For the Media:
Eric Hargis Remarks at American Medical Association Media Briefing on Antiepileptic Drug Guidelines

Transcript of remarks by Eric R. Hargis, President & CEO, Epilepsy Foundation, presented in San Francisco, Monday, April 26, 2004, at the American Medical Association media briefing on new guidelines on antiepileptic drugs issued by the American Academy of Neurology and the American Epilepsy Society.

San Francisco, CA, April 26, 2004 -- Thank you and good morning. I represent the Epilepsy Foundation, the only national voluntary health organization that speaks on behalf of the more than 2.5 million Americans with epilepsy.

I'm pleased to be here because today's announcement of new guidelines by the American Academy of Neurology and the American Epilepsy Society is great news for people with epilepsy and their families. Today there is a significant gap between what can be done to treat people with epilepsy and what gets done. Unfortunately and too often, people with epilepsy settle for less than optimal seizure control or endure unacceptable side effects. These new guidelines will assist physicians in working with their individual patients to address these issues. We believe strongly that these guidelines promise a brighter future for many people with seizures – and for several reasons.

First, is the obvious assistance they offer doctors, especially those with more limited experience in treating seizures. We know that the prescribing patterns for epilepsy in general neurology have not changed significantly for the past 10 years although during that time many new treatment options have been approved. As is clear in the guidelines, epilepsy is not a one-size-fits-all disorder and there is no "best" epilepsy medication.

Today's epilepsy treatment goal is 'no seizures, no side effects.' What the new treatment guidelines tell us is that the best possible chance of achieving that goal, and the resulting productivity and contribution to society that optimal treatment can convey, is for patients and their doctors to have access to all drug options.

In that respect, we see these new guidelines as a powerful weapon in the effort to fight restrictive anticonvulsant drug formularies that Medicaid in many states, HMO's, and insurance companies are beginning to establish. And we fear similar or worse restrictions in the new Medicare prescription drug benefit. The Epilepsy Foundation has been battling this trend for some time, and we hear frequently from patients, families and physicians struggling to access medications that for one reason or another are not available to them.

The fact is, entities that reimburse medical expenditures are trying to save money by limiting the number of drug choices available to physicians and their patients. This makes sense if the less expensive drug provides the same therapeutic benefit. But for people with epilepsy these restrictions are disastrous. They're disastrous because drugs that prevent seizures, as these guidelines clearly show, are not cookie cutter drugs. Again, one size does not fit all. Epilepsy drugs work differently from each other, affect different brain processes, may work on one type of seizure, but not another, and – as these guidelines demonstrate – have very different side effects that in turn impact quality of life.

We are seeing that, in an attempt to contain costs, Medicaid, Medicare and insurance companies use drug formularies to assess the amount they will reimburse patients covered under their plans. The formulary drugs are supposedly selected by the health plan based on safety, efficacy and cost. When patients use formulary drugs, they pay less for their medications. But this system does not always guarantee the best treatment for patients.

Over the past two to three years, there have been efforts in almost every state to limit options available to Medicaid patients to a few of the older drugs. The older medications are cheaper, so these are the ones that tend to be covered under formularies. It's a dollars and cents issue. But if a patient has one seizure because of being on the wrong medication, it can cost thousands in terms of emergency room visits, loss of job or physical injury. And even if the seizures are controlled equally well, if it comes with side effects such as memory-loss that forces the patient out of work or out of school, where is the benefit?

In recent years, opposition from patients and physicians has been successful in delaying or turning back efforts in some states – for example, Alabama, Kentucky, Michigan, and Illinois -- to limit access or require special time-consuming paperwork to authorize newer medication. However, the trend continues – and it's a worrying one. Similar tactics are being considered for implementation of the new Medicare prescription drug benefit. Given that the elderly are the fastest growing population to be affected by epilepsy, this too is a disturbing trend.

The irony, of course, is that cost savings achieved by restricting drug choice are often illusory when it comes to epilepsy. If the cost of taking the wrong drug is a seizure, any savings per dose are overwhelmed by the costs of a trip to the emergency room and all the other expenditures associated with hospital care. Sometimes the failure to cover certain medications has the paradoxical effect of driving patients onto the welfare rolls. One woman in Washington state who was working – and wanted to work -- found that her seizure medication was not on the state formulary list and that she would have to pay $1000 a month out of pocket for it. At first her parents helped her out, but could not continue to shoulder the expense. Yet without the medication, her seizures became worse and worse. Finally, she reluctantly applied for Medicare disability benefits and became totally dependent upon the government. A bad bargain all round.

Frequently the proposed restrictions make no sense from a treatment standpoint, either. Washington State recommended that Medicaid only cover carbamazepine. As you will note in the guidelines, this is an excellent medication for some patients; but what about the thousands of patients for whom carbamazepine is not the right choice?

Another problem faced by people with epilepsy is the "fail first" policy of some plans—try formulary drugs first and if these fail, then the patient can have access to the newer, more expensive drugs. But when the condition is epilepsy, failure can be serious indeed. When the condition is epilepsy, failure means having a seizure. And that one seizure as a result of a fail first requirement can cause a cascade of life-altering events, including possible emergency room care, which, as I mentioned earlier, immediately wipes out any cost savings, and loss of driving privileges. If patients happen to be around water or to be driving at the time of that seizure, they may lose their own lives and put other lives at risk. Even if they recover safely from the seizure, because of the stigma associated with the disorder, they may lose their jobs. Unemployment is at least 25 percent among people with epilepsy. Seizures produce other negative social consequences as well. Although epilepsy is one of the oldest medical conditions known to humankind, it is still surrounded by mystery, ignorance and fear. For example, in a survey of 20,000 U.S. teens, 50 percent thought it was contagious, 50 percent thought it was a mental illness and two thirds stated they would not date a person with epilepsy.

So fail first policies that make having a seizure the price of access to newer drugs are bad news for people with epilepsy. Fail first policies can also have the unintended effect of forever consigning a patient to a drug that, while it prevents seizures, is associated with so many adverse side effects that normal living is greatly compromised. This level of care is clearly inadequate and we hope to use the guidelines to fight it. What's more, adequate treatment pays off in the long run if it can return people to productive lives and make taxpayers out of them. We know that about $1.7 billion are spent annually on direct treatment-related costs for epilepsy, compared to $10.8 billion spent on indirect costs, mostly in lost employment and productivity.

The new guidelines also offer new treatment options to physicians and patients. Defining the efficacy of treatment in people with epilepsy can be tricky. Treatment decisions have often been based on seizure control alone and not on the patient's quality of life. If a patient is put on a certain medication and has a significant reduction in seizures, that's great. But, again, if that person is also walking around in a fog, or can't go to school, or can't work, or has memory problems because of the medication, then that's not treating the patient, that's only treating the seizures. It's important that everything that is going on in the patient's life be clinically evaluated.

The new guidelines, which compared the side effect profile of some of the newer antiepilepsy drugs, should encourage physicians to consider potential side effects, or their absence, when making prescribing decisions. For some, it will mean moving on from old favorites to something different. For the past 10 years general neurologists who are not seeing a large number of people with epilepsy may have found that a certain drug works well and it then becomes the drug of choice, even though new medications have come on the scene. The problem is, that drug might be the best drug for only 70 percent of their patients. Epilepsy is a very individualized condition and it is often said that its treatment is as much art as it is science. These guidelines will boost both the art and the science.

And, to recap my earlier comments, they also give new urgency to the need to expand coverage of all epilepsy medications and access to all epilepsy medications, based on patient need. The Epilepsy Foundation believes strongly that treatment decisions for epilepsy need to be made by informed physicians in partnership with their patients and not by Congress, state regulations, HMOs or insurance companies.

Our congratulations and thanks to the experts who worked on these guidelines and to American Academy of Neurology and the American Epilepsy Society for their commitment in sponsoring them.

# # #

Media Advisory:

To interview Eric Hargis, contact Peter Van Haverbeke at (301) 918-3772 or pvanhaverbeke@efa.org.

On the day of the briefing, call the AMA Science News Department at (312) 464-2410, the AAN Press Room at (415) 978-3521 or email kstone@aan.com.