Combination Drug/Diagnostics: Fueling Growth
of Personalized Medicine
Below is an excerpt
from an interview in the Insight Pharma Report, Combination
Drug/Diagnostics: Fueling Growth of Personalized Medicine. For
more information about this report, please go to
www.insightpharmareports.com/reports_report.aspx?id=98186&r=7012.
Stephen Eck, MD, PhD
Vice President, Translational Medicine & Pharmacogenomics Eli
Lilly
Insight
Pharma Reports (IPR): Could you discuss the economic challenges of
personalized medicine?
Dr. Eck: I do not think that anyone would argue that having
greater prescribing precision is bad. Physicians would love to know exactly
who to give a medication to, and who not to give it to. I think that the
payers would be very happy with the same because they do not want the
empiricism where you start a patient on one thing and if something happens
you change medicines. These changes tend to drive up the cost of healthcare
not to mention not achieving the benefit the patient needs. From the
manufacturers’ perspective, companies invest a lot of money tracking adverse
events, which one would prefer to avoid. I think that everyone would agree
that greater precision in the use of medicine is good for healthcare. What
is not clear is how the value of personalized medicine is captured.
Let’s suppose that you have a new medicine for an important disorder, and
that new medicine is best used with a test that will tell the physician who
should take it. Maybe there is a device used in administering the drug as
well. As a result of these new technologies, (the device, the drug, the
test), there will be much better care for patients. To make this
hypothetical situation as attractive as possible, let’s say that this new
and better care results in a cost savings to society. How is that value
captured? How much of this value is returned to society as lower medical
costs overall? How much of this value is allocated to the diagnostic? How
much of this value is allocated to the manufacturer of the device, and how
much of this value is allocated to the manufacturer of the drug? Each party
has an important role in healthcare. Another economic consideration is the
timing of investments. Most drug development companies are not diagnostic
companies. They do not have large diagnostic operations, in part because
that is a very different kind of business. Such companies are going to need
to partner with another company to develop the companion technologies. In
the case of Abacavir, GSK relied upon LabCorp to make sure that HLA-B*5701
testing was available for their drug. Such arrangements will become more
common. But, if we want a diagnostic company to work with a drug developer,
the diagnostic company will assumes some risk to their investment as the new
drug might never get approved. The diagnostic company has to work on the
test for the new medicine before approval so that the test is available at
the time of the launch. In some cases the drug manufacturer has to invest in
the intellectual property for the diagnostic test, and then make that
available to the diagnostic company. Many of these issues are not well
worked out although they are not insurmountable. However, there have not
been a many examples of drug-diagnostic combinations to provide confidence
in the industry. There is still some uncertainty as to what is the mix of
risk and benefit is as the diagnostic, device, and pharmaceutical companies
work together to bring a new products to market. It is clearly doable, but
most drugs do not have companion diagnostics at this point.
IPR: Are there any other major economic issues?
Dr. Eck: The one issue which you do not see frequently addressed is how
society will support the innovation that will allow personalized medicine to
succeed while ensuring that some of the healthcare expenditure savings that
results from personalized medicine accrues back to the public.
It is widely believed that in the United States there is more consumption of
healthcare resources in some sectors than is necessary to achieve quality
health outcomes. I do not mean just drugs, but also procedures and tests.
Some segments of the population are very high consumers of medical care, and
in some cases this may be beyond the point of additional benefit. The amount
of additional benefit that is derived from any one test, procedure, or
medicine can be very difficult to ascertain. Nonetheless, redirecting
expenditures from marginally beneficial activities to activities that offer
great medical value is an area of growing concern. It is hoped that
personalized medicine may help address this issue. If we bring more
precision to therapeutics, we may be able to simplify medical care to the
point where the care that is available will be more likely to improve
outcomes for individual patients. If personalized medicine provides greater
precision in the use of new drugs, but overall increases the cost of
healthcare, the adoption of personalized medicine will be slowed.
Malignant brain tumor therapy is a good example. Brain tumor patients
require tremendous medical resources in terms of radiology tests, radiation
therapy, neurosurgery, drugs, and specialized care. This is a very large
healthcare burden for what is typically a very poor outcome. There is
clearly a huge societal benefit to having a better therapy, but a better
therapy that is unaffordable fails to fully address the public needs.
Ideally, some of the gain from the use of personalized medicine has to
contribute to overall healthcare savings so that everyone can have access to
the best care.
IPR: You briefly mentioned people paying for healthcare. Please talk about
some of the reimbursement issues today, and what you think they will be in
the future.
Dr. Eck: It is likely that new laboratory tests will accompany new medicines
as companion diagnostics. For the diagnostic test, it is not clear how it
will be incorporated into the fee structure. One of the concerns that I have
heard from diagnostic manufacturers and from clinical pathologists is that
there is some uncertainty as to how they will be reimbursed for doing the
additional work to help identify the patient who should or should not get
the medicine. There may be a need to restructure how we compensate for that
new service. If each drug requires its own diagnostic, you could have an
explosion of diagnostics, all of which add costs. These costs would be
offset by savings in other areas (e.g., few adverse events, fewer physician
visits for follow up, etc). There is the additional issue of how to manage
an increasing number of diagnostic platforms each with its own specialized
equipment and expertise. We are seeing this now with testing for variations
in drug metabolizing enzymes. There is significant interest in drug
metabolizing enzymes because genetic variations in these enzymes may
influence the exposure that an individual has to a drug, and therefore may
have an impact on drug efficacy. Many of these enzymes can be tested on a
uniform platform. For example, Affymetrix, with whom we have done extensive
work, has a DNA chip called DMET Plus®. That chip could be used to assess
individual genetic differences of many different drug metabolizing enzymes
and drug transporters. If approved for such use, it would bundle many tests
together. Several other companies are developing competing platforms. To the
extent that you have these very utilitarian platforms, that could
potentially drive down costs.
Lilly is also working with GE Healthcare on a platform for oncology
diagnostics, where one can assess 25 or more specific analytes in a tumor
simultaneously. This will allow for very dense information collection from a
single sample and a single analysis of a variety of tumor proteins. This is
intended to be broadly applicable to all tumor specimens. A physician might
not need all of the information for every patient, however, it may someday
allow these multiple analyses to be done in a simple, automated way that can
potentially drive down costs. This would appear to be preferable to ordering
the tests in an à la carte sequential fashion where each test has a separate
fee. I think that you will start to see more of these multiplexed assays.
Affymetrix uses a DNA chip platform. The GE system is based on
immunohistochemistry. But, the concept is the same. They are standardized
platforms that will give you multiple assessments from a single test sample.
The complete transcript of Insight Pharma Reports’ interview with Dr. Eck is
included in the report Combination Drug/Diagnostics: Fueling Growth of
Personalized Medicine.
