Expert Insights into Value-Based Care for Polymyalgia Rheumatica

Dr Larry Hsu, MD, and medical director at HMSA, joins us today to discuss value-based care and treatment costs for patients with polymyalgia rheumatica.

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Welcome back to PopHealth Perspectives, a conversation with the population health learning network where we combine expert commentary and exclusive insight into key issues in population health management and more.

Dr Larry Hsu, internist and medical director at HMSA, joins us today to discuss value-based care and treatment costs for patients with polymyalgia rheumatica.

Do you want to start off by telling us a little about yourself?

Dr Larry Hsu: My name is Larry Hsu, MD. I'm an internist by trade and currently the medical director at the health plan called HMSA, which is the Blue Cross Blue Shield plan of Hawaii.

When we think about rheumatic conditions and value based care, it’s often associated with high costs for patients who have to go through these different treatment regimens. So, because of that complexity and because treatment is usually long term, could you offer any insights into common treatment approaches that are considered cost effective for patients?

Dr Larry Hsu:Yeah. If this is the umbrage of rheumatic diseases and maybe use an example of rheumatoid arthritis, clearly the guidelines do state, let's say in rheumatoid arthritis of using the nonbiological DMARDs, which are methotrexate, sulfasalazine, and hydroxyquinone and LEF. All of these are generics. And these patients do fairly well, but then for people that are not responding, clearly the paradigm has shifted now to using the biological DMARDs, which are the biologic agents in the classes of TNF, which is adalimumab, and then we have some of the interleukin agents out there, tocilizumab, and certolizumab, Actemra, and Kevzara, respectively.

All of these can be used. But specifically, since we're talking more about PMR, polymyalgia rheumatica, in our discussion, what is cost effective and the standard care is low dose steroids. They're generic. Most people do respond. We'll talk a little bit about that. Patients, most people do fairly well. And over X amount of time, they can be tapered over the course. So, it is very cost-effective therapy. More so in the people that do respond and don't require long-term treatment.

Usually when patients are looking for medications, while they want to receive the best treatment possible, they are looking for cost associations with those. Do you have any stance on generics versus biologics besides what we just discussed previously? Or, it's dependent on the patient case?

Dr Larry Hsu: Well, overall, the concept brand for generic and biosimilar for biological, clearly the use of a generic for that brand is the most cost effective. And clearly a biosimilar for that branded or innovative biosimilar is cost effective. The issue of substituting let's say, a generic brand for biological agent out there or the opposite, or having biosimilar for a branded, is where it's individualized depending on the drug class, depending on the patient. So, there's a lot of factors on that, but pun intended, generically speaking, generics are most cost effective. The biosimilars are more cost effective compared to the brand and innovative drug.

Now, just staying with that topic and thinking about how health care professionals across the globe are trying to focus on value-based care to have those patient-centered outcomes where it's individualized, it's cost effective, and it works—How do payer organizations evaluate that value and the outcomes of treatments with patients for these conditions that we mentioned: rheumatoid arthritis, polymyalgia rheumatica, disease states like that?

Dr Larry Hsu:Yeah. If the concept of a value-based outcome contract, let's say the health plan engages with the manufacturer saying, “okay, we're going to allow the use of this drug, but yet we're going to pay differently depending on the outcome.”

In other words, if the patient responds great, we pay the contractor rate. If the patient does not respond and we have some objective criteria to measure that, then the health plan is not obligated to pay the full price of that. That is some of the value-based or outcome-based contracts out there.

In the area of rheumatic diseases, it’s hard to develop that kind of contract. While there are measurements out there, they're hard to measure and rheumatologists clearly state that some of the measurements are a clinical tool in research and not clinical. For example, some of the measurements used out there will be the ACR criteria. It's very onerous. It's hard to do. And once again, the rheumatologist complained inappropriately. That's the clinical research tool. So, to use that in a, for example, in a value-based contract, it's going to be hard to obtain that information. It requires a chart audit and requires cooperation of rheumatologists.

So, without that fairly easy objective way of measurement like ACR or even some of the DAS scores out there, or also the clinical disease active index, the CDAI, it is very hard to engage in a value-based or outcome-based contract in these agents.

In light of recent research indicating a high relapse rate in patients with polymyalgia rheumatica during glucocorticoid tapering, which we did mention earlier when we started, and then the potential use of interleukin-6 blockade, do you have any insights on the potential impact of interleukin-6 blockade in the management of these conditions?

Dr Larry Hsu:Yeah, it can be significant. You know, while most people do respond to glucocorticoid steroids in PMR, not all do. Clinical research and some of the guidelines that are out there show that approximately 50% of all patients with this diagnosis can stop steroids within 1 to 2 years. I think that's pretty good news.

However, there are subsets of the population that are not in that 50%. Right? In fact, there are some studies in public health literature, particularly in one center that the median duration of steroid use is 3 to 7 years. Wow. Okay. Long-term use of steroids. And then there's another study about a third of the patients in this study required glucocorticoid steroids for 6 years.

Of course, some are low dose, some are high dose, but still to have almost a third in that study for this diagnosis requiring steroids—that's not good. We also know that patients with PMR, while they do respond to steroids, cannot taper. They don't have one adequate response steroids, or they have a flare during a tape brain.

So, there is a met need. And with the study of Kevzara that’s found in the New England Journal of Medicine back in October, and before that, with the approval, I think Kevzara can help in this area. This is not a promotion of Kevzara, but clearly the clinical results showing that individuals do respond very well, are able to reduce their steroid dose with the support of the interleukin-6 agent is great. That's good news.

It begs the question and, you know, starts that debate of while glucocorticoids may be the cheaper option, you have to combine that with the long-term effects that can happen on top of the fact of what you just said, you know, patients sometimes have to stay on it for 6, 7 years. And being on a steroid that long comes with adverse reactions and difficulty tapering off if they're even able to taper off. And then you have something like interleukin-6 blockade, which doesn't have that same effect that glucocorticoids bring patients and ends up being a treatment that is effective for this patient profile.

Dr Larry Hsu: Yeah, I would agree with that. And I think the main focus is not the expense or lack of a corticosteroid, but what is cost effective and meeting patient needs. Clearly, if it meets the patient needs with inexpensive steroid, great. But if it's not, then there's unmet need. And the biological approval of Kevzara, I think, does meet the unmet need. Once again, for people who are not responding to steroids and cannot tolerate steroid tapering.

When we think about these treatment options and what we know about trying to determine the best treatment approach for polymyalgia rheumatica, calprotectin levels come to mind as a potential biomarker for disease activity and the detection of treatment responses. Do you envision health insurance companies leveraging these biomarkers in coverage and reimbursement decisions when health care professionals try to determine a treatment regimen?

Dr Larry Hsu: As long as there's accuracy and sensitivity of that. But before I go on, you know, calprotein is being investigated. We know that it is a calcium binding protein released by neutrophils. So, in the activity of inflammation going on, neutrophils release this protein. And so using it as a biomarker to assess disease activity and or response is very intriguing and needed.

But, before you jump on the bandwagon and say that it should be used, there has to be clinical public peer review literature showing that it is accurate, high sensitivity, high specificity. And the important thing is that, in the public peer reviewed literature that this testing improves health care outcomes, and if it does, I think that gives you the adage that all physicians are trying to achieve. And as a health plan we also embrace the right treatment for the right patient at the right time. Right? If this is a biomarker that you can follow clinically to say, “yep, it's changing, and there's a direct correlation to the medication treatment.” That is great. In other words, if the biomarker is going the right way and they're on the right treatment or dosing, continue.

If the biomarker is not going the right way, meaning disease activity is increased or not stable, we need to rethink how the patient is being treated. So that individualized treatment, the monitoring, using the biomarker properly, is much needed in this area and certainly in other areas of medicine.

If we ever reach a point where there is that data, there are those studies, there is the proof that this preemptive testing can help reach treatment decisions and help these patients, do you envision this biomarker test to be folded into any policies with health insurance?

Dr Larry Hsu:Yeah, at the end of the day, what's most important is the clinical evidence before using a test or authorizing in our situation as a payer, where is the clinical evidence? Where's the clinical evidence of this biomarker, whether you're using it as a diagnostic test or as monitoring the patient response? Where's the accuracy? How high is it? Where's the sensitivity and specificity of it? And once again, importantly, which we focus on over and over, does it have clinical utility? In other words, at the end of the day, does it positively impact the patient's outcome? Does the patient's outcome improve because you did the test versus the patient who did not get the test?

That's the link. You have that link, which is clinical evidence. I think not only should it become the standard of care, clearly as a payer, we would allow that because once again, it gives the clinician, the appropriate tools and means to diagnosis and or monitor the patient.

Is there anything that you want the audience to walk away with from this interview? Any key points?

Dr Larry Hsu:Well, I think the key point specifically with the PMR is not all people respond to steroids. And if there's an unmet need is serious, we now have a interleukin-6 agent, which is FDA approved and supported by the clinical literature of these outcomes.

That's 1. Two, is clearly there still unmet need of appropriate biomarkers for, let's say, a diagnosis and or monitoring of PMR. That would be great. Having those tools, having evidence, the audience should know it's something that we need and certainly would accept and embrace as a standard of care and use in the practice setting, assuming that the evidence is there.