Video

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.

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.

Related Videos
Mei Wei, MD, an oncologist specializing in breast cancer at Huntsman Cancer Institute at the University of Utah.
Alexander Mathioudakis, MD, PhD, clinical lecturer in respiratory medicine at The University of Manchester
Screenshot of Susan Wescott, RPh, MBA
Screenshot of an interview with Adam Colborn, JD
Screenshot of an interview with James Chambers, PhD
Screenshot of an interview with Megan Ehret, PharmD
Interview screenshot with Megan Ehret, PharmD
Screenshot of an interview with Susan Wescott, RPh, MBA
Screenshot of an interview with Nadine Barrett, PhD
Female doctor in coat with stethoscope on blue background - Pixel-Shot - stock.adobe.com
Related Content
AJMC Managed Markets Network Logo
CH LogoCenter for Biosimilars Logo