An “eye” on cost savings with preventative action

NUTRITION
JIM GRIFFITHS
Council for Responsible Nutrition
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Washington, DC 20036, USA
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Jim Griffiths
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4
MAY/JUNE 2014
An “eye” on cost
savings with
preventative action
against eye
diseases
This is the second in a series on dietary supplements and health care cost savings, based on
information from a Frost & Sullivan economic analysis, “Smart Prevention – Health Care Cost
Savings Resulting from the Targeted Use of Dietary Supplements.” The report was funded
through a grant from the CRN Foundation.
O
ptimal visual sensation is one of
the most critical “necessities”
irrespective of our age, as
evidenced by eyeglasses, contacts,
and refractive eye surgeries for a large
percentage of the population desiring
accurate and detailed optical experiences. But
as we reach more advanced ages, age-related
eye disease (ARED), such as macular
degeneration and lenticular cataracts, become
more likely, and are a much more serious and
often uncorrectable condition. Any possible
preventative strategy that allows the
maintenance of visual acuity would be of
utmost value, especially if the visual
decrement would not be correctable by any
surgical or pharmaceutical means. Any
prevention or prolongation of normality would
be orders of magnitude more desired than an
uncorrectable conclusion that could not be
reversed or undone.
Age-related macular degeneration (AMD)
usually affects older adults (greater than 55
years of age) and results in irreversible
damage to the macula, which causes
complete loss of the sensitive cells in the
center of the retinal visual field. The area of
the macula (approximately 2 cm wide)
comprises roughly two percent of the total
retina, but the loss of seemingly an
insignificant percentage area-wise, is very
significant as the loss of this central portion
profoundly affects virtually all visual
functioning, especially reading, watching
television, videos and movies, driving and
even recognizing faces. It is estimated that
almost half of the visual cortex in the brain is
devoted to processing just the macular
information.
There are two diagnosed forms of AMD.
The “dry,” or nonexudative form, is
characterized by the deterioration of the
photoreceptors through infiltration of fatty
yellow pigmented deposits called “drusen.”
Drusen is similar in molecular composition to
plaques and deposits in other age-related
diseases, such as Alzheimer’s disease and
atherosclerosis. As the drusen deposits
enlarge and multiply over time (slowlyprogressive), the pigmented cell layer under
and around the macula are disrupted and
atrophy, losing their ability to transmit light
and images. The photoreceptors, particularly
the rods and blue-light sensitive cones are
most affected. The dry form of AMD accounts
for nearly 90 percent of diagnosed cases and
is considered the early, slowly-progressive less
debilitating form of AMD.
In the “wet,” or exudative form, of AMD,
blood vessels grow up from the choroid
behind the retina, often disrupting and
detaching the retina causing severe distortion
of central straightforward vision. It rapidly
develops, but also may be treatable via
specific laser surgery and/or with medication
that could arrest and sometimes even reverse
the growth of the wayward blood vessels. Wet
AMD accounts for the remaining nearly 10
percent of cases, is more severe and more
sudden, and accounts for the majority of the
cases of significant loss of vision.
Unfortunately, AMD is a disease that
affects a large percentage of the aged
population and poses a significant financial
burden, not to mention psycho-social burdens
and a dramatic loss in the quality of life.
Approximately 10 percent of patients 66 to
74 years of age will have some form of
macular degeneration and the prevalence for
the disease increases to 30 percent in
patients 75 to 85 years of age.
A cataract is clouding of the lens inside
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Figure 1
the eye, which leads to a decrease in
vision just as a cloudy window or dirty
eyeglasses would in a similar fashion
decrease visual clarity. In short, the
degenerative opacification of the lens
prevents light from passing through and
being focused on the retinal layer at the
back of the eye. Cataracts are the most
common cause of blindness and for the
most part are conventionally treated with
surgery. It is most commonly due to the
unavoidable aging process, but other
extrinsic and intrinsic factors such as
oxidative insult that may cause insoluble
oxidized lens proteins, may also play a role
in the age of onset, progression and
severity. The most common visual
problems include difficulty in appreciating
colors and changes in contrast and coping
with glare from bright lights. If not
surgically corrected, it greatly affects
reading, operating automobiles and
machinery, and recognizing faces.
Lutein (Figure 1) is a xanthophyllic
carotenoid synthesized only by plants, and
is found in high quantities in leafy green
vegetables, such as spinach, kale, Swiss
chard and turnip and collard greens.
Animals can only obtain lutein through
ingestion of plants (or animals that have
eaten plants) and is most strikingly
observed as the yellow coloring of egg
yolks, and chicken skin and fat deposits.
Lutein is lipophilic, insoluble in water and
is present in plants as fatty-acid esters,
with one or two fatty acids bound to the
two hydroxyl-groups. The principal natural
stereoisomer of lutein is (3R,3’R,6’R)beta,epsilon-carotene-3,3’-diol. The
presence of the conjugated double bonds
provides the distinctive light-absorbing
properties of lutein and other carotenoids
of interest. Lutein predominates in the
retina, functioning as a photoprotectant for
that sensitive tissue layer from the
damaging effects of free radicals produced
primarily by blue light (wavelengths
shorter than 480 nm).
Zeaxanthin (Figure 1) is one of the
most common carotenoid alcohols found
in nature. It is synthesized by plants and
some micro-organisms. It is the
xanthophyll pigment that gives the
characteristic orange-yellow color to corn,
oranges, saffron, and paprika. Xanthophylls
occur primarily in plant leaves, and their
NUTRITION
function is thought to
modulate and quench
light energy that
manifests as triplet
chlorophyll (an excited
state) that is overproduced during
photosynthesis.
Animals derive
zeaxanthin from a
plant diet, or from
animals that have eaten primarily plants.
Both lutein and zeaxanthin are available as
dietary supplements.
Lutein and zeaxanthin carotenoids are
the two major components of the macular
pigment of the retina and in the primate
lens; acting as powerful antioxidants and
filters of high-energy blue light. Lutein and
zeaxanthin differ from other carotenoids in
that they each have two hydroxyl groups,
one on each side of the molecule.
Zeaxanthin is a stereoisomer of lutein,
differing only in the location of a double
bond in one of the terminal C6 rings. The
hydroxyl groups appear to control the
biological function of these two
xanthophylls. Some dietary lutein appears
to be converted to a non-dietary form,
meso-zeaxanthin, which may also play a
role in optimal eye health. Lutein appears
to have an affinity for the peripheral retina
and rods, while zeaxanthin seems to be
preferentially taken up by the cones of the
macula. Because xanthophylls are fatsoluble nutrients, bioavailability to these
eye tissues is dependent on a number of
factors, including nutrient source (whole
food or supplement), state of the food
(raw, cooked, or processed), extent of
disruption of the cellular matrix via
mastication and digestive enzymes, and
absorption by the enterocytes of the
intestinal mucosa (primarily the
duodenum).
In 2012, an estimated 2.1 million people
developed the wet-form of age-related
macular degeneration, resulting in severe
vision loss less than six months from onset
of symptomology. During the same 12
month period, it is estimated that more
than 3.7 million Americans over the age of
55 suffered a cataract event and pursued
surgery or other direct hospitalization
services to treat the condition, with a total
affected cataract-inflicted population
(individuals with some stage of cataract
opacity in progress) of nearly 25 million. In
2012, for the 55 year old and older U.S.
demographic, the total direct medical costs
associated with both AMD and cataracts,
plus the related expected costs of postprocedure nursing care and assisted living
services was estimated at approximately
$ 17 billion. Additional indirect costs such
as loss of independence and the
assistance needed to perform daily tasks
associated with both work and home life
are not captured but could be many times
the cost of the direct hospitalization
services. Emotional distress and quality of
life decrements are also unaccounted for.
With the available data on the
incidence of age-related (55 year olds and
older) eye diseases (AMD and cataracts)
and hospital utilization expenditures,
coupled with the role (as a percentage) of
the carotenoids, lutein and zeaxanthin that
could be expected to play in protecting the
eye from oxidative damage, one could
perform a health care cost savings
assessment. In fact, with a grant from the
CRN Foundation, the highly respected
economic analysis firm, Frost & Sullivan,
did just that. Based on their findings, here
are some things to consider.
The expected event rate for AMD in
the target population of U.S. adults over
the age of 55 is 2.8 percent. The expected
event rate of cataracts in the same target
population is 33.0 percent (Table I). The
weighted AMD event relative risk
(weighted for sample size variance) is
77% for AMD and 84.7 percent for
cataracts. The number of people needed
to be treated to avoid one age-related
macular degeneration event (NNTAMD) is
159 persons, i.e., for every 159 persons
over the age of 55 that would take the
Table I
MAY/JUNE 2014
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Lutein and zeaxanthin dietary supplements and Age-Related Eye Disease (ARED).
lutein + zeaxanthin dietary supplements at
the preventative daily intake levels, one
AMD event could be avoided. The NNTCAT
for cataracts is 28. Based on the incidence
rate of AMD and cataracts in the target
population, and the respective NNT’s, if
the entire target population took the
prescribed dietary supplements, then
14,408 AMD events could be avoided and
close to one million cataract events could
be avoided per year. At close to $ 3,500
cost to treat per AMD or cataract event
(lumped together for further analyses as
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MAY/JUNE 2014
Age-related eye disease (ARED)) the
savings per year would be almost $ 4
billion in direct hospitalization utilization
expenditures.
In considering these conclusions, it is
important to note there are, however,
some assumptions and limitations that
need to be stated. There are also
significant direct and indirect potential
savings that are not counted in this
simplistic model.
Because several of the dietary
supplement versus disease-related event
scenarios examined the same disease end
point (e.g., coronary heart disease (CHD)),
and each dietary supplement regimen
independently yielded a positive
(beneficial) net cost savings, crosscomparisons cannot be calculated. The
disease risk reduction for each dietary
supplement regimen was undertaken in a
controlled setting, independent of use of
other dietary supplements. It is still
reasonable to assume that there could be
an even more beneficial health care cost
savings realized if the at-risk population
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took a combination of dietary supplements
each of which has been shown to be
independently advantageous. Future
research may substantiate whether such
combination products are accumulative
(the sum of the independent cost
savings), synergistic (a higher value than a
simple summation of the independent
cost savings), or antagonistic (a lower
value than a simple summation of the
independent cost savings).
Cost estimates also have built-in
assumptions regarding the current and
forecast increases in health care costs, i.e.,
the average annual growth rate of the
hospital utilization events. The at-risk target
population also depends upon forecasted
growth rates. The incidence rate of the
medical events attributed to each disease
is also assumed to remain stable.
The cost to treat each disease was
derived from the hospital utilization and
attendant costs as provided by the Agency
for Healthcare Research and Quality
(AHRQ) Medical Expenditure Panel Survey
(MEPS), 2010 (http://meps.ahrq.gov/
mepsweb/). There was no effort to
consider the additional cost of related preand post-disease pharmaceutics and
health care providers, nor any long-term
rehabilitation or assistance costs. Though
impossible to quantify, but perhaps most
important to each of the individuals who
would “avoid” the expected disease,
NUTRITION
would be the maintenance or at least nondiminishment of “quality of life” and
personal financial and psychosocial norms,
a very important consideration for the
generally aged (greater than 55 year old)
at-risk populations.
The infographic accompanying this article
demonstrates a “Lutein and Zeaxanthin
Cost Analysis: Net Health Care Cost
Savings Summary Results 2013-2020.”
One corrective factor that will be
applied to this health care cost savings
analysis will be to take into account the
segment of the target population (U.S.
adults over the age of 55) who already are
using the prescribed preventative regimen,
in this case lutein + zeaxanthin. According
to the 2012 Council for Responsible
Nutrition (CRN) Consumer Survey on
Dietary Supplements conducted by Ipsos
Public Affairs, four percent of the target
population are regular users of lutein
(which is often manufactured and sold as
a supplement also containing the similarlyacting and chemically similar, zeaxanthin).
This segment already has a reduced risk of
experiencing a costly ARED event because
they are benefiting from the scientifically
established risk reduction. However, the
remaining 96 percent do not yet have this
benefit. Therefore, of the nearly $ 970
million dollars in net potential direct health
care cost savings from reduced
hospitalization utilization services, nearly $
40 million is subtracted as that subpopulation is already taking lutein +
zeaxanthin in a daily preventative regimen.
In summary, there would still be an
estimated 972,000 “avoidable” ARED
events per year to be realized at a total net
savings of $ 928 million. The principle
source of these potential costs is
attributable to post-ARED-event reduced
vision and the costs to surgically and/or
pharmaceutical address some of the
deficiencies. Cataracts and AMD obviously
limit a person’s independence and
precipitate many intangible costs such as a
decrease in the quality of life and
emotional and physical stress and distress.
It is estimated that five percent of the
target population who suffer a catastrophic
ARED event will require costly post-AREDevent assisted living and/or nursing care at
an estimated $ 59,000/year. These costs
will be borne most likely by governmental
Medicare programs or relatives. Any
opportunity to limit or reduce these
potential societal costs should be actively
explored and preventative measures
actively adopted.
For more information on the Frost &
Sullivan economic report, visit
www.supplementforsmartprevention.org
MAY/JUNE 2014
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