Approaching Access to Oral Oncolytics in CLL


Evaluating the current state of coverage for oral oncolytics in chronic lymphocytic leukemia, the panel of experts share insight on the process of attaining access to these therapies.


Troy Trygstad, PharmD, MBA, PhD: It sounds like this is a hodgepodge though. Is that accurate? It sounds to me like this is ever changing. It’s part of your practice, which is, “OK, once we have diagnosis, once the treatment is this versus that—I’m on oral oncolytics—now my differential on adherence is forgetfulness, etc, etc, or lack of access to being able to procure it because of financial circumstances or coverage.” Now I’m down that pathway, and there’s a whole myriad of ever-changing patient adherence programs with respect to patient access, co-pay, or foundations. That sounds like a lot of work.

Michael Reff, RPh, MBA: And so it’s a lot of work. And I think 1 thing is having that capability and that commitment at the practice level certainly has helped patients. And from discussions that we’ve had with payers, they are interested in the level of support that we the practice provide to our patients. So tracking and having metrics around co-pay assistance, free drug, foundation support, and all the different vehicles that can help a patient afford their therapy in a practice-tracking app, and being able to communicate their story for doing the right thing for the right reasons are important because what I’ll say is that not all stakeholders in this space, including some of the mail-order pharmacies, offer that level of support for patients to uncover all the financial support. And we, with our quality standards, have got the commitment to provide that, and we call it passionate financial support.

Troy Trygstad, PharmD, MBA, PhD: So just the whole construct then. As Christina was mentioning, 10 to 15 years ago, we got into a mold, into a steady state, with how we treated cancer with respect to radiation or infusion. Then came along the oral oncolytics and a totally different insurance construct, particularly in the elderly, right? Because most of these patients are going to be Medicare Part D or legacy pension products. And so is this Part B, Part D? How does that change now that I’ve got these oral oncolytics. We’re used to procuring it this way; we’re used to billing it this way. Now we have these products. A similar circumstance happened with zoster in the immunization space, where, wait a second, it’s covered in a different place. But what did that mean then for this being mostly covered in Part D for these practices? It was a change of direction, right?

Michael Reff, RPh, MBA: Yes. And again, that goes back to what we were speaking to earlier in our conversation. The fact that the practices have been very good at doing IV [intravenous] therapies for decades. They’ve been in practice for a long time.

Troy Trygstad, PharmD, MBA, PhD: It’s what they’re used to.

Michael Reff, RPh, MBA: And all of a sudden, here come these orals—and they came in a flurry. And we realized that they’re efficacious. There are adherence issues. There are toxicities. We need to help manage that, and now there’s this financial piece that is totally different.

Troy Trygstad, PharmD, MBA, PhD: So if I’m the office manager, I call up Mike and say, “No, you need to come over here and help us. I’ve got Christina saying that we want to use these and they’re good for our patients. But we don’t know how to handle this. We’re used to this other way of doing things,” right? Is that the experience you went through?

Christina Patterson, PA-C: Oh, yes. And I have physicians say, “Well, we want it, and the patient needs it. Make it happen.”

Troy Trygstad, PharmD, MBA, PhD: What sort of additional people and offices are needed? You have financial counselors now, you have staff that tried to figure out patient assistance programs. What’s the additional work and infrastructure of people now that need to be in place in order to successfully allow these patients to thrive on these treatments?

Christina Patterson, PA-C: In our practice, we have a patient financial advocate, a financial counselor, and she helps with both oral and IV therapy. But then in more of our medically integrated dispensing, we have staff there who help with our fills within the practice but who also help all of our patients outside oral oncolytics.

Troy Trygstad, PharmD, MBA, PhD: Right, because now you’ve got pills somewhere in the practice.

Christina Patterson, PA-C: Yes.

Troy Trygstad, PharmD, MBA, PhD: You’ve got to figure out how to get those pills. They may or may not be from the same wholesaler or mechanism or whatever else. Now I’ve got to figure out how to send a claim for these new products. I’ve got new software. I need to figure out now how to have people in services who are on the phone doing proactive or virtual outreach, perhaps, or something that’s coordinated with the practice. It sounds a little bit like practice transformation that’s occurring here. Does that sound right?

Christina Patterson, PA-C: Yes. So basically we have the IV side and the oral side within the practice. You’re working altogether, but you have to have staff to handle all your oral therapy.

Troy Trygstad, PharmD, MBA, PhD: Sounds a little bit like The Matrix. We now have the green pill and the blue pill.

Kirollos Hanna, PharmD, BCPS, BCOP: For example, in our practice at the University of Minnesota Medical Center, in 1 of our clinics we have over 550 patients on oral oncolytics. And there are 3 financial coordinators who break up the alphabet and handle these patients, whether it’s a patient with a commercial plan, a Medicare patient, an underinsured patient, or a noninsured patient. These personnel need adequate training to be able to identify which foundation they should go to—or which resource—to be able to find financial support for these patients. Because these are thousands and thousands of dollars’ worth of medication, and obviously it’s really important for those patients with aggressive disease to start as soon as possible. And then you run into problems, again supporting the medically integrated systems. You run into problems from year to year. So when patients have insurance changes, the new insurance may require something, they may require a new PA during the year. If patients have a job shift or a job change and new insurance plans, got on the spouse’s insurance, or experience anything like that—all support—that’s why having that 1 umbrella for patients is really, really important in their care.

Troy Trygstad, PharmD, MBA, PhD: What about transition from private living circumstance to institutional care or assisted living? Is that another place where you say, “OK, now I’ve got a whole new group to coordinate with frequently in this area”? Let’s say I’m a patient, and I come into your practice, Christina. I meet with you in the exam room. You tell me, “The bad news is you’ve got CLL. The good news is you have these options. Now you can still go down to your summer home in Phoenix,” and then you say, “So it looks like you’re on X commercial plan, and I’m going to have you talk with this patient assistance person.” What does that typically look like for me? It looks like I might get assistance from a manufacturer, and it isn’t based on my income. What are my options if I’m in the nonpublic-payer space?

Christina Patterson, PA-C: So first we always check with the insurance group. Most commercial plans, most insurance providers, require prior authorization. So first of all, staff go through obtaining a prior authorization.

Troy Trygstad, PharmD, MBA, PhD: All the typical work that says, yes, they should get this medication.

Christina Patterson, PA-C: Yes.

Troy Trygstad, PharmD, MBA, PhD: P&T stuff.

Christina Patterson, PA-C: Yes. And then we check how much the co-pay would be because, again, the drugs are expensive, so co-pays are usually higher. And then we work out all possible options for the patient. Is there a co-pay assistance card through the manufacturer? Are they eligible for that? Is there any foundation assistance, any grants they may be eligible for? And then the other thing we look for then is free medication through the manufacturer.

Troy Trygstad, PharmD, MBA, PhD: OK, so I can go to the manufacturer for a program to reduce my out-of-pocket expenses. I can look at a local foundation, or I can ask the manufacturer for grace, so to speak.

Christina Patterson, PA-C: Yes.

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