Given the importance of patient adherence in any disease paradigm, the panel of experts consider how patient adherence in chronic lymphocytic leukemia might be improved or circumvented in oral oncolytics.
Troy Trygstad, PharmD, MBA, PhD: Let’s talk about adherence. So you would think that adherence is top of mind for any patient. I’m not well into the oncology space, but I’ve seen a number of instances in every practice, the type that I’ve been in and around, where severity of disease state doesn’t necessarily translate to perfect adherence. And so what I hear in this space is not only do you have a dynamic care plan, a dynamic regimen that’s requiring feedback and adjustments based on constant contact with the practice, but you’re also relying much more on the patient to follow this dynamic care plan. So I would imagine that this practice change that you talked about, over the last 10 to 15 years, to oral oncolytics is good for patients—better options, better treatment, better outcomes, better quality of life—but you’ve had to add some medication supports—adherence reinforcements—to the practice. What does that look like in your practice?
Christina Patterson, PA-C: First, we definitely have our education classes. We educate the patient. We also do follow-up calls to our patients for day 8 once they start. We do a risk assessment of the patient and the treatment. And depending on the risk assessment of the individual patient, as well as their treatment, we will decide if we need more follow-up calls or to actually bring the patient in for more nursing assessment. Depending on the patient, do they need to come in more frequently for labs whether it be depending on the medication or the treatment. We were talking about venetoclax. There’s a whole different treatment dynamic there versus ibrutinib. You may see them every 2 weeks at the beginning and then once a month, whereas with venetoclax you’re going to see them more frequently at the beginning with all the labs and hydration. So we have built our regimens off that and our patient factors.
Troy Trygstad, PharmD, MBA, PhD: Unfortunately the conventional thinking in the broader health care system is when you say precision medicine, they automatically think drug product. And so we do have these tailored medications. But as you describe that, that makes me think that precision medicine really has an intervention and human-support aspect to it as well. Because what you’re describing is, these are really individualized care plans, and they’re dynamic. Yes, there’s the precision aspect of immunotherapy, and it’s targeted, and there are biologics and gene therapy. But there’s also this aspect that we don’t want to lose sight of, which is the precision medicine in you and your circumstance—your financial circumstance, your comorbid circumstance, your lab circumstance, your phenotype circumstance—such that we actually need to administer this drug and follow up with you in a very individualized way. So that’s the precision medicine support part of the precision medicine product. Accurate? Is that the Mayo Clinic’s view of things too?
Kirollos Hanna, PharmD, BCPS, BCOP: Absolutely, and that’s actually very important in CLL, because when you think about CLL being a disease of the elderly, 40% of patients are over 75 and 30% of patients are over 80 at diagnosis. So when you look at this patient population, really risk stratify the patient groups and determine your adherence. So when you look at different oral oncology practices, some sites in my practice, definitely some might risk stratify patients and determine how frequent they need to follow up with patients. Whereas some just have a standard. We will call this patient prior to each refill and just see how they’re doing this month, this month, this month.
Both ways have never been compared, but both ways are optimal ways to really manage these patients. So yes, this model is very appropriate in the management of patients and speaks volumes to the importance of having the medically integrated models. Because everyone will have hands on this patient.
Michael Reff, RPh, MBA: The comments that my 2 experts shared speaks squarely on the NCODA quality standards and the sharing of best practices where 1 size doesn’t fit all if you’re talking about a particular product in patients. Both provided great examples of when practices, back when orals were just coming out, were thinking that a weekly call or 1 call was good enough. And then you find out once you get experience with the compound that maybe that’s not good enough, and we share best practices across our network on how to best take care of our patients. And so those are some great examples.
Troy Trygstad, PharmD, MBA, PhD: So what are some specific interventions? The differential diagnosis and support and adherence to needs? What does an intervention look like in your practice specifically for a patient? So I’m a patient, and you tag me as at risk for this type of nonadherence related to forgetfulness, because I have dementia and I live home alone. Do you have a program for that particular type of risk?
Kirollos Hanna, PharmD, BCPS, BCOP: Yes. So we actually have really interesting things going on. So I practice both at Mayo and the University of Minnesota Medical Center. So at the university there are a couple of interesting things. So we ensure that every month a patient is touched by a pharmacist, at least for the first year of therapy. During cycle 1 or cycle 2, as Christina said, we call them on day 8 or a week into therapy and really follow them closely and then go on a monthly basis if they’re doing OK.
We help coordinate their labs. So we have a flow sheet that we document. And in that flow sheet we’re able to document the start of a cycle, when the next cycle would be due, the number of missed doses, the adverse effects that were reported by the patient, and what type of interventions were taken to address these adverse effects. We also document whether it was an easy intervention, such as a pharmacist prescribing some Zofran on behalf of the provider, or if the patient required to talk to a midlevel provider or a provider themselves to address something.
The University of Minnesota is 1 of the first cancer clinics that’s trying a technology called Proteus. Several people may be familiar with Proteus outside the oncology space. There are over a million administrations outside, where they’re able to encapsulate a pill, and the patients are able to take this medication. Also, patients will have a patch. So that encapsulated pill and the patch are able to communicate to a smart device, oftentimes their smartphones or an iPad, and this is transmitted to a portal.
So on this portal the pharmacists are able to access this information, and they’re able to see, “Oh, my patient was supposed to take 1 pill versus 3 pills. Oh, they didn’t take the dose today,” or, “They took 2 instead of 3. They’re supposed to take the medication twice daily, but they took it only once. They missed this dose.” Or, “This patient is frequently taking their medication 3 hours early, and we’re noticing more hand-and-foot syndrome,” for example, as with Xeloda. And we’re able to assess this adherence this way and really intervene when needed. This is in very early stages, and this is, again, the first time in oncology that we’re trying such adherence parameters or adherence monitoring. But it’s exciting.
Troy Trygstad, PharmD, MBA, PhD: Yes. This sounds to be like a medication adherence EKG [electrocardiogram] concept. Right? So I can read the EKG and say, “Now I know what’s going on,” and we can really tweak medication. So, Mike, these are all great services that any policy person would look at and say, “Well, this is great, but how do we finance these activities?”
Michael Reff, RPh, MBA: Yes, that’s a great question. Financing activities. I was going to build on the adherence question of what some of the things are that we have in place to help out with adherence. And we know, based on studies, that 1 of the major reasons for nonadherence is the financial impact to the patient and whether or not they can afford it. And you know, as co-pays go up or out-of-pocket expenses go up, adherence goes way down. Have a system and be medically integrated and have a commitment to uncovering all the resources, whether you’re a commercial patient and you have co-pay cards that are available or whether you are a Medicare patient and you look for foundation support, whether it’s through the national foundation alliances or through advocacy organizations or some of our own practices.
Troy Trygstad, PharmD, MBA, PhD: So I’ve got manufacturers that might provide programs for those who would be eligible. I’ve got local foundations that might be the equivalent of the Jimmy V Foundation for my local area, much as hospice agencies have these as well.