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Francis Collins, former director of the National Human Genome Research Institute, provided a cogent, multifaceted overview at the Achieving ROI in Personalized Medicine: Barriers, Incentives, and Pathways to Successful Commercialization conference hosted by the Personalized Medicine Coalition. He spoke about Moore’s Law, as some other speakers at the conference did, comparing the trajectory of scientific advances in genomics favorably to the exponential increase in computing power that was the basis of Gordon Moore’s original thesis. “Beating them hands down,” Eric Lander was quoted as saying. Collins cited numerous major projects (e.g., the Human Microbiome Project) and reminded the audience that rapid advances are a given and must be taken into account in any development models. He spoke enthusiastically of the need for rigorous data about gene-environment interaction and thus a prospective large-scale study (dubbed, aptly I thought, “Framingham on steroids” by someone in the audience). Collins also proposed some urgent action items, such as the need for more adequate oversight of genetic testing and the help needed by healthcare providers. He suggested that healthcare providers need education on personalized medicine, later supported by Janet Woodcock, FDA, who commented, “Clinicians dislike information without instructions.” Collins also noted that today’s primary care physicians are not adequately compensated for face time with patients.

On the subject of reimbursement, James Utley, Coventry Health Care, took the audience through the payer’s decision-making process: the determination of medical necessity (essentially a benefits vs. risk assessment) and demonstrated value, which relies on clinical evidence and, in his words, is “unbiased to cost.” The ROI calculation and coverage decision that follows then becomes an actuarial issue, which can affect changes in premiums as well as benefits. Utley referred or deferred to this actuarial decision several times in his discussion. While I thought his presentation shed light on how clinical evidence is reviewed and the level of information required, I was disappointed that it offered no insight on how coverage is determined. Later in the discussion, Utley did make the bold and sobering statement that somehow the nation needs to come to grips with the fact that the pot for healthcare is not unlimited. Indeed, several speakers suggested that the incremental funding needed to advance some of the exciting developments would have to come from reducing wasteful spending.

Which brings me to the subject of healthcare spending and future directions in healthcare delivery. The Hon. W.J. Billy Tauzin of Pharmaceutical Research and Manufacturing of America (PhRMA) gave an impassioned talk about his personal experience with cancer and the very personal treatment decisions he and his doctor had to make. Most important, he made a strong and convincing case for the transition from prevention to intervention, from “sick care” to healthcare, especially in chronic diseases (e.g., obesity, diabetes) that are reaching epidemic proportions.

Change is coming.

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