Chapter 1

INTRODUCTION AND SUMMARY
OF THE

KIDNEY DISEASE PROGRAM ANALYSIS

I. INTRODUCTION

A. Objectives and Goals of the Report

In the spring of 1967 the Surgeon General of the U. S. Public Health
Service established, among others, a health program analysis group to under-
take studies and analyses in the area of kidney disease. Members of the
group were chosen from among senior staff of the National Institutes of
Health and other bureaus of the Public Health Service, who were responsible
for ongoing kidney disease-related programs or whose competence lay in the
areas of program planning and analysis. In his charge to the group, the
Surgeon General directed it to describe and discuss the nation’s kidney
disease problem, to outline the current state of knowledge and ongoing programs
in the area of kidney diseases, to consider advanced states of knowledge
and desirable programs, to develop goals and objectives for effective amelio-
ration of the problem, and to explore alternative approaches to the attainment
of these objectives.

An important part of the group's work was to be a logical analysis of

Programs leading to a solution or amelioration of the problem of kidney disease,
ro

including: |
1) A thorough discussion of goals and objectives and ways of measuring
then;
2) A description of alternative approaches which could lead toward the
same objectives;
3) An analysis of the cost of reaching various points on the continuum
of objectives by means of alternative approaches; and
4) A discussion of the basic assumptions upon which conclusions depend,
of uncertainties which affect the estimates used, and of the issues
which cannot be resolved at this time.
The work of the kidney disease program analysis group is intended to
guide the Office of the Surgeon General and, ultimately, the Office of the
Secretary, Health, Education, and Welfare, in the development of future prog1

long range financial plans and budgets, and legislative proposals.

B. Background

During the last five years, diseases of the kidney have steadily gained
in significance as an area of social importance for both Federal and non-
Federal research and service efforts. Much of the impetus for this
increasing interest in kidney diseases has come from the development of
two dramatic but expensive therapeutic approaches to end-stage disease—-
chronic hemodialysis and kidney transplantation. The successes of both
techniques--coupled with other research advances leading to a better under-
Standing of Kidney diseases—-have led to a proliferation of activities.

directed toward reducing the morbidity and mortality these cause in the

population.
There are a number of mechanisms, or program components, that are

traditionally brought to bear on a disease problem such as this. These

are:
1)
2)

3)

4)

5)

6)

7)

Expanded use of existing preventive techniques.

Expanded use of existing diagnostic techniques.

Expanded use of existing treatments, including chronic dialysis,
kidney transplantation and conservative management (drugs, diets,
etc.).

Laboratory and clinical research to produce new preventive,
diagnostic, therapeutic and rehabilitative methods.

Increased specialized scientific medical and paramedical train-
ing to provide the manpower needed for the research and treatment
attack on the kidney disease problem. This also includes
continued postgraduate education to train practicing physicians
in the use of the latest diagnostic and treatment modalities.
Increased public education to alert potential victims of kidney
disease to seek medical help at the earliest possible emergence
of warning signs.

Provision of specialized facilities not currently in existence
which are essential for the execution of any of the above

programs.

It must be understood from the outset that these program components

are interdependent in most cases. For example, preventive techniques

exist that need further research to make them maximally effective for

braod application. New treatment methods are useless if existing diag-

Nostic techniques are not being applied in medical practice. Because of

Gw
the present inadequacies of existing treatments, be they dialysis, trans-
_ plantation, or conservative management, a considerable research effort
is called for to increase their efficacy and economy to make them more
broadly useful.
Cc. Consideration of Program Approaches

. It is unlikely that a single program component would lead to a major
reduction in the national kidney disease problem; therefore, a mixture
of approaches will have to be employed by the Federal Government to
reduce the morbidity and mortality due to kidney disease. The total
funding level and the respective Proportions for each approach in the
Overall effort will determine, to a large extent, the benefits attain-
able in each Successive year fron this effort. Advances in the state of
knowledge will affect the nature of this "mix" and will shift the emphasis
from certain program components to others if we are to continue to derive

maximum benefits from the total expenditure of funds in this area.

including money spent by state and local governments, voluntary agencies,
universities and foundations, and the large segment of private expenditures
for medical diagnosis and treatment. Here, the precise choice of direction
of the placement of Federal funds can determine to a large degree whether:
1) The resulting fruits of research or increased case findings at
an early stage of the disease will stimulate an expanded use

of nongovernmental money for earlier and more effective treatment——
with an overall beneficial effect on the state of kidney disedse
in the nation; or |

2) Whether certain choices for the expenditure of Federal funds
would serve to diminish the participation of the nongovernmental

“

sector in efforts against kidney disease by naking it financially
more attractive to "let Sam do it."

It is obvious therefore, that under a given set of conditions where
unlimited Federal funds are not available for the solution of a single
national disease problem, such as kidney disease, a rational balance must
be struck between the various relevant program approaches-—investigative,
preventive, therapeutic and educational--so as to derive maximum benefits
from any current or possibly extended future Federal efforts.

D. Program Analysis for Decision Making

The future of Federal programs in the field of kidney diseases, be
it for research, disease prevention, improvement of treatment methods
including hemodialysis and transplantation, or manpower training needs
decisions based upon a thorough, dispassionate and logical analysis.

With the aid of such analysis, public officials responsible for health
programs who face the problem of allocation of limited financial resources
in the struggle against kidney disease could make such decisions on the
basis of logical priorities. These priorities would be based on the
present state of knowledge and on needs based on present morbidities

and mortalities, as well as on the basis of anticipated developments

in ‘the future state of the art and the pertinent changes which they.

are likely to introduce into the overall kidney disease picture. The
fundamental intent of such an analysis and its raison d'etre is to.

provide maximum benefits in terms of prolonged, rewarding lives and reduced
morbidity for those aseeteted with kidney- disorders and for those in

the population who will be stricken by it in the future, from the
application of Federal funds to research, disease prevention, treatment,
and manpower training, directed against kidney disease.

E. The Analysis

Faced with the fact that its study and explorations could perforce
not be infinitely exhaustive it was decided that, for the sake of practi-
cability and feasibility, the heterogenous field of kidney disease be
divided into four major Sroups as follows:

I. Infectious Diseases of the Urinary Tract,

II. Hypersensitivity Diseases of the Kidney,
IIl. Kidney Diseases Associated with Hypertension, and
Iv. End-Stage Kidney Disease.
The first three groups encompass in foto about 75 percent of kidney
morbidity and mortality; the fourth group, end-stage kidney disease,
exemplifies progressive and ultimately fatal kidney failure from-all
possible causes.

Each of these groups accounts for a major percentage of overall kidney
morbidity and since each group of diseases was based on one major distinct
causative principle it was felt that it is possible to discuss logically
each group individually in terms of the common overall mechanisms involved
and in terms of the application of the various possible program elements—-
research, prevention, treatment, professional training and lay education—-
to the solution of the problem which it represents.

In addition to the first groups, there remains a miscellaneous group

of renal diseases of variable and distinct etiologies:
a) Diseases of development (polycystic disease, hypoplastic

kidneys, anomalies of position or structure, eta);

b) Renal involvement in metabolic diseases (diabetes, gout, amy-

loidosis, oxaluria, etc.);

c) Kidney damage due to obstruction (benign prostatic hypertrophy

of the aged, kidney stones, etc.);

d) Cancer of the kidney, both of primary or secondary origin; and

e) Mechanical injury.

2. Limitations

Programs and approaches for solution or amelioration of problems
associated with this latter mixed group of renal diseases are discussed
in the text of the report but were not subjected to individual cost-
effectiveness or benefit-cost analyses. This decision was made to
avoid an unwieldy, and in many cases, impractical fragmentation of the
report. Moreover, each one of these disorders may be the end result
of a primary disease for which there exist other, independent research
and preventive and/or curative efforts which, hopefully, would affect
beneficially the existing prevalence of the disease.

For example, research advances of the last seven years in the area
of gout, once they are rigorously applied in the everyday practice of
medicine, will decrease considerably the prevalence of kidney damage due
to neglected or long standing chronic gout. Similar considerations were
applied to other disorders belonging to the residual mixed group of mis-
cellaneous diseases impinging on the functional integrity of the kidney.

It was also decided to exclude neoplasms of the kidney from the

Program analysis. Inclusion of this category in the present analysis
was felt to be undesirable because other extensive research and public
health programs affect the state of the art in cancer; moreover, in a
large percentage of patients afflicted with primary or sécondary cancer
of the kidney, kidney function Ber se does not deteriorate until the
extent of the lesion becomes overwhelming--at which point the life of
the patient is usually threatened by the neoplasm and its metastases
more than by the attendant renal failure.

The present analysis was limited to kidney diseases which are pre-—
dominantly chronic or to mechanisms which though they may precipitate
“acute kidney disease, play a major role in eventual or potential chronicity
of the disorder. ‘Thus, acute renal poisoning due to accidental causes
or suicide attempts, and nephrotoxic drug reactions were not included
in the analyses or program projections.

3. Appendices

In the course of discussing possible Programs and their specific
impacts, new ideas were developed which seemed of sufficient interest
and potential benefit to be included in the report. Subsequently, the
overall principles involved were fitted into the logical mainstream of
the report. For the sake of brevity and continuity, however, the more
detailed projections or applications of such future programs were
included in appendices to the report, whenever they appeared of interest.
4. Recommendations

In projecting future programs and in analyzing their possible impact
on the mortality and morbidity due to each major sub-group of kidney

diseases, the committee attempted to avoid implied or overt recommendations .
It was felt that in each case ‘the analysis and its logical extrapolations

spoke for themselves.

It. SUMMARY

The following summary presents the committee's most significant
generalized findings and a discussion thereof, and is not intended to
include all observations made. These will be found in detail in the
body of the report.

As a first step in its analysis in depth of kidney disease as a
national health problem, the committee studied each of the many diseases
of diverse etiologies which are encompassed in the general term ‘kidney
disease'. (Please see Chapter 2, Kidney Disease-—Current Status)

In each case the current state of scientific knowledge for each disease
was determined including its underlying etiology, mechanisms of
pathogenesis, symptomatology, prognosis, severity and duration, methods
of diagnosis, and treatment. Where applicable, consideration was given
to existing gaps in knowledge, additional research needs, possible
prevention, diagnosis, and treatment under the conditions of present or
future states of the art, and interrelationships with other diseases.
Up-to-date statistical data were collected, such as. prevalence in the
population, mortality, morbidity in terms of days of restricted activity,
average cost of treatment, and other relevant costs.

Since the subject matter embraces a vast number of diseases with
highly divergent pathogenic mechanisms and nature, the committee made

decisions-in-principle concerning which of these would serve best as a
10

basis for a rational analysis under the limitations of the present study
(please see INTRODUCTION, E.,1., Organization of the Subject Matter). The
three main groups of primary kidney diseases and end-stage kidney disease
common to them were utilized in the statistical analyses in this report. This
group encompasses the overwhelming majority of kidney mortality and morbidity.
The remaining primary and secondary kidney diseases of statistically lesser
import were discussed in the text of the report but were not included in the
present program analysis.

Subsequently a thorough study was made (Chapter 3, Current Kidney Disease
Control Programs) of the current governmental kidney disease programs and
relevant public and private expenditures for the nationwide treatment of kidney
disease. The latter includes cost of physician care, hospital care, nursing
home care, and other professional services for diagnosis and therapy of kidney
diseases, as well as the cost of drugs and net insurance costs. In addition,
the cost was estimated for ongoing research efforts, for demonstration,
screening and detection programs, for education and training efforts and for
that portion of the cost of construction of hospital and medical facilities

which can be prorated to the use of patients with kidney disease.

Program Analysis Models

Based on the substantive information obtained and statistical and economic
data collected, the committee analysed the benefits to be gained by different
approaches to the solution or amelioration of the overall national kidney
disease problem at different expenditure levels of HEW funds. Models were

devised after experimentation with various statistical mechanisms and indices.
ii
They are based on a benefit-cost’ analysis for the four disease groups studied,
i.e., infectious diseases of the urinary tract, kidney diseases related to
hypersensitivity phenomena, kidney diseases related to hypertensive vascular
diseases, and end-stage kidney disease. Four specific programs are considered
for each disease group. These programs which are delineated by time, funding
level, and state of the art comprise the following:
1) Hypothetical Program at the Current HEW Expenditure
Level, Based on the Current State of the Art;
2) Hypothetical Program at an Intermediate HEW Expenditure
Level, Based on the Current State of the Art;
3) Hypothetical Program at an Accelerated HEW Expenditure
Level, Based on the Current State of the Art; and
4) Hypothetical Program for Fiscal Year 1975, at an Accelerated
HEW Expenditure Level, Based on the Expected Advanced State
of the Art in 1975.

Each program consisted of a hypothetical situation where a specific level
of HEW program funding was divided among a rational mix of program components
(screening, diagnosis and treatment, research, training, etc.) based on the
particular characteristics of the specific disease group involved, and was
applied to specifically involved or particularly vulnerable groups or, as the
case may be, to the entire population. ‘The benefits “accriable ‘from these ©
progiatis werd ‘thea “estisiated “aiid “stated in"terms of overall reduction of
nortal ity; ‘prévalencé, “and morbidity dué ‘to kidney @iséase./ Wherever the making
of assumptions was unavoidable, the resulting estimates were based on the best

scientific evidence and available data and were held within conservative limits.
-Benefit indices were quantified in terms of the reduction in annual?”
mortality, the reduction in annual morbidity (number of sick days per year)
and in terms of the disease prevalence in the total population due te the”
specific type of kidney disorder analyzed which would accrue thanks to the
impact of the various program components--such as research advances, disease
prevention and improved treatment. It was felt that these specific benefit
indices were more appropriate for the purposes of this study than other
potential indices such as "loss of productivity," loss of gross national
product due to the death of individuals, or loss to the Federal Government of
tax revenue due to death or inactivity of individuals. Moreover, it was felt
that it would be more desirable to quantify the benefits which could accrue
from HEW-supported programs aimed at the kidney disease problem in terms
related directly to the human beings who are to benefit from such expenditure,
rather than in terms of a highly impersonal inert commodity--dollars. The zaet
that mortality and morbidity figures could be manipulated statistically just
as well as dollars, but could be used without introducing too many estimates
and assumptions ("What is thé price of a human life?", "How much money is lost,
and to whom, when a sick person does not report to work?") induced the committee
to choose these indices for its benefit~cost analyses.

A detailed explanation of the various postulated programs and the analysis
of their potential benefits will be found in Chapter 4, Research Methodology,
and Chapter 5, Program Analysis. The nature of these programs, and the benefits
and costs associated with each of the four programs in each disease group are

Summarized and discussed below.
13

Summary of Alternative Programs for Individual Disease Groups

1.

Infectious Diseases of the Urinary Tract

a. Hypothetical Program at Current HEW

Expenditure Level, Based on the Current State of the Art

A major component of this program is the screening of the

following specific high-risk groups: patients in hospitals and

nursing homes, non-hospitalized pregnant females, and non-
hospitalized diabetic patients. This would be followed by the
establishment of definitive diagnoses and vigorous treatment of
any kidney infections discovered. A second major projected»
program component is laboratory and clinical research directly
relevant to infections of the kidney. Other program components
are concerned with the education of medical personnel and the

specific training of additional manpower. The cost to HEW is

estimated at $9,203,000.

Short-term benefits of this program (discernible when the
program reaches full operation), would be represented by an annual
reduction in mortality of 70, a reduction in prevalence of
3,231,260 cases and a reduction of 15,962,420 morbid days in the
involved vulnerable group- Long-term benefits (to be seen many
years after the program becomes fully operational) are represented
by the avoidance of irreversible, fatal uremia in 1,750 individuals

per year.

b. Hypothetical Program at an Intermediate HEW Expenditure Level,
Based on the Current State of the Art .

At the intermediate program level, HEW expenditures are about
two times greater than in the preceding program. Again a major

component of this program is the screening, diagnosis and treatment
of urinary tract infections. An additional high-risk group has
_ been added: ‘females 6 to 9 years of age. The. cost ‘to HEW is
estimated at. $20,179,000.

Short- term benefits attributable to this program are quantita-
tively greater (percentage reductions do not change) , due to the
‘addition of another high-risk group. A reduction in short-term
mortality of 70 is again expected due to the very low mortality
from infections of the urinary tract in the added vulnerable group.
Prevalence is reduced by 3, 243, 860 and morbid days: by 16,273,640.
A yearly reduction of fatal end-stage kidney disease by 1,770 is
expected.

Expansion of the proposed basic program (see previous model)
to a level which is two times larger, in an effort to include an
additional vulnerable group, did not result in a near-proportionate
increase in benefits. Once a new potentially vulnerable group
was included in which the percentage of individuals harboring
urinary tract ‘infections was much lower than in the previous hypo-
thetical situation, the point of rapidly diminishing returns was
reached. Thus an indication was received of the possible limits
of effectiveness for a screening-diagnosis-treatment program for
infectious diseases of the kidney in the general, non-morbid
population under conditions of the current state of knowledge.

c. Hypothetical Program at an Accelerated HEW Expenditure Level,
Based on the Current State of the Art

In this projected situation, the HEW expenditure level is about
’ two and one-half times greater than the current level. Again, a

major component of this program is the screening, diagnosis and
15
treatment of infections of the urinary tract. The high-risk group
at which the program is aimed has been expanded to include all
females under 21 years of age.

The short-term benefits attributable to this program include
- a similar percentage reduction in mortality and morbid days as
before, but since a larger vulnerable population was involved,
quantitative benefits are greater. The cost to HEW is $27,394,000.

Short-term benefits include an annual reduction of 70 deaths,
3,292,860 cases, and 17,483,880 morbid days.

Long-term benefits are represented by the elimination of
irreversible, fatal uremia in 1,870 individuals per year.

The same comments made on the less-than propartionate increase
in benefits in the intermediate program apply, even more strongly,
‘to this hypothetical situation. It is obvious that under the
conditions of the present state of the art the limits of effective-
ness for this approach have been reached at the previous level

of expenditure, in the intermediate program.

d. Hypothetical Program, for Fiscal Year 1975 at an Accelerated
HEW Expenditure Level, Based on an Advanced State of the Art

In this projected situation, the HEW expenditure is about.
three and one-half times greater than the original program. Funds

for research have been increased considerably. Screening, diagnosis

and treatment still remain a major program component.
Under an advanced state of the art it is assumed that the
extensive research efforts have made possible:

1) More effective antimicrobial therapy,

2) Better understanding of the pathophysiology of urinary

tract infections, and
ea
G3

3) Better understanding of the natural history of
pyelonephritis.
The cost to HEW is estimated at $31,228,000.

Short-term benefits now include an annual reduction of 80
deaths, 5,630,780 cases, and 26,064,430 morbid days. Long-term
benefits are represented by the elimination of irreversible,
fatal uremia in 4,125 individuals per year.

Hypersensitivity Diseases of the Kidney

a. Hypothetical Program at the Current HEW Expenditure Level,
Based on the Current State of the Art

It was concluded that present knowledge of hypersensitivity
diseases of the kidney is insufficient to justify a special program
of case finding, diagnosis and treatment since it is doubtful
whether it could make an effective impact on current morbidity
and mortality figures due to these diseases. The most important
projected program component is laboratory and clinical research
relevant to immunology and hypersensitivity diseases of the kidney.
An additional component is postgraduate physician education,
research training, and expansion of research facilities. The
cost to HEM is estimated at $7,480,000.

Short-term benefits expected are a reduction of 610 in
immediate mortality, primarily due to the postgraduate physician
education and. consequent improved medical practice. No immediate
benefits are expected from the pesearch | effort undertaken.

A 1% reduction in mortality, a 50% reduction in prevalence

and a 65% reduction in morbid days is anticipated over a future
1?

ten-year period as a result of this program primarily due to
anticipated research advances, and secondarily due to a higher
quality of medical care (see anticipated benefits for 1975).

This was one of the most uncertain estimates made; it was based

on the research advances of the last 10 years and on the arbitrary
assumption that the rate of new developments will remain the
ome.

b. Hypothetical Program at_an Intermediate HEW Expenditure Level,
Based on the Current State of the Art

In this situation, the program components have not changed
essentially, but the HEW expenditure level has been increased.
The most important program component is, again, research. The

cost to HEW is estimated at $20,000,000.

Short-term benefits would remain similar to those described
at the previous, lower expenditure level (see above).

“Long-term benefits will only be increased significantly over
the previous program if the funds for research in the latter had
been a Limiting factor for productive research.

c. Hypothetical Program at _an Accelerated HEW Expenditure Level,
Based on the Current State of the Art

In this situation, the program components have not changed
essentially, but the original HEW expenditure level has been
tripled. The most important program component is, again, research.
The cost to HEW is estimated at $23,875,000.

Short-term benefits would remain similar to those described

at a non-accelerated HEW level (see above).
Here again, long-term benefits will only be increased
significantly over the previous program if the funds for
research in the latter had been a Limiting factor for productive
research.

d. Hypothetical Program at_an Accelerated HEW Expenditure Level,
Based on an Advanced State of the Art (1975)

Under an advanced state of the art, it is assumed that the
preceding research has resulted in the development of effective
means of preventing hypersensitivity diseases of the kidney, or
of treating them. Possible examples are:

1) An effective anti-streptococcal vaccine;

2) Failing that, discovery of a means for early detection of
streptococcal infections and for the interruption of the
immunological mechanisms that lead to acute glomerulonephritis
and/or |

3) Increased understanding of the meaning of proteinuria and
means for identification and treatment of individuals in
whom it heralds eventual chronic renal disease.

A program based on.the use of an anti-streptococcal vaceine in

a majority of the population and on early detection and treatment
of persistent proteinuria would yield the following short-term
benefits: an annual reduction in mortality of 770, a reduction in
prevalence by 62,250 cases and a reduction of 2,610,000 morbid days
in those affected.

Long-term benefits would be represented by a decrease of 8,610
individuals per year who would otherwise reach end-stage kidney
failure in the future. The cost to HEW has been estimated at

$77,320,000.
[=
uo

It is important to note that any of the program approaches
involving the advances mentioned above would have a profound
impact on the prevention and treatment of hypersensitivity diseases
in general, such as rheumatic fever, rheumatic heart disease,
and others.
Kidney Diseases Associated with Hypertension

a. Hypothetical Program at the Current HEW Expenditure Level,
Based on the Current State of the Art

The projected program consists of three major components:

1) Screening, diagnosis and treatment of individuals 17
years of age and over with curable (non-essential)
hypertension and non-curable hypertension;

2) Postgraduate education of practicing physicians and
education of the population relevant to early recognition
and treatment of the disease; and

3) Laboratory and clinical research.

A relatively minor component for research training of physicians
and allied personnel is. also included. HEW costs are estimated at
$9,180,000.

Estimated annual short-term benefits include a decrease in
mortality by 7,830, a reduction in prevalence of 54,000 cases, and
a reduction of 5,959,000 in morbid days due to hypertensive disease.
It has been assumed that approximately 30% of the benefited
individuals with hypertension have renal involvement. Thus the
figures for benefits accruing to patients with renal disease
associated with hypertension are 2,190, 27,000, and 1,802,000,

respectively.
2l

A reduction of 4,330 per year in the number of individuals
dying from irreversible uremia is expected as a long-term benefit.

b. Hypothetical Program at an Intermediate HEW Expenditure Level,
Based on the Current State of the Art |

The projected program is similar to the preceding one except
that under an increased funding level (about two and one-half
times greater than before) an additional population group is
subjected to screening, diagnosis and treatment. Reference is to
persons 17 years of age and over who have had no care from a
physician during the preceding year. The program affecting the
additional group is expected to cover a six-year cycle. Estimated
costs for HEW are $21,207,000.

Estimated annual short-term benefits for patients with renal
involvement are now increased to 2,270 avoided deaths, a reduction
in prevalence of 34,880 cases and a reduction in morbid days of
2,056,820. Expected long-term benefits are estimated to include
an annual reduction in fatal end-stage uremia of 4,820 cases.

c. Hypothetical Program at an Accelerated HEW Expenditure Level,
Based on the Current State of the Art —

This program is similar to the one postulated for an inter-
mediate level of expenditure except that the program affecting the
additional high-risk group of previously unscreened individuals
has been accelerated to cover a three-year cycle rather than six
years. The estimated cost to HEW is $28,639,000 (about three
times the original level of expenditure).

Estimated annual short-term benefits for patients with renal
involvement now include 2,380 avoided deaths, a reduction in

prevalence of 42,750 cases, and a reduction in morbid days of
21

2,311,340. Expected long-term benefits are estimated at an
annual reduction in end-stage uremia of 4,820 cases.

In this case, further expansion of the program above the
intermediate level did not appear warranted by the resulting increase
in benefits, which was very far from proportional. Here again,
an indication was received of the possible limits of effective-
ness for a screening-diagnosis-treatment program for kidney
diseases associated with hypertension in the non-symptomatic
population ("individuals who have not seen a physician during
the preceding year"), under conditions of the current state of
knowledge.

d. Hypothetical Program at an Accelerated HEW Expenditure Level,
Based on an Advanced State of the Art (1975)

Under an advanced state of the art it is assumed that the
preceding extensive research efforts have resulted in the following:
1) Advances in understanding of the underlying cause(s) of

hypertension;
2) Improved diagnostic tests for detecting hypertension;
3) Specific effective therapy(ies) directed toward the various
underlying causes; and,
4) Advances in surgical methodology for the types of hypertension
amenable to such treatment.
Screening, diagnosis and treatment still remain the major program
Components in this projected situation. The target population is
the same as in the preceding programs. HEW costs are estimated at
$35,832,000.
Estimated annual short-term benefits for patients with renal

involvement include a 9,300 decrease in mortality, a reduction of
289,700 in prevalence and a reduction in morbid days of 5,579,000.
Long-term benefits are expected to result in an estimated

annual avoidance of fatal end-stage kidney disease in 9,480

individuals.
4. End-Stage Kidney Disease

End-stage kidney disease as indicated earlier exemplifies
Progressive and ultimately fatal kidney failure from all causes.
Because of the unique and costly treatment methods currently available
this group was studied not only from the standpoint of the four program
alternatives (used for the three primary disease groups) but also from
the standpoint of a program which attempts to treat all patients with

chronic kidney failure.
a. Hypothetical Program at Current HEW Expenditure Level Based
on the Current State of the Art

The major component in this program consists of treatment of

 

patients in end-stage renal failure by dialysis and/or kidney
transplantation. A second program component is laboratory and
clinical research relevant to both treatment modalities, develop-
mental research for dialysis hardware improvement, and development
of organ preservation technology and facilities. A third program
component, considerably smaller, involves training of relevant
Manpower and provision of needed facilities. The estimated HEW
cost is $21,000,000.

The benefits in this program are measured in terms of mortality
avoided in the total group of patients in irreversible renal failure
whose lives are in jeopardy. Under the circumstances of this

particular program, 600 patients will be maintained through
AD
td

chronic dialysis and 90 lives yearly will be saved through
successful transplantation.

This program of dialysis and transplantation, at current
HEW expenditure levels, provides life-saving care for about 1.5% of
the number of patients threatened by death during that particular
year because of end-stage kidney disease.

b. Hypothetical Program at an Intermediate HEW Expenditure
Level, Based on the Current State of the Art

In this projected situation the level of HEW funding has
been increased appreciably to reflect the immediate urgency posed
by the threatened lives of patients in irreversible renal failure.
Treatment expenditures have been increased by a factor of 5 over
the previous level, research expenditures by a factor of 1.5 and
training and facilities by a factor of 5.

Under the circumstances of this particular program, about
1,150 patients would be maintained by chronic dialysis and about
420 individuals would be cured by transplantation.

This program which involves about $56,000,000 of HEW funds
will provide life sustaining treatment for about 3% of the annual
number of persons who have end-stage kidney disease during the
first year of the program. During the second a of such a
program, however, because of the carry-over of about 80% of the
patients dialyzed during the preceding year,, the same sum of
money will provide treatment for considerably less than 3% of the
uremic patients threatened by death during the second year.

Because of the increasing carryover load of dialysis patients
24
from previous years, this limiting effect will increase with
each successive year of such a program. Unless the budget,
manpower, and facilities are increased considerably during each
succeeding year over the respective previous levels, only a
small proportion of the total group threatened with death due
to end-stage kidney disease each year will actually be saved
in such a program. This problem is discussed in greater detail
later in this summary chapter and particularly in Chapter 6,
The Cost of Treating All Patients with Chronic Kidney Failure.

c. Hypothetical Program at an Accelerated HEW Expenditure
Level, Based on the Current State of the Art

In this projected situation, the level of HEW funding has
been increased tenfold to reflect the immediate urgency posed
by the threatened lives of patients in irreversible renal
failure. Although the overall funding is increased tenfold in
an effort to extend treatment to as many patients as possible,
research funds have only been doubled over the current level,
since this was felt to be the limit of research and development
which could possibly be productive at this point in time.
Training and facility expenditures have also increased tenfold
. because of the immensely increased patient load.
Under the circumstances of this particular hypothetic program
4,100 lives will be maintained through chronic dialysis and
3,575 lives will be saved yearly through successful transplantation.
This program, which utilizes $210,000,000 of HEW money (about

$170,000,000 of which are expended for patient care), provides
25

‘treatment for about 15% of the overall number of patients
threatened by death because of end-stage kidney disease and
available during the first year of the program. The same
problem of buildup of carry-over patients in future years exists
under this program and interferes with the achievement of its
goals unless the level of expenditure is raised appreciably

' during each succeeding year.

d. Hypothetical Program at an Accelerated HEW Expenditure
Level, Based _on an Advanced State of the Art in 1975

Under an advanced state of the art, it is assumed that the
preceding extensive research efforts have resulted in the
following advances:

1) Dialysis treatment can be carried out by the patient

essentially independently of treatment facilities
(except for periodic medical checkups), and the debili-
tating complications seen in patients on dialysis
therapy have been eliminated;

2) A highly developed program for organ matching and
preservation is in existence, {mmunosuppressive techniques
are highly effective, transplantation survival is vastly
increased, and the procedure can now be carried out in
most of the general hospitals in the United States; and

3) In the case of both treatment modalities the cost has
been reduced appreciably.

In this projected situation, the total HEW expenditure is

smaller than the accelerated budget level assuming current state

of the art (see above). The expenditures for research have been