Access and Cost-Benefit Analyses for Wet AMD Treatments

Peter L. Salgo, MD: We have these 3 drugs, and 2 are on-label, but 1 is not. Is it important for a practice or for patients to have access to all 3? Or only 1 or 2? How does that work?

Charles Wykoff, MD, PhD: I do believe that it’s valuable to have a choice, for many reasons. And I think—the example I gave before, and I use it all the time with patients—there’s a reason there are more than 1 cholesterol drug and more than 1 blood pressure drug: it is that some patients do respond better to one over the other. I have switched between all 3 of them. I have actually never, in my own clinic, seen a patient that bevacizumab works better for, but I’ve definitely seen some patients where ranibizumab works better or aflibercept works better. It’s nice to have a choice.

Peter L. Salgo, MD: Is there a way that you could choose a priori and know a priori—which one is the best choice?

Charles Wykoff, MD, PhD: So far, in my practices, I have not been able to tell that.

Jared Nielsen, MD: And people are looking for biomarkers, certainly with the diabetes space. The worse vision space has really helped us to understand where one agent may have a better outcome than another agent, but we’re looking for that all the time in our patients.

Charles Wykoff, MD, PhD: The other thing to add to that is we know from AMD and diabetes that the earlier you start treating people, the better they do and the fewer injections they need.

Peter L. Salgo, MD: But if I heard you correctly, it’s not just the time that you start but also which drug you use. In other words, if you’re going to start early with a less effective drug, that’s not, in your view, as good a plan as starting early with a very effective drug?

Charles Wykoff, MD, PhD: Absolutely.

Gary L. Johnson, MD, MS, MBA: Excuse me, what’s the role of your professional organization and their policy statements regarding this topic?

Charles Wykoff, MD, PhD: So, the American Society of Retina Specialists is heavily involved with this space, and they’re also a big believer in choice. They want all 3 drugs to be available, which I support.

Jared Nielsen, MD: And the American Academy of Ophthalmology also follows suit in that recommendation.

Charles Wykoff, MD, PhD: As you pointed out, the drugs are very different. I always tell patients 20-fold different: $50 to $2,000. If somebody really has no insurance, then it’s fantastic that we have access to bevacizumab.

Jared Nielsen, MD: Or for other conditions that aren’t covered on-label by any of the labeled agents.

Peter L. Salgo, MD: It’s also fair to say that it would be great if every drug was available and every drug was free. That would be terrific, but that’s not the world we live in. So, what factors do you think you need to consider when you determine the cost effectiveness of this? For any new drug—the cost effectiveness and the expense of this drug—how do you start working this problem out?

Gary L. Johnson, MD, MS, MBA: First and foremost, what drug is most efficacious? Then the question is, what patient needs the most efficacious drug? We try to balance those as best we can with our medical policies and our pharmacy polices.

Peter L. Salgo, MD: If I told you—let’s take a reductio ad absurdum—I’ve got a drug, which is going to cure a disease 100% of the time, but it’s going to cost a billion dollars. Are you going to approve it?

Gary L. Johnson, MD, MS, MBA: No.

Peter L. Salgo, MD: I didn’t think so. But, if I’ve got a drug that doesn’t work and it’s free, are you going to approve that?

Gary L. Johnson, MD, MS, MBA: I don’t know of any physician who would want to administer that drug to the patient.

Jared Nielsen, MD: Yes, let’s hope that they wouldn’t.

Peter L. Salgo, MD: But those are the 2 extremes. So, in the clinical meetings that you must have to determine how you balance effectiveness versus cost, how do you do that?

Gary L. Johnson, MD, MS, MBA: Yes, we do that by developing formularies that choose the most cost-effective drugs. You mentioned lipid treatment earlier. We don’t have all of the lipids—we didn’t when they were all branded—on the formulary. We chose the ones that were most cost-effective, and we made others available by exception.

Peter L. Salgo, MD: Let’s take a look at these drugs, and let’s take a look at the cost-benefit ratio of the 2 that are on-label and the 1 that is not. Do you know those numbers? Do we have a handle on these numbers at all?

Peter Dehnel, MD: In terms of cost-effectiveness?

Peter L. Salgo, MD: Yes, cost-effectiveness ratio.

Peter Dehnel, MD: I do not have that information at my fingertips, so to speak. And I think that, in terms of just looking at either these drugs or the broader segment of future drugs that hopefully will meet a broader population and with more effectiveness. We need to hear from the professional societies. So, if a professional society is saying, “Well, there’s really no difference,” that all 3 should be on-label and should be available—that’s significant versus “You should definitely only have the 2 on-label drugs as part of your choices.” So, the professional society is important. We need to have a conversation ahead of time, before a new drug that’s very expensive is released, so we can prepare for it.

Peter L. Salgo, MD: But what I’m hearing—tell me if I’m wrong—is that the physician community is saying, “Aflibercept or ranibizumab are great drugs, they work. There’s 1 that’s off-label that works, but not nearly as well.” They’re telling you that, right? I’m also hearing that patients don’t necessarily have appropriate access to these on-label drugs. Did I hear that right?

Charles Wykoff, MD, PhD: That’s true.

Peter L. Salgo, MD: So, what do you do?

Peter Dehnel, MD: Again, I can just speak from my plan.

Peter L. Salgo, MD: Please speak.

Peter Dehnel, MD: We didn’t have the off-label one as an option. We do now. We have left it up to the practicing community to make the choice, and we will cover all 3 at this point.

Peter L. Salgo, MD: Are you going to push back? If he calls you up and says, “I’m going to start a patient on aflibercept,” are you going to push back and say, “Please try the cheaper one”?

Peter Dehnel, MD: We haven’t, nor will we in this particular space.

Gary L. Johnson, MD, MS, MBA: Nor have we.

Peter L. Salgo, MD: So, these 2 plans aren’t pushing back. That’s not what I heard you say.

Charles Wykoff, MD, PhD: Thank you, thank you for not pushing back. I think physician choice and patient access are really important to us.

Peter L. Salgo, MD: But you are getting pushed back?

Charles Wykoff, MD, PhD: Oh, substantially.

Peter L. Salgo, MD: So, by some other plan. When you get pushed back, what do you hear? What are they telling you?

Charles Wykoff, MD, PhD: It is cost. It’s driven by the bottom line. And unfortunately, we as retina specialists and you as payers don’t determine what’s being charged for these drugs. There’s no discussion there, of value, that I’m aware of. So, I tell patients, “Look, we’re going to start with the inexpensive choice, and if you’re not responding, I’m going to fight for you and we’ll get access to the drug if we need to.”

Peter L. Salgo, MD: But, if I’m playing devil’s advocate and I heard you say that within days this thing can turn into a forest fire, and I haven’t started with the most effective drug, have I done my patient a favor by containing cost?

Jared Nielsen, MD: Well, I certainly think there’s a question there. I think bevacizumab is an effective agent. We know that from the trials; we know that from our own experience. I think, for me, safety issues, repackaging, and those sorts of things are paramount. I don’t think that if I treat somebody with bevacizumab initially, they’re going to have a sight-threatening event that I could have prevented by using something different the very next day.

Peter L. Salgo, MD: So, it’ll hold the fort is what you’re saying?

Jared Nielsen, MD: Yes, I think in most cases it will. But we’ve got to understand that there is damage that occurs over time and policies that implement a plan that requires us to use a certain number of treatments, to not be able to use our judgment as to when to switch—that becomes more of an issue. If the can is kicked down the road further, then I think we’re in a situation where we can end up having some vision loss in cases where we may have been more effective using an on-label agent initially.