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…

Optimal Matching Techniques

In randomized controlled trials, participants are randomized to different groups where each group receives a unique intervention (or control). This process insures that any differences in the outcomes of interest are due entirely to the interventions under investigation.   While RCTs are useful, they are expensive to run, are highly controlled and suffer from their own…

The AMA on value-based drug pricing

The American Medical Association released a statement yesterday in support of value-based pricing of pharmaceuticals.  However, AMA claims that value-based pricing should follow the following core principles. Value-based prices of pharmaceuticals should be determined by objective, independent entities. They also should be evidence-based and the result of valid and reliable inputs and data that incorporate…