Joyce O’Shaughnessy, MD: Let’s talk about it in the context of the CDK4/6 inhibitors. The first thing we’ve got to do is identify the right patient for the CDK4/6 inhibitor. That’s pretty easy to do these days because we’re going to use them for first-line metastatic breast cancer. If someone has recurred on an aromatase inhibitor, for example, we’re going to use fulvestrant and one of the CDK4/6 inhibitors. If they are recurring not on endocrine therapy, for example, we will generally use an aromatase inhibitor with one of the CDK4/6 inhibitors. So that’s the easy part.
We’ve got to choose among them for patients. We have 3 excellent options. As you said, the efficacy is, by and large, very similar in terms of the improvement in progression-free survival. So then we drill down on some patient-specific issues. Some of this is medical and some of it is financial. The amount of the co-pay can really matter to individual patients, so you really have to strive to get that down as low as you possibly can. So, for example, palbociclib is a very well-tolerated agent. You just have to watch out for myelosuppression. Obviously for someone whose marrow is pretty sensitive, that can be a little challenging. It’s a minority of patients, but that’s an example.
With ribociclib, for example, the issue there is that sometimes the economics of it can be a little bit better for the patient, and therefore, for the overall cost of the system. When you dose reduce from 600 mg to 400 mg because of myelosuppression, the patient pays less of a co-pay because the cost is less for that. And so, how do you think about that? In the medically integrated setting, you’re looking at the patient’s insurance and what their co-pay options are, if they are on Medicare, if there are co-pay cards available, etcetera. Do you think that can be a benefit to some patients?
Michael Reff, RPh, MBA: It certainly can be, and I think that’s one of several elements that a medically integrated pharmacy team looks at. They try to work with a team such as the prescriber, such as yourself, to provide feedback regarding when it may be appropriate to say, “You know, this patient has a comorbidity.” Maybe the pharmacist or the oral oncology nurse navigator picked up on this. It’s all in the electronic medical record [EMR]. Or maybe there’s a patient who we know has a history of poor adherence. So they’re not real compliant, right? And so, we may say that a compound that has a less-than-every-day type of dosing scheme may not be ideal. It may be manageable, but it may require a bit more hand-holding. It still might be an option of choice, but with the 3 compounds that we have, that are sort of on the shelf and are ready to be dispensed, there are nuances with each of them. Some are once-a-day dosing, while another one is twice-a-day [bid] dosing. So I think we have to take a look at that, too. And again, I think that onus resides with the oral oncology nurse navigator and the pharmacist. Again, they are a part of that medically integrated team.
Joyce O’Shaughnessy, MD: Yes. With ribociclib, we have to get 3 EKGs [electrocardiograms]. Now practices have EKG machines available and are set up to be able to get a rapid read from the cardiologist. So that actually is quite reasonable. You just have to be sure that there aren’t drug-drug interactions, for example, or a history of any cardiac conduction issues. With the abemaciclib, it’s daily dosing. You don’t take the week off. It’s not the 21 days on and 7 days off regimen, which is the way it is with palbociclib and ribociclib. But it is bid dosing. So what do you think about that, in terms of adherence issues? For some patients, I find that it might be a little easier to have them take the drug every day, depending on if they are using multiple medicines and are taking everything else every day, for example. What do you think about that?
Michael Reff, RPh, MBA: It is a consideration, for sure. But, again, is it offset by the fact that it’s every day dosing, so you don’t have to count 21 days and then 7 days off? So it’s a balance. This is one of the quality standards within the NCODA [National Community Oncology Dispensing Association] framework: talking about how frequently we are getting back to the patient. Certainly the provider, the subscriber, is seeing the patient for certain biomarkers and is seeing how well the patient is tolerating therapy. But it’s incumbent that the medically integrative pharmacy team also check back with the patient on certain elements that they need to follow up on, like some of the adverse effects that we talked about, right? For example, some of the diarrhea that is prevalent with one drug over another, or the neutropenia, or dosing. So if a patient is prescribed a compound that has twice-a-day dosing, that’s an element for which the oral oncology nurse navigator or the pharmacist should be checking up with the patient. Ask them how many tablets or capsules they have left. When did they start? Document that in the EMR. Then you know what the answer should be. If there is any discrepancy when you follow up with them regarding why it may be different, you can develop a course of therapy to help them better understand the importance of adherence.