Oral Oncolytics: Exploring Challenges in Cost, Adherence, and Management - Episode 8
Bruce A. Feinberg, DO: We’ve got a lot of different ways in which the rising cost of care is being managed. Oral [drugs] have certain tools that can be worked with, from a payer solution, that really don’t apply to infused drugs. So, we’ve seen them, but not so much in oncology. Obviously, prior authorization is pervasive across all diseases.
But in other diseases where you see a lot of high-cost biologics, like in rheumatologic diseases, [you see] step edits and drug tiering. We’re seeing different mechanisms to address it. Is it in oncology where there are not enough orals to make it a prudent choice? Is it politically incorrect? Why do you think payers haven’t really moved yet into that, and are we there?
John L. Fox, MD, MHA: I think in many states, at least 26 states, there are mandates to cover drugs. That doesn’t mean that we can’t manage them, but I think there is a fear of being in the court of law, or in a court of public opinion, in the press that’s made us demure.
I would say that we’re moving in that direction, slowly, where we’re more willing to manage the therapies and to provide oversight. I think the number of strategies that we have include making sure that in patients, for a drug that has a molecular marker, a molecular marker is indeed present. For drugs that are oral, 2-week fills, our data show that 28% of people who were started on oral cancer medication don’t refill it.
Bruce A. Feinberg, DO: So, oral cancer medication specifically?
John L. Fox, MD, MHA: Right, they don’t get a second dose. Whether or not that’s because of toxicity.
Bruce A. Feinberg, DO: Twenty-eight percent of cancer patients on an oral don’t get a refill?
John L. Fox, MD, MHA: After a 14-day fill.
Bruce A. Feinberg, DO: After a 14-day fill.
John L. Fox, MD, MHA: Yeah.
Bruce A. Feinberg, DO: Wow. Is that surprising to you?
Bruce J. Gould, MD: Yeah, that seems high to me, but I can’t say I’ve ever tracked that number.
John L. Fox, MD, MHA: So, that’s one way, and it saves half the cost of a monthly prescription. Then, every month you have that probability that a patient will stop the therapy. So, it’s a small savings, but we’re looking for incremental savings. I think we’ve moved in the direction of having preferred agents. In prostate cancer, we have a preferred agent. In CML (chronic myeloid leukemia), we have preferred agents.
Bruce A. Feinberg, DO: You do have a preferred agent now in CML?
John L. Fox, MD, MHA: Yeah.
Bruce A. Feinberg, DO: How is that distinguished for the provider, what that difference is? Is it a difference only for the member who’s going to have a different co-pay or coinsurance out-of-pocket? Or is it a difference at the provider level?
John L. Fox, MD, MHA: Well, it depends on the disease state. This applies for all diseases, but now, we’re applying it to cancer, too. Sometimes we have step therapy in prostate cancer; we have step therapy unless you can’t take the preferred agent.
In CML, we have step therapy, as well. In other conditions, we just say, “This drug may produce a better outcome, but it’s significantly more costly.” So, it’s going to be on a higher-cost tier. The member can still have it as first-line—or for whatever indicated line. They don’t have to step through, but there’s going to be greater out-of-pocket cost sharing.
Bruce A. Feinberg, DO: We talked about step therapy, and it brings up [some questions about] generics. We have biosimilars; that is going to impact the infusion world. But again, most of these small molecules are chemically synthesized. So, like Gleevec, they will be a generic. Now, you may not be seeing quite the degree of savings that you would have hoped to see in a generic, but there’s still some. So, do you see generics applying to those rules as you start to create them in these different conditions?
John L. Fox, MD, MHA: Yes, I absolutely do. I think we’re going to lock out the branded drugs for new patients, and at some point, I think we’ll lock them out completely and force a mandatory switch—especially in a AB-rated generic space.
Bruce A. Feinberg, DO: We’ve got an initial lead, at least from the FDA, in the way they apply the generic version of Remicade. It was pretty broad.
John L. Fox, MD, MHA: The biosimilar?
Bruce A. Feinberg, DO: As a biosimilar.
John L. Fox, MD, MHA: Yeah.
Bruce A. Feinberg, DO: So, I’m thinking that we target AB substitution without a lot of data. Is there concern there? If the FDA makes the ruling, you’re going to trust that?
John L. Fox, MD, MHA: I think we have statutory ability to. Actually, I take that back. I don’t think we have statutory ability to mandate the biosimilars, but I think we have the FDA standing behind us saying that these are equivalent and that they can be used in any condition. Now, it will be even a much stronger position for the biosimilars when we have an interchangeability designation. Then, I think we’ll treat that like an AB-rated designation.
Bruce A. Feinberg, DO: So, from the provider’s side, if it gets to be more scripted: “This is the drug that you have to use first, and it’s going to be the generic version of the drug,” in the case of an oral, do you think there’s going to be a lot of pushback? How do you feel about it? Is the provider community as comfortable with the FDA coming [out] with a ruling and just going with it even when there’s not a lot of evidence behind that?
Bruce J. Gould, MD: I think most doctors will be. We do use generic drugs for intravenous therapy, so I think there is some comfort level with using generics. This is just generics in a different form, and, of course, we’re used to using generics for nonoral oncolytics.
Bruce A. Feinberg, DO: You were surprised by the number on the split fill. Do you see that as another impediment to being able to deliver good care to patients when you start the prior authorization piece (which is a cost burden, as well as a delay, potentially, for initiation of therapy)? For these different techniques, you understand the “why” behind that, but do you see it as a potential burden both to the practice and to the patient? Delays in therapy, do you have an alternative?
Bruce J. Gould, MD: Well, certainly I understand preauthorization, and as long we’re able to capture those scripts, at least we’re able to recoup some of the costs that went into getting that preauthorization. With split fills, that’s a little bit more problematic for our pharmacies. Again, if it’s an even dose of 2 weeks, then a lot of times, if another patient comes in that’s getting started on that particular drug, we can use the rest of that bottle, which typically comes in a 28-day bottle. [We can] give that to another patient.
Bruce A. Feinberg, DO: So, this is just a practical side of operationalizing it.
Bruce J. Gould, MD: Right.
Bruce A. Feinberg, DO: Because you’ve got carrying costs, right?
Bruce J. Gould, MD: Exactly. There are certain drugs, once you open the bottle, that you have a certain timeframe in which that drug has to be used; if not, it expires. That’s wasted product, and that costs the practice money.
Bruce A. Feinberg, DO: We get back to the fact that you’re a big believer that community site-of-care is more cost-effective.
John L. Fox, MD, MHA: Yes.
Bruce A. Feinberg, DO: But, again, there are policies here that make it more problematic for them to run their businesses, where they may depend on that revenue stream as ability for them to stay in community practice.