Cost vs Clinical Benefit of PCSK9 Inhibitors

Peter L. Salgo, MD: What are manufacturers doing now? Supposing you can’t get this drug approved or at least not classically, are the manufacturers stepping in to help with cost control for some patients?

Cheryl Allen, BS Pharm, MBA: They will. There are manufacturer patient assistance programs. Now, assistance programs are typically for indigent patients—those who can’t afford the therapy.

Peter L. Salgo, MD: That’s what you hear on television, right? “If you can’t afford this drug, we may be able to help you with that.”

Cheryl Allen, BS Pharm, MBA: Exactly. There is help for some patients who are indigent. There’s also help for commercially insured patients with commercial co-pay cards. There are some foundations that are supporting patients with financial needs.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: What you struggle with is your Medicare patients, because they usually don’t qualify for patient assistance because they have a government-funded insurance. Occasionally, they can get some help, but they have to be, for example, 300%, 400% below the federal poverty level. It could be hard, and that’s who a lot of these patients are—they’re 65 years old and older, and they have Medicare, and we can’t get help. It’s costing them $300 a month on a fixed income.

Bryan Bray, PharmD, CPP: I struggle with the co-pay cards for commercial patients, especially in a self-funded insurance program for an employer group because it’s taken the patient decision out of the equation. We talked about co-pays being a little bit higher, and patients are making better decisions about whether they need it. If you take that totally out, then it drives prescribing. Then, the patient is equivocal about whether they’re going to use it because it’s not going to cost so much.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: And they like it because it goes towards their deductible.

Jeffrey Dunn, PharmD, MBA: We can talk all day about a love-hate relationship with these types of programs. We keep saying “appropriate.” If the drug is appropriate for a patient (whatever we can do to make the drug more affordable, and help with compliance and everything else), we’re all for it. But it’s when these coupons are used to circumvent the benefit and drive inappropriate utilization, maybe before a statin or any number of other reasons, then, that’s where we have problems with it.

Peter L. Salgo, MD: If you’re saying, “Use our coupon. It’s affordable. That will be your co-pay and you don’t have to be on a statin and you don’t have to do this other stuff,” that’s not an appropriate use of the coupon? Is that what you’re saying?

Jeffrey Dunn, PharmD, MBA: When they’re used to circumvent tiering, and steps, and other things, then we don’t like them. But, again, if they’re used in patients who are on the drug and should be on the drug, then fantastic.

Peter L. Salgo, MD: Let’s just round this all up, and everybody can jump in on this. Are we, as a society, making the correct cost versus clinical benefit right now, today? You’ve all sort of alluded to this— if you give these drugs and they work up to their promise, people will live longer and the cost to society will be lower (maybe). But the drugs, themselves, cost a lot, and if you start paying for these drugs, your fourth quarter doesn’t get made. In fact, it gets trashed. Are we, right now, where we should be with this?

Jeffrey Dunn, PharmD, MBA: I don’t think so. I don’t think we’re there. Again, I look to Europe. I think they’re ahead of us a little bit, but obviously, based on prices in Europe, drugs are considerably less money. So, I would love to work with societies, specialty pharmacies, providers, and everything else, and get to some kind of consensus where there was a quality-adjusted life year or value threshold on how we were covering medications. Then, we would have some kind of leverage with how these drugs are priced.

Right now, unfortunately, there are too many silos that exist. There are misincentives driving towards rebates, and there are misincentives doing all different kinds of things. So, I don’t think we’re doing this appropriately, but, again, the key is, we’re practicing population-based medicine and we have to figure out the right channels for individualizing it to the right patient.

Peter L. Salgo, MD: You’re practicing population-based medicine. Some people are practicing individual patient-based medicine. And these are the 2 conflicts, right? This is where the push and the pull is. What do you think?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: I keep coming back to this, but I think it’s an important point—I do think these drugs are good, and they’re going to be good for people, but I also think that we’re using drugs too often and that we are taking some responsibility away from the patients for doing what they should do, as well. So, how do we incorporate patient responsibility into the cost of all this—stopping smoking, eating appropriately.

Peter L. Salgo, MD: So here we are, back where we started with these really hard choices. I mean, as hard as paying for this is, and as hard as getting approval is, that’s harder. Getting buy-in from patients to change their diet, change their weight, stop smoking—that doesn’t happen.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: It doesn’t, but I think we have to factor patient personal responsibility into this somehow, and I don’t know how to do it. I don’t have the answer to that.

Peter L. Salgo, MD: He could do it. He could say, “Unless you lose 50 pounds, you can’t have this drug.”

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Sure.

Bryan Bray, PharmD, CPP: Some employer groups actually offer incentives for patients to enroll in weight loss programs, or enroll in smoking cessation programs, and those types of things. There are ways to incentivize the patient to do that.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: I think you have to incorporate that in when you’re talking about drugs that cost this much, whether it’s employer-based, or whatever it is.

Peter L. Salgo, MD: You talk about long-term data? You don’t have enough long-term data. I’ve got long-term data on weight loss—that doesn’t work. Smoking cessation—reasonably ineffective. Diet change and, “Get off the hamburgers,”—doesn’t work . Unless you change human nature, or change the human race, it doesn’t work. So, is that a nonstarter?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: No.

Peter L. Salgo, MD: You’re such an optimist.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: It’s hard, I know, but I feel like we have to incorporate the patient responsibility into it. I don’t know how that works, but I don’t think we can not acknowledge that piece of the puzzle.

Jeffrey Dunn, PharmD, MBA: Yes, and the mechanisms, right now, are deductibles, coinsurance, and things I mentioned. Those are not long-term solutions.

Peter L. Salgo, MD: Are there long-term cost benefits, looking forward, to all of this here in terms of using these drugs versus not using these drugs?

Cheryl Allen, BS Pharm, MBA: I think so. I want to go back though and address some of the things that are being done. There are some self-insured employers that offer programs that are designed around patients’ and employees’ everyday life. So, for instance, if I work at a grocery store and my discount at the grocery store depends on my body mass index, my weight, and whether or not I smoke. It ranges, maybe, from 20% to 30%. There’s incentive every single day for me to make sure that I’m getting the maximum amount of discount on everything. So, there are some employers who are doing some pretty novel things to get patients engaged.

Peter L. Salgo, MD: What do we need to know, right now, that we don’t know to make this discussion easier? Is it that we just need more research on the way these drugs are being used, or do we need to know something else?

Cheryl Allen, BS Pharm, MBA: I think, from our perspective where we sit, we would like clear guidelines. Jeff mentioned his guidelines. It’s beautiful that we’re relying on diagnosis from a cardiologist, and it’s based on a cardiologist and the patient, and it’s reported information from the low-density lipoprotein (LDL) measure and, then, the patient history. Where we have a struggle is, it’s all across the board—the barrier of access from a criteria perspective. So, standardized criteria would certainly help.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: From a clinical practice perspective, I would completely agree. If the criteria were uniform, it would be much easier.

Cheryl Allen, BS Pharm, MBA: And I think that would help, too, because we have 80% initial denials, and Jeff said he’s getting prescriptions in, or requests in, where there’s no statin use. So, maybe it’s prescriber education through guidelines.

Jeffrey Dunn, PharmD, MBA: I agree with the guidelines better data, and obviously, cost containment. There’s all kinds of examples. Hepatitis C is a perfect example. That was a huge concern with states and payers, just given the prevalence, again, and the cost of these medications. And the criterion, initially, was very restricted. As we got a third entry, due to competition, prices came down and criteria opened up. We’re not going to get a third entry here. So, if you address the cost issues, then the cost-effectiveness equation changes and we have more funds to treat more patients.

Peter L. Salgo, MD: OK. This has been a tremendous discussion. There’s still more to talk about, but I think we really have to, at this point, give you each a moment by yourselves to leave us with 1 important point that you think we may not have covered or you really want to cover again. So, each of you gets 1 last shot at the audience. Cheryl, why don’t you start?

Cheryl Allen, BS Pharm, MBA: Wonderful. I think that not only with this class of drugs but with all classes of drugs that we’re dealing with, we’re seeing patients’ out-of-pocket costs are higher. We have 47% of self-insured employers that have these high out-of-pocket deductible plans, and patients are opting in because of economic purposes. No one expects to become the patient who gets written a PCSK9 (proprotein convertase subtilisin/kexin type 9). So, it’s about understanding that and understanding that patients will end up in situations where the $300 out-of-pocket just cannot happen. I think it’s important that we, together as the overall society, make sure that those who need the drug therapy get the therapy.

Peter L. Salgo, MD: Bryan?

Bryan Bray, PharmD, CPP: I think that after all we’ve talked about in the studies, still, it’s very clear that the primary treatment of these patients is with high-intensity, maximally tolerated statins. And I think with the growing data we have (with not only the LDL reduction), with the benefit in patients with ASCVD (atherosclerotic cardiovascular disease), in the right patient, these drugs are clinically speaking, an alternative add-on to a maximally tolerated statin therapy.

Peter L. Salgo, MD: Jeff?

Jeffrey Dunn, PharmD, MBA: I could probably refer to similar things—reduction in cost, better data. If I had to pick one thing, though, I think I would just focus on the better collaboration between the different stakeholders so that we have a better understanding of who the appropriate patient is. Then, we can reduce barriers to access, and we can prescribe these more appropriately.

Peter L. Salgo, MD: And that leads you, Jennifer. May you provide the last word?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Yes. I’ll echo Bryan’s thoughts, mostly, in that making sure that we’re using these in the appropriate patients. I also agree with Jeff—always the appropriate patient, adjunctive therapy, not forgetting that these are just a piece of the puzzle, and that we need to start with statins and lifestyle modifications, and all of those important things not as the sole treatment, but just as a piece of the puzzle.

Peter L. Salgo, MD: I want to thank all of you. This has been a great discussion. Everybody got beaten up. That’s good. I want to thank you, too, for watching. I’ll see you next time. I’m Dr Peter Salgo.