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B-Cell Malignancies: Coverage, Access, and Cost


In-depth considerations for the coverage, access, and cost of novel therapeutic agents used to treat B-cell malignancies.


Michael A. Kolodziej, MD: Payers historically have defaulted coverage policy to FDA label and compendia listing. Now, over the years, there have been a number of CMS recognized compendia. The reason that’s important is because CMS coverage policy is actually dictated by law. Commercial payers technically are not bound by that same law. However, the majority of states have passed rules from the insurance commission, if you will, that require the same coverage policy for commercial payers. The way it stands now is that commercial payers would pay for FDA labeled indications and they’ll pay for compendia listing. And, as it turns out, these days National Comprehensive Cancer Network [NCCN] compendia are the most commonly referred to, and it’s been that way for years. Yes, they clearly pay close attention to what it says. They pay close attention to what it says in the guideline. They pay close attention to what it says in the footnotes. They pay close attention to what it says in the text. And of course, they pay close attention to the compendia, which are a derivative of the guidelines.

Now, we should be very clear that coverage is different than access. Let me explain what I mean by that. Coverage means the insurance company says, “We cover it,” but there’s been a lot of discussion about having preferred agents. It doesn’t mean the non-preferred agent is not covered. It might be covered, but access is dictated by let’s say formulary placement or placement on the pathway or something like that. We have not seen a ton of that yet, but as we’ll discuss, in patients who are being treated for chronic lymphocytic leukemia, there are actually a lot of treatment choices now. And there are multiple drugs in a class. And that opens the opportunity for payers to consider access and specifically favoring 1 agent within a class over another if they’re otherwise pretty much interchangeable.

There were some interesting presentations at the American Society of Hematology [ASH] meeting regarding durability of response, regarding management of toxicity, and regarding combinations that heretofore have not really been in the mainstream. Some of those presentations are very interesting. For example, we had a presentation on the durability of ibrutinib in mantle cell lymphoma. It’s pretty durable, which is good. I don’t have a dog in this fight, so I look at this and I think, well, that’s probably class effect, right? It’s probably going to be true of acalabrutinib and zanubrutinib. Whether 1 is going to wind up being superior to another will remain to be seen.

I think the other thing that’s interesting about that class, for example, is whether there are going to be toxicity differences because they really are different agents. The toxicity profile may ultimately impact the drug of choice. And then of course, we haven’t even started talking about cost. These drugs are very expensive. On the one hand, durable is good. On the other hand, durable means cumulative cost is high. We have this tension right now in hematological malignancies between a concept that we have fallen in love with the last few years, which is turning cancer into a chronic disease, and we’ve flipped that on its ear and are thinking about, can we actually cure some of these cancers? That’s the chimeric antigen receptor T-cell therapy [CAR T] approach. So we’re going to continue to experience this tension.

It’s so interesting to me because as you may know, Institute for Clinical and Economic Review [ICER] looked at a cost effectiveness profile for the CAR T therapies. And they looked at milestones and projected durability and whether CAR T would be cost-effective at different time points. And there’s clearly a point at which it becomes cost-effective if it’s that durable. The problem is we don’t know right now if it’s that durable. It costs a lot of money up front. That’s a whole different issue regarding healthcare financing. But if you could offer a therapy and cure the patient, is that theoretically a better approach than taking a pill every day forever? And I think a lot of people would say, yes, that’s better. We’ll see.

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