Personalized medicine policy challenges: measuring clinical utility at point of care

Abstract

Pharmacogenomics, driven by advances in genomics, helps to explain patients’ individual variability in response to therapies. Personalized medicine, the application of the increasing understanding of pharmacogenomics, and information technology are intertwined from discovery to delivery at point of care, through to tracking clinical outcomes. Although exemplary cases of personalized medicine adoption demonstrate patient benefit and cost–effectiveness, a remaining barrier to large-scale real-world uptake of this novel approach in medicine is policy change. At point-of-care implementation, case studies will need to measure personalized medicine application outcomes of relevance to policy-makers and as evidence of clinical utility. Assessments need to be consistent across case studies. Standardizing specifications for case studies will better inform policy-makers performing economic evaluations on the use of personalized medicine.

Keywords::

• case studies
• clinical uptake
• economic evaluation
• genomics
• information technology
• patient outcomes
• personalized medicine
• pharmacogenomics
• point of care
• policy change

Financial & competing interests disclosure

T van Rooij is the recipient of a Mike Wolowyk Graduate Scholarship. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.