Overcoming Access Barriers for PCSK9 Inhibitors

Peter L. Salgo, MD: Everybody can agree that if there was a drug which was a billion dollars a dose and many people needed it, and we knew that everyone who got it would have a really good chance of a much longer life, we couldn’t afford that. And if it was free, we would all get it. So, who’s going to draw the line? Is it the practitioner? Is it the payer? Who’s got the hand on the throttle here?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: I can tell you if all those results that you said came out the way they did, prescribing would go way up. Just as you mentioned earlier with statins, we saw the population expand for who they were indicted for, and prescribing went way up. Cost has also come way down. But if all of those events are reduced, and they see that prescribing is going to go up because they care about their individual patients…

Peter L. Salgo, MD: I guess if enough people want it, the cost-per-dose might drop, right? Or, they’ll go generic or something. But, if we have incontrovertible evidence that they save lives, it’s going to be tough to say no, isn’t it?

Jeffrey Dunn, PharmD, MBA: With the oncology model, you get an extra 2 months for $150,000 a year. We can’t say no to that. But, again, that may be in a handful of patients rather than thousands of patients. We can spend hours, probably, talking about the society impact and the fact that we spend more in this country on healthcare than any other country. Every other country has single-payer systems and there’s cost controls, and they make coverage determinations based on quality-adjusted life year, etcetera. Here, it’s free market. We pay way more for drugs here. There are no price controls. We have trillions and trillions and trillions of dollars in unfunded debt. At some point, it’s going to be a problem.

Peter L. Salgo, MD: At some point the tank is empty.

Jeffrey Dunn, PharmD, MBA: Who’s going to manage that? And right now, I don’t know how to answer that other than saying that payers will. CMS (The Centers for Medicare & Medicaid Services) and government—yes. There’s pros and cons to that. I don’t know. But if it’s not managed…

Peter L. Salgo, MD: Who’s taking on the voluntary role of being that bad guy?

Jeffrey Dunn, PharmD, MBA: I think we do a lot of dirty work and we’re cast as the bad guys, a lot.

Peter L. Salgo, MD: Is it fair to say that because you take all that on your shoulders, he gets to work with the patient say, “I’d love to give you this drug but he won’t let me?” That’s not fair.

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

Jeffrey Dunn, PharmD, MBA: I think it’s changing. To Jennifer’s point earlier, it is changing with deductibles, and coinsurance, and ACOs (accountable care organizations). We’re spreading risk around a little bit but, at the end of the day, it’s better now than it used to be. But I would challenge that if you ask a lot of doctors that are potentially prescribing some of these medications, how much they cost, I don’t know if they could tell you.

Peter L. Salgo, MD: Well, OK, let’s do this then. Take money off the table, just for a moment. I know we can’t, but let’s just take it off the table.

Jeffrey Dunn, PharmD, MBA: If you do, these should be prescribed for anybody.

Peter L. Salgo, MD: There you go. Now, in your view, as a prescriber, do your patients have appropriate (and appropriate is a fuzzy word here as they may have to be on a statin first) access to these drugs? Or are you angry?

Bryan Bray, PharmD, CPP: Currently?

Peter L. Salgo, MD: Currently.

Bryan Bray, PharmD, CPP: I’m angered. Not angered, because angered would be too strong of a word. I’m frustrated, because it’s just used in a setting where (to be able to prescribe that drug for a patient) it is difficult, and it deters actually prescribing that drug for that medication. So, we tend to not do it. We tend to do other things. The data that just came out made me a little more frustrated, because the data is even more proven, or understanding, in the situation where I can’t get that drug approved for a patient. In situations where they’re easily approved, it’s not a problem.

Peter L. Salgo, MD: Is it splitting hairs when you talk about this data? Is it saying, “This was a specific study where they were all on statins, and it was only 2 years,”?

Jeffrey Dunn, PharmD, MBA: That’s right.

Peter L. Salgo, MD: Doesn’t your gut tell you that they’re pretty good drugs?

Jeffrey Dunn, PharmD, MBA: Yes. I’m not telling any secrets. The answer is, we practice “evidence-based” medicine because of cost. To your point earlier, if you took cost off the table, managed care wouldn’t even exist. So, again, it’s unfair to talk about efficacy and safety without talking about cost.

Peter L. Salgo, MD: Fair enough. That’s a fair enough comment. But, what I’m also asking is, isn’t it a bit disingenuous to use the research that’s out there because it’s fairly limited and say, “Until you get more studies, and until you get the people off the statins, and until you get this, use that,”?

Jeffrey Dunn, PharmD, MBA: Yes. My pushback, though, is, is it the payer’s responsibility to fund that data? We’re not setting the price of the drug, and we’re not doing the clinical trials. We’re basing our decisions on what we have because of the financial implications. So, give us the data and we’ll respond to it. I don’t think it’s necessarily our job to fund it.

Cheryl Allen, BS Pharm, MBA: But I think you are seeing the manufacturer community step up and look at value-based risk shared contracting.

Peter L. Salgo, MD: What does that mean?

Cheryl Allen, BS Pharm, MBA: Yes, risk sharing.

Peter L. Salgo, MD: What does risk-shared contracting mean?

Jeffrey Dunn, PharmD, MBA: There we go.

Peter L. Salgo, MD: What does that mean?

Jeffrey Dunn, PharmD, MBA: We’ve been dealing with outcomes-based contracts for years, and what that means is you get an extra couple rebate points for doing a whole bunch of extra work. I have yet to see a risk-based contract.

Peter L. Salgo, MD: What is a risk-based contract?

Jeffrey Dunn, PharmD, MBA: It’s semantics, but a risk-based contract would be, if the drug doesn’t work, then the pharmaceutical company is either paying for part of that drug or they’re paying for part of the event. They’re not doing that. The other issue is in how operationalizable they are. So, how do we measure this in something like this? We had a low-density lipoprotein measure, but outside of that, how do we measure? If a patient is on one of these drugs, and they go in and have a stroke, with all the other things going on with that, how do we get to the point with the pharmaceutical company that we’re agreeing that they’re at risk for that?

Bryan Bray, PharmD, CPP: With a disease state like coronary artery disease, where you catch them in the continuum, are you catching them when they first start developing atherosclerotic disease? Or, are you catching them 2 years away from a myocardial infarction? And, are you going to be able to make much of a difference?

Jeffrey Dunn, PharmD, MBA: My point is, that’s a great concept. I love it. We’ve been talking about it and we’d love to figure it out. But, the 2 biggest barriers are, first, that we don’t know how to operationalize it because we don’t know how to define what an outcome is. And this may be the case when it’s subjective or not measurable, when you don’t have a lab, or even if you have a lab, is the pharmacy benefit manager going to get a lab? No. And then, the second barrier is, is it risk, or is it a small extra rebate? If they’re willing to go at-risk, then we’ll have different conversations.