The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics

TitleThe clinical benefits, ethics, and economics of stratified medicine and companion diagnostics
Publication TypeJournal Article
Year of Publication2015
AuthorsTrusheim, MR, Berndt, ER
JournalDrug Discovery Today
Volume20
Pagination1439 - 1450
ISSN1359-6446
Abstract

The stratified medicine companion diagnostic (CDx) cut-off decision integrates scientific, clinical, ethical, and commercial considerations, and determines its value to developers, providers, payers, and patients. Competition already sharpens these issues in oncology, and might soon do the same for emerging stratified medicines in autoimmune, cardiovascular, neurodegenerative, respiratory, and other conditions. Of 53 oncology targets with a launched therapeutic, 44 have competing therapeutics. Only 12 of 141 Phase İII\} candidates addressing new targets face no competition. \{CDx\} choices might alter competitive positions and reimbursement. Under current diagnostic incentives, payers see novel stratified medicines that improve public health and increase costs, but do not observe companion diagnostics for legacy treatments that would reduce costs. It would be in the interests of payers to rediscover their heritage of direct investment in diagnostic development.

URLhttp://www.sciencedirect.com/science/article/pii/S1359644615003943
DOI10.1016/j.drudis.2015.10.017