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clear, Burrill says, because of the variability Berger, who came to Pfizer from United- outcomes in the area of osteoporosis with
in what payers and regulators around the Health Group last year to head a new group data culled from Regenstriefs information
world regard as the value of a medicine. studying patient outcomes, notes that on 13 million patients.
Burrill and others point to a concerted Pfizer recently formed a partnership with We are involved in a number of conver-
effort in which drug companies, payers, Humedica, a health care analytics compa- sations with potential partners, Jain says.
and regulators are working, sometimes in ny, to mine Humedicas database and glean The idea is to garner meaningful informa-
partnership, to harness the data available insights into the health impact of therapies. tion to advance what has long been the
in clinics, doctors offices, and patients Sachin H. Jain, chief medical informa- companys mission of improving patient
homesanywhere electronic data are be- tion and innovation officer at Merck, also health. That mission is not changing, he
ing generated on patient health. We are acknowledges a focus on outcomes in the says, but with better information on pa-
clearly moving into the era of big data and pharmaceutical industry tied to a height- tient outcomes, the companys business
data analytics, and everyone is trying to fig- ened effort to deliver personalized care. model will change.
ure out what data are meaningful and how Although the industry has always been AstraZeneca is also working with part-
to use them, he says. concerned with real-world outcomes, Jain ners to access patient data, according to
says, access to data and advances in health Greg Rossi, vice president of payer and
INFORMATION ON the effectiveness of care IT have catalyzed a surge in activity. real-world evidence. In addition, the com-
a drug compared with its alternatives is The increased focus on patient out- pany employs a group of epidemiologists,
becoming more important throughout the comes across the industry is driven by our bioinformaticians, and other health out-
health care enterprise, agrees Robert Tem- ability to measure it, he says. Electronic come researchers who focus on determin-
ple, deputy director of clinical science at medical records have been a boon, but only ing real-world evidence of its drugs benefit
FDA. What everybody is interested in now lately have drug companies and academic to patients. Its an increasing capability
is comparative data: Which antidepressant research institutions begun the arduous that I think the industry needs to have and
works better? he says. But those are not task of amalgamating and standardizing we have to develop, he says.
easy studies to do, because when the effect the data from a vast field of sources.
of something is not huge, it is hard to show Like other drug companies, Merck has THE CHALLENGE, according to Rossi, is
the difference between two drugs. Its hard acted to access data through partnerships, getting at data outside the controlled envi-
enough to show the difference between including one with Regenstrief Institute, a ronment of clinical trials. Drug companies
drug and placebo. nonprofit medical informatics and health have to shift their focus from gathering in-
Even placebos become an issue, Temple care research organization affiliated with formation on people with a particular dis-
says, because the use of a placebo and other Indiana University School of Medicine. ease, the kind that is derived in the clinic,
standard practices in controlled clinical The partners are studying patient health to gathering information about individual
trials is not feasable in real-world patients. If I can measure in close
ASTRAZENECA
ASTRAZENECA
NOVARTIS
as with our internal R&D organiza- project. That being the case, the
tions to better design our own criti- partners have begun negotiations to
cal programs, Rossi says. extend their initial four-year agree-
Timothy Wright, the global head ment, which expires next year.
of development at Novartis, says his Humedica, founded in 2008 by
firm is also channeling outcome data former pharmaceutical executives
into drug development research. He to conduct drug effectiveness stud-
expects that outcomes will increas- ies, also sees a big rise in outcomes
ingly influence the entire science and research. Now, 40% of our revenue
business life cycle of a drug. comes from outcome studies as
Typically in clinical trials, we opposed to drug effectiveness stud-
would launch a drug and try to get ies, says Steve Davis, the firms vice
as many people to take it as pos- president of life sciences. We didnt
sible based on its safety and efficacy even go after that business. It came
profile, he says. The assumption Rossi Wright to us. Humedica is currently doing
followed that a drug would have a work for 20 drug companies, he says.
patent-protected life span during which network of Indiana hospitals. It currently The Boston-based company, which
Novartis could explore options for follow- manages a data bank of 4 billion data points claims to have the worlds most com-
up drugs. from 13 million patients, including lab prehensive clinical database, says it has
Whats different now, Wright says, studies, radiology studies, prescribed med- access to information from health care
is that were looking at our portfolio, ications, test reports, insurance claims, and provider organizations treating approxi-
figuring out how we can find something of other routine medical data. mately 30 million patients in more than
transformational valuesomething that 38 states.
can change the outcome in a significant A VENTURE that started as an academic Drug firms and their partners agree that
way such that the drug will become a new and public health system information gaining access to such large stores of data
standard of care, a new drug of choice for resource, Regenstrief now has booming on patient outcomes will lead to near-tec-
physicians to offer patients. collaborations with industrial partners. In tonic shifts in health care. But the change
Whereas this used to be a postmarket- addition to the Merck partnership, Regens- may be more radical for pharmaceutical
ing exercise, we are now bringing this trief has worked with GlaxoSmithKline and companies than anyone can anticipate.
thinking and some of these end points into its neighbor in Indiana, Eli Lilly & Co. Its Right now, we are still in the business
our development program, Wright says. a great time to do what we do, Duke says. of selling productsthe pill or injections,
Soon we will not just be launching and Someone described it as selling umbrellas Novartis Wright acknowledges. But in
selling the pill, but selling it with the out- in a rainstorm. the future, if we were to go down the road
come data that show the value of it to the Marcus Wilson, president of Health- of actually delivering specific outcomes,
patients, physicians, and the payers. Core, also sees a growth market because there is a bit of a scenario where pharmas
Many of the health care data analysis drug companies lack the resources to add become like insurance companies, mak-
firms that have partnered with pharma- real-world studies onto their current clini- ing risk-based determinations of outcome
ceutical companies have been collecting cal trial organizations. If they studied ev- criteria and appropriate payments. Its a
outcomes data for decades. Like the drug- ery population, it would cost $20 billion to matter of whether the system evolves in
makers, they cite the rise of electronic get a drug to market instead of $10 billion, this way. If it does, it will require a different
medical records in the health care industry Wilson says. It would take 20 years. set of skills.
as important in advancing patient outcome Wilson points to a complex, shifting Whether drug companies will, like in-
research. They also cite payer pressure for health care landscape in which the drug surance companies now, make decisions
outcome data as a catalyst for change in the companies are only one element undergo- on which patients will be reimbursed for
drug industry. ing change. Physicians are assuming great- drugs, is a good question for a glass of
When drug executives speak of sell- er risk as reimbursement for care becomes wine, HealthCores Wilson says. I dont
ing outcomes rather than pills, they are tied to improving the health of the patient think patients will be denied drugs. But
speaking the language of the payer, says through a regime in which prescription the question remains: How well do the
Jon Duke, an assistant professor at Indi- drugs are only one facet. drugs work? All decisions today are based
ana University School of Medicine and a HealthCore was launched in the early on suboptimal information, Wilson says.
research scientist at Regenstrief. Health 1990s and acquired by WellPoint in 2003. None of the decisionmakers have all the
care reform writ large is about value-based Wilson says the group operates behind information needed, and the biggest price
care. Yes, they are trying to sell products, a fire wall, making it possible to partner is paid by patients.