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AstraZeneca, HealthCore CER Collaboration Will Look at Genomically Defined Subpopulations


Originally published Feb. 15.

By Turna Ray

By joining with national payor WellPoint to conduct comparative effectiveness studies, AstraZeneca will get access to HealthCore's vast enrollee database, which may allow the drug developer to advance more pharmacogenomically guided treatments.

Earlier this month, AstraZeneca announced it was working with WellPoint's research subsidiary HealthCore to conduct CER that would inform its pipeline.

CER conducted by AstraZeneca and HealthCore "will include prospective and retrospective observational studies on disease states, as well as comparative effectiveness research, [and] will analyze how medicines and treatments already on the market are working in a number of disease areas, with a special emphasis on chronic illnesses," the partners said in a statement. "It also will provide insight into the types of new therapies most needed for treating and preventing disease."

According to an AstraZeneca spokesperson, research conducted under this collaboration may focus on how genomically defined subpopulations of patients respond to various treatments. "The breadth of data that will be available through the collaboration will also support studies of sub-populations, some of which may be genetically defined," AstraZeneca spokesperson Katie Lubenow told PGx Reporter.

To conduct these types of studies, HealthCore will use its database of pharmacy information and laboratory results of 36 million enrollees in local Blue Cross and/or Blue Shield plans across 16 states. AstraZeneca noted that the types of studies it will be conducting with HealthCore will not necessarily be controlled clinical trials, but "real-world evidence studies" that use observational data from electronic medical records, medical claims, and patient surveys.

"By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, re-admissions, overall health status, cost of care, and other key evidence-based outcomes," AstraZeneca said in a statement. HealthCore said that it plans to collect and incorporate new types of data into its system as part of its CER efforts, but did not provide further details.

According to Lubenow, the CER aspect of the collaboration will most readily benefit AstraZeneca's personalized medicine efforts in oncology and cardiovascular diseases. Data from CER and other studies will help AstraZeneca make decisions about which treatments to advance in its pipeline and eventually commercialize.

"When combined with data from randomized controlled clinical trials, real-world data provides powerful insights that can help inform discovery, development, and commercial decision-making. The research will provide a better understanding of the impact of our medications on the overall cost and quality of treating diseases," Lubenow said. "The research also will help us identify the impact of treatments on patients, while also highlighting areas of unmet patient needs. This can help inform decisions for both our approved products and our drug-development efforts going forward."

AstraZeneca has so far only discussed its personalized medicine efforts in oncology. In the US, the drug developer is working with Myriad Genetics to develop companion tests for the PARP inhibitor olaparib that it is developing in breast and ovarian cancer (PGx Reporter 06/30/10). In addition, diagnostics firm Dako and contract research organization Quintiles have said they are helping AstraZeneca develop a drug and diagnostic combination product in oncology (PGx Reporter 11/03/10).

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Additionally, AstraZeneca recently announced it was working with Cancer Research UK to advance a multi-gene panel tests for its non-small cell lung cancer drug Iressa, which it only markets in Europe (see related story, in this issue). Through this collaboration, AstraZeneca is funding Cancer Research UK's efforts to set up standardized processes for providing physicians with access to multi-marker genetic tests that inform treatment decisions.

In the same vein, AstraZeneca's work with HealthCore in the US will yield data on whether treatments improve patient outcomes and lower healthcare costs, which in turn will be used by payors to decide whether to provide insurance coverage for a particular intervention.

"While randomized controlled trials are still the gold standard, robust comparative effectiveness studies are commonly evaluated and part of the decision-making process in determining the company’s drug formulary," Colleen Haines, staff VP of clinical pharmacy services at WellPoint, told PGx Reporter. "CER is another piece of information used in conjunction with the trials and all the other information that WellPoint uses to make decisions."

Gathering this type of data is also of interest to the US government, which has recently doled out funding to several HHS agencies for conducting CER. Additionally, the government has created an independent body, called the Patient Centered Outcomes Research Institute, responsible for funding and advancing CER (PGx Reporter 09/29/10).

Many personalized stakeholders have expressed concern that CER projects funded by PCORI will focus on medicines for the general population and not patient subpopulations. However, in announcing its collaboration with HealthCore, AstraZeneca acknowledged that CER is particularly informative when investigating the clinical utility of phamacogenomically driven treatments.

“In an era of advancing medical knowledge in pharmacogenomics and the dawn of personalized medicine, it will be increasingly important to understand why drugs are more effective in certain individuals,” WellPoint Chief Medical Officer Sam Nussbaum said in a statement. “While we want to focus on prevention, the mainstay of treatment of chronic illness is the effective use of drug therapy to reduce the consequences of these illnesses."

AstraZeneca and HealthCore plan to invite other public and private organizations to participate in their partnership. "We believe that the results [generated through CER studies] would be useful to different healthcare stakeholders, from health plans and pharmacy-benefit managers, to communities with health information initiatives, employers, state and federal government," Lubenow said.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.