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

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 III 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.

journal_name

Drug Discov Today

journal_title

Drug discovery today

authors

Trusheim MR,Berndt ER

doi

10.1016/j.drudis.2015.10.017

subject

Has Abstract

pub_date

2015-12-01 00:00:00

pages

1439-50

issue

12

eissn

1359-6446

issn

1878-5832

pii

S1359-6446(15)00394-3

journal_volume

20

pub_type

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