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In this part one video, Briana Contreras, associate editor of MHE caught up with MHE Editorial Advisory Board member David Calabrese, who is market president of Health Plans/PBMs at OptumRx. Calabrese shared his thoughts on the approval of the Alzheimer’s drug Aduhelm, as well as the Biden Administration's interest in putting more generics and biosimilars in the market.
Below is a brief Q&A of the interview with Calabrese that has been edited for clarity.
Q: Were you surprised by the approval of Aduhelm?
A: Was I surprised? I'll say no. It's not the first time we've seen the FDA make decisions that have varied from what an advisory committee may have recommended. Do I agree with the decision? I'd have to say that as a clinician who's prided himself on decisions based on evidence-based hierarchy, I think I'm a little disappointed by the decision, but I am appreciative of the challenges that the FDA had in front of it. Alzheimer's is a horrendous disease - growing prevalence as our population ages, we've had next to nothing in terms of new valued options for this patient population. The evidence is very limited. The evidence is is questionable.
I think the organization is under a good deal of pressure from advocacy groups and so forth in terms of their evaluation here. I think it's now up to the payers to make the decision as to how they feel. This product should or shouldn't be covered for their patient populations based on the evidence at hand. We'll see the additional studies that are going to be done and real-world evidence that will be accumulated over time with those that are going on the product to determine the true impact of the drug on disease progression. There's a lot of unanswered questions right now. I think time will tell, but again, I wasn't surprised because we've seen similar types of decisions. This was another great example, where the data was very limited, very questionable, FDA still proceeded with the approval. Was that the right decision? I think it led to follow on drugs that are demonstrating more and more value. So, there were positives that came from that and I'm hopeful that we'll see something similar here.