Seizure Management Across Health Care Settings: Payer Perspective

Edmund Pezalla, MD, MPH, PHD, and Winston Wong, PharmD, shed light on the payer perspective of seizure management, centering their discussion around the impact of formulary restrictions, the ability to select an individualized treatment, and health care resource utilization. 

• Speaker: Edmund Pezalla, MD, MPH, CEO of Enlightenment Bioconsult, Wethersfield, CT
• Moderator: Winston Wong, PharmD, President of W-Squared Group, Longboat Key, FL

This video series is sponsored by Sunovion Pharmaceuticals, Inc and is part of a 4-part series on “Seizure Management Across Health Care Settings.” View the rest of the series here.

Read the full transcript:

Dr Wong: Welcome to an installment at the Population Health Perspectives, Seizure Management Across Healthcare Settings. We have Dr Ed Pezalla, who is here representing the payer perspective. Ed is the CEO of Enlightenment Bioconsult and has focused on unlocking the value of innovative pharmaceutical products by developing industry leading approaches to incorporating payer requirements into development programs, technology assessment plans, and value frameworks.

Overview of Seizures

Dr Wong: The most important question facing clinicians and patients is, which is the most effective and best tolerated anti-seizure medication for new onset seizures? The unfortunate response is that there is no clear answer and that clinicians must individualize a choice of anti-seizure medications for each patient.

Clinicians must therefore formulate treatment plans based upon several considerations related to the drug, the seizure type, and the presentation, as well as patient specific factors.

For many patients the cost of their medication is also an issue, and whether a specific anti-seizure medication is on a list of preferred medications by a payer, and which also may be influential in the choice of the antiseizure medication chosen for the initial therapy.

So, Ed, we just heard a number of factors that talk about the need to go on individualized treatment for patients with seizures. So, in terms of trying to go and establish a formulary, what are the attributes of an anti-seizure medication that you consider when putting your formulary together?

The Need for Individualized Treatments for Patients

Dr Pezalla: Well, that's a great question, Winston, because as you mentioned, when you're tailoring to individual patients, it's very difficult to have much in the way of a guideline. We do have some guidelines, but they are rather broad for really good reasons. And so, we have to take into account that there's going to need to be a balance between efficacy and safety, age related issues, tolerability of the drug. And also, the fact that half of the patients, although they get seizure relief from the first medicine they're on, may require other medications later on. And half of those patients that start out on a seizure medicine, it doesn't work for them, or it doesn't get them to their goal. And so, we have to count on the fact that there will be plenty of switching as we attempt to find the right medication. And also, many patients, especially those with more difficult seizure disorders of various sorts, are on multiple medications. And also, we have to take into account that some seizures are related to specific syndromes, which can be diagnosed, but can be difficult to treat, and there are medications that are indicated just for those.

So, in constructing a formulary, the first thing we look for is what's the track record of the drug. We have lots of seizure medications that have been available for a long time. These medications have proven their usefulness, that's why they're still around and they are often the backbone of therapy.

What we want to be sure is that we have the different forms of those drugs; that is a liquid form for children or older adults, perhaps, as well as if there is a difference in the molecules. For example, there may be some that are modified so that they're longer lasting, improving compliance.

So, there's a lot of things to look for, but your first thing is efficacy. Does the drug work? Is it being used by physicians? Or if it's a new drug, is it potentially going to be used by physicians and patients because the efficacy in seizure reduction is important. And so, some of the things we're looking for there would be reduction in total seizures over particular periods of time. We look for how that compares to the other drugs on the market. We're also very interested in seizure free days. And do we have patients who are free of seizures for an entire period of time, like 30 days?

Safety comes in too. It's very difficult to prefer, or require, the use of a particular drug if it has certain safety problems, or if it's going to interact with other medicines that the patient may have; especially,

in older adults, and this is an issue in Medicare. Cost does matter. Fortunately, the majority of patients are receiving a generic, or perhaps one generic, as part of their grouping of medications. Newer medications tend to be more expensive; but given the setting, the need for those medications, and the difficulty of determining which patients really need them, oftentimes these are basically just placed on formulary without a lot of utilization management, such as step edits. Occasionally prior authorizations are seen, but that's more likely for drugs that have very specific indications such as, the more unusual childhood seizure disorders associated with particular syndromes.

Utilization Management Programs and Seizure Medication

Dr Wong: As you mentioned, a lot of the medications are generic, so that's definitely that they've been effective and they're definitely mainstays. And luckily, the generics are still effective, and they haven't really been replaced. So, I say all that to kind of pose my next question, which is it worth having a utilization management program, a PA, step edit or anything here? And if it is, what would it look like? When you take a look at the newer generation agents, obviously they are branded, do you have a utilization management program around those newer generation medications?

Dr Pezalla: Utilization management here is possible, and you certainly see health plans who will do that because of their concern for cost factors. However, the majority of plans have little utilization management. As I mentioned, they may have some prior authorization criteria, some policy criteria for drugs that have specific niches for particular kinds of patients, these tend to be younger patients with syndromes. But, generally speaking, they don't do a lot of management other than formulary placement on particular tiers. And physicians are well aware of the cost of these medications and the cost of the patient. And we have to look at what sort of patients are being treated here.

So, as you mentioned, the incidence is fairly high amongst the smaller children tailing off into adolescents, and then picking up again over the age of 60. In between, of course, the patients who started out having seizures oftentimes continue to have them, but often they stabilize during that time as well.

And so, I think what we see is there's a lot less utilization management in this as opposed to other areas where there are multiple drugs, just because they don't really substitute for each other. But the physicians are oftentimes choosing drugs in part based on what's known about them, they're experience with the drugs. So, older drugs and generic drugs are more likely to be chosen, and also those are the ones that are easiest on the patient's outpatient budget.

And children with seizure disorders, nearly half of those children may be in a public program such as Medicaid. And so, Medicaid is very, very sensitive to cost; but they do cover everything for children.

And fortunately, their copays are low, but there are all sorts of reasons why Medicaid can be difficult for patients to deal with. Commercial plans, generally you're covering most everything and doing not a lot of utilization management, but tier placement matters. And so, branded products will be on more expensive tiers. And depending on the cost of the drug per month, they could be on a specialty tier if that exists in your commercial plan; and most commercial plans have specialty tiers now.

In Medicare, almost all of these drugs are covered. This is a protected class. Absolutely everything does not have to be covered. There are some exceptions to that. The language says all, or substantially all, medications in the class must be covered. But that substantially all leaves a little bit of legal room for certain things to fall off. But generally speaking, you'll find all the epilepsy drugs on your Medicare plans are part D drugs. But the problem is that if they go over the thresholds, around $700 a month, they'll end up in a specialty tier, which can be expensive for the patients. And those patients also are taking other medicine. Adults with seizure disorders, especially new seizure disorders, they have something else going on. They have problems and they're going to be on other medicines, and they're going to have other healthcare expenditures. So, doctors are generally trying to keep these patients on the less expensive medications, even if the managed care plans are not actively pushing us.

Dr Wong: Interesting. You mentioned that this is a protected class with CMS, and rightfully so. As I mentioned, the incidents within the older population is much higher than even within the infants incidence. So, with that in mind, and it's protected, for those plans that have multiple lines of business, Medicare, commercial, small group, do you see those formularies differ, or is it pretty much the same?

Dr Pezalla: In epilepsy they differ a little bit, but not as much as they might in other categories. Some of the biggest differences will be that in Medicare you'll frequently see generic medications and absolutely no branded medicines to those generics. Whereas ,you might see the branded medications on a commercial formulary, acknowledging the fact that in some instances you may want patients to stay on a branded product, or a particular manufacturer's product, because of the differences in bioavailability. And in seizure medications, as you know, many of them really need to be within a fairly tight range, kind of a small therapeutic index. And so, patients can opt to have the branded product.

It would be best actually, if you could have the patient on a generic medication and guarantee that they were going to get that generic medication from the same manufacturer all the time. But that's difficult to do because of purchasing based on cost and because there might be supply issues. And also, if they change pharmacies and things like that. So, if you're trying to keep the patient on a particular drug, you're going to need to keep them on the branded product, even though there's been a generic to it for many years.

You don't see that in Medicare. So that's probably the biggest difference. But there is quite a range of medications on both formularies, because eventually many patients do have to try out a number of medicines, and because you have to accommodate the fact that there are different mechanisms of action, which means that there might be different reasons for adding drugs together. And this is really unpredictable at this point, and it really depends a lot on trial and error, physicians trying very hard to get to the right combination for particular patients. So, the formularies tend to be broad across Medicaid, Medicare, and commercial plans.

Payer Plans and Switching Between AEDs

Dr Wong: So going back to your Aetna days, and I can surely remember this in my Blue's days,

What's been your experience in terms of member impacts as they move from one prescription plan to another? And do you have any experiences, or any feeling, as to whether that the patients who are on anti-epileptic drugs having to go on switch because of formulary preferences?

Dr Pezalla: So, that definitely can happen. If you're moving to a plan that has a preferred product and that they enforce that through a step edit, or through a prior authorization, more likely, then you could run up against some issues there. However, with epilepsy, oftentimes exceptions are granted. So even though you might have to go through the appeals process, that can usually be overcome. The biggest issue probably is that drugs might be on different tiers, so your copay could change when you're changing plans. And that allows for some difficulty in terms of patients budgeting and trying to figure out what they're going to pay for their medications. But oftentimes, if there's some kind of prior authorization, and there may be for some drugs, and certain plans have more than others.

Generally, most plans will say, "Well, if you're on a medication that doesn't mean that you get to stay on it." The grandfathering in epilepsy is somewhat more common than in others, and that's certainly the case in Medicare plans as well. If you switch part D plans and your drug isn't covered, which is unlikely, or more likely it's covered at a higher tier, you may be able to get a tier exception. So, the big thing is that you have to leave enough time to deal with this.

Dr Wong: It sounds like the plans are, more or less, kind of open, or aware of, the impacts of switching therapies on patients, at least who are stabilized on antiseizure medications. Would that be a true statement, I guess?

Dr Pezalla: It is for the most part. You're going to run into some plans that are really sticklers for, "Oh, it doesn't matter what you got, you got to deal with our preferred products. You have to go through our step edit. We're not going to do it any other way." And you will also find some plans where if a medication's not a formulary it's not covered. And that's unusual, but it does happen. And that's more likely in say HMO plans, or other highly restricted less expensive plans.

Dr Wong: Great. So, as we look to the future, and looking at some of the barriers that may be out there, how do you think payers will react to this class of drugs, as well as maybe any other class of drugs where switching from one product to another may actually have some type of a detrimental effect?

Dr Pezalla: So, payers are aware of detrimental clinical effects on some of these, and epilepsy's certainly class where they're aware of that. And so, you don't see a lot of heavy management other than prior authorizations looking for diagnosis and biomarkers, and stage of therapy, and that sort of stuff. And so, there are definitely some areas where you don't see a lot of patients switching.

And epilepsy is sort of a moderate category because of the concern that you'll lose control, or that switching from one type to another will cause blood levels to drop off and that sort of thing. And payers are aware of the danger of having a seizure, especially if you're in a situation where you may be injured, if you lose consciousness. Or in some instances for some of the childhood syndromes, the more seizures you have, the worse off you are. And so being well aware of those things, they're trying to do the right thing clinically. But what happens is that then the drugs become more expensive because they end up, instead of having prior authorizations or step edits, if they end up on higher tiers.

This is difficult to manage because we're really looking at an entire population of people, some of whom don't have anything wrong with them at all, but they have to pay the same premium as everyone else. And so, it's very difficult to know what it is right. Do you charge people who are using resources more because they're using those resources? Or do you charge them not as much as you might and spread it out more on others? But they're paying a premium, and that premium is a significant portion of their household budget. Or it might be that their employer doesn't give them a raise because they can't give a raise to their employees because they're increasing healthcare costs.

Final Remarks

Dr Wong: So, do you have any closing thoughts with regards to epilepsy and anti-seizure medications?

Dr Pezalla: Yeah, so epilepsy continues to be an evolving field. And there's certainly been improvements here, as you mentioned. And we've gone from a handful of drugs, and now there's a lot more choices and it's somewhat bewildering. But we need those choices because there are, for some of the drugs, real differences.

Now, some of them, they're not especially different from each other, they're basically just a different form of the same thing. And we need to watch out for whether those really add value or not, and really focus on having a variety of choices in terms of the type of drug, what class it falls into, its potential, perhaps known or suspected mechanism of action, so that we can have that variety because it's still difficult to determine which drugs are really going to benefit which patients. And also, because patients have side effects, and so they need... So, we need to keep choice open here as much as we can, but that means that this is really a point at which we need to manage cost. And I think plans are hoping that physicians and patients will help them manage cost by not reaching for the most expensive drug to start with. If another one has been shown to be effective in the type of seizure disorder the patient has and there doesn't seem to be any reason why the patient shouldn't take that in terms of adverse events.

Dr Wong: Sounds good. Well, this concludes this installment of the Pop Health Perspectives. And thank you Ed for your time.

Dr Pezalla: Thank you, Winston, and thanks to all of our listeners.