Peter L. Salgo, MD: What about the 2 that are on-label: how do you choose between those 2?
Jared Nielsen, MD: To some degree, I look at different lesions. There are certain lesions that I might treat with 1 agent. There are certain lesions that I might treat with another agent. I think everybody has their own view about which agent they feel more comfortable with, so for me, it’s a very individual decision.
Charles Wykoff, MD, PhD: I have 2 thoughts on that. It’s nice to have options. There’s a reason that we have more than 1 blood pressure medication: not everybody responds the same way to a given medication. It’s nice to be able to switch around medications, and some people do respond better to 1 drug than another. I think the biggest thorn in our side as retina specialists, from a payer perspective, is when we are forced to use 1 medication over the other. That is extremely frustrating, especially for patients that are suboptimal responders and we cannot switch them off.
Peter L. Salgo, MD: So, let me venture a wild guess. The 1 that’s cheapest is the 1 that’s off-label, bevacizumab, is that right? Are you guys going to require they try that first?
Peter Dehnel, MD: In all fairness, from a payer standpoint—not just for this subject but in the broader sense of things—the FDA product label has an incredibly important role for us. And so, up until recently, we only had FDA-approved products as an option. We have since expanded that, but, because it has so many other implications to other conditions, FDA product endorsement of a particular item is really important.
Peter L. Salgo, MD: Okay. But, again, unless I’m wrong, bevacizumab is a lot cheaper?
Jared Nielsen, MD: Oh, it’s a fraction of the cost.
Gary L. Johnson, MD, MS, MBA: Anywhere from 40x to 50x less the cost of the approved agents.
Peter L. Salgo, MD: Well, that’s a dramatic difference.
Gary L. Johnson, MD, MS, MBA: It’s a profound difference. If it was double the cost or three times the cost, we probably wouldn’t have so much discussion, but we’re talking about 40x to 50x difference.
Peter L. Salgo, MD: Let’s role play for a second, because I’m going to spare you guys the fight. I’ll be the retinal specialist. I’m going to call you up and say, “Hello, this requires this drug or that drug.” And you’re going to say, “That’s 40 times too much. Why don’t you try bevacizumab first?” Is that what you’re going to say?
Gary L. Johnson, MD, MS, MBA: Probably.
Peter L. Salgo, MD: But I’m going to say that it doesn’t work as well.
Gary L. Johnson, MD, MS, MBA: But if we would stick to that position if the physician says “No, I really do believe that the 40x to 50x more expensive product is the one that my patient needs,” I would say, almost all the time, that would be approved.
Charles Wykoff, MD, PhD: I want you to cover my practice, because that’s not my experience.
Gary L. Johnson, MD, MS, MBA: That’s what I do every day: I handle appeals for pharmaceuticals.
Charles Wykoff, MD, PhD: I guess getting to you on the phone might be the challenge.
Peter L. Salgo, MD: But, remember, you’re handling appeals, so the first thing this guy heard was no.
Charles Wykoff, MD, PhD: I think this is really important. The question is, what drug would you want in your eyes? I ask you very personally, because that’s what it is to me and my patient. For example, I’m looking at Miss Jones and I’m telling her, “I’ve got 3 drugs, and guess which 1 your insurance company wants me to use first.” I use that line all the time because it’s true. I’ve been kicked off plans. I’ve been audited multiple times. It’s a frustration because the truth is, what drug do I want? Do I want the one that comes in a glass vial that has proven safety and efficacy or do I want the one that’s compounded cheaper?
Gary L. Johnson, MD, MS, MBA: My answer to that would be, “Tell me the difference in cost, because I have something called coinsurance where I pay 20% of the cost of the drug.” If a drug costs $2,000 a month, 20% of that is a lot different than 20% of a drug that costs $50 a month. And then I would say, “What does the literature say, what do the large clinical comparative effectiveness trials say about the 3 drugs?” And what would your answer be?
Charles Wykoff, MD, PhD: Thank you for bringing that up. Briefly, we have 2 major trials that compared head-to-head: DRCR.net Protocol T in diabetes and CATT in AMD. There are others, too, but those are the 2 big ones. Tell me, do you realize that there is a major difference in the bevacizumab that’s used in both of those trials compared to the bevacizumab that Jared and I use every single day in practice—did you know that?
Gary L. Johnson, MD, MS, MBA: I’m not aware of that.
Charles Wykoff, MD, PhD: Did you know that?
Peter Dehnel, MD: I did not know that, no.
Charles Wykoff, MD, PhD: Well, let me tell you what the difference is. This is so important, because the drug that was used in those trials came in a glass vial, and the drug that we use every day comes in a plastic syringe. The difference is that when you store a biological molecule in a plastic syringe it degrades. The quality goes down. It has been published over and over in peer-reviewed manuscripts that it’s not reproducible, it’s not as effective, and it’s not as safe. We need comparative data that uses the drug that we use every day in practice. We don’t have it, and yet we keep pointing—all of us, retina specialists, too—to these trials that use a different from of bevacizumab than what I use every day.
Jared Nielsen, MD: Charlie and I were recently—our whole specialty was—hit with repackaged bevacizumab that contained silicone oil droplets, and virtually every practice in the country was affected by this.
Peter L. Salgo, MD: I’m assuming that’s a bad thing.
Jared Nielsen, MD: Well, if you have permanent floaters in the center part of your vision that appeared after your injection, and they’re preventing you from seeing and doing the things that you like to do, that’s a horrible thing. And if that leads to you needing surgery later on, that is a horrible thing.
Peter L. Salgo, MD: Is that a consequence of the compounding pharmacy?
Jared Nielsen, MD: It’s a consequence, actually, of a change in the manufacturing process of the syringe that was given to the compounding pharmacy. And this was widespread. We all had patients that were affected by it. I’ve operated on patients that were affected by it. So, every time that you have to use it, you’re thinking about this in the back of your mind. You’re also thinking about the compounding pharmacy. What type of practices are they using ensured to protect me? And while the cost of the bevacizumab is so much cheaper, it does not recognize the cost of these risks or the liability that my practice has to take on to use it.
Charles Wykoff, MD, PhD: Yes. I actually am a believer that, in many circumstances, bevacizumab, given our current economic and fiscal issues, is a reasonable first-line option. I really am. But please, will you put it in writing so that, when there’s a lawsuit, they come after you and not me? I mean it, because we’ve been kicked off of plans, and we call them and behind the bushes they tell us, “Well, the reason is that you use too much on-label.” It’s just not right to practitioners across the country. Put it in writing because that way, we can stand behind it and actually support you.