Access Considerations for PCSK9 Inhibitors

Peter L. Salgo, MD: What are your coverage criteria for PCSK9 (proprotein convertase subtilisin/kexin type 9) use? What are they?

Jeffrey Dunn, PharmD, MBA: Label. They either have FH (familial hypercholesterolemia) or they have ASCVD (atherosclerotic cardiovascular disease), and we are allowing physician attestation.

Peter L. Salgo, MD: You’re not requiring genetic testing?

Jeffrey Dunn, PharmD, MBA: We’re not. It’s pretty simple. They have to have an elevated low-density lipoprotein (LDL) of either 100 mg/dL or 70 mg/dL, based on whether or not they have risk factors, and they have to be on a maximal-dose statin.

Peter L. Salgo, MD: So, if he calls you up and says, “I’ve got a patient here who’s on a maximal statin with an LDL of 100 mg/dL and I will attest that he’s got a family history and other evidence of FH. I want him to go on a PCSK9.” That’s all you need?

Jeffrey Dunn, PharmD, MBA: Yes.

Peter L. Salgo, MD: That’s it?

Bryan Bray, PharmD, CPP: Well, I mean, I think that’s fair. I think from a prescriber standpoint (just speaking of private practice), we see that the prior authorization process is difficult. And I think the simpler it gets made, the easier. To me, that’s a simple process. To me, when you’re in a private practice setting and you’re prescribing, it’s almost like you’re trying to create hoops to jump through so that you don’t prescribe it—that type of thing. I think that’s the attitude, and I think there has to be education of the prescribers that that’s really not the case. But, I think the simpler that prior authorization situation is, the...

Jeffrey Dunn, PharmD, MBA: There are payers who have different incentives, and they may have more restricted criteria. But, generally, reflecting the label is what I would imagine most payers do. The only other thing that I’ve seen a lot of is the requirement of 2 statins, or a statin plus ezetimibe, as a step therapy before a PCSK9.

Peter L. Salgo, MD: There was a sharp intake of breath to my right.

Cheryl Allen, BS Pharm, MBA: Yes.

Peter L. Salgo, MD: What was that about?

Cheryl Allen, BS Pharm, MBA: I have criteria, here, that is from a large payer, and this is the hurdle for the FH patients. There has to be disease documentation, a LDL or DNA sequencing test, or a mutation analysis, along with (and you mentioned it) a Dutch lipid score greater than 8.

Bryan Bray, PharmD, CPP: That’s correct.

Cheryl Allen, BS Pharm, MBA: And Simon Broome diagnostic criteria needs to be met, along with a LDL greater than 100 mg/dL for 60 days, and trial failure to high-intensity statins.

Peter L. Salgo, MD: See the hoop?

Jeffrey Dunn, PharmD, MBA: So, they’re going beyond the attestation and require the testing.

Cheryl Allen, BS Pharm, MBA: This is familial, right? And then, for ASCVD (atherosclerotic cardiovascular disease), a major risk score greater than or equal to 15, or the Framingham Risk Score should be greater than or equal to 20. So, when we have patients who need this type of documentation, they don’t meet the criteria. That’s in there—in the 80% that gets denied.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: My question is, for the genetic testing, are the payers paying for that? That’s a hoop. That’s a whole different hoop.

Cheryl Allen, BS Pharm, MBA: Exactly.

Bryan Bray, PharmD, CPP: Not to mention, just doing that in a busy primary care practice. We don’t have time to do it, so what does a physician do?

Jeffrey Dunn, PharmD, MBA: There is another criterion that we didn’t mention that we, and most payers, still require—that the prescription comes from a specialist or, at least, a consult.

Peter L. Salgo, MD: So, you’re not going to let primary care physicians prescribe this?

Jeffrey Dunn, PharmD, MBA: We’re not going to let the primary care physician who spends 5 minutes with a patient, dealing with diabetes and 5 other disease states, prescribe these, initially. I don’t see any reason why these shouldn’t be a primary care drug, other than because they’re expensive. And so, that is a criterion.

Peter L. Salgo, MD: But that’s going to cost as well. Who’s going to pay for the visit to the cardiologist? Are you going to pay for that?

Jeffrey Dunn, PharmD, MBA: Yes.

Peter L. Salgo, MD: Oh, OK.

Jeffrey Dunn, PharmD, MBA: An office visit is relatively inexpensive.

Peter L. Salgo, MD: If a cardiologist comes and says, “Give the drug,” then you’re going to give the drug?

Jeffrey Dunn, PharmD, MBA: Right.

Peter L. Salgo, MD: But if a fully licensed primary care physician, perhaps operating in an area where there are very few specialists, wants to give this drug, you’re going to say you’ve got to drive 200 miles to go see a cardiologist?

Cheryl Allen, BS Pharm, MBA: Unfortunately, that’s part of the initial 80% that gets denied, and then the ultimate, almost 60%, that gets denied. There’s no way around the payer criterion.

Peter L. Salgo, MD: When one pushes back on these 80% denials, at this point (and I’m assuming that you’re part of this team that’s helping put together a package to get this approved for a patient that you deem worthy), at the end of the day, how many patients get approved?

Cheryl Allen, BS Pharm, MBA: I think the study that was put out and was released by some folks out in California said that 57%, ultimately, get approved. And I should say that for the 2 drugs that we have available today, there are programs in place that help prescribers and patients to work through these barriers for access and help them work with their provider for appropriate utilization.

Jeffrey Dunn, PharmD, MBA: And that gets back to what you interpreted as a slam on specialty pharmacies (SPs).

Peter L. Salgo, MD: OK. Well, this is your opportunity to explain.

Jeffrey Dunn, PharmD, MBA: If there is somebody helping the patient and the provider do that, that’s great. But when we get form letters in, and we get the same letter from 2 doctors, then we become skeptical on some of these other helpers in trying to get through the process.

Peter L. Salgo, MD: A form letter is a form letter. If it’s accurate, it’s accurate, no? Or, you just don’t like the fact that you see the same wording in both letters?

Jeffrey Dunn, PharmD, MBA: Yes, from 2 different patients, and 2 different providers, that’s written by a pharmaceutical company or something else. That’s not individualized to the patient and to the case.

Cheryl Allen, BS Pharm, MBA: I, again, would say that’s going to be the exception rather than the rule, because audit processes just would not allow that in an accredited specialty pharmacy. But, you have to remember, as well, these drugs aren’t necessarily in specialty. This is a broad channel drug product. Sometimes they’re being routed into specialty by payers, but many of these are finding their way into other settings.

Peter L. Salgo, MD: Are you saying if somebody goes to “Al and Lil’s Starlight Lounge,” an all-night pharmacy, compared to the specialty pharmacy, they’re less likely to get this drug even though their need may be the same?

Cheryl Allen, BS Pharm, MBA: I’m not really saying that, because I think there are supportive measures in place to help patients and prescribers with the initial prior authorizations and appeals, if needed. I think if patients have access, there’s just a heavy lift there. So, it is prior authorization that has varying documentation. I mean, we looked at the heavy lift here with the documentation to help support appropriate utilization, whereas your recommendation is it’s a cardiologist saying, “My patient needs this.” That’s the bigger determinant of whether the patient gets access to drug therapy.

Jeffrey Dunn, PharmD, MBA: Yes. I don’t think it’s the channel. There are other reasons on mandated specialty pharmacy, etcetera. But I do agree that the SP is more equipped to navigate the approval process.

Cheryl Allen, BS Pharm, MBA: And then there was Jennifer’s example. She’s got a patient. The patient got approved for a drug like that because of family history, but it’s $300, out-of-pocket, per month.

Peter L. Salgo, MD: Yes, that’s what statins used to be before things changed. Now, let’s take a look into the future. I want you to anticipate outcomes data for me. Make a guess. If you want my guess, it’s going to be good. Outcomes data shows that these drugs really work. The LDL of 30 mg/dL is better than an LDL of 80 mg/dL. The side effect profile looks good. The decrease in heart attacks that we’ve already documented, and the decrease with strokes that we’ve already documented, is all to the better. There is a decreased death rate. Once we get that outcomes data, what’s going to happen to access, from your side?

Jeffrey Dunn, PharmD, MBA: It’s still about appropriate patients. We have to change the definition of appropriate patient. It’s probably going to expand the number of patients eligible for these drugs. It’s probably going to move into primary care and a number of other things. The challenge is going to be looking at it, strictly, from a cost-efficacy perspective or from a quality-adjusted life year perspective. These are not cost-effective. So, it’s still about appropriate patient. It’s just the definition of who that patient is that probably has to change.

Peter L. Salgo, MD: But what do you mean they’re not cost-effective? If they’re lengthening life, or if what the outcomes data shows, that the death rate is reduced when you use these drugs compared to not using them…

Jeffrey Dunn, PharmD, MBA: In an individualized patient, it’s absolutely cost-effective. Across a population with numbers needed to treat, and quality-adjusted life year, and all of the other cost-effective analyses that you can apply to this (by definition), they’re not cost-effective.

Peter L. Salgo, MD: And here comes the specter that every doctor and every payer deals with every single day. We’ve unroofed it. We unroof it at every broadcast, by the way. Who do you care about when you’re sitting across from a patient? Do you care about the society cost of this drug, the cost to the payer of this drug, or do you care about your patient’s well-being, exclusively?

Bryan Bray, PharmD, CPP: Well, the answer to that (to the prescriber) is going to be, the patient. And certainly, you want to be cost conscious to the patient and to society, but you’re going to care, only, about that patient and get that patient the correct medicine.

Jeffrey Dunn, PharmD, MBA: But if they have skin in the game, maybe it’s a different question.

Bryan Bray, PharmD, CPP: And I think it still gets back to that whole silo effect that we talked about in the very beginning. If I’m going to give this patient with ASCVD or CAD (coronary artery disease) this drug, and it’s going to prevent them from dying, and that patient is in front of me, we’re talking about risk and we’re going to play the gamble. Well, you may not be the one that dies from a MI early, or whatever. We’re going to treat that patient. We’re going to be aggressive. If we prevent 1 event, how much money do we save for the overall health system despite that we’re spending more money on the medication?

Cheryl Allen, BS Pharm, MBA: In the analysis that you’re doing to say that there’s no cost benefit from a population perspective, does that take into account the avoided cardiovascular events?

Jeffrey Dunn, PharmD, MBA: Yes, it’s a reduction in events.

Bryan Bray, PharmD, CPP: But it’s across population.

Jeffrey Dunn, PharmD, MBA: Right. So, my answer is, we care about all of the above. We have formularies and premiums, and everything else, by nature, are population tools. But there has to be avenues in place. That’s the physician’s assistant, and that’s the care management, and other things, to manage individual patients. So, on an individual patient perspective, these are cost-effective if it’s appropriate across a population. What I’m saying is, if you give these drugs in patients who, again, aren’t on a statin, who don’t have FH, then are they really serving society?