TRENDS & PERSPECTIVES
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Last November, the Department of Health and Human Services’ Initiative on Personalized Health Care issued its second report, “Personalized Health Care: Pioneers, Partnerships, Progress.” The purpose of this report was to bring into focus a sampling of current activities in different parts of the private and academic healthcare sectors toward integrating personalized healthcare into clinical practice. Such activities include employing genomics and other molecular-level techniques in clinical care, using health information technology in care (including integrating clinical care with research goals), and realigning traditional organizations toward enhanced individualization of treatment and patient-centric approaches.
“The report was intended to focus on the business practices and the translational science areas within not just academic health centers but large healthcare systems,” says Gregory J. Downing, PhD, the initiative’s director. “For example, how do you go about integrating genomic medicine and individualized patient care within a healthcare delivery setting?”
For this report, the initiative commissioned seven papers, examining the challenges and opportunities of personalized healthcare from the perspectives of different stakeholder elements in the healthcare sector. These perspectives ranged from the integrated health delivery organizations and academic medical centers to medical professional societies, venture capital firms, and patient advocacy organizations.
The initiative also invited several leading communities (i.e., medical institutions and their partners) to contribute reports on their activities and plans toward different aspects of personalized healthcare. Ten community case studies in this report illustrated how personalized healthcare is coming to be defined, designed, and delivered at the leading edge.
In addition, the report examined the role of IVD manufacturers in personalized medicine as key technology developers. According to Downing, one of report’s findings concerned the challenges involved in integrating different technologies.
“One of the things that struck me is that this isn’t just one test for one disease, but rather it’s an integration of technologies, whether it’s a combination of genes or a combination of genetic tests and imaging,” says Downing. “The technology platforms are also integrated with the intellectual property considerations. This is something that’s been getting a lot of discussion in various circles about how to de-complicate the licensing circumstances in which access to different components are needed for tests to be developed. The cross-licensing arrangements are fairly complicated.”
Another conclusion that the report reached regarding the role of IVD companies in personalized medicine relates to the relationship between technology developers and the healthcare delivery system.
“Increasingly, we’re seeing results or circumstances in which technology developers enter into evaluation arrangements with health plans or healthcare delivery systems,” says Downing. “Basically, the clinical validity piece and the clinical utility piece come from that. Looking at cost effectiveness issues, developing those relationships helps identify where cost savings and potential applications might come from. If there’s one thing we would like to see moving forward, it would be that there are more of those kinds of collaborative efforts that are bringing the technologies to the hands of the delivery system to get a sense of its real value. With the changes going on in Medicare, that’s going to be an increasingly vital part to the equation of figuring out whether this stuff has value or not.”
Having been involved in the initiative for nearly two years, Downing believes that the biggest challenge still facing personalized medicine is a combination of the lack of evidence in many circumstances and the clinical understanding about how to apply the information. It is not abundantly clear how the various healthcare communities should be educated regarding personalized medicine, such as physicians, pharmacists, and nurse practitioners. However, the issue is not just about the technology. Rather, the knowledge about the test result coupled with the test itself is where the real intellectual piece lies. Integrating information about a particular patient and how to use it to make a clinical decision is not easy, and it is not necessarily a technology question.
“In my view, it’s an overall systems problem. How do we create a system in which there’s continued learning and interaction based on the patient’s biology, the patient’s preferences, and the knowledge base that surrounds the test itself,” says Downing.
Additional information about this report is available via the HHS Web site at www.hhs.gov/myhealthcare/news/presonalized-healthcare-2008.html.
