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Publications and Products
The Economics of Diabetes Mellitus:
An Annotated Bibliography
TYPES
OF INTERVENTION
Tertiary
Intervention
Renal
Care
92
TITLE:
Cost Analysis of Kidney-Pancreas and Kidney-Islet Transplant. Lenisa,
L.; Castoldi, R.; Socci, C.; Motta, F.; Ferrari, G.; Pozza, G.; Di Carlo,
V. Transplantation Proceedings. 27(6): 3061-3064. December 1995.
OBJECTIVE:
To compare outcomes and costs for patients with diabetes undergoing kidney-pancreas
or kidney-islet cell transplantation.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Costs for kidney-pancreas and kidney-islet cell transplantation were nearly
the same. Pancreas grafts had better actuarial survival than islet cell
grafts.
RECOMMENDATION:
Improvements are needed in isolation and purification techniques for islet
cell transplantation, which might lower costs for that approach.
ABSTRACT:
The authors report the costs for 51 kidney-pancreas transplants and 21
kidney-islet cell transplants in patients with type 1 diabetes transplanted
at an Italian hospital since 1989. Among kidney-islet cell patients, 14
received islet cells after kidney transplantation and 7 received islet
cells simultaneously with the kidney. All 72 patients received the same
immunosuppression and antimicrobial and vascular thrombosis prophylaxis.
Actuarial survival was calculated from life tables. Expenditures were
the actual costs incurred for hospitalization from pretransplant evaluation
until discharge; kidney-islet cell costs were calculated based on using
islets from two pancreases per kidney-islet cell transplant and assuming
simultaneous transplantation of islet cells. Actuarial survival at 48
months was 70 and 52 percent for pancreas and islet cell grafts, respectively.
Peri-operative mortality, morbidity, and incidence of surgical complications
were 1.9 and 5 percent, 54 and 29 percent, and 43 and 4.8 percent for
kidney-pancreas and kidney-islet cell, respectively. Total transplantation
costs were comparable ($46,085 for kidney-pancreas and $47,550 for kidney-islet
cell). Graft retrieval cost $1,400 for kidney-pancreas versus $2,260 for
kidney-islet cell; islet cell isolation cost $15,500. Costs for surgery,
hospitalization, and immunosuppression were higher for kidney-pancreas
than for kidney-islet cell ($5,440 versus $2,580, $30,765 versus $20,790,
and $5,640 versus $3,760, respectively). Patients stayed in intensive
care a mean of 7 days for kidney-pancreas versus 3 days for kidney-islet
cell transplantation and in the medical department a mean of 60 versus
50 days, respectively. Hospitalization represented 67 percent of kidney-pancreas
and 44 percent of kidney-islet cell costs; islet cell isolation represented
32 percent of kidney-islet cell costs. The mean length of hospital stay
(the major cost for both groups) is likely to be lowered. Improvements
in islet cell isolation might decrease costs for kidney-islet cell transplantation.
2 figures, 2 tables, 6 references.
93
TITLE:
The Cost of Immunosuppression and Coverage of Immunosuppressive Drugs
for Kidney Transplant Recipients Under the Medicare Catastrophic Coverage
Act. In: Cost and Outcome Analysis of Kidney Transplantation: The Implications
of Initial Immunosuppressive Protocol and Diabetes (Final Report: Volume
I). Evans, R.W.; Manninen, D.L.; Thompson, C. Battelle Human Affairs
Research Centers, Seattle, Washington. 1989. Chapter 13.
OBJECTIVE:
To provide the Health Care Financing Administration with information it
needs to quantify the economic consequences of the Medicare Catastrophic
Coverage Act of 1988.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
There are likely to be relatively few changes in transplant immunosuppression
between 1988 and 1995 that will seriously affect the overall costs of
organ transplantation.
RECOMMENDATION:
None.
ABSTRACT:
The Medicare Catastrophic Coverage Act of 1988 will shield Medicare beneficiaries
from excessive hospital, doctor, and outpatient prescription drug bills.
In this chapter, the authors project the number of kidney transplant recipients
likely to be eligible for Medicare catastrophic coverage through 1995,
estimate per-patient annual expenditures for immunosuppressive drugs during
the year of transplant and subsequent years, and highlight future developments
in the field of transplant immunosuppression. In 1987, there were 39,585
living kidney transplant recipients; for 1995 the authors project totals
ranging from 63,910 (base case) to 144,653. The authors note that cyclosporine
was approved by the Food and Drug Administration in 1983; for 1990 through
1995 they project that 95 percent of transplants (cadaver or living related
donor) will use this drug as a primary immunosuppressive agent. They present
cost estimates associated with major immunosuppressive protocols in use
in the United States; per the "high" estimate, total first-year
costs range from $947 for conventional immunosuppression without antithymocyte
globulin to $12,819 for quadruple-drug cyclosporine therapy. Subsequent-year
annual costs range from $793 for conventional immunosuppression to $8,227
for triple-drug cyclosporine therapy (U.S. variation); this cost is $6,870
for quadruple-drug cyclosporine therapy. Per the National Task Force on
Organ Transplantation (1985), the cost-effectiveness of cyclosporine therapy
is believed to exceed that of conventional therapy, but the Task Force
assumed that patients on cyclosporine would be converted to conventional
therapy within 1 year after transplant. The authors state that triple-drug
and quadruple-drug cyclosporine therapy appear to be equally cost effective.
56 tables, 5 figures.
94
TITLE:
Cost-Effective Treatment for Diabetic End-Stage Renal Disease: Dialysis,
Kidney, or Kidney-Pancreas Transplantation? Lenisa, L.; Castoldi, R.;
Socci, C.; Motta, F.; Ferrari, G.; Spotti, D.; Caldara, R.; Secchi, A.;
Pozza, G.; Di Carlo, V. Transplantation Proceedings. 27(6): 3108-3113.
December 1995.
OBJECTIVE:
To compare the survival, morbidity, and cost of hemodialysis, kidney transplantation,
and kidney-pancreas transplantation in patients with end-stage renal disease
associated with type 1 diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
In terms of survival rate and financial savings, kidney-pancreas transplantation
is the most cost effective of the three treatments.
RECOMMENDATION:
None.
ABSTRACT:
The authors report survival, morbidity, and cost data for 122 patients
with type 1 diabetes treated at San Raffaele Hospital in Milan, Italy.
All patients had undergone hemodialysis (HD); in this study, 48 remained
on HD, 23 underwent kidney transplantation (K), and 51 had a kidney-pancreas
transplant (KP). Survival rates were calculated by life-table methods
from the beginning of HD for all patients and from the third month after
transplantation for K and KP. To correct for selection bias, survival
curves were also calculated from the day of transplantation for the K
and KP groups and from 25 months after initiation of HD for the HD group
(25 months was the mean duration of dialysis at transplantation for the
transplant groups). Expenditures were the actual costs (undiscounted)
incurred for hospitalization from pretransplant evaluation until discharge
and for consumable materials, depreciation of machinery and buildings,
and personnel costs. Actuarial survival 96 months from initial HD for
HD, K, and KP was 40 percent, 70 percent, and 87 percent, respectively
(p < .001 for K and KP compared with HD); 84-month survival
from date of transplantation or from 25 months after HD initiation (for
the HD group) was 36 percent, 65 percent, and 96 percent, respectively
(p < .001 for K and KP compared with HD). In KP, there were
five kidney transplant failures and one pancreas graft failure; in K,
there was one graft failure. Peri-operative mortality was 8.7 percent
in K and 1.9 percent in KP. The first year of HD cost $43,150 for 3 treatments
per week, monthly assessment, and vascular access. Transplantation costs
were $30,090 for K and $46,085 for KP. Surgery, hospitalization, and rejection
treatment costs were higher for KP than K. Estimated costs for each year
after transplantation were $13,070 for K and $10,880 for KP, which were
32 percent and 27 percent of expected yearly HD costs, respectively. 4
figures, 3 tables, 15 references.
95
TITLE:
Cost-Effectiveness Modeling of Simultaneous Pancreas-Kidney Transplantation.
Holohan, T.V. International Journal of Technology Assessment in Health
Care. 12(3): 416-424. Summer 1996.
OBJECTIVE:
To compare simultaneous pancreas-kidney transplantation and kidney transplantation
plus continued insulin therapy in patients with type 1 diabetes using
a cost-effectiveness model.
CATEGORY:
Tertiary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
The model predicted that simultaneous pancreas-kidney transplantation
would be less cost effective than a kidney transplant plus continued insulin
therapy except for patients with complicated diabetes that was poorly
responsive to exogenous insulin and whose costs of maintaining blood glucose
control were high. In that scenario, the two interventions were equal
in cost-effectiveness.
RECOMMENDATION:
These cost-effectiveness analyses should be reviewed periodically as data
on pancreas survival after simultaneous pancreas-kidney transplant accumulate
and as more comprehensive cost information becomes available.
ABSTRACT:
In the authors' cost-effectiveness model, estimated costs for 100 hypothetical
recipients of simultaneous pancreas-kidney transplants were compared with
those for 100 hypothetical recipients of a kidney transplant only. Cost
estimates for transplant procedures and for maintaining blood glucose
control in those without a normally functioning pancreas as well as estimates
of the quality of life resulting from transplant were considered. Costs
were estimated for a 3-year posttransplant period; costs for kidney transplant
alone included ongoing expenses of treating hyperglycemia or hypoglycemia.
The model assumed no renal graft loss in either group; pancreas graft
survival rates were based on United Network for Organ Sharing data. The
costs of combined transplant included managing hyperglycemia or hypoglycemia
in those patients whose pancreas grafts failed over time. Payment data
for the procedures were obtained from the Health Insurance Association
of America, the Health Care Financing Administration, and a survey of
transplant centers. The cost per quality-adjusted life-year of the two
procedures was equivalent only when the annual cost of blood glucose control
was in the range of $28,000 to $40,000. Simultaneous pancreas-kidney transplant
was therefore likely to be equivalent in cost-effectiveness to kidney
transplant plus continued insulin therapy only for those patients whose
annual direct costs of blood glucose maintenance were high, in the range
of $15,000 to more than $40,000 per year. Average annual direct costs
for treating diabetes and its complications have been estimated to be
$6,280 by the American Diabetes Association. 1 figure, 4 tables, 65 references.
96
TITLE:
Cost-Effectiveness of Screening and Early Treatment of Nephropathy in
Patients with Insulin-Dependent Diabetes Mellitus. Siegel, J.E.; Krolewski,
A.S.; Warram, J.H.; Weinstein, M.C. Journal of the American Society
of Nephrology. 3(Suppl 1): S111-S119. October 1992.
OBJECTIVE:
To determine the effect of angiotensin-converting enzyme inhibitors (ACEIs)
on survival and the cost of using these drugs at an early stage of nephropathy;
to determine what kind of intervention program with ACEIs would be appropriate.
CATEGORY:
Tertiary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
Early treatment of type 1 diabetes with ACEIs can be a very cost-effective
use of health care resources.
RECOMMENDATION:
None.
ABSTRACT:
Researchers developed a model to simulate the progression of renal complications
in newly diagnosed type 1 diabetes patients to determine the effectiveness
of using ACEIs as a treatment modality. Three alternative strategies (programs)
were analyzed (versus standard antihypertensive treatment); patients were
screened twice annually for renal complications in each. Overt proteinuria,
significant microalbuminuria, and microalbuminuria were treatment indicators
for ACEIs in programs 1, 2, and 3, respectively. The progression of nephropathy
and medical care costs incurred with the new programs were compared with
those for standard treatment. Cost-effectiveness was considered the ratio
of the net increase in health care costs (discounted by 5 percent per
year) to the discounted net improvement in health outcome (life expectancy).
With standard treatment, a cohort of 15-year-old patients with type 1
diabetes had a median life expectancy of 44.9 years (undiscounted) and
lifetime costs for treatment of $4,706 per person (discounted). Program
1 was used as the baseline to calculate cost-effectiveness ratios because
it had lower costs and it improved life expectancy more than standard
treatment. Program 1 lifetime costs were $4,643 per person (discounted)
and additional life expectancy was 45.1 years (undiscounted), assuming
a starting age of 15 years. Values for program 2 were $5,542 and 45.3
years; program 3, $5,927 and 45.5 years. Program 2 offers additional life
savings at an additional cost; however, it is not a cost-effective option;
the substantial increase in screening and treatment costs from this program
is not offset by a sufficient increase in life expectancy. Program 3 had
the highest initial costs but avoided twice as many cases of renal failure
as program 1; it provided an additional 5 to 8 months of life expectancy
(not discounted) and its incremental cost-effectiveness ratio was $7,900
to $16,500 per additional year of life saved. Resources permitting, program
3 would be the preferred choice. 1 figure, 6 tables, 23 references.
97
TITLE:
The Costs of Nephropathy in Type II Diabetes. Borch-Johnsen, B. PharmacoEconomics.
8(Supplement 1):40-45. 1995.
OBJECTIVE:
To discuss the problem of nephropathy in patients with diabetes, including
the social cost of this disorder and the economics of prevention.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Review of studies.
Perspective: Societal.
CONCLUSION:
Screening, intervention, and treatment for nephropathy is cost effective
in type 1 diabetes patients; more research on this issue is needed for
type 2 diabetes.
RECOMMENDATION:
Future controlled clinical trials on the benefits of screening for diabetic
nephropathy should focus on type 2 diabetes patients.
ABSTRACT:
The lifetime risk of diabetic nephropathy may be as low as 15 to 25 percent
in type 1 diabetes patients. Studies of the natural history of nephropathy
in patients with type 2 diabetes are difficult to perform, but research
in selected high-risk populations has found incidence patterns to be similar
for types 1 and 2 diabetes. Patients with diabetic nephropathy have an
increased risk (versus other patients with diabetes) of developing other
late diabetic complications (e.g., they have a relative risk of 5-10 for
acute myocardial infarction and 2-4 for stroke). Genetic susceptibility
appears to be essential for developing nephropathy. Important risk factors
for nephropathy among type 2 diabetes patients include young age at diagnosis,
familial predisposition, poor metabolic control, hypertension, retinopathy,
and microalbuminuria. The author discusses a model for estimating the
actual costs of diabetic renal disease in a society; epidemiological data,
results of controlled clinical trials, and reliable cost data are needed
for the model. Studies of type 1 diabetes patients show the costs of treating
end-stage renal failure to be so high that, even for rather expensive
screening, intervention, and treatment programs, the benefits exceed the
costs; a separate analysis would be needed for type 2 diabetes patients.
In white populations in western Europe and North America, most type 2
diabetes patients will die from vascular disease. In nonwhite populations,
the incidence of type 2 diabetes in patients below age 50 is much higher
than in whites, and these patients will live long enough to develop diabetic
nephropathy. Intervention trials targeted at preventing end-stage renal
failure in type 2 diabetes patients are urgently needed; studies in Asia,
the Pacific Islands, and Latin America (high-risk areas for early-onset
type 2 diabetes) should be encouraged. 1 figure, 4 tables, 21 references.
98
TITLE:
Economic Analysis of Captopril in the Treatment of Diabetic Nephropathy.
Rodby, R.A.; Firth, L.M.; Lewis, E.J.; the Collaborative Study Group.
Diabetes Care. 19(10): 1051-1061. October 1996.
OBJECTIVE:
To determine the long-term impact on health care costs of using captopril
therapy in patients with diabetic nephropathy to delay the progression
to end-stage renal disease (ESRD) or death.
CATEGORY:
Tertiary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-benefit analysis.
Perspective: Societal.
CONCLUSION:
The analysis showed that captopril therapy in patients with type 1 or
type 2 diabetes and overt nephropathy saves substantial direct costs and
reduces health care expenditures for treatment of ESRD.
RECOMMENDATION:
None.
ABSTRACT:
The authors assessed the long-term impact on health care costs of treating
patients with diabetic nephropathy with captopril, an antihypertensive
drug. A medical treatment model was developed to compare the costs and
benefits of captopril therapy in delaying the progression to ESRD or death.
The model was based on data derived from a prospective, double-blind,
multicenter clinical trial of captopril in patients with type 1 diabetes
and nephropathy. In that model, captopril therapy reduced the risk of
both progressive renal insufficiency and the combined endpoint of death,
dialysis, and transplantation by about 50 percent. Data for patients with
type 2 diabetes were projected from the type 1 study. The model assessed
the economic impact of captopril therapy over the projected lifespans
of patients in the study (31 years for patients with type 1 diabetes and
12 years for patients with type 2). Projected costs for ESRD included
direct costs associated with treatment (dialysis and transplantation),
including transportation, and indirect costs related to disability and
premature death. Direct and indirect costs were stated in 1994 dollars;
both costs and life-years saved were discounted at 5 percent. Direct lifetime
cost savings associated with captopril use were $32,550 per patient for
those with type 1 diabetes and $9,900 per patient for those with type
2. Indirect per-patient cost savings were $84,390 and $45,730 for those
with type 1 and type 2 respectively. These savings included future monies
not spent on ESRD treatment because of death of some patients from other
causes, such as cardiovascular disease. According to the model, if captopril
therapy were initiated in 1995 for patients with either type of diabetes
and nephropathy, the aggregate health care costs savings would be $189
million a year for the year 1999 and $475 million a year in 2004; the
present value of cumulative health care cost savings over 10 years would
be $2.4 billion. 4 figures, 2 tables, 2 appendixes, 66 references.
99
TITLE:
Economic Evaluation of the Contribution of Captopril in the Treatment
of Diabetic Nephropathy: A Cost-Effectiveness Approach. (Article in French
with an English abstract.) Le Pen, C.; Petitjean, P.; Lévy, P.;
Hannedouche, T. Nephrologie. 17(6): 321-326. 1996.
OBJECTIVE:
To evaluate the cost-benefit ratio of the use of captopril to treat nephropathy
in patients with type 1 diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-benefit analysis.
Perspective: Health care system.
CONCLUSION:
The use of captopril to treat nephropathy in patients with type 1 diabetes
is therapeutically and economically efficacious, especially for patients
who require antihypertensive therapy as well.
RECOMMENDATION:
None.
ABSTRACT:
The authors analyzed the cost benefit of captopril treatment of nephropathy
in patients with type 1 diabetes, using previously published data from
a randomized, double-blind, clinical trial (Lewis. New England Journal
of Medicine 329: 1456-1462. 1993). Patients had been diagnosed at least
7 years previously and had proteinuria greater than 500 mg/24 hours and
blood creatinine less than 221 Fmol/L at entry. Serum creatinine doubled
in 25 of the captopril group (n = 207, 25 mg, 3 times per day for an average
of 883 days) and in 43 of the placebo group (n = 202, average of 824 days;
p < 0.007). The combined death, dialysis, or transplantation events
numbered 23 (8 deaths) in the treatment group and 42 (14 deaths) in the
placebo group (p < 0.006). Costs were calculated based on 1993 French
health care costs and on the Lewis data from which the effects of other
antihypertensive treatment could not be separated nor costs of screening
for admission to the study or follow-up determined. Captopril treatment
cost 1,263,017 French francs (FFr) for the cohort (FFr 6,101.53 per patient);
other antihypertensives cost (in FFr) 543,271 in the captopril group and
649,832 in the placebo group. In the captopril and placebo groups, hospitalizations
cost (in FFr) 630,312.98 and 712,752.14, respectively, and dialysis/transplantation
cost (in FFr) 13,842,500 and 20,912,500, respectively. Overall, the cost
savings in the captopril group was FFr 5,995,983; a savings of 131 life-years
was also realized in the captopril group. If all patients were treated
with captopril for nephropathy, the net cost-benefit would be FFr 475
per patient. These savings actually underestimate cost-benefit since they
do not include, for instance, the hospitalization costs for vascular access
and initiation of dialysis or pretransplant examinations. Further economic
benefits from captopril would be expected from a study of longer duration.
5 tables, 10 references.
100
TITLE:
Employment, Work Disability, and Income Support Program Participation.
In: A Cost and Outcome Analysis of Kidney Transplantation: The Implications
of Initial Immunosuppressive Protocol and Diabetes (Final Report: Volume
I). Evans, R.W.; Manninen, D.L.; Thompson, C. Battelle Human Affairs
Research Centers, Seattle, Washington. 1989. Chapter 8.
OBJECTIVE:
To examine the employment and work disability experience of renal transplant
patients after their transplant surgery.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Survey.
Perspective: Societal.
CONCLUSION:
Kidney transplantation is not very effective in allowing previously disabled
dialysis patients to return to the labor force.
RECOMMENDATION:
None.
ABSTRACT:
In this multicenter observational study (sponsored by the Health Care
Financing Administration) of patients who underwent kidney transplantation,
questionnaires were used to find out about employment status in the year
prior to transplant and at 3, 6, 9, 12, and 15 months after the procedure.
Sample sizes frequently differed by analysis. Just over half (50.7 percent)
of patients reported they were employed either full time or part time
in the year prior to surgery; 3 months after surgery, only 28.7 percent
said they were employed. In an analysis by primary renal diagnosis, less
than half (43.3 percent) of those whose diagnosis was not diabetes and
33.3 percent of those with a diabetes diagnosis were employed full time
before transplant; 23.8 and 20.0 percent, respectively, were employed
full time 3 months later. On the issue of ability to work (not employment
status), rates for the diabetes and nondiabetes groups were as follows:
not able to work for pay, 63.1 percent and 39.1 percent; limited in kind
of work, 83.1 percent and 58.6 percent. Three months posttransplant, 43.5
percent of transplant patients were receiving Social Security retirement
or disability benefits and 17.8 percent were receiving Supplemental Security
Income. More than half (53.8 percent) of patients with a primary renal
diagnosis of diabetes were receiving Social Security retirement or disability
benefits at that time. Although 97.2 percent of transplant patients said
they received assistance (Medicare, State Kidney Program, Medicaid, etc.)
in paying for immunosuppressive drugs, 22.8 percent said they had difficulty
paying for the drugs. Fifteen months following transplantation, 43.1 percent
of patients reported being employed either full or part time, but the
number of patients for whom employment status was known was very small
(n = 51). 27 tables.
101
TITLE:
Hospital Charges. In: Cost and Outcome Analysis of Kidney Transplantation:
The Implications of Initial Immunosuppressive Protocol and Diabetes (Final
Report: Volume I). Evans, R.W.; Manninen, D.L.; Thompson, C. Battelle
Human Affairs Research Centers, Seattle, Washington. 1989. Chapter 12.
OBJECTIVE:
To analyze costs of the initial hospital stay and follow-up periods for
patients undergoing kidney transplantation.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Kidney transplantation is an expensive procedure.
RECOMMENDATION:
None.
ABSTRACT:
In this multicenter observational study of kidney transplantation, which
was sponsored by the Health Care Financing Administration, the authors
analyzed hospital charges rather than costs. The mean charge for the transplant
procedure (the initial hospital stay), including professional fees, was
$41,046 (range: $18,484 to $727,392); length of stay ranged from 6 to
252 days (n = 396). Patients were compared by whether their primary renal
diagnosis was diabetes: Average transplant charges for the nondiabetes
group were $41,587; for the diabetes group, they were $39,718. Estimated
follow-up hospital charges (not including professional fees) in the first
year after transplant were $22,098 for the diabetes group and $12,533
for those without the diabetes diagnosis. Patients with a diabetes diagnosis
averaged more follow-up hospital days than other patients in the first
four posttransplant periods (each 3 months), with the most pronounced
difference in the 6-9-month period (5.8 days versus 1.5 days). For the
24 patients who experienced a graft failure or died between initial hospital
discharge and the 3-month checkpoint, hospital charges for this period
(excluding professional fees) averaged $31,049. In contrast, for the 346
patients with functioning grafts at 3 months, average charges were $3,835.
13 tables.
102
(Cross-Reference
161)
TITLE:
Is Screening and Intervention for Microalbuminuria Worthwhile in Patients
with Insulin Dependent Diabetes? Borch-Johnsen, K.; Wenzel, H.; Viberti,
G.C.; Mogensen, C.E. British Medical Journal. 306(6894): 1722-1725.
June 1993. Correction: 307(6903): 543. August 1993.
OBJECTIVE:
To analyze the cost benefit of screening for microalbuminuria and providing
antihypertensive treatment for early renal disease indicated by microalbuminuria
in patients with type 1 diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-benefit analysis.
Perspective: Health care system.
CONCLUSION:
Assuming drug treatment effects (delay in normal progression of microalbuminuria)
of 33 percent or 67 percent, median life expectancy increased by 4 or
14 years, respectively, and the need for dialysis or transplantation decreased
by 21 percent or 63 percent. Establishing a screening program for microalbuminuria
for patients with type 1 diabetes would be economically neutral at a treatment
effect of 11 percent and a discount rate of 6 percent.
RECOMMENDATION:
A screening program including annual measurement of urinary albumin excretion
rate should be implemented to help increase life expectancy and reduce
end-stage renal failure, and an intervention program of antihypertensive
treatment should also be considered (it is known to be effective in patients
with nephropathy, and its effectiveness for microalbuminuria has been
suggested by clinical studies).
ABSTRACT:
This cost-benefit analysis of the effects of a screening and antihypertensive
intervention program for microalbuminuria used a computer simulation of
a 30-year program involving an imaginary cohort of 8,000 patients with
type 1 diabetes, whose urine was screened annually beginning 5 years after
onset of the disease. Objectives were to estimate mortality, incidence
of nephropathy, and need for kidney transplantation or dialysis as well
as the direct costs and savings associated with preventing or postponing
the development of nephropathy. One scenario described the natural progression
of the cohort and another the progression of the same cohort with screening
and treatment. The economic evaluation was based on direct costs (screening,
antihypertensive treatment in patients with microalbuminuria and nephropathy,
dialysis, kidney transplantation, and immunosuppressive agents in patients
needing transplants). Costs (and savings) were based on 1991 German sickness
fund prices and were given in Deutschmarks (DM). A progression rate of
20 percent was assumed for untreated microalbuminuria. Assuming treatment
effects (decrease in progression rate) of 33 percent or 67 percent, median
life expectancy would increase by 4 or 14 years, respectively; onset of
nephropathy, by 6 or 24 years; and the need for kidney transplantation
or dialysis by 21 percent or 63 percent, respectively. Costs and savings
would balance with a real discount rate of 6 percent a year and an antihypertensive
treatment effect of 11 percent or with a real discount rate of 2.5 percent
and an 8 percent treatment effect. Savings per patient would range from
DM 1,500 (U.S. $800) with a discount rate of 6 percent and a treatment
effect of 33 percent to DM 11,000 for a discount rate of 2.5 percent and
a 67 percent treatment effect. 4 figures, 3 tables, 35 references.
103
TITLE:
Pancreas Transplantation as a Treatment for Diabetes: Indications and
Outcome. Sutherland, D.E. Current Therapy in Endocrinology and Metabolism.
5: 457-460. 1994.
OBJECTIVE:
To review the indications for various pancreas transplantation options
and their outcomes and costs.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Review of studies.
Perspective: Health care system.
CONCLUSION:
It is more expensive to treat diabetes with a pancreas transplant than
with insulin injections, but if secondary complications are ameliorated,
health care costs over a lifetime may be less than if the recipient remained
diabetic. Improved quality of life in patients who have received a pancreas
transplant also justifies the cost of the procedure.
RECOMMENDATION:
None.
ABSTRACT:
The author examines pancreas transplantation in terms of medical and quality
of life outcomes as well as costs. Worldwide, more than 4,000 pancreas
transplants had been reported by 1992, including 2,600 in the United States.
Successful pancreas transplantation may stabilize retinopathy over the
long term and significantly improve survival probability in patients with
severe nephropathy. Kidney function is adversely affected by immunosuppressive
drugs. As long as rejection is prevented, improvement in quality of life
for patients with transplanted pancreas and kidneys is dramatic, because
both insulin dependence and dialysis are prevented. Patients with only
a pancreas transplant must balance the benefit of relief from diabetes
with the difficulties of immunosuppression. In a study of 131 patients,
92 percent found immunosuppression was easier to manage than diabetes.
Standardized well-being indices showed that 100 percent and 85 percent
of patients with successful and failed grafts, respectively, would recommend
transplantation. Insurance coverage for kidney transplant is routine but
highly variable for pancreas transplantation. Pancreas transplants performed
as a solitary procedure at the University of Minnesota cost $65,000 for
hospital care plus the cost of immunosuppressive drugs. 27 references.
104
TITLE:
Simultaneous Pancreas-Kidney Transplantation (SPK): A Cost-Effectiveness
Analysis Model (abstract). Holohan, T.H. Annual Meeting of the International
Society for Technology Assessment in Health Care. 1996; 12:25.
OBJECTIVE:
To compare cost per quality-adjusted life-year (QALY) of simultaneous
pancreas-kidney transplantation and kidney transplant only.
CATEGORY:
Tertiary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-utility analysis.
Perspective: Health care system.
CONCLUSION:
Even though the model's assumptions favored the combined transplant, in
terms of cost per QALY the combined transplant was equivalent to a kidney
transplant alone only for patients whose annual treatment costs for managing
diabetes were quite high ($15,000 to $40,000) or for patients whose quality
of life after a simultaneous transplant has been shown to be superior
to the quality of life of patients having a kidney transplant alone with
continued insulin therapy.
RECOMMENDATION:
None.
ABSTRACT:
The author describes a model developed to compare costs associated with
a combined pancreas-kidney transplant to treat end-stage renal disease
in people with type 1 diabetes with that of a kidney transplant alone.
The model assumed that improvement in secondary complications (neuropathy,
nephropathy, and retinopathy) resulting from a combined transplant remained
unproven; that a combined transplant resulted in improved quality of life,
although there are few objective data to support this assumption; that
no technical failures occurred with the combined transplant; and that
there were no renal graft failures. The model accounted for a period of
3 years, the length of time for which graft survival data were available.
Benefit was expressed in terms of QALY, and costs included costs or charges
related to the transplant operation and those associated with treating
hypoglycemia or hyperglycemia in patients getting kidney transplant alone
and in patients with pancreas graft failure.
105
TITLE:
Therapeutic Interventions in the Progression of Diabetic Nephropathy.
Lewis, E.J. American Journal of Hypertension. 7 (9 Part 2): 93S95S.
September 1994.
OBJECTIVE:
To determine whether the drug captopril exerts kidney-protective effects
independent of the effects it has on systemic blood pressure.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Statistical analysis.
Perspective: Health care system.
CONCLUSION:
The protection that captopril offers against deterioration in renal function
is significantly greater than that attributable to control of blood pressure
alone. Captopril is very cost effective compared with other therapies
and has no costs associated with life-years gained.
RECOMMENDATION:
Treatment with captopril can potentially eliminate high annual treatment
costs for dialysis and kidney transplantation in numerous patients.
ABSTRACT:
A prospective, double-blind, randomized, placebo-controlled multicenter
trial was conducted in 30 clinical centers in the United States and Canada.
Captopril (25 mg 3 times daily) was compared with a placebo in 409 patients
with overt nephropathy associated with type 1 diabetes (average age, 35;
mean duration of diabetes, 22 years). Three quarters of the patients either
had hypertension at entry or were already on antihypertensive treatment.
In both groups (n = 207, captopril group; n = 202, placebo group),
the aim was to maintain blood pressure below set limits using agents other
than an angiotensin-converting enzyme (ACE) inhibitor or a calcium antagonist
during the median 3year follow-up so that the potential kidney-protective
effect of ACE inhibition by captopril could be assessed independently.
The primary outcome measure was a doubling of the baseline serum creatinine
concentration (among study participants, median time from doubling of
serum creatinine to requiring dialysis was 9 months). In the placebo group,
43 of 202 patients doubled their serum creatinine, versus 25 of 207 in
the captopril group, which had a risk reduction of 51 percent. The placebo
group lost renal function at a rate of nearly 17 percent per year versus
10 percent in the captopril group. The combined endpoint of endstage renal
disease or death was reached by nearly twice as many in the placebo group
(n = 42, 21 percent) as in the captopril group (n = 23, 11 percent, p
= 0.006). Nephroprotective therapy could double the time to dialysis from
3 years in a patient who has routine blood pressure control to 6 years
on captopril. An economic model (Rodby R.A. et al., unpublished study)
to determine the economic value of treating nephropathy patients with
captopril to reduce progression to end-stage renal disease found significant
overall cost savings. Projecting figures from this study yields a savings
of more than $2.6 billion over 10 years for end-stage renal disease. 2
references.
106
TITLE:
Type I Diabetic Nephropathy: Clinical Characteristics and Economic Impact.
Chukwuma, C. Journal of Diabetes and Its Complications. 7(1): 15-27.
January-March 1993.
OBJECTIVE:
To examine the incidence, prevalence, pathogenesis, risk factors, and
costs of nephropathy associated with type 1 diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Direct medical costs are much higher in diabetes than in other diseases.
Type 1 diabetic nephropathy necessitates kidney replacement in many patients.
The cost of renal replacement therapy is greater for patients with diabetes.
RECOMMENDATION:
The pathogenesis and treatment of type 1 diabetes nephropathy needs to
be elucidated to reduce the economic impact of that disorder.
ABSTRACT:
The author reviews the incidence, prevalence, pathogenesis, risk factors,
and economic impact of diabetic nephropathy in patients with type 1 diabetes.
About one-third of type 1 patients develop diabetic nephropathy. Several
risk factors, including poor metabolic control, hypertension, and genetic
factors are related to its development. End-stage renal disease (ESRD)
is a frequent consequence of nephropathy. The incidence of ESRD from diabetic
nephropathy increased in the United States from 10 percent in 1973 to
30 percent in 1987. Also in the U.S., Medicare costs in 1982 for ESRD
among persons with diabetes were $330 million. These costs appear to be
increasing at a rate exceeding $800,000 per year. ESRD therapy is more
costly for patients with diabetes than for other causes because of a higher
hospitalization rate and poorer treatment outcomes.
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