TY - JOUR
T1 - Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research
T2 - A report of the ISPOR personalized medicine special interest group
AU - Faulkner, Eric
AU - Annemans, Lieven
AU - Garrison, Lou
AU - Helfand, Mark
AU - Holtorf, Anke Peggy
AU - Hornberger, John
AU - Hughes, Dyfrig
AU - Li, Tracy
AU - Malone, Daniel
AU - Payne, Katherine
AU - Siebert, Uwe
AU - Towse, Adrian
AU - Veenstra, David
AU - Watkins, John
PY - 2012/12
Y1 - 2012/12
N2 - Background: Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. Objectives: In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Methods: Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. Results: These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Conclusions: Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine.
AB - Background: Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. Objectives: In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Methods: Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. Results: These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Conclusions: Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine.
KW - diagnostics
KW - health economics and outcomes research
KW - health technology assessment
KW - personalized medicine
KW - reimbursement
UR - http://www.scopus.com/inward/record.url?scp=84871217315&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84871217315&partnerID=8YFLogxK
U2 - 10.1016/j.jval.2012.05.006
DO - 10.1016/j.jval.2012.05.006
M3 - Article
C2 - 23244820
AN - SCOPUS:84871217315
SN - 1098-3015
VL - 15
SP - 1162
EP - 1171
JO - Value in Health
JF - Value in Health
IS - 8
ER -