Payer Coverage Decisions vs FDA Labeling in Wet AMD

Peter L. Salgo, MD: I’m trying hard to understand that there are 2 drugs that are on-label use and 1 that’s off-label use. The payers are insisting on the off-label drug, but I thought you said that you could only pay for on-label?

Gary L. Johnson, MD, MS, MBA: I’m not sure we’re insisting. Some may.

Jared Nielsen, MD: There are definitely are a good percentage.

Gary L. Johnson, MD, MS, MBA: But I’m not sure that that’s universal. I know our medical policy says it’s the physician’s choice.

Peter Dehnel, MD: And initially, up until a year or 2 ago, we did not allow for the off-label use. So, we have allowed it, because the physician community came to us and said, “We want to use this.” We do allow it, but we don’t mandate it.

Peter L. Salgo, MD: So, you actually would prefer the on-label drugs, not bevacizumab?

Peter Dehnel, MD: Well, for a lot of reasons other than just for care of the eyes.

Peter L. Salgo, MD: Is it your experience that physicians would rather use bevacizumab?

Charles Wykoff, MD, PhD: I think there is a concern that the on-label drugs are exceptionally expensive. Unfortunately, I played no role in determining what they cost. That’s a whole other discussion. But I try to treat my patients as I would want to be treated if I was in their shoes.

Peter L. Salgo, MD: Let me ask just 1 final question in this segment: given the choice of the 2 on-label drugs or bevacizumab, for your vision, which would you pick?

Charles Wykoff, MD, PhD: There’s no choice there, it’s the on-label drugs.

Jared Nielsen, MD: You’ve asked an important question, which has actually been evaluated by one of our colleagues. We have a survey that goes out and asks, “What would you do for your patient and so forth?” And it’s interesting to see that there is a dichotomy, a difference between what they would do for their patients and what they would they do for themselves or a mother. It’s interesting, because most people would choose on-label therapy most of the time.

Peter L. Salgo, MD: Put me into some data-driven choices here, comparing the on-label drugs with bevacizumab. What is the difference clinically? Does bevacizumab work at all?

Charles Wykoff, MD, PhD: Right, so 2 packages. Bevacizumab works exceptionally well in many eyes. Let’s take the safety issues off the table that we’ve already explored; let’s look at just efficacy for a second. There are very good data from all of the comparative trials put together that ranibizumab and aflibercept are better drying agents, which means that they get the retina drier, faster, and they require fewer shots in the long term.

Jared Nielsen, MD: With diabetes, in fact, the DRCR.net Protocol P trial showed, within the first year, a substantial vision effect. When patients were 20/40 or worse when they were treated with aflibercept, they were more likely to recover their vision over that time period. As a patient, I want to see as well as I can as quickly as I can, and that evidence is restricted to diabetes, but we also see that within our patients in the clinic with AMD.

Peter L. Salgo, MD: So, it’s not that 1 drug doesn’t work, but it’s that the other 2 drugs seem to work a lot better. Can you quantify that?

Charles Wykoff, MD, PhD: Yes. “A lot” is a relative term. How many shots do you want in your eye? The fewer the better.

Peter L. Salgo, MD: But how about as many as it takes?

Charles Wykoff, MD, PhD: Yes, exactly. I think if you had to quantify it, the best thing to point to is exactly what Jared brought up: in diabetes, if you take the worse-sighted eyes, the on-label drugs are better drying agents. Aflibercept, in particular, did better from a visual acuity perspective than bevacizumab.

Jared Nielsen, MD: I think another important thing for payers to recognize is that the patient sitting in my lane wasn’t necessarily the patient that was treated in the clinical trial. And so, oftentimes, Charlie and I are stuck with a patient who has very recalcitrant disease—never would have made it into a trial, because of the size of the lesion or their vision. Yet, I’m still obligated to treat that person, and they’re not going to behave like a person in the trial. They may need much more intensive treatment than was offered in any of the pivotal phase III trials.

Peter L. Salgo, MD: But isn’t it fair to say that that’s true for almost all trials? Patients in trials tend to do better than patients out there in the real world.

Jared Nielsen, MD: It is, but I’ve spent the last couple of weeks working with payers on trying to get coverage for our patients that need more intensive treatment. And when I hear an argument back to the clinical trial, I always get frustrated as a clinician because I’m not dealing with a clinical trial, I’m dealing with the patient right in front of me.

Charles Wykoff, MD, PhD: We might be looking at this backwards. A lot of times we’re—it sounds like it’s not true for your practices, in your payer system—often forced to start with bevacizumab, whether we like it or not. And then, we can switch to an on-label drug if we’re getting suboptimal outcomes. If you look at AMD, that’s totally backwards. We should get these eyes dry with the best drug possible, and then talk about long-term maintenance with a drug that may not be as good. It’s the treatment upfront that matters the most.

Peter L. Salgo, MD: It’s those patients who are at risk of losing their vision right now, catastrophically. So, you want to hit with the big, expensive gun right now.

Charles Wykoff, MD, PhD: In my thought process, yes.