The Ethical Ramifications of Companion Diagnostics (CDx) Stratified (Precision) Medicine

Highlights provided here were presented on October 1, 2013 at the

Mayo Clinic’s

Individualizing Medicine Conference

For more information, please see www.CDxPrecisionHealth.com

Despite the promise of CDx-stratified healthcare, commercialization challenges still persist. For example, biomarker cut-off choice is not just an economic issue but also an ethical one. We will explore these competing tradeoffs using Herceptin as a case study, where the Her2/Neu CDx test is employed to identify sub-populations of women with breast cancer who will respond favorably to the Herceptin targeted Rx, a recombinant mAb.

Companion Diagnostics-Stratified Medicines: Competing Economic & Ethical Considerations

Prepared by Alan K. Hauser For more information, please see www.CDxPrecisionHealth.com

Biomarker-enabled Companion Diagnostics (CDx)-Stratified Healthcare vs. Empirical Medicine

A Case Study: Breast Cancer

Breast cancer patients

Treat with Herceptin

HER2 testing*

“Right therapy for the right sub-population of patients at the right time.”

• Over time, clinical evidence suggested that those with lower biomarker scores might also benefit.

• The Herceptin cut-off has thus moved to the left over time.

• Herceptin began with a higher cut-off and fast adoption.Breast Cancer

Case Study

RespondersNon-Responders

Selecting biomarker cut-off can be complex in practice

Commercializing CDx-Stratified Medicines

Ethical Considerations

✤ Is it better to treat all who might benefit even if some or many will not benefit but still incur significant side effects (the low biomarker cut-off)?

✤ Or is it better to treat only those we are highly certain will benefit (the high biomarker cut-off) and deny care to those with poorer odds?

✤ The cut-off selection is likely case specific & quantitative analysis serves to elucidate these important trade-offs.

From this companion diagnostics-stratified healthcare study, we conclude that the biomolecular marker cut-off choice is not just an economic consideration but also an ethical one, e.g.:

© 2013 CDx Precision Health