B-Cell Malignancies: Cost and Integration of Novel Therapy

Due to cost of novel therapeutic strategies, an expert shares insight on how these agents could be integrated into treatment pathways.


Michael A. Kolodziej, MD: One of the presentations at the American Society of Hematology [ASH] meeting that got a lot of interest was the combination of venetoclax and ibrutinib. Now, this idea of putting together drugs is older than I am. It’s been around forever in oncology. Choose 2 pathways that are different, nonoverlapping toxicity, put them together. And the preliminary report on that combination is promising. Here’s the problem. You take one drug that’s $12,000 and another drug that’s $14,000, and now we’re looking at $26,000 a month. For how long, we don’t know. And how much better is worth it better?

So the challenge I think as we move forward is, and this is actually well exemplified in the chronic myelogenous leukemia [CML] space, there’s little doubt that the second and third-generation tyrosine kinase inhibitors [TKIs] in CML are a little bit better than Gleevec, than imatinib. It’s imatinib now. It’s generic imatinib and in fact, although it took a little while, the price of generic imatinib has dropped a lot. It took actually several years, and people were freaking out but it’s resolved.

So, if you come to me as a payer, I know that through access, I’m going to give you access to those later-generation drugs but imatinib is so good. So what we’re going to see I think is this replay in combinations. We have a wealth or riches right now in these diseases. We’re going to figure it out from a clinical standpoint and then we’ll start thinking about the money. It’s so interesting. In multiple myeloma, which we started with at the very, very beginning, there has been so much new stuff, it’s almost unfathomable. I stopped seeing cancer patients about five years ago. As I’m frequently reminded by my wife and friends, I wouldn’t even know how to treat a patient with myeloma anymore. There’s a lot of truth in that.

I hate to say it’s not possible to get it wrong, that’s a little bit of exaggeration, but there are a ton of very effective therapies out there. We have a million effective therapies, they all cost a lot of money, and we haven’t the foggiest idea how to sequence them or which biological markers predict response to one versus the other. And now we’re going to have 2 or 3 chimeric antigen receptors [CAR] T-cell therapies by the end of the year and that’s going to change everything. So to me, I guess it’s a little bit challenging trying to balance the desire to get access for patients to these tremendously effective drugs yet recognizing that we’re making it up as we go along. I hate to say it. But it may be that it doesn’t matter. It may be that it does.

Regarding the issue of how the National Comprehensive Cancer Network [NCCN] is going to tackle this, how pathways companies are going to tackle this stuff, I think they’re struggling like the rest of us. NCCN has always had the perspective that they want to make sure that they acknowledge all effective therapies. They’ve never really been in the pathways business, that’s not their thing. Now, they recently have become more interested in the value proposition. Initially it was evidence blocks, there were categories of preference. So they’re interested in it, but especially the categories of preference are really focused on efficacy, overwhelmingly.

I don’t know about pathways companies. I think we’re going to have a period now, a transition period, where evidence is immature, incomplete. We’ll know enough such that we’re giving good therapy to the patients. We won’t know for a while what the best therapy for our patients is. It’s different. It’s so funny, it’s completely the opposite of the way it used to be when I was a young oncologist and we had nothing that worked. We’d try to find treatments based on our best available evidence and best available reasoning to treat our patients. Now we’ve got a lot of therapies that work. We just don’t know how to line them up. I’m actually hopeful that our understanding of the biology will improve our decision making. So we’ve already talking about deletion 17p in CLL. There’s some preliminary evidence that there may be similar genotypic mechanisms for determining optimal therapy in myeloma, if we could possibly get our hands around what molecular markers predict who should get what.

The other thing is that I think we may see some changes in considering paying for patients in a more global way. So we pay for drugs now one at a time or in combination sequentially, right? So you could imagine me saying, “Dr Kolodziej, you’re going to get this much money to take care of your patient with CLL, choose wisely.” And we may see that evolve. Of course, the fear is that if the number is set too low, patients will be harmed. We want to avoid that at all costs. But, on the other hand, we do want to promote and encourage value-based clinical decision making. So, if you don’t need to give a super-expensive combination of specialty drugs, you shouldn’t do it.

And I think that’s going to evolve. That’s going to take a little while to evolve. But I think there’s some evidence that we are headed in that direction, and so that will impact us. And then of course there’s the patient. How would we forget the patient? Financial toxicity is a huge issue right now. We need to deal with how much patients have to pay for these drugs. So, if you have commercial health insurance right now, you’re out of pocket is capped. That doesn’t mean it’s trivial, it just means it’s capped at $6000 $7000, $8000. That’s a lot of money. If you’re a Medicare patient, as of today, it’s not capped. If you’re a Medicare patient who has Part D coverage, you have to pay the catastrophic portion of your specialty drug, which is 5% and there is no cap. So just think about that for a second. You’re a retiree Medicare beneficiary, Part D, and you have to go through the initial phase and the donut hole and all that and then you’ve got 5%. So 5% of $150,000 a year is $7500. Of course, it’s more than that because they have to pay their initial phase of therapy.

There are, of course, bills in front of Congress to try to fix that. I would say that even in today’s political environment, it is likely that that will get fixed. There will be a cap in Medicare Part D, but I think the impact of these novel therapies on patients’ finances hasn’t gotten as much notice or attention as perhaps it ought to. But I think the pendulum has swung in the direction of it is going to become very, very important.

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