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.
Overview / 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.
Activities and Accomplishments:
ISPOR 15th Annual International Meeting in Atlanta, Georgia
ISSUES AND CHALLENGES IN THE DEVELOPMENT AND REIMBURSEMENT OF PERSONALIZED MEDICINE: HOW CAN HEALTH ECONOMICS AND OUTCOMES RESEARCH HELP?
Forum Presentation
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.)
Working Group:
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