Dr Steven Pearson: ICER Can Provide More Information When a Drug is Approved With Limited Data

The Institute for Clinical and Economic Review will work with drug manufacturers, patients, and clinical experts to get supplemental information of newly approved drugs, explained Steven Pearson, MD, MSc, president ICER.

Transcript

How do ICER reports help fill in information gaps of newly approved drugs?

Every drug that comes to market as soon as its FDA approved, there will always be remaining uncertainties. We work on the topic for almost 8 months before FDA approval, and during that time we have the ability to work with the manufacturer to get, often, academic and confidence information that can help supplement what’s available publicly. We’re also able to do a deeper dive into some of the results from the pivotal trials, not just to understand what the label will say but where are the grey areas at the margin or where are some of the comparative issues between this treatment and other potential comparators. So, that’s what our reports try to do, and I would also highlight that during those 8 months, we work very closely with the patient community and with clinical experts because we know that their input is really going to help flush out what we can judge by the evidence and how we can think carefully about how to apply it to coverage criteria and other policies.