ISPOR PERSONALIZED MEDICINE SPECIAL INTEREST GROUP

Chair:
Eric Faulkner, MPH
Senior Director, RTI Health Solutions, and Executive Director, Genomics Biotech Institute, National Association of Managed Care Physicians, Research Triangle Park, NC, USA

Members:
Lieven Annemans, PhD, MSc; Finley Austin, PhD, BS; Kevin Bowen MD, MBA; Pat Deverka, MD, MS; Lou Garrison, PhD; Mark Helfand, MD, MPH; John Hornberger, MD, MS; Dyfrig Hughes PhD, MSc; Tracy Li PhD; Daniel Malone PhD, RPh, BS, MS; Guy Nuyts PhD; Katherine Payne, PhD; Kevin Schulman, MD, MBA; Uwe Siebert, MD, MPH, MSc, ScD; Adrian Towse, MA; Dave Veenstra, PhD, PharmD; John Watkins, RPh, MPH

Goal:
To identify the issues and challenges in the development of personalized “medicine” (i.e. personalized health care treatment), to develop good research practices on the design of studies involved in personalized medicine, to develop a checklist on study attributes for publications of personalized medicine research studies, and to develop a taxonomy of terms used in personalized medicine.

Background:
There is an ongoing trend in the health care environment towards personalized medicine / pharmacogenomics. While until recently most treatments were applied broadly (with varying success), increasingly, treatment is becoming tailored to selected patient groups defined for instance by molecular markers. This concept can be defined quite broadly, including risk assessment, screening and diagnosis, prognosis, prediction of response and monitoring of response.

On first sight this evolution is very attractive to all stakeholders. For patients, personalized medicine will reduce uncertainty, improve care and provide less exposure to ineffective treatments. For physicians, personalized medicine provides better options and outcomes for their patients. Regulators will benefit from increased safety and efficacy. Payers will appreciate more efficient use of our healthcare dollar, and policy-makers can provide more cost-effective healthcare. Pharmaceutical industry will benefit from innovative products that offer a clear improvement for patients.

Many issues occur regarding the development, approval and reimbursement of molecular markers. This ISPOR Personalized Medicine SIG will consider different perspectives [clinical/scientific, regulatory, economic, ethical, organizational] when addressing these issues.

Current Activities:

Issues and Challenges in the Development and Reimbursement of Personalized Medicine
Manuscript Outline
This paper will address issues and challenges in the development and reimbursement of personalized medicine looking at the “big picture” from five perspectives (researcher, diagnostic biomarker/test developer, therapy developer (e.g. drug or device), diagnostic test / biomarker and therapy developer government regulator (e.g. FDA or EMEA) and payer.)

Activity		Deadline:
Develop first Personalized Medicine SIG paper topic and draft outline		September 1, 2009
Personalized Medicine SIG members to provide comments on first paper topic and draft outline		September 18, 2009
Reach a consensus on paper outline		October 14, 2009
Assign sections of the paper to members		November 1, 2009
First draft of each section of the paper completed		March 1, 2010
Draft paper prepared and submitted to Reviewer Group for comments		April 1, 2010
Draft paper presented at ISPOR Forum at 15th Annual International Meeting for comment		May 17, 2010
Draft paper revised based on comments		July 1, 2010
Paper submitted to Value in Health		August 1, 2010