Precision Benefit Design

A recent viewpoint from Fendrick and Shope (2018) argues for the need for Precision Benefit Design. Successful implementation of precision medicine will need to address several system-wide challenges, including administrative complexities, the creation of new financing models, and aligning provider- and patient-focused initiatives. The enormous clinical potential of precision medicine sheds light on the critical…

Precision medicine will increase drug prices and that’s a good thing

Check out my latest article at MedCity News looking at how the advent of precision medicine will affect patients, regulators and payers. The article describes how precision medicine will be good for patients.  Precision medicines will likely be more expensive that regular therapies, but–because they are targeted to more specific populations–aggregate spending on pharmaceuticals could increase…

How to regulate precision medicines

Currently, pharmaceutical treatments that are used in the U.S. need to gain an approval from the FDA.  The FDA’s approval is contingent on a demonstration of efficacy and safety in a randomized controlled trial (RCT).  However, precision medicine makes the standard FDA approval problematic. As described in Breckenridge et al. (2016), in the precision medicine…