Studies of Biologics on Cardiovascular Outcomes and Cost

The panel discuss the studies looking at treating patients with biologics even in patients with comorbidities.


Peter L. Salgo, MD: There’s some post-hoc analysis out there for some of these new drugs, tildrakizumab for one. What are the data like? What would be the impact of these data on treatment plans? What do we do here?

Joel Gelfand, MD, MSCE, FAAD: Well, I think that one of the advantages of psoriasis is that there’s a lot of good high-quality level A studies, randomized placebo-controlled trials that answer a lot of questions precisely from the evidence-based medicine point of view. These other studies, some of the post-hoc ones, and some that are a priori design, like we’ve done a series of placebo-controlled trials looking at the effects of TNF [tumor necrosis factor] inhibitors, phototherapy, ustekinumab, and secukinumab on cardiometabolic disease. What happens to people’s HDL [high-density lipoprotein] function, what happens to their inflammation in the aorta based on PET [positron emission tomography] scans? These are important things to be aware of I think, in terms of where the field is going. But ultimately, patients care mainly about outcomes, and we don’t have rigorous data yet to say that this treatment strategy is going to lead to better cardiovascular outcomes than this other treatment strategy.

Peter L. Salgo, MD: The jury is out.

Joel Gelfand, MD, MSCE, FAAD: The jury is still out, yes.

Peter L. Salgo, MD: Having looked at some of this data, do you have any preference for a drug? Are they all sort of the same? Is one better, one cheaper, one more effective, one safer? Help me out here.

Steven Feldman, MD, PhD: There’s no 1 drug that is better than all the others on every dimension of drug quality. And so different drugs in different situations.

Joel Gelfand, MD, MSCE, FAAD: Right. And also, patients come with all different histories and sizes and shapes and comorbidity profiles. So someone comes in, they’ve already been on 2 TNF inhibitors, and going to a third may not make sense if they haven’t responded to their first 2. And so you might want to go directly to a different mechanism of action.

Peter L. Salgo, MD: Is it fair to say that these new drugs are game changers perhaps in the treatment here in terms of treatment intervals and efficaciousness, or efficacy?

Steven Feldman, MD, PhD: The first biologic that made a dramatic impact on psoriasis I think was etanercept.

Joel Gelfand, MD, MSCE, FAAD: Yes.

Steven Feldman, MD, PhD: And it was a game changer. Patients would come in at their first return visit going, “Oh my God, my life has changed. I didn’t know how sick I was until I took this medicine. I had no energy before and didn’t even know it. Now I’m on this, I can go out and play soccer with my kids.”

Peter L. Salgo, MD: You sound like one of those TV commercials.

Steven Feldman, MD, PhD: And I thought, I’m never going to see another quantum leap forward like that again. And then they came out with instead of a 1-week, an every-other-week drug, that was even more effective within the TNF class. Then they came out with an IL-12/23 [interleukin-12 and 23] inhibitor that was every 3 months, and it was just as effective as the best of those, and it was safer. And I thought, oh, OK. And then, the IL-17 drugs came out that were even more effective. Are the newest ones with the IL-23s a game changer compared to the ones that we had before? I don’t think so.

Joel Gelfand, MD, MSCE, FAAD: I actually think they are, in that this is a life-long disease that patients have, right? What chronic disease are we able to manage with 1 drug for the rest of your life? I can’t think of one, right? Most patients, say with diabetes, go on to other therapies over time. In psoriasis, it’s often the case for a good number of patients. And so if we didn’t have the IL-17s and IL-23s, my patients would be in a lot of trouble right now.

Steven Feldman, MD, PhD: Oh, because they would have failed the other ones.

Joel Gelfand, MD, MSCE, FAAD: They would have lost response over time.

Peter L. Salgo, MD: Again, we’ll come back to money. Is there a difference in cost among the newer agents? And if so, what do you approve?

Peter Dehnel, MD: Right now, most plans will have some sort of a step therapy where if patients have moderate to severe disease, there are a few qualifiers in there. If they have moderate to severe disease, they are likely to have to go through a couple of steps to get the newer products.

Peter L. Salgo, MD: And do you have cost data analysis on the efficacy and safety of these new agents with comorbid conditions, psoriasis and metabolic syndrome?

Peter Dehnel, MD: Not that I’m aware of. That would be a level of information I don’t have.

Joel Gelfand, MD, MSCE, FAAD: I will push back a little bit. I think as a community practitioner, and led by the AAD [American Academy of Dermatology], we’re very much interested in seeing step therapy go away, because that causes a lot of problems for our patients, a lot of overhead for our offices, what have you. So the way we think about it is that, well, I know this patient in my opinion needs a biologic. But what’s the most cost-effective one? We really need help from the payer because we have no insight into what the costs are. It’s completely opaque to us, no one lets us know. We don’t know whether there’s discounting going on. We have no way of knowing.

Steven Feldman, MD, PhD: Although when they tell us this is the one we pay for, I think we can safely assume that that’s probably the most cost-effective one based on particular contracting.

Joel Gelfand, MD, MSCE, FAAD: And it would be acceptable in many cases, right, unless there’s an unusual circumstance of the patient not being indicated for that drug.

Peter Dehnel, MD: And so for many plans, you’re looking at adequate short-term efficacy versus long-term improvement in health. There are different perspectives that we need to acknowledge here.

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