Barriers for Novel Agents

Jacob Kettle, PharmD, BCOP, reviews some potential barriers to adding novel agents to the armamentarium for the management of breast cancer.

Allison Butts, PharmD, BCOP: Jacob, I’m wondering: From a more administrative standpoint, what have you gone through and what have you seen in terms of availability and cost related to the subcutaneous product specifically?

Jacob Kettle, PharmD, BCOP: Across the board, everybody shares the enthusiasm, at least from what I’ve encountered, that you and I share for what these products can deliver. The reality is that this is not always easy to implement. You’ve alluded to some of these things already. For the operationalization of these drugs, we have to build them in the EHR [electronic health record], nurses have to be educated on administration, and the pharmacy needs education on handling and preparation for those kinds of things.

Another key issue of operations as well is this: Do we have enough safety alerts in place to make sure we don’t accidentally start giving the subcutaneous product intravenously? Do we switch from that way or the other? Pertuzumab was our first time dipping our toe in this water. We had to be careful to make sure we didn’t just think, “I’ll just take the Rituxan [rituximab] off the shelf, and we’ll get that subcutaneously.” That is not how these products work. They are totally distinctive entities; it’s not just a different approved dosage form. You can’t use the product on your shelf. Those were some of the key hurdles there to go live with these, because we can’t ever overlook the financial impact. What are the payers going to do with these drugs, particularly in light of this biosimilar world we’re living in?

These are commonly used drugs that have substantial impact on the finances of an institution. While our mission is always to deliver high-quality care, we have to be cognizant of financial matters. We can’t ignore them. If we do, we’re eventually going to be underserving our community. Small changes with these drugs can have potentially substantial budgetary impacts. If there are slight shifts in costs or slight shifts in revenue, those can drive major differences in the bottom line at the end of the year.

That may change how we’re able to grow and adapt as an institution to continue to serve our community. It’s never as simple as, “A new product is available. Let’s switch everybody because it’s more convenient.” Nothing operates in that type of vacuum, so those are all the considerations you have to keep in perspective for launching these drugs.