000
0
1

10

15

20

25

30

35

Treatment Duration

40

45

50

DCCT

Discounted Average Lifetime Costs

Annual costs of therapy + costs of complications

$66,076

Conventional

$99,822

Intensive

$0

$20,000

$40,000 $60,000

U.S. Dollars

$80,000 $100,000

DCCT

Cost Implications of DCCT

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

Intensive therapy will cost about $4 billion

more than standard therapy over a lifetime

DCCT

Mortality Cost-Benefit of Intensive Therapy

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.
DCCT

Sensitivity Analysis

Incidence of Complications
Annual Cost of Therapy
Discount Rate
Health State Utilities
Compliance to Intensive Therapy
Mortality rate
DCCT

Sensitivity Analysis
Assumption

Cost per life

year 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 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 Conventional
Inpatient
Outpatient
Case-management
Self-care
Side-effects of therapy

TOTAL

127
1,243
548
1,866
210

155
1,244
554
3,621
210

58
513
116
909
70

$4,014 $5,784

$1,666
DCCT

Costs of Complications of
Type 1 Diabetes
laser therapy
ACE inhibitor
blindness
renal failure
amputation

$948 / episode
$725 / yr
$1,911 / yr
$46,207 / yr
$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
prenatal care
-blockers following MI
anti hypertensive rx
cronary bypass surgery
DCCT Intensive therapy
hormone replacement
renal dialysis
cholesterol lowering therapy

n
12
4
6
8
1
13
20
19

median cost / life-year

<$0
$2,000
$15,000
$26,000
$28,661
$42,000
$46,000
$154,000
DCCT

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