Role of Specialty Pharmacies for PCSK9 Inhibitors

Peter L. Salgo, MD: If we want to get people on these drugs, and access to these drugs is difficult, where does the specialty pharmacy come into the picture? How do they work into this?

Cheryl Allen, BS Pharm, MBA: Getting patients on drug therapy with PCSK9s (proprotein convertase subtilisin/kexin type 9s) is a multi-pronged approach. We have patients who are not in specialty pharmacies. We have prescribers who aren’t specialty. So, it’s really direct-to-consumer information and education to the consumer and prescriber. It’s also in helping those patients with supportive educational services.

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

Cheryl Allen, BS Pharm, MBA: It could be a website, or it could be a 1-800 line. It’s information that allows these patients to educate themselves and then bring that information into their physician’s office. It also serves as a resource for the prescriber. Many times, these hurdles that need to be jumped through to get these patients on therapy are substantial. It’s about having a support system in place. These are patient- and provider-facing services that happen. Many times, this happens in a hub setting. It can happen at the pharmacy level, but in this class of drugs, I think you’re seeing a lot of heavy lift go on with these supportive services.

Jeffrey Dunn, PharmD, MBA: Yes. You mentioned earlier that one of the challenges with specialty pharmacy is cardiovascular disease has not historically been a specialty category. So, if specialty pharmacy is now managing the PCSK9s, they’re not managing the oral diabetes drugs, they’re not managing the ACE (angiotensin-converting enzyme) inhibitors, and the statins, and everything else. It really gets back to, again, the data and managing these patients a little bit differently from a care management perspective. But, I agree—I think the benefit of the SP (specialty pharmacy) is education back to the patient and to the provider, but also maybe coverage determination and helping the physician's office understand the different criteria that payers require (and even applying the coupons for patient assistant programs, if done appropriately).

Cheryl Allen, BS Pharm, MBA: Exactly. These drugs are broadly distributed. They are broadly available. When the drugs do wind up in specialty pharmacies, specialty pharmacies are equipped to deal with all aspects of that patient. This includes pulling in information on comorbid conditions, as well as all of the drug therapy, and then helping to get the patient to stay compliant.

Peter L. Salgo, MD: How does the physician involve specialty pharmacy in the first place? In other words, I want to give this drug. I’d like to get it approved. Do I call my local “Drugs ‘R’ Us,” or do I call the specialty pharmacy right away?

Cheryl Allen, BS Pharm, MBA: Well, the prescriber community, here, is very vast, right? It could be the surgeon writing the script. It could be the cardiologist. It could be the general practitioner. So, that’s a very large prescriber base. Specialty pharmacies are generally dealing with specialty prescribers—oncologists, immunologists, rare disease experts, geneticists. That community of prescriber isn’t familiar with the specialty pharmacy. They’re generally writing prescriptions or electronically prescribing. So, these prescriptions are winding up across the channel and the approach to deal with this medication has to be a channel-wide approach.

Peter L. Salgo, MD: Should there be a trigger? If the drug costs you more than $1000 a month, that gets put right over to the specialty pharmacist?

Cheryl Allen, BS Pharm, MBA: Well, many times payers do that. These drugs are, at times, winding up in specialty pharmacies, and it’s for the cost reasons right now. It’s cost as well as patient education. We haven’t really talked about the difficult administration and education that goes around that for these patients.

Peter L. Salgo, MD: I was just going to get there, because these drugs are not, “Pop a pill and goodnight.”

Cheryl Allen, BS Pharm, MBA: Exactly. And these patients aren’t necessarily (unless they’re comorbid and they’re using insulin for diabetes) used to injections. So, there’s a great deal of training that has to go on with the patients before they’re able to inject themselves.

Peter L. Salgo, MD: And specialty pharmacy can do that.

Cheryl Allen, BS Pharm, MBA: Specialty pharmacy is equipped to do that, absolutely.

Jeffrey Dunn, PharmD, MBA: And the specialty pharmacy and/or the payer, somehow, also needs to be appropriately following up with that patient every month, or every 2 months, rather than just maybe auto-ship refills. That’s another touch point, and that’s another opportunity for specialty pharmacies to help educate the patient.

Peter L. Salgo, MD: Do you see yourself in the specialty pharmacy as a patient advocate? Do you see yourself as the point person? If the doctor can’t make this phone call and can’t drive this to approval, you’re going to do it?

Cheryl Allen, BS Pharm, MBA: You know, I think that’s really the genesis of specialty pharmacies. It’s difficult therapies and it’s challenges to access for these patients. That’s really where specialty pharmacy fits. As far as advocating for that individual patient, we look at all of the criteria for use. The majority of drugs that we deal with in specialty require prior authorization. The PCSK9s, 99.9%, are going to require prior authorization.

Jeffrey Dunn, PharmD, MBA: Yes, but that’s part of the issue, though, with SPs and payers. We understand there are definitely positives associated with specialty pharmacy, and the augmentation of programs. Part of a challenge, though, is if you have a certain SP who is playing the pill game and doing things that are, maybe, inappropriate to drive utilization. Then, there’s a little bit of disconnect there. So just like there's importance with collaboration between the payer and the provider, it’s important to collaborate between the SP and the payer. I can give you off-handed examples of where drugs are going out that are questionable.

Cheryl Allen, BS Pharm, MBA: Yes. We probably have about 250 or so specialty pharmacies that are accredited by URAC (Utilization Review Accreditation Commission) or the ACHC (Accreditation Commission for Health Care). So, specialty pharmacies go through accreditation and have policies and procedures in place to support quality initiatives. And each and every aspect of a patient coming through the system is auditable. With respect to some of the things that are going on, I wouldn’t let a couple bad apples kind of spoil the great work that specialty pharmacies do.

Peter L. Salgo, MD: He was just dumping on specialty pharmacies.

Jeffrey Dunn, PharmD, MBA: I wasn’t.

Peter L. Salgo, MD: That’s what I heard.

Jeffrey Dunn, PharmD, MBA: I just said the key is collaboration because of incentive. Just like with other stakeholders, there is a potential for misaligned incentives. It is still the payer’s money, so the criteria, and the process, and the refill process, and everything else, has to be appropriate.

Cheryl Allen, BS Pharm, MBA: Is it the payer’s money, or is it the patient’s benefit?

Jeffrey Dunn, PharmD, MBA: It’s the employer’s money. But if you’re fully funded, it’s the payer’s money.

Cheryl Allen, BS Pharm, MBA: Most of the time, these are commercial patients. They have a job. It’s their benefit. I think we owe it to the prescribers and the patients to appropriately vet the patients for therapy. We’ve talked about what is to label, and there are probably a million patients out there that probably could benefit from this. So, it’s about making sure that we're going through the criteria and hopefully working with guidelines that we hope will be updated with some sort of a tried and true measure of success as the science continues to support this. Then, we’ll find a way to make sure that we are treating these patients.

Peter L. Salgo, MD: You said it’s the employer’s money, and you said it’s a benefit they negotiated. It’s really the employee’s money that he or she has deferred for healthcare, right? Can you both be right?

Jeffrey Dunn, PharmD, MBA: It depends on if you’re self-funded or fully funded. There’s other issues that go into that. Whose money it is.

Peter L. Salgo, MD: I’ll tell you what an employee might say, “My union went in and negotiated. I got less money in my paycheck, but I’ve got a health plan.”

Cheryl Allen, BS Pharm, MBA: “I got my benefit.”

Peter L. Salgo, MD: “That’s my benefit. That’s my money. It’s not my boss’ money. It’s my money.”

Jeffrey Dunn, PharmD, MBA: The question is, at the end of the day, who’s paying for that claim?

Peter L. Salgo, MD: Who is paying?

Jeffrey Dunn, PharmD, MBA: The member pays a co-pay. The health plan or employer is paying for that claim at the end of the day.

Peter L. Salgo, MD: But who’s funding the employer’s bank from which that payment comes? Isn’t that what you were saying?

Cheryl Allen, BS Pharm, MBA: Right. I believe that it really starts with the patient or the employee. As long as we are looking at appropriate utilization of drug therapy, that’s the patient’s benefit.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: I think with high-deductible health plans it’s a little bit gray. It’s grayer than it used to be. People are more directly responsible for some of their cost.

Peter L. Salgo, MD: Are you saying that people may decide to stay with the lower drug, and that they don’t need the heavy hand of the payer to do that for them?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Patients are being more of consumers.

Jeffrey Dunn, PharmD, MBA: People are more educated about cost.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Yes. To some extent, I would agree that it is the patient’s benefit. I see both sides, so I think you can both be right. From a clinician standpoint, I am mostly looking at the patient. I try to be cost conscious for patients, but I also want to do, clinically, what’s best for the patient. They have to be educated and make their decision. But I see a lot of our own health plan self-insured people, and I want to be cost conscious for the business as well. I think most clinicians are weighing that in their mind as well.

Cheryl Allen, BS Pharm, MBA: But wouldn’t we all agree that if prescribers prescribed and payers paid according to label, that’s appropriate use and should be covered?

Jeffrey Dunn, PharmD, MBA: Yes.

Peter L. Salgo, MD: Okay.

Cheryl Allen, BS Pharm, MBA: All right, that’s the common ground.

Jeffrey Dunn, PharmD, MBA: But it was brought up that 80% of the time these claims aren’t being prescribed. So, there’s the issue. Is it 80% of the time these drugs are not being prescribed appropriately? What’s going on?

Cheryl Allen, BS Pharm, MBA: Is it that, or is it the payer’s criteria for utilization? We heard from the clinicians that they’re not doing, necessarily, the genetic testing or some of the other requirements. So, the payer’s bar for approval of these drugs is here, in some cases, and the patient doesn’t have that information to support because their provider is not doing that type of diligence.