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PCAST Personalized Medicine Draft Report Slated for Spring 2008

BOSTON — The President’s Council of Advisors on Science and Technology plans to issue a draft report on personalized medicine next spring, a member of the council announced during a conference here yesterday.
Between Jan. 10 and Nov. 28, PCAST heard public and private testimony by representatives from more than 75 federal agencies and institutes, companies, universities, health providers, payors, venture funding companies, and law firms, said M. Kathleen Behrens, a member of PCAST and a speaker at a conference on personalized medicine hosted by Harvard Partners Healthcare Center for Genetics and Genomics.
After having heard input from stakeholders for the report, Behrens noted that “some of us are cautiously optimistic that personalized medicine will solve some of the health care issues” like rising health care spending, the lack of efficacy of marketed drugs, and the management of drug-induced serious adverse reactions.
According to Behrens, one of the main concerns surrounding pharmacogenomics-based personalized medicine is reimbursement for diagnostics.
PCAST, in eliciting input from stakeholders, specifically heard from a number of payors and insurers, including EDSHCA, Kaiser Permanente, Marshfield Clinics, Medco Health Solutions, Partners Healthcare, RTI Health Solutions, United Healthcare Group, and Wellpoint.
Reimbursement of diagnostics was a hot topic at the conference. Many conference participants felt that evolving payor and insurer demands for diagnostics developers to provide clinical utility data via randomized clinical trials were overly stringent. Speakers called for insurers to consider alternative assessment methods that would not be economically burdensome to Dx shops.
Beyond reimbursement, the scope of the PCAST report on personalized medicine promises to take a broad look at all the issues — regulatory, scientific, and economic — surrounding the advancement of personalized medicine.
Among the issues to be considered in the report are regulation of therapies and diagnostics by FDA and CMS; reimbursement of therapies and diagnostics by CMS and private insurance companies; genomic diagnostics, intellectual property, and related emerging patent issues; patient privacy; information technology and issues of electronic patient records and associated data/databases; the economics of personalized medicine; personalized medicine technology/tools; and patient, physician, and public education.
According the Behrens, the threat of rising health care costs is increasingly focusing attention on the need for personalized medicine. However, “the regulatory and reimbursement policies appear to be moving toward what is necessary to move personalized medicine forward,” she said.
Ahead of issuing the draft report, PCAST is planning to hold public and private briefings in January next year. The council plans to send its recommendations to the President in the summer.

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