Is the Price Right? Heart Failure Drug Choices

This transcript has been edited for clarity.

Ileana L. Piña, MD, MPH: Hello. I'm Ileana Piña. I'm the Quality Chief at Thomas Jefferson for the cardiovascular line in Philadelphia, and this is my blog. We're coming off very successful American Heart Association (AHA) sessions. Among the papers that were presented was a very interesting one by Dr Neal Dickert from Emory.

Neal, welcome. I'm so happy that we finally got together to do this. You are part of the School of Public Health at Emory?

Neal W. Dickert, MD, PhD: I'm primarily in medicine. I do have a secondary appointment in public health, but my primary appointment is in cardiology.

Guideline Directed vs Affordable HF Drugs

Piña: Your abstract sounds like a public health abstract. You talked about the price of drugs and discussing it with the patients. I don't think that any of us really do that. I almost assume that a patient's insurance is going to cover it. Then the patient comes back and says to me, "Did you know that I had a $500 co-pay for X drugs?" The newer drugs, like the sodium-glucose cotransporter 2 (SGLT2) inhibitors, that seem to have these incredible benefits that happen very early are also very expensive.

The angiotensin receptor-neprilysin inhibitor (ARNI) was ridiculous. When it first came out, it was $12.50 a day compared with $4 a day or something like that for an angiotensin-converting enzyme inhibitor (ACE) or an angiotensin receptor blocker (ARB). Where did you come up with this idea?

Dickert: I'm a clinical cardiologist, and I'm also a medical ethicist. I do a large amount of work related to ethics and decision-making. The truth is that the advent of ARNIs stimulated this project when, as you described, we shifted from a package of very cheap generic drugs to having some drugs that had appreciable benefits, but also appreciable costs, such that the decisions about whether to take them became preference-sensitive because of cost.

When decisions are preference-sensitive, we know that's a time where shared decision-making is important; we need to engage patients' values, priorities, and real-life circumstances so that we can make sure we make decisions that are in line with what they care about. The project actually started related to ARNI. After it got funded, we had the advent of SGLT2 inhibitors, so the trial in terms of planning shifted a bit.

Piña: Who funded you?

Dickert: The Agency for Healthcare Research and Quality (AHRQ).

Piña: Tell me about the structure.

Dickert: The primary sites were Emory and Colorado. We had collaborators from Duke and Penn, and we brought together a team of people who work in clinical cardiology, ethics, and decision-making. We know that there are many price transparency efforts happening; out-of-pocket costs are becoming more available within electronic medical record (EMR) systems, and other tools exist.

We don't know much about what happens when price is available, and we don't know how best to help clinicians and patients to have those conversations. The basic idea for this trial was, if we can build this into clinical encounters, what happens to the way that clinicians and patients actually talk about their medications and in what ways does it seem to impact decisions that they make?

Piña: Many of the drugs are very cheap. I think spironolactone is $0.25 a tablet. It's one of the cheapest. Certainly, metoprolol succinate is also pretty cheap. Carvedilol is also generic. How do you make these decisions? How do you structure this?

Dickert: In this trial, we built it on the platform of the EPIC-HF checklist that Larry Allen and colleagues demonstrated previously to help increase both dose titration and addition of guideline-directed medical therapies (GDMT). We provided patient-specific out-of-pocket costs for essentially the more expensive items on that list.

That included eplerenone as well as the medicines that are not generically available, including all the SGLT2 inhibitors, ARNI, vericiguat, and ivabradine, because those were approved during the time that we were doing the study. We added that on top. That was our intervention. The control group got the EPIC-HF checklist.

Piña: With no discussion of drug prices.

Dickert: That's right. It did not have any specific information. It did have some generic information about copay assistance programs on the back of the sheet. Clinicians and patients basically just got the list. The intervention group got the patient-specific out-of-pocket cost in the right-hand column of an EPIC-HF checklist. The physicians and patients both got that checklist.

Do Price Discussions Increase Drug Adherence?

Piña: What did you find?

Dickert: Our primary outcome was, do people talk about cost in the context of the encounter? We saw about a 19% increase in occurrences of cost conversation, from 49% to 68% in our primary model. We did see a significant impact in whether people talked about cost.

We, of course, weren't interested in just whether they talked about it, but we were curious about how. We saw some interesting patterns in terms of reduction in things like contingency planning. That's a little bit of a complex outcome, but contingency planning is what happens that many of us unfortunately have happen often, which is like the situation you described above.

We say, look, this is a medicine that can be expensive. I don't know exactly what it's going to cost you. When you get to the pharmacy, if it's too expensive, let me know, and we'll consider alternatives. That's a contingency plan. We did see a reduction in contingency planning from the control to the intervention, which was a nice signal that it actually did help people make more informed decisions.

It wasn't statistically significant, but we saw a little bit of a signal that people were more likely when we followed up with them 2 weeks later to be taking the medication that they had decided upon when they were in the intervention group vs the control group. There was a little bit of a signal that it actually does impact the way people approach decisions.

Piña: The conversation could lead to more adherence?

Dickert: That's the hope. We have a 3-month electronic health record (EHR) follow-up that will look at this. This is limited, I'll be honest. It's a 3-month EHR base, what's on their record in terms of what they're taking. It's not a perfect assessment of what they're actually taking. The hope is that by making more informed decisions up front, people will be able to be on the medicines that are prescribed because there'll be a better-informed decision.

Piña: Are your decisions ever based on when the drug is going generic? I know that one of the SGLT2 inhibitors is going to go generic fairly soon.

Dickert: We did some focus groups with clinicians who were in our study. One of the things they really liked was, for some insurance companies, there might be a significant price difference for patients between dapagliflozin and empagliflozin, for example. Clinicians did like the fact that they could see what that was going to be so they can make an informed choice and patients would be on the cheaper option when they felt like they were functionally pretty equivalent and didn't have strong views about one or the other. That was a nice aspect of our study that people felt was useful.

Piña: You're educating the doctors, too, besides educating the patients.

Dickert: Absolutely. The checklist was provided to patients and clinicians. That was very intentional. One of the main roles of price transparency tools will be to make clinicians more aware of what the individual patient might face. If you see 10 or 15 patients in a row, you may have 10 or 15 different costs that a patient may bear.

Piña: When I was an attending at Case Western, it was when everything was generic. We created lists of pharmacies within the region that had different prices. For example, Walmart would have carvedilol for $4, but another drug right across town at CVS or Walgreens would have very different prices.

We started giving the patients the list of pharmacies that had the better prices when the patients went home. That was right around the time of the readmission scare. Everybody was running wild about readmissions. Well, if you can take your medicines and you can afford them, the chances of you getting readmitted are much lower because you're going to be better medicated. We know that from the STRONG-HF trial.

What are you going to do next? This is really interesting. What's next?

Measuring Success Not Standard

Dickert: There are a couple of things we're really interested in studying. I will preface it by saying that — and the reason I'll get into in just a second — it's a little bit of a tricky type of information to study. The main thing that we want to do is study this in larger populations with more easily implementable price disclosure tools.

We got patient-specific out-of-pocket costs through a partnership with a financial counseling firm. It was pretty labor intensive. Two weeks ahead of time, we'd identify people. If they were willing to have their visit recorded — we didn't tell them everything that we were going to get, but we would get costs and whatnot. It was high-touch in some sense.

More tools are being made available through the EMR that make this available at the time of the encounter. Many of them are not quite optimized. The real plan is to look at a population level as these tools get rolled out. What kinds of trends are we seeing in terms of adherence, and how do we optimize these tools in a way that can really be implemented at a large scale?

Piña: What about giving the patients the information of what one particular drug is going to add to their well-being? Because, for example, if you look at vericiguat, it had no mortality benefit at all. There was somewhat a difference in hospitalizations. I can't tell you what symptoms changed. I did the trial. I can't tell you if the patients were less short of breath or thought their extremities were warmer. I can't tell the difference.

Here's a very expensive drug for a small benefit that is not even part of GDMT. Does that enter the discussion?

Dickert: It's a great question about what kinds of information we can provide to help. Really, what patients and their clinicians are making is a cost-benefit trade-off discussion.

Piña: Exactly.

Dickert: It's ideal to be able to provide both the cost and the potential benefit so that that can be really well informed. That gets harder. One of the things we wanted to do was to at least provide a mechanism for providing one part of that in a pretty efficient 1-page form.

If you start to look at providing complex benefit information, risks, side effects, or other things, that gets much more complicated to think about how to do that in an efficient way that patients can understand. We're very interested and I will say that we're looking more now at how the benefits of different drugs are being described. There are many secondary analyses that will come out of these data because we have 247 recorded encounters.

Is the benefit side being discussed, and if it is, how is it being discussed? How is the decision being framed? Hopefully, we can come up with a combination of tools that will help clinicians and patients to have those discussions in a better way. We had a very, I thought, lovely discussant at AHA. You raised really great questions about how to measure impact.

Some things, we want to just look at uptake. We want more people on good drugs. If the copay is cheap — so if they pay $5 a month no matter what it is — then the right thing is to get them on more medications. You want an uptake in that.

Piña: The required medications.

Dickert: If the medicine is expensive and the patient has financial constraints, the right thing might be for them to choose a cheaper option, right? You don't want to just look at rates of prescription. Really, you want the right decision for the right patient at the right time. Measuring that on a population level gets pretty tricky.

You may see upticks in some portions of the population and downtrends and others. That actually might be the right thing. We have to be careful.

Piña: When you compare the ARNI vs an SGLT2, you have alternatives for the ARNI.

Dickert: That's exactly right.

Piña: Cheaper alternatives. You have none for the SGLT2s.

Dickert: Exactly.

Piña: Sometimes, I have to make that decision, too, whether the patient just can't afford both.

Dickert: That's right.

Piña: I will not give them the ARNI, I'll give them enalapril, which is $4 for 2 weeks.

Dickert: Exactly.

Piña: Or an ARB, if they're ACE intolerant.

Dickert: Yes.

Piña: This is fascinating. I'm glad you have Larry Allen on board with this, because Larry is a thinker. He has thought deeply about many of these issues with the patients.

Dickert: We collaborate on a number of projects. This one started with a pitch I made to him in a bar outside of AHA. If there's ever proof of the value of in-person contact at meetings, it's the discussion that we had about this study. It's really led to a wonderful collaboration.

Piña: All the ideas that surface are best discussed in person.

Dickert: That's right.

Piña: I want to thank you for your time here today. I think your message is resounding. I'm not sure I have a solution, but it is an issue. It's real life. This is what the patients are dealing with, particularly right now, where we are, where food is so expensive, gas is expensive, and they're having to make choices of what they're going to buy. Here's one way that they can do it with their drugs. I want to thank you again. Say hello for me to all your colleagues in Emory.

Dickert: Thanks so much. I really appreciate your interest in the work and the opportunity to talk with you about it.

Piña: Thank you. This is Ileana Piña, signing off. I hope you enjoyed this very lively and informative discussion. Have a great day.

Ileana L. Piña, MD, MPH, is a heart failure and cardiac transplantation expert. She serves as an advisor/consultant to the FDA's Center for Devices and Radiological Health and has been a volunteer for the American Heart Association since 1982. Originally from Havana, Cuba, she is passionate about enrolling more women and minorities in clinical trials. She also enjoys cooking and taking spin classes.

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