Academic–Community Partnerships and Real-World Data in Value-Based Oncology: Jason Bergsbaken, PharmD, MBA, BCOP

At a recent Institute for Value-Based Medicine® event, Jason Bergsbaken, PharmD, MBA, BCOP, emphasized that real-world data are increasingly essential in pharmacy decision-making to both validate the adoption of new therapies and guide de-implementation when treatments fail to deliver expected value. Although randomized controlled trials remain the gold standard, he noted that accelerated FDA pathways can shorten premarket study periods, making postapproval surveillance critical. Bergsbaken, interim manager, oncology pharmacy at UW Health, and clinical assistant professor at the University of Wisconsin-Madison School of Pharmacy in Madison, urged vigilance, local and multicenter outcomes tracking, and widespread dissemination of findings to identify trends.

On the operational side, Bergsbaken highlighted the importance of academic–community oncology partnerships to reduce financial and time burdens for patients, address infusion center capacity constraints, and determine the most appropriate care setting based on treatment complexity, ultimately striving to keep care as close to home as feasible while maintaining high-quality outcomes.

This transcript was lightly edited; captions were auto-generated.

Transcript

How can real-world data be more effectively incorporated into pharmacy decision-making to support both the adoption and de-implementation of therapies that may not deliver expected value in practice?

Real-world data are very important, probably increasingly important right now in our environment. We think about how we as clinicians would like to see agents studied. Certainly, a randomized controlled trial is still a gold standard. It really provides ideal conditions for how we study efficacy and safety for agents as they're approved. That said, some randomized controlled trials might capture some real-world things that that we need to account for, such as diversity of the population, adherence, and things of that nature. The other thing I think is really important with real-world evidence is that, increasingly, via the various FDA pathways, we are seeing agents come quicker to market. Overall, I think that's really a good thing for patients or giving them hopefully quicker access to life saving therapies. But that might shorten the time that we study that agent. It's really important to kind of survey that agent on the market.

In terms of our approach, I think number one is just vigilance. As these new agents are approved, I think being curious and really trying to understand what patient outcomes are when they ultimately are approved and seeing any trends, really, at the local or institutional level. I think at that point certainly we're seeing increases in institution-specific studies and trying to look at in the real world how these patients are doing. Then hopefully continuing to find ways, really, from a multi-center approach, to try to better illustrate and identify some of the trends.

Then I think, lastly, we all have a responsibility to kind of report that presentation [through] publication and coming to our avenues to share that out and make sure that if we're seeing something at the local, institutional level, that we're broadcasting that, and we're seeing trends across the entire market.

How can academic and community oncology partnerships collaborate to reduce financial toxicity, manage drug shortages, and optimize infusion center efficiency while navigating reimbursement challenges?

Partnerships between academic and community centers are very important. For myself, working in an academic health system, we very much value our community partnerships and our community relationship. You really think it's really a 2-way street in terms of how we manage our patients.

Certainly, I think when we think about how we manage our patients and how they want to be treated, many of our patients would prefer to be treated as closely to home as possible, and we're always looking to minimize financial or time toxicity, and really account for the time that it might take to come to large academic center like ours. We really want to partner with patients and understand what's going to work best for them.

In terms of some of the specific challenges—you mentioned infusion centers and capacity—I think that continues to be a challenge at a lot of our centers. We're increasingly looking to partner between academic and community sites to understand how we alleviate those challenges, and again, treat the patient as appropriately and close to home as possible. Our agents are increasingly complex. We want to understand based on the unique requirements and complexity of the treatment, where is the most optimal setting to treat that patient, and maybe in the community that may be in the academic center, but that's really why we need to partner really, to try to optimize that care setting.