washingtonpost.com  > Health Correction to This Article Previous versions of this article misspelled the name of Tito Fojo, of the National Cancer Institute. This version has been corrected. Review of prostate cancer drug Provenge renews medical cost-benefit debate TOOLBOX Resize PrintE-mailReprints By Rob Stein Washington Post Staff Writer Monday, November 8, 2010; 7:52 AM Federal officials are conducting an unusual review to determine whether the government should pay for an expensive new vaccine for treating prostate cancer, rekindling debate over whether some therapies are too costly. The Centers for Medicare & Medicaid Services, which dictate what treatments the massive federal health-insurance program for the elderly will cover, is running a "national coverage analysis" of Provenge, the first vaccine approved for treating any cancer. The treatment costs $93,000 a patient and has been shown to extend patients' lives by about four months. Although Medicare is not supposed to take cost into consideration when making such rulings, the decision to launch a formal examination has raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups. Provenge, which was approved for advanced prostate cancer in April, is the latest in a series of new high-priced cancer treatments that appear to eke out only a few more months of life, prompting alarm about their cost. "This absolutely is the opening salvo in the drive to save money in the health-care system," said Skip Lockwood, who heads Zero - the Project to End Prostate Cancer, a Washington-based lobbying group. "If the cost wasn't a consideration, this wouldn't even be under discussion." Those concerns have been heightened because the review comes after the bitter health-care reform debate, which was marked by accusations about rationing and "death panels." The appointment of Donald M. Berwick to head Medicare only intensified anxieties. President Obama sidestepped a Senate battle by naming Berwick, who has advocated for scrutinizing costs, when Congress was in recess in July. Because men tend to be elderly when they get diagnoses of advanced prostate cancer, Medicare's decision will have a major effect on Provenge's availability. Regional Medicare providers paying for Provenge would have to stop. Private insurers also tend to follow Medicare's lead. Medicare officials, who are convening a panel of outside advisers to vet the issue at a public hearing Nov. 17, say Provenge's price tag isn't an issue. But Berwick and other officials declined to discuss the rationale for the review. "Certainly no one in the Medicare program would publicly state that the price tag would have anything to do with Medicare looking at it. But they are human beings, too. They notice things like that," said Sean Tunis, director of the Center for Medical Technology Policy and a former chief medical officer at Medicare. ...

1. washingtonpost.com
> Health
Correction to This Article
Previous versions of this article misspelled the name of Tito
Fojo, of the National Cancer Institute. This version has been
corrected.
Review of prostate cancer drug Provenge renews medical cost-
benefit debate

2. TOOLBOX
Resize
PrintE-mailReprints
By Rob Stein
Washington Post Staff Writer
Monday, November 8, 2010; 7:52 AM
Federal officials are conducting an unusual review to determine
whether the government should pay for an expensive new
vaccine for treating prostate cancer, rekindling debate over
whether some therapies are too costly.
The Centers for Medicare & Medicaid Services, which dictate
what treatments the massive federal health-insurance program
for the elderly will cover, is running a "national coverage
analysis" of Provenge, the first vaccine approved for treating
any cancer. The treatment costs $93,000 a patient and has been
shown to extend patients' lives by about four months.

3. Although Medicare is not supposed to take cost into
consideration when making such rulings, the decision to launch
a formal examination has raised concerns among cancer experts,
drug companies, lawmakers, prostate cancer patients and
advocacy groups.
Provenge, which was approved for advanced prostate cancer in
April, is the latest in a series of new high-priced cancer
treatments that appear to eke out only a few more months of
life, prompting alarm about their cost.
"This absolutely is the opening salvo in the drive to save money
in the health-care system," said Skip Lockwood, who heads
Zero - the Project to End Prostate Cancer, a Washington-based
lobbying group. "If the cost wasn't a consideration, this
wouldn't even be under discussion."
Those concerns have been heightened because the review comes
after the bitter health-care reform debate, which was marked by
accusations about rationing and "death panels." The
appointment of Donald M. Berwick to head Medicare only
intensified anxieties. President Obama sidestepped a Senate
battle by naming Berwick, who has advocated for scrutinizing
costs, when Congress was in recess in July.
Because men tend to be elderly when they get diagnoses of
advanced prostate cancer, Medicare's decision will have a major
effect on Provenge's availability. Regional Medicare providers
paying for Provenge would have to stop. Private insurers also
tend to follow Medicare's lead.

4. Medicare officials, who are convening a panel of outside
advisers to vet the issue at a public hearing Nov. 17, say
Provenge's price tag isn't an issue. But Berwick and other
officials declined to discuss the rationale for the review.
"Certainly no one in the Medicare program would publicly state
that the price tag would have anything to do with Medicare
looking at it. But they are human beings, too. They notice
things like that," said Sean Tunis, director of the Center for
Medical Technology Policy and a former chief medical officer
at Medicare. Tunis said, though, that other factors, such as the
special nature of the therapy and lingering questions about its
effectiveness, were probably playing a more crucial role.
The review comes as the Food and Drug Administration
considers withdrawing an approval for another expensive cancer
treatment- Avastin for metastatic breast cancer - which
triggered a similar debate even though the FDA too is not
supposed to factor costs into its analyses.
Medicare usually covers new cancer drugs once they have been
approved by the FDA. The decision in June to scrutinize
Provenge prompted several members of Congress to question
the action. Supporters have inundated the agency with hundreds
of thousands of comments.
"I don't want to blame Obamacare, but it just kind of figures
that people are taking a look at what the cost-benefit ratios are
and all that sort of stuff," said David Dykes, 69, of Lorton, a
retired federal employee who was hoping to try Provenge. "That
may sound pretty good to the people who want to cut costs, but
it doesn't sound too good to me. This is something that could

5. extend my life. I'd like to give that a shot."
Some fear the move will discourage pharmaceutical companies
from developing new cancer drugs.
"It is extremely chilling if, after spending a huge sum of money,
time and effort to get a drug through FDA approval, you'll then
have to go through it all again to see if CMS will pay for it,"
said Allen S. Lichter, head of the American Society of Clinical
Oncology. "Firing a shot across the bow like this is not the way
to have an intelligent and meaningful discussion about how we
start to address the complex issue of drug costs."
Provenge has long been the center of controversy. The FDA
delayed Provenge's approval in 2007. The rejection triggered
outrage among patients, advocates and investors in Dendreon,
the Seattle company that developed Provenge. The campaign to
win Provenge's approval included anonymous death threats,
accusations of conflicts of interest, protests, congressional
lobbying and vitriolic Internet postings.
Prostate cancer strikes 192,000 men in the United States each
year and kills about 27,000. The only therapies are surgery,
radiation, hormones and the chemotherapy drug Taxotere.
Unlike standard vaccines, which are given before someone gets
sick to stimulate their immune system to fight off infections,
Provenge is a "therapeutic vaccine," designed to attack cancer
cells in the body.

6. To produce Provenge, doctors remove immune system cells
from patients, expose the cells in the laboratory to a protein
found on most prostate cancer cells and an immune system
stimulator, and infuse the cells back into the patient in a month-
long series of three treatments. In a study involving 512
patients with advanced prostate cancer, Provenge increased
median survival from 21.7 months to 25.8 months.
"To charge $90,000 for four months, which comes out to
$270,00 for a year of life, I think that's too expensive," said
Tito Fojo of the National Cancer Institute. "A lot of people will
say, 'It's my $100,000, and it's my four months.' Absolutely: A
day is worth $1 million to some people. Unfortunately, we can't
afford it as a society."
Others agreed, especially given the modest benefit.
"I'd like to think cost doesn't need to come up when it's a slam
dunk," said H. Gilbert Welch of the Dartmouth Institute for
Health Policy and Clinical Practice. "But when it's a close call
like this, it certainly has to be a factor. That's $100,000
Medicare can't spend elsewhere."
But such commentary has caused widespread alarm among
patients and advocates.
"The men most impacted by prostate cancer are African
American men. If CMS doesn't approve this, then this treatment
becomes an exclusive kind of treatment for men who can afford
it out of pocket," said Thomas Farrington, president of the
Prostate Health Education Network.

7. Others stressed that many men live far longer on the treatment
and that even four months is extremely valuable to some.
"Whenever you are faced with a disease where you can lose
your life, you really would like to extend it as much as you
can," said Leibel B. Harelik, 61, a prostate cancer patient who
is executive director of the Prostate Cancer Resource Center in
Austin.
Company officials say the cost is not out of line with that of
other cancer drugs. Each treatment with Provenge, which the
company estimates cost nearly $1 billion to develop, is tailored
to each patient.
"Because of that, we have higher costs associated with this
product," said Mitchell H. Gold, Dendreon's chief executive.
"Provenge is a unique new medicine that prolongs the lives of
patients with late-stage prostate cancer. These patients need
access to innovative new medicines."
Whatever the outcome on Provenge, many on both sides agreed
that more debate over other new high-tech therapies was likely
to come.
"At some point, if we keep paying these very high prices for
treatments that provide very limited benefit, we're going to
reach the point where we can no longer afford health care," said
Alan Garber, a professor of medicine and economist at Stanford
University. "Some say we're living through that right now."

8. © 2010 The Washington Post Company
Improving Population Health
Policy. Practice. Research.
HomeAbout This BlogEditor's WelcomeCounty

9. Health Rankings & RoadmapsIn the LiteratureArchivesContact
Us
What Is Population Health?
(Also see health outcomes, health determinants/factors, and
policies and programs.)
What is population health?
The population health perspective taken by this blog is a broad
one, as the model below illustrates (1) [This model was adapted
from the original Evans
and Stoddart field model (2) and expands on Kindig and
Stoddart (3)].
Policies and programs produce changes in health determinants
or factors, then produce the health outcomes in the left hand
box.
Population health is defined as the health outcomes of a group
of individuals, including the distribution of such outcomes
within the group. (3,4) These groups are often geographic
populations such as nations or communities, but can also be
other groups such as employees, ethnic groups, disabled
persons, prisoners, or any other defined group. The health
outcomes of such groups are of relevance to policy makers in
both the public and private sectors.

10. Note that population health is not just the overall health of a
population but also includes the distribution of health. Overall
health could be quite high if the majority of the population is
relatively healthy—even though a minority of the population is
much less healthy. Ideally such differences would be eliminated
or at least substantially reduced.
The right hand side of the figure indicates that there are many
health determinants or factors, such as medical care systems,
individual behavior, genetics, the social environment, and the
physical environment. Each of these determinants has a
biological impact on individual and population health outcomes.
Isn't this so broad to include everything?
Population health, as defined above, has been critiqued as being
so broad as to include everything—and therefore not very useful
in guiding specific research or policy. The truth is, no one in
the public or private sectors
currently has responsibility for overall health improvement.
Policy managers, for example, tend to have responsibility
for a single sector while advocacy groups likewise focus on a
single disease or factor.
The inherent value of a population health perspective is that it
facilitates integration of knowledge across the many factors that
influence health and health outcomes. For population health
research, specific investigations into a single factor, outcome
measure, or policy intervention are relevant, and may even be
critical in some cases--but they should be recognized as only a
part and not the whole.
What is the difference between population health and public

11. health?
The distinction between public health and
population health deserves
attention since it has been at times both confusing and even
divisive. Traditionally, public health has been
understood by many to be the critical functions of state and
local public health departments such as
preventing epidemics, containing
environmental hazards, and encouraging healthy behaviors.
The broader current definition of the public
health system offered by the
Institute of Medicine reaches beyond this narrow
governmental view. Its report, The
Future of the Public’s Health in the 21st Century, calls for
significant movement in “building a
new generation of intersectoral partnerships that draw on the
perspectives and resources of
diverse communities and actively
engage them in health action (5).”
However,
much of U.S. governmental public health activity does not have
such a broad mandate even in its “assurance” functions, since
major
population health determinants like health care, education, and
income remain outside public
health authority and responsibility. Similarly, current resources
provide inadequate support for traditional--let alone emerging--
public health
functions. Yet for those who define public health as the “health
of the public,” there is little
difference from the population health framework of this blog.
References:
1. Kindig D, Asada Y, Booske B. (2008). A Population
Health Framework for Setting National and State Health Goals.
JAMA, 299, 2081-2083.

12. 2. Evans R, Stoddart
GC. (1990). Producing
Health, Consuming Health Care. Soc. Sci. Med. 33, 1347-1363.
3. Kindig, DA, Stoddart G. (2003). What is population health?
American Journal of Public Health, 93, 366-369.
4. Kindig DA. (2007). Understanding Population Health
Terminology. Milbank Quarterly, 85(1), 139-161.
5. Institute of Medicine. (2002). The Future of the Public's
Health in the 21st Century. Washington, DC, The National
Academies Press. What is Population Health?Recent
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14. NURS 6050: Policy and Advocacy for Improving Population
Health
“Population Health”
Program Transcript
DR. PETER BEILENSON: Your zip code that you live in makes
more difference
in your health and well being than the genetic code that you're
born with.

15. NARRATOR: Doctor Peter Beilenson discusses the influence of
social
determinants on population health. And how epidemiologic data
is used to
identify population health problems. Doctor Beilenson shares
examples from his
experience as Baltimore City's health commissioner.
[MUSIC PLAYING]
DR. PETER BEILENSON: The bottom line that we use all the
time is place
matters. The place that you grow up matters hugely. And if
there's a four legged
stool of the things, of supports that allow for people to grow
healthfully, and into
decent social economic wellness, if you will-- it's access to
health care. It's
access to decent education. To decent safe housing. And
probably most
importantly, access to livable wage paying jobs. It's those four
things that if you
do you have them, you're going to turn out much, much better in
general than if
you don't have them.
I can give a perfect example of this in real life. Neighborhood
in Baltimore called
The Oliver Neighborhood. Which is a particularly decimated,
vulnerable, under-
served, left-behind neighborhood. It used to be very working-
class African
American. It's now a drug infested area. There's dilapidated
housing with lead
poisoned kids. There's housing that has fallen down. The broken

16. window theory
of-- once a couple of houses have broken windows, the
neighborhood tends to
go downhill because it looks like things aren't being taken care
of. And so more
crime occurs. So it's heavily crime infested.
There are a lot of the uninsured adults who don't get their health
care taken care
of. So there's a lot of chronic disease-- diabetes, high blood
pressure, strokes, et
cetera. So there's lack of decent housing, lack of health access.
The schools that
serve this neighborhood, Oliver, are particularly poor.
And lastly, not only is it a food desert in terms of not having
good produce and
fresh foods available because there are no supermarkets in the
neighborhood.
It's literally a wage desert. I can't think of any business in the
Oliver
neighborhood that pays a livable wage job.
So that's a perfect crystallization of having nothing of the four
legged stool of
social determinants of health. Compare that with Howard
County, Maryland. 12
miles away. Maybe three or four zip codes away. Where the vast
majority of the
© 2012 Laureate Education, Inc. 1

17. population has access to great recreation facilities, excellent
housing. There's
been one lead poisoned kid in the entire county of 300,000
people in the last
couple of years, total. The percent of folks who are uninsured in
that county is
about 7% to 8%, 9%. Compared to 30% of the adults in this
neighborhood in
Baltimore.
The school system is ranked the best in the state. Probably one
of the top 10 in
the country. And there are innumerable living wage jobs. And,
not surprisingly,
the healthiest county in the state of Maryland is Howard county.
And the poorest,
the least healthy county in the city/county in the state of
Maryland is Baltimore.

18. [MUSIC PLAYING]
DR. PETER BEILENSON: So the paradigm that the Institute of
Medicine put out-
- probably now it's 15, 18 years ago. But it's looking at health
problems and
health policy with a three step process. And epidemiology is
particularly
important in the first and third steps.
First step is doing a needs assessment of whatever population
you're serving.
You assess the needs of the population that you're serving. And
that's where
epidemiology comes in. Statistics, data, et cetera. Depending on
what issue you
want to deal with. And when we picked priority areas when I
was in Baltimore
City, the Baltimore City Health Commissioner. We looked at
areas that had large
numbers of years of productive lives lost. Basically means if the
average life
expectancy is, let's say 75 in the community, and something
tends to kill people
in their 30s, like AIDS did several years ago, that's 40
something years of
productive life lost. And so that's an important thing to focus
on.
Similarly, infant mortality. That's 75 years of productive life
lost. So the paradigm
needs assessment can be done in looking at years of productive
life lost. It can
also be in a specific policy area like immunization. The needs
assessment might
be what part of your population is particularly un-immunized.

19. And then go after
that.
And then the second phase of this paradigm is policy
development. So you
assess the needs of your population. And to deal with them, you
come up with
policy. It could be legislation to address the issue that you've
found. It can be a
program that you start up. It can be advocating for change in a
certain area to get
that need addressed.
And the third component is assurance. Which is basically
evaluation. We almost
always in my work-- whatever initiative that we launch-- we
always build in an
evaluation tool at the end. So you can see if what you did, the
policy you
developed, met the need that you assessed.
© 2012 Laureate Education, Inc. 2

20. There are three classic examples that I've worked on in the last
15 years or so
that highlight the use of this paradigm that The Institute of
Medicine uses in terms
of looking at ways to look at public health problems. Of needs
assessment, policy
development, and assurance.
And the first is the immunization issue. In the mid to late
1990s-- 1996 '97 to be
exact-- we had worked with the Agency for International
Development. At that
time Vice President Al Gore wanted to choose an American city
to show that the
lessons that were learned outside our borders by the AID could
be brought to
bear on third world parts of the United States. And we were
chosen first, here in
Baltimore.
So the vice president came, along with the mayor and myself.
And we went
around a lot of vulnerable areas. And he was talking about some
of the success
stories that AID had had internationally.

21. And one of them was that the immunization rate in several
impoverished
developing countries, including Kenya, were significantly better
than the
immunization rates we had in our schools here in Baltimore.
Even though there is
a law that requires kids to be fully immunized before they go to
school. It just
wasn't being enforced. Only 62% of kids in the school system
were fully
immunized or have records there of.
So the policy that we developed was multi-pronged. One of
which was to do a lot
of public relations communication to parents saying, hey we're
going to be
dealing with this. We're going to start holding you responsible.
We had huge
clinics in the school system buildings prior to school starting in
the '96- 97 school
year. Where we had thousands and thousands of kids coming in
to get
immunized. And by the way, at the same time, not just school
aged kids but their
little siblings. So we hoped it would make a difference for kids
coming up.
So we instituted these two policies. Again, this is something we
could do
ourselves. It was both communications based as well as offering
services. And
we went from 62% of kids at the beginning of that school year
to 99.8%
immunized within three months. And because we enforced this--
so we went from

22. something like 40,000 of the 100,000 kids unimmunized at the
beginning to about
200. And as far as we could tell, from a lot of heavy work, most
of those 200
actually moved out-- they just were incorrect information that
school system had
about them. They actually weren't even in the school system
anymore.
So we basically went from one of the worst immunized cities in
the country to one
of the very best. And it stayed that way for the last 12, 14 years
because the
enforcement tools have been kept in place.
So needs assessment-- in this case pretty simple. You just look
at the data from
the school system that show we were very under-immunized.
Policy
© 2012 Laureate Education, Inc. 3

23. development, communications, legal ramifications. And offering
clinics to
immunize kids.
And assurance, following up to make sure that the law was
enforced. That the
rules were enforced at the schools system level. And keeping
track of the kids
going forward that were immunized. So a good public health
success story. And
a little bit unusual in that most public health problems, from
AIDS to chronic
disease, take decades to develop. And usually take a while to
fix. In this case it
took a decade to develop, but it took three months to fix.
Early 1998 the CDC-- the Center for Disease Control and
Prevention-- comes out
with their national rankings on syphilis. And Baltimore not only
ranks first in the
country, but we have one of every 20 cases in the entire United
States in
Baltimore City. You've got to assess what's the epidemiology
behind this
outbreak. And it was very interesting. We actually, by the way,
had hit the trifecta
of being number one the country not only in syphilis but

24. gonorrhea and
chlamydia, too. Obviously, you would think somewhat related,
but in reality not.
And that was because gonorrhea and chlamydia we're tending to
hit 13 to 25-
year-olds if you looked at the data. Serially monogamous, which
many nurses
know, especially if you've taken care of teens. Serially
monogamous means
basically-- you're talking to the teenager, how many partners
you have? One.
How many partners in the last seven weeks? Five. Well you've
been serially
monogamous. But they tend to know their partner. And so it's
easy enough to do
contact tracing. And to get the partners notified and medicated
so that you can
deal with the gonorrhea chlamydia outbreak. And so that was
being done a lot
through the school system and through our family planning
clinics for teens.
Syphilis, when you looked at the data, was very, very different.
It was 25 or older.
More like 30 to 50-year-olds. Who were involved in drugs for
sex, particularly
crack. And were in crack houses and barely knew the person's
first name, if that.
And so it was much harder to track and much harder to deal
with. And looking at
the epidemiology of it actually looked like it was sort of
dispersed around the city.
Which was surprising. But if you followed Baltimore's history
you knew that the
year before a lot of the high rises that were disastrous, that

25. concentrating a lot of
impoverished drug-using population were torn down. And so
they sort of
shredded the populous and placed them all over the place. And
so that was
actually, we think, part of the reason for the spread. Because it
wasn't
concentrated in one, or two, or three, or four places. But was all
over the place.
And so your chances of coming in contact with someone with
syphilis was
greater.
And once enough of the population, particularly the drug using
population, of that
age were infected then you've reached a tipping point whereby
which you're
more likely to come in contact with someone who's infected and
therefore get
infected yourself.
© 2012 Laureate Education, Inc. 4

26. So the policy we develop was a multi-pronged again. Partly was
communication.
So we wanted patients, or individual citizens, as well as
providers, doctors and
nurses, to know the signs and symptoms of syphilis. Because it
was actually
relatively rare before. And so we were seeing a lot of patients
coming in from
emergency rooms who had been treated for fungus. When
actually they didn't
have a fungal infection, they clearly had syphilis. But the doctor
or nurse
practitioner had not seen a syphilis patient ever. And so they
were
misdiagnosing.
And so we actually encouraged people to send folks with genital
lesions to our
STD clinics. Because just as with heart bypass, the more you
do, the more you
know. The more you see, the better you are at treating it. So we
did that. We
actually trained our disease trackers in blood drawing. And sent
them out. We
didn't do this terribly much, but we sent them out to crack
houses to draw blood.

27. Why? Because that's where you do syphilis testing. And then we
would come
back and either shoot people up with penicillin there or bring
them back to our
clinics.
And then the third thing we did which was actually the biggest
yield was-- if you
think about it-- because they're involved in the sex for drugs
trade, a significant
portion of this population is going to some way get arrested
during a given year.
Either for possession charges, or distribution charges, or
prostitution charges, or
whatever. And so we did STAT testing for syphilis at the
central booking center.
Which is where everybody comes in who gets arrested in
Baltimore. And we had
a huge yield of syphilis positive individuals.
And so they were at least-- although you're supposed to get
three shots of
penicillin-- they at least got one before they were released
within a day or two or
three. And then we tried to follow up with many of them. But
one shot at least
makes a difference.
So within a year we had an 82.4% drop in our syphilis cases
from 660 to
something like low hundreds, mid hundreds. And it has stayed
at or below that
level virtually the entire time since. Because we've done a lot of
outreach and are
making sure that people who are in vulnerable populations are
tested. We're still

28. too high. But we dropped out of the trifecta. And we are no
longer number one in
gonorrhea, chlamydia, or syphilis. And so it's a significant
success story.
Although certainly we did not eliminate syphilis.
[MUSIC PLAYING]
© 2012 Laureate Education, Inc. 5