An Introduction to Oral Oncolytics in CLL


Given the advent of oral oncolytics in the chronic lymphocytic leukemia paradigm, the panel of experts consider how these oral agents might fit [into] a patient’s treatment plan.


Troy Trygstad, PharmD, MBA, PhD: I’m now in your office, you’ve diagnosed me, what’s the conversation we now have? So I have this thing, CLL, I sort of understand it, what’s the next step?

Christina Patterson, PA-C: After diagnosis?

Troy Trygstad, PharmD, MBA, PhD: I’m in front of you in the exam room. Now what?

Christina Patterson, PA-C: So we’re at the point of 1) Do we treat? Or is it a watch-and-wait situation? What is our treatment plan? And the treatment plan can be observation, which seems a little odd when you’re talking about a chronic lymphocytic leukemia [CLL]. They hear those words, and it’s very scary. But we have to remember that chronic lymphocytic leukemia is a chronic condition.

Troy Trygstad, PharmD, MBA, PhD: Right, chronic and oncology, you oftentimes don’t put those two things together, right?

Christina Patterson, PA-C: Correct. But CLL is a disease state that can be watched sometimes, but you need to monitor closely for it.

Troy Trygstad, PharmD, MBA, PhD: Watchful waiting.

Christina Patterson, PA-C: Yes, watchful waiting is one treatment option. But sometimes you do need treatment, and that’s when we would decide on a treatment plan, whether [it’s] oral or IV [intravenous] treatment options.

Troy Trygstad, PharmD, MBA, PhD: Oral is another word that I don’t typically associate with oncology. We now have these oral oncolytics. How has that changed? So if I was sitting in your office 5 or 10 years ago versus now, it was different, so tell me how much different it is now.

Christina Patterson, PA-C: Very different. Ten, 15 years ago we didn’t even talk about oral oncolytics for CLL. We had very few oral oncolytic therapies for any cancer process.

Troy Trygstad, PharmD, MBA, PhD: And we were not talking about radiation.

Christina Patterson, PA-C: No.

Troy Trygstad, PharmD, MBA, PhD: So that’s off the table.

Christina Patterson, PA-C: Radiation is off the table in CLL.

Troy Trygstad, PharmD, MBA, PhD: I’m basically talking about these infusions.

Christina Patterson, PA-C: Yes, there would have been an IV. If we needed treatment for CLL, we would have talked about IV therapy.

Troy Trygstad, PharmD, MBA, PhD: And now I’ve got this option of oral oncolytics. So as I’m sitting there looking at the options, I can take this with me to my summer home. I can go through therapy. And so from your practice perspective, it’s changed how we interact and treat patients. Is that right?

Christina Patterson, PA-C: It has definitely changed our interaction with patients. It changed patients’ lifestyles also. They were coming in, say, every 3 weeks for therapy. It could have been a treatment plan of coming in for several hours once every 3 weeks for 6 treatments. Now they just take a pill every day for the rest of their life and come in for their follow-ups.

Troy Trygstad, PharmD, MBA, PhD: Interesting. So there’s another concept of it truly being a chronic disease state.

Christina Patterson, PA-C: Yes.

Troy Trygstad, PharmD, MBA, PhD: So it’s oncology with the concepts of type 1 diabetes actually mixed together. Look, this is going to be something that, until gene therapy comes around, we’re going to be doing for quite a long period of time because it’s a chronic disease state.

Christina Patterson, PA-C: It’s definitely something that we educate patients on, that this is a chronic condition.

Troy Trygstad, PharmD, MBA, PhD: So it’s doubly important in this particular space, as far as the oral oncolytics, that I can live my life and have this chronic [oncological] scenario.

Christina Patterson, PA-C: Yes.

Troy Trygstad, PharmD, MBA, PhD: What does the algorithm look like? Is it first line, second line, like other conditions? As you’re presenting these options, how do you present them? First option, second option, third option—what does that look like?

Christina Patterson, PA-C: Several years ago, I’d even say 2 years ago, we were still presenting the option of possibly an IV for 6 cycles versus an oral agent, especially depending on patients’ finances. But now with the data to support the oral agents, they have taken first line.

Troy Trygstad, PharmD, MBA, PhD: And what type of data?

Christina Patterson, PA-C: The clinical data to support the outcome.

Troy Trygstad, PharmD, MBA, PhD: OK. And are you seeing that at Mayo Clinic? You practice in Mayo Clinic, Kirollos.

Kirollos Hanna, PharmD, BCPS, BCOP: Yes.

Troy Trygstad, PharmD, MBA, PhD: In a large health system.

Kirollos Hanna, PharmD, BCPS, BCOP: Yes.

Troy Trygstad, PharmD, MBA, PhD: So you have a lot of data. What’s been your experience in a very large practice?

Kirollos Hanna, PharmD, BCPS, BCOP: So one important thing when we initially diagnosis patients is determining their comorbid states. As Christina was saying, there are 2 groups of patients. CLL is a disease of the elderly. So oftentimes these elderly patients are frailer. They’re not able to tolerate extensive chemotherapy.

The advent of oral oncolytics has given us extensive opportunities to be able to treat patients with therapies that are more tolerable, therapies that they can take in the outpatient setting, so they don’t have to come to the clinic and whatnot. Primarily ibrutinib has really changed the pace of how we treat CLL.

An important thing to also determine up front in CLL is cytogenetics, the karyotypes that these patients have. Are they deletion 17p? Are they deletion 11q? Because a lot of the cytogenetic abnormalities are associated with more aggressive disease, diseases more likely to progress, extensive lymphadenopathy, or splenomegaly. So that also helps us determine which patients we watch and see how they do—did they become symptomatic?—versus the ones who we initiate rapid treatment in.

I think historically, age was a big factor. Patients younger than 65 years old, we need to treat them; patients older than 65, we can watch and wait. The comorbidities were there as well, such as the deletion status of 17p. That was the big driving prognostic factor.

Troy Trygstad, PharmD, MBA, PhD: So what I hear you saying then is, we used to think in terms of age and risk-reward with older options. But now that we have newer options, there’s this concept of 45-year-olds who present as 65-year-olds, and there are 75-year-olds who present as 55-year-olds. We’re looking more at the specific conditions, specific variants, and the comorbidities. There’s still somewhat of a practice and an art here to what our plan of care is. It’s very individualized, it seems.

Kirollos Hanna, PharmD, BCPS, BCOP: Absolutely. So every patient is going to be different, and how we treat them is based on how they present.

Michael Reff, RPh, MBA: And I think one other thing that we all consider [are] the differences between oral agents and IVs. When you have a patient who’s going to be infused, they’re in your chair, and adherence is 100%. But with oral agents, adherence becomes an issue. So convenience and independence go up, but the risk associated with nonadherence also goes up. And then, of course, we’re talking about the medical benefit on the IV side and the pharmacy benefit on the oral side. And Christina and Kirollos mentioned the financial impacts of having an oral therapy and what that looks like to a patient. And all of that goes into the decision-making process with the provider and the patients.

Troy Trygstad, PharmD, MBA, PhD: And is it highly variable from an out-of-pocket perspective? Not generalized, but it could be any kind of circumstance with different types of payers and different types of diagnoses and circumstances and prior authorization and so on and so forth?

Michael Reff, RPh, MBA: Yes.

Kirollos Hanna, PharmD, BCPS, BCOP: Absolutely. So there are definitely different models, whether patients are receiving oral oncolytics or not, and both are expensive. Because when you look at the infusion side they’re receiving, for example, anti-CD20 monoclonal antibodies, which are nowhere near cheap. And then on the oral chemotherapy side you have these targeted therapies, which are also expensive but oftentimes with that billing model and the types of dispensing models, it all varies throughout.

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