Jay Andersen, MD, shares his perspective on breast cancer treatment and potential barriers to care.
Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: In terms of CDK4/6 selection, does that drive anything in your practice? In that early-stage patient, you may be limited by an FDA approval, but from what we learned in the metastatic setting and the differences of tolerability there, how does that impact your treatment decision-making for that patient?
Jay Andersen, MD: Again, to comment or to clarify, in the metastatic setting we have 3 choices. Early-stage, we have 1 as of now so we don’t have options in the early-stage setting. Curious and excited to see the NATALEE [NCT03701334] data, and that may potentially offer another opportunity. And if it does, then we have to compare and contrast the data and the adverse effect profile as we already do in a metastatic setting. As we have already alluded to, the PFS [progression-free survival] data is largely very consistent in metastatic disease. The OS [overall survival] data with ribo [ribociclib (Kisqali)] is favorable in the metastatic setting. How that will translate in the adjuvant setting with longer follow-up, we’ll have to wait and see. We already referenced diarrhea with abemaciclib [Verzenio]. I find that largely manageable with appropriate patient education and dose finding in that first month or so. In monarchE [NCT03155997], I think 40% of patients had to have a dose reduction, and I think it was 16% that had to discontinue the drug. So we navigate issues like that day in, day out in clinical practice. Ribo [ribociclib] does not have diarrheal issues. There’s a slight instance of QT prolongation. I believe it’s under 2%, but it warrants an EKG [electrocardiogram] at baseline, day 15, and day 30, which is very simple to do. So there are some nuances I think and adverse effects that I think largely we navigate. The neutropenia, leukopenia issue, I think we know how to manage that. There’s a very rare incidence of febrile neutropenia. It’s a matter of monitoring their counts, especially in the first 2 months, and dose modification if needed. But usually, there’s not a clinical sequelae related to that.
Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: In terms of the QT prolongation with ribo [ribociclib], I’ve seen one of those thumb QT readers that’s available from a pharma partner, which is really interesting to see. And it’d just be interesting to just expand that for other therapeutics in that space. In terms of access and cost, obviously, again in that front-line setting, we only have 1 option. But do you see cost or access in the metastatic setting between these 3? Are there any trends toward 1 over the other based on those kinds of things? Obviously, these are oral oncolytics, all branded products. Everybody’s going to have copay assistance, some type of voucher program, and so on. But [are there] any trends in your practice around access to those?
Jay Andersen, MD: I’m blessed to have a very aggressive, helpful oral therapy program, so I write it and they manage it. I usually don't hear of huge barriers, but there certainly can be differences between patients and copay costs. I’ll point out, I think one convenience with ribo [ribociclib] is dose reduction is easier in the metastatic setting because you just drop 1 pill if needed. You don’t have to write a whole new script. For the other 2 agents, if you’re going to dose-reduce, you likely have to write a new prescription. I’ve had some patients who were not super happy that they just refilled with a new copay. So I think dose reduction, which is common across this entire class, is easier with ribo [ribociclib].
Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I think from an access perspective, sometimes it’s not our specialty pharmacies filling those prescriptions. They’re going out, and I think that also creates some barriers there, especially if you are having that patient experiencing diarrhea or neutropenia and you’re trying to see them in clinic before prescribing their next cycle. But if that prescription isn’t coming in from your site, you’re sometimes having to preemptively start that process because you know it takes about a week for that patient to get it. But then they come and see you, and they do have that diarrhea or that neutropenia that requires you to dose-reduce, which I think again poses some challenges for us.
Samyukta Mullangi, MD, MBA: I have a question, actually. In the event that you do have a medically-integrated specialty pharmacy, do you guys have any policies or protocols that say no automatic dose refills until you’ve seen that patient for a follow-up so that you can make those dose adjustments?
Jay Andersen, MD: I don’t know that we have an across-the-board blanketed statement on that. But I think the team is fairly well-educated, especially in the first 2 months. They have regular communication, so I think they tend not to refill until they know they have a follow-up. I’ve had a few exceptions though.
Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: That’s an excellent question, Sam, and I can speak to that a little bit. Oral oncology support across the country really varies significantly in how that infrastructure is designed. Some really great programs that I’ve seen work well. No. 1, obviously, integrate some type of pharmacist support, whether or not those patients are filling at your institution or not. So even when they’re going to PBMs [pharmacy benefit managers] and larger pharmacies externally, the pharmacists can still support and mitigate some of those challenges. I have seen institutions where the standard of prescribing oral oncolytics does not include refills. So it helps more micromanage that prescription versus an external pharmacy just going on an auto-refill kind of policy. Now, an imatinib [Gleevec] CML [chronic myeloid leukemia] patient who’s been on treatment for 5 years, sure. You could give them a year’s worth of refills versus this space. I think we do—we should be managing it more closely. And I have even seen some institutions implement some type of collaborative practice agreement with their pharmacists where there’s a grading system or an algorithm. If a patient calls their pharmacist at that site and it’s a grade 1 diarrhea, the pharmacist could recommend some Imodium over the counter. Or if they simply need a refill on their antinausea or antiviral medications on a myeloma regimen, something of that sort, it really takes that burden off of some of our physician providers. So again, this is 1 site that I’ve seen. But I’ve seen so much variability across the country.
Transcript edited for clarity.