Peter L. Salgo, MD: Let’s talk about some specific criteria, if you can. What are the criteria that you would use as a payer to determine coverage for aflibercept and ranibizumab—those 2 drugs to start— whether or not you’re going to cover them at all versus please start with something less expensive?
Gary L. Johnson, MD, MS, MBA: It’s basically whatever the label says. We would cover it to the label, and certainly for Medicare, they’re covered according to the label.
Peter L. Salgo, MD: What about Medicare Part B versus commercial coverage? Is there a difference?
Gary L. Johnson, MD, MS, MBA: In our plan, essentially the answer is no. We try to keep them the same.
Peter L. Salgo, MD: What about your plan, is there a difference between commercial coverage and Medicare Part B?
Peter Dehnel, MD: When you say commercial, unfortunately, that’s not just a single policy.
Peter L. Salgo, MD: You mean there’s not just 1 carrier in the United States?
Peter Dehnel, MD: Not even within my plan can you say, “Well, this is a Blue Cross plan,” because you will have many variations of what’s covered at what rate, and it’s a very challenging experience.
Jared Nielsen, MD: About the label, it’s interesting that the label really defines how these plans, or these policies, are administered, and one of my frustrations as a retina specialist is that the labels are crafted from phase III trials. The phase III trials aren’t there to determine how we’re to use this in our clinics, they’re there to get FDA approval. So, as a person who has been involved in designing these trials and executing these trials, we’re looking for safety and efficacy approval of the FDA. We include a very narrow window of patients, and they’re on a structured regimen of treatment, but not every patient will fit into that. And that’s a challenge when you have somebody who does not fit the label—a large majority of the patients in our clinic can fall into that category if you look at the strictest guidelines for it. It’s a challenge to then have to deal with a policy that is crafted solely after the label.
Gary L. Johnson, MD, MS, MBA: What I should have said is that we start with the label. We also, if it is something that is off-label and payment is requested for it, look at the medical compendia. And if there’s evidence in the compendia, then we will also cover that. In fact, for Medicare, we’re obligated to cover a compendia list of products.
Peter L. Salgo, MD: I guess what you’re saying is that a lot of the trials are there to get approved, but they’re not necessarily clinical guidelines going forward.
Jared Nielsen, MD: I’ll take a personal example. I treat a 92-year-old gentleman. He was a war veteran physician. He’s retired now, and he just happens to have bilateral lesions that require treatment every 3 weeks. If we go without it for 3 weeks and 3 days, he has loss of vision. We see exudative activity. We have correlation between his anatomy and the vision. And yet, I have this payer pushing against me to prevent him from getting the treatment that he needs to continue to see in both eyes.
Gary L. Johnson, MD, MS, MBA: Are they restricting the number of injections?
Jared Nielsen, MD: Correct. And the intervals between the 2.
Gary L. Johnson, MD, MS, MBA: The intervals?
Jared Nielsen, MD: If they say, “Well, it’s 21 days rather than 28 days; this is not a covered service.”
Gary L. Johnson, MD, MS, MBA: Speed dial.
Jared Nielsen, MD: I’ve dialed that number a bunch of times, but it’s always busy and no one responds to my email. Our specialty side is really helping to try and get involved.
Gary L. Johnson, MD, MS, MBA: That’s a no-brainer, of course that person needs it every 3 weeks.
Jared Nielsen, MD: Then, you mention the labels. There’s no label for Avastin (bevacizumab), so you think, “Maybe I can fit an Avastin treatment in between.” Well, there’s a policy against that. And that makes no sense if you’re saying, “Well, our policies are label-driven,” while we have something that has no label for our use. We should have a lot more freedom to use that, but really that’s not the case either.
Gary L. Johnson, MD, MS, MBA: And the dosing frequencies are much more loosely defined than the indication.
Jared Nielsen, MD: For this gentleman who’s dependent on these medications, our practice has to make a decision: are we going to let this person fall to his policy, or are we going to step up and bear the burden of the cost of his treatment? And that’s a challenge as somebody who’s running a medical practice.
Peter Dehnel, MD: I’m not sure if this is going to help you at all, but other plans will not regulate the dosing schedule to that degree. But to Gary’s earliest point, that this is not high on the radar screen, we are not going to manage the dosing interval to that level of specificity.
Charles Wykoff, MD, PhD: Certainly, there are a lot of plans around the country—fortunately, you 2 are not—that are very tight about the 28 days. If it’s less than 28 days, they will not pay it. And yet, there’s very good literature to show that some patients—a small percentage of patients, actually a tiny percentage of patients, probably less than 5%—do benefit from more aggressive dosing.
Jared Nielsen, MD: So, Charlie mentions a label—and I’m sorry to harp on this—but the label for ranibizumab says “about every 28 days.” In the clinical trial, there was actually a window, and it was from 23 to 37 days that you could have gotten that injection. If we’re going to mirror the label or the trials, let’s at least look into some of those windows when we develop a policy.
Gary L. Johnson, MD, MS, MBA: And if your patient has Medicare, CMS regulations absolutely require exceptions to any recommended doses that might be on the label.
Jared Nielsen, MD: So, my patient is contacting his senator, but it’s sad that that’s what it’s taking now to get some of the patients the care that they need.
Peter L. Salgo, MD: Is it foreign for you to hear this more? You claim, “If you apply this to me, then I’m going to approve that” and that you only use the drugs that are on-label, but they’re telling you that out in the real world, it’s different.
Peter Dehnel, MD: To clarify, I’m well aware of these conversations that go on. It just doesn’t happen to deal with wet AMD right now. But in other areas and other treatment courses, it does very much happen on a daily basis.
Peter L. Salgo, MD: Well, it goes on with them for AMD, right?
Peter Dehnel, MD: Yes.
Jared Nielsen, MD: For me, it’s a big deal because I would say, for about one-third of patients that I see on a daily basis, I’m treating this particular case—I’m treating the wet AMD patient who’s having to see me on a regular basis. And so, if you have a busy practice like mine, you have a few patients that will all of a sudden run up against these policies. It can take substantial efforts from the practice to continue to be able to manage them.
Charles Wykoff, MD, PhD: I realize our practice is getting rich from these challenging patients over time, because the patients that are doing beautifully and need fewer treatments, you’re seeing them less frequently. It’s the ones that need intensive dosing that seem to accumulate. So, we do see these patients regularly. They come up all the time. The other example that has been around a lot is every-other-month dosing versus every-month dosing. Initially, the aflibercept trial showed that monthly dosing and every-other-month dosing were, from a visual perspective, non-inferior to each other—identical.
Jared Nielsen, MD: For the patients in the trial?
Charles Wykoff, MD, PhD: For the patients in the trial. But, even anatomically, for the patients in the trial, there was a benefit to using monthly dosing on a population. If you drill down into the data—and this didn’t come out until 3 years after the original trial was published—20% of patients actually do better if you continue monthly dosing versus every-other-month dosing. So, you need to individualize therapy. It’s hard to be cookie-cutter about a disease that’s so variable across patients.