McKesson Health Informatics and HEOR Vice President Sarah Alwardt expanded on how health economics and outcomes research works, and what real-world evidence brings to the table for biopharma clinical development and commercialization process.
Below are two excerpts from a Q&A with Alwardt from McKesson’s website:
How would you define HEOR as it applies to biopharmaceutical manufacturers?
Alwardt: HEOR is a very broad term that can apply to everything from drug efficacy to the value of a drug in the marketplace to different stakeholders. From our standpoint, and from the standpoint of biopharma companies, HEOR means using rich data sets to look at how drugs are being used by prescribers to treat patients and how the drugs are performing clinically with the targeted patient population. The overall intent of HEOR in this context is to answer relevant clinical questions that provide RWE and insight to biopharma companies and ultimately improve patient care.
How widely are biopharmaceutical manufacturers using HEOR to collect RWE?
Alwardt: HEOR has been around for a long time. It’s only now coming into its heyday as a method to collect RWE. Almost every single biopharma company is doing it in some form. The reason it’s coming into its own is twofold. First, the FDA has acknowledged the value of RWE in expanding the use of a biopharmaceuticals from its initial use. The initial use was based solely on clinical trial data. Second, biopharma prescribers, payers and patients have acknowledged that what happens in a clinical trial isn’t necessarily what happens in the real world after a new drug comes to market. By using HEOR to gather RWE, manufacturers can close the knowledge gap between clinical trial and real-world outcomes.