The 'fourth hurdle' of pharmacogenomics

Pharmacogenomics (PGx) has been recognized as a possible leader down the path of personalized medicine in the 21st century. While this field has been burgeoning, particularly after the completion of the sequencing of the human genome in 2001, the diffusion of this technology into clinical practice has been limited. Interest groups, including industry, payers, providers and patients, have a variety of concerns regarding the utilization of this technology. However, all groups have voiced concerns over possible economic impacts, with different concerns based on the perspective. In order to clear the proverbial 'fourth hurdle', the use of PGx will have to prove not only to possess clear clinical utility, but positive or neutral economic consequences. The role health services researchers can play in facilitating research not only in economics, but also in clinical effectiveness and epidemiology, is critical. Public and private entities have begun taking steps towards guidance for use of this technology and the facilitation of communication and research across entities. A larger, robust evidence base will hopefully allow interest groups to make clear assessments as to the overall impact and utility of PGx.