Balancing Efficacy, Safety, and Cost in Formulary Decisions for Cell and Gene Therapies: Clayton Irvine, PharmD, MBA, MS

At a recent Institute for Value-Based Medicine® event, Clayton Irvine, PharmD, MBA, MS, discussed how ensuring value-based access to cell and gene therapies requires standardized clinical protocols, seamless coordination with local providers for patients transitioning between sites of care, and strategies to minimize financial burden. Irvine, senior manager of oncology cancer care at the Mayo Clinic in Rochester, Minnesota, emphasized evaluating prior authorization processes and leveraging support programs to offset travel or lodging costs, enabling patients to receive treatment in the most appropriate setting. Irvine also underscored the importance of critically assessing formulary inclusion for emerging therapies by weighing efficacy, safety, and both direct and indirect costs—such as hospitalization for adverse events (AEs)—and aligning therapy sequencing with pathway and economic considerations.

This is the third video in a series with Irvine.

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

Transcript

With the rapid evolution of cell and gene therapies, what are the key pharmacy-led strategies to ensure value-based access, appropriate site-of-care selection, and long-term patient monitoring?

We have to have a way to have standardized protocols, because when we're talking about, how do we care, how do we treat adverse effects, how do we monitor these patients, having standardized protocols [is important]. Those patients sometimes are going to go back home, or they may switch sites of care, or they may not have immediate access in their hometown to a higher-level center, so being able to coordinate with local providers, with community oncologists, with care closer to home is really important, and making sure that the care plan that's set up from the start is continued and followed through, and how those patients are managed. So, I think that's a big one.

I think going back to continuing to look at prior authorization, evaluating the landscape, and optimizing that based upon what is a great financial decision for the patient. We have to look at the financial part of this, because if we give a patient a therapy, and we give it in a certain site of care, but that therapy is going to cost the patient X incremental amount more, does it make sense to do that? If it doesn't, can we use other grants or support programs, whether that's travel assistance, helping to cover hotel stays, helping to cover some of those other barriers that may prevent the patient from being able to get that drug at a site that makes the most sense, not just for the institution, but also for the patient.

I think that as we see more drugs come to market, we really have to look at how we are structuring them on formulary. So does it make sense to carry every single cellular gene therapy that's on the market? Some institutions and providers may say, “Yes, it does,” and then some may say, “No, it doesn't.” But regardless of where you sit on that side of the fence, it's really important that we take a critical look to, what do the clinical trials—what are we seeing from an efficacy standpoint, safety, and then what's the economics look like? What is that financial burden, not just to the institution, but also to the patient? It's not just the cost of the drug. We need to be looking at all those indirect costs that we don't think about. What is the cost of the treatment if the patient has AEs? If they need to be hospitalized, what does that look like? We need to run those models, and we need to be making decisions and sequencing things on pathways and/or formularies that really align with some of those strategies.