ABSTRACT

The challenges and opportunities of precision medicine in the context of health economics and outcomes research (HEOR) are considered, with an emphasis on regulatory and methodological issues, including analytical techniques, HEOR data assessment pathways, and genomic biomarker development. Reference is made to the need for close collaboration among various stakeholders, including pharmaceutical companies, regulatory agencies and other health care providers, to enhance the conventional drug development paradigm to facilitate health technology assessment in this evolving area.