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PCAST Plans Draft Personalized Medicine Report for Spring; Reimbursement Key Issue

BOSTON – The President’s Council of Advisors on Science and Technology plans to issue a draft report on personalized medicine next spring and send its recommendations to the President in the summer months, a member of the council announced during a conference here last week.
Between Jan. 10 and Nov. 28, PCAST heard public and private testimony by representatives from more than 75 federal agencies and institutes, companies, universities, healthcare providers, payors, venture funding companies, and law firms, said M. Kathleen Behrens, a member of PCAST and a speaker at the conference on personalized medicine hosted by Harvard-Partners Center for Genetics and Genomics.
Having heard input from stakeholders for the report, Behrens noted that “some of us are cautiously optimistic that personalized medicine will solve some … healthcare issues” like rising healthcare spending, the lack of efficacy of marketed drugs, and the management of drug-induced serious adverse reactions.
After getting high-level, broad-view briefings from stakeholders, Behrens offered some of PCAST’s general perspectives on the state of personalized medicine during the conference. According to PCAST, there needs to be greater government-private sector dialogue to facilitate and coordinate technology advancement, while protecting patients and consumers. Additionally, detailed policy recommendations are necessary for affecting short-term technology and product developments.
According to Beherns, PCAST is preparing the Personalized Medicine study “during a period of meaningful change for regulation by FDA, CMS, and the Patent and Trademark Office.”
She added that “government/industry interactions are providing more detailed insights and involvement than typical for PCAST policy reports and recommendations.”
Reimbursement in Question
According to Behrens, one of the main concerns surrounding pharmacogenomics-based personalized medicine involves 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 participants felt that evolving payor and insurer demands for diagnostics developers to provide clinical utility data via randomized clinical trials are overly stringent.
Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology & Biopharmaceutics, called for insurers to consider alternative assessment methods that would not be economically burdensome to Dx shops.
Previously, Lesko advised that for older drugs that have been on the market for many years, observational studies are sufficient [see PGx Reporter 02-28-2007].   
One salient example of insurers’ evolving evidence requirements for genetic tests is Aetna’s refusal to cover Roche’s AmpliChip. According to one Roche official, payors are holding Dx developers to the same evidence standards as pharmaceutical companies, which may end up hindering the development of innovative tests [see PGx Reporter 04-25-2007].
Throughout the conference, participants questioned whether insurers would be willing to conduct some of these clinical utility studies themselves or if they were at least willing to partner with diagnostics shops to facilitate the studies.
However, WellPoint Executive VP and Chief Medical Officer Samuel Nussbaum said that while the insurance company would love to get into conducting research of this kind, it is waiting to see if various diagnostic tests are actually being adopted by physicians.

“Regulatory and reimbursement policies appear to be moving toward what is necessary to move personalized medicine forward.”

A representative from Aetna expressed a similar unwillingness to conduct clinical utility studies either alone or in concert with Dx shops. According to Joanne Armstrong, Aetna’s Senior Medical Director for Women’s Health and Clinical Lead for Genomics, the insurer has “very limited” resources to contribute to such research efforts.
“We’re not a research organization,” Armstrong said.
Despite this unwillingness to support or conduct clinical utility studies for genetic tests, some players in the insurance game are getting involved in gauging for themselves the clinical utility of genetic tests.
Two pharmacy benefit managers, Medco and PharmaCare, have partnered with Mayo Clinic and Clinical Data, respectively, to look at the clinical and economic utility of warfarin sensitivity tests [see PGx Reporter 12-06-2006]. Medco also has a partnership with LabCorp to look at whether using Roche’s AmpliChip to prescribe the cancer treatment tamoxifen is clinically useful [see PGx Reporter 10-31-2007].
HPCGG is conducting a similar pharmacogenetic and phamacoeconomic study for warfarin [see PGx Reporter 11-15-06]. (See related story, this issue).
A unit of Kaiser Permanente, the nation’s biggest managed-care company, this year announced plans to create a large repository of genetic material in order to examine the genetic and environmental factors affecting disease and patient response to medications, the company announced earlier this month [see PGx Reporter 02-28-2007]. 
At the conference, Behrens noted that PCAST received a great deal of input on the study, which she views as a positive sign that stakeholders are eager to engage in dialogue about the reimbursement issues related to personalized medicine.
Beyond reimbursement, the PCAST report promises to take a broad look at all the issues – regulatory, scientific, and economic – surrounding the advancement of personalized medicine.
The report will cover the following topic areas: 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 emerging patent issues; patient privacy; information technology, electronic patient records and associated databases; economics of personalized medicine; personalized medicine technology and tools; and patient, physician, and public education.
Topics that still require consideration by the council, according to Behrens, include patient privacy, advocacy, and education; physician education and training; direct-to-consumer marketing; trade associations; and further assessment of technology/tools.
According the Behrens, the threat of rising healthcare 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.

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