new guidelines on the treatment of epilepsy with the new antiepileptic drugs: from the epilepsy...

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Editorial New guidelines on the treatment of epilepsy with the new antiepileptic drugs From the Epilepsy Foundation Four months ago, the American Academy of Neu- rology (AAN) and the American Epilepsy Society (AES) published evidence-based guidelines on the use of the new antiepileptic drugs in the treatment of children and adults with newly diagnosed and refractory partial and generalized epilepsy (French JA, et al. Neurology 2004;62:1252–73). A 24-member study team, represent- ing the Therapeutics and Technology Assessment sub- committee and the Quality Standards subcommittee of the two organizations, reviewed the professional litera- ture on seven antiepileptic drugs (AEDs) approved by the U.S. Food and Drug Administration in the last 10 years (gabapentin, lamotrigine, topiramate, tiagabine, oxcarbazepine, levetiracetam, and zonisamide). In ad- dition to publishing the results of the study in a pro- fessional journal, the Academy also summarized the findings in information sheets for clinicians and for patients and caregivers, which, in the case of refractory epilepsy, included a summary of previously published results on surgery and vagus nerve stimulation (VNS) therapy as treatment options. In general, the new guidelines describe the new AEDs on which there were sufficient research findings as equally effective as and better tolerated than the older drugs. The Epilepsy Foundation welcomes the new guide- lines and commends the efforts that have been made to summarize them for physicians, patients, and families alike. We believe these guidelines promise a brighter future for many people with seizures for several reasons. First is the obvious assistance they offer physicians with 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 despite the new treatment options that have been ap- proved. Epilepsy is not a one-size-fits-all disorder. The new guidelines will help physicians select the most ef- fective and best-tolerated treatment based on individual patient needs. TodayÕs goal for epilepsy treatment 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 so- ciety that seizure control can convey, is for patients and their doctors to have access to every available treatment option, including the newer drugs, VNS, and surgery. In that respect, the new guidelines will be a powerful weapon in the FoundationÕs struggle against restrictive anticonvulsant drug formularies that some states, HMOs, insurance companies, and treatment centers are beginning to establish. The Epilepsy Foundation has been concerned about 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. What we are finding is that too many entities that reimburse medical expen- ditures are trying to save money by limiting the number of treatment choices available to physicians and their patientsa potentially disastrous trend for patients. As we all know, and as the guidelines demonstrate, AEDs are not cookie cutter drugs, and like epilepsy, one size does not fit all. Again, the new guidelines will help us make that case. They will also help us make the case against a two-tier health system. Over the past 2 to 3 years, there have been efforts in several states to limit options available to Medicaid patients to a few of the older, cheaper drugs, which, because of their lower cost, tend to be covered under formularies. Opposition from patients and phy- sicians to such restrictions has been successful in de- laying or turning back efforts in some states, for example, Alabama, Kentucky, Michigan, and Illinois, to limit access or require special time-consuming paper- work to authorize newer medication. However, the trend to cut costs by limiting access continues, and itÕsa 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 dis- turbing 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 1525-5050/$ - see front matter Ó 2004 Published by Elsevier Inc. doi:10.1016/j.yebeh.2004.05.004 Epilepsy & Behavior 5 (2004) 433–434 Epilepsy & Behavior www.elsevier.com/locate/yebeh

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Page 1: New guidelines on the treatment of epilepsy with the new antiepileptic drugs: From the Epilepsy Foundation

Epilepsy&

Epilepsy & Behavior 5 (2004) 433–434

Behavior

www.elsevier.com/locate/yebeh

Editorial

New guidelines on the treatment of epilepsy with the newantiepileptic drugs

From the Epilepsy Foundation

Four months ago, the American Academy of Neu-

rology (AAN) and the American Epilepsy Society (AES)

published evidence-based guidelines on the use of the

new antiepileptic drugs in the treatment of children and

adults with newly diagnosed and refractory partial and

generalized epilepsy (French JA, et al. Neurology

2004;62:1252–73). A 24-member study team, represent-ing the Therapeutics and Technology Assessment sub-

committee and the Quality Standards subcommittee of

the two organizations, reviewed the professional litera-

ture on seven antiepileptic drugs (AEDs) approved by

the U.S. Food and Drug Administration in the last 10

years (gabapentin, lamotrigine, topiramate, tiagabine,

oxcarbazepine, levetiracetam, and zonisamide). In ad-

dition to publishing the results of the study in a pro-fessional journal, the Academy also summarized the

findings in information sheets for clinicians and for

patients and caregivers, which, in the case of refractory

epilepsy, included a summary of previously published

results on surgery and vagus nerve stimulation (VNS)

therapy as treatment options. In general, the new

guidelines describe the new AEDs on which there were

sufficient research findings as equally effective as andbetter tolerated than the older drugs.

The Epilepsy Foundation welcomes the new guide-

lines and commends the efforts that have been made to

summarize them for physicians, patients, and families

alike. We believe these guidelines promise a brighter

future for many people with seizures for several reasons.

First is the obvious assistance they offer physicians with

limited experience in treating seizures. We know that theprescribing patterns for epilepsy in general neurology

have not changed significantly for the past 10 years

despite the new treatment options that have been ap-

proved. Epilepsy is not a one-size-fits-all disorder. The

new guidelines will help physicians select the most ef-

fective and best-tolerated treatment based on individual

patient needs.

Today�s goal for epilepsy treatment 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 so-

1525-5050/$ - see front matter � 2004 Published by Elsevier Inc.

doi:10.1016/j.yebeh.2004.05.004

ciety that seizure control can convey, is for patients and

their doctors to have access to every available treatment

option, including the newer drugs, VNS, and surgery. In

that respect, the new guidelines will be a powerful

weapon in the Foundation�s struggle against restrictive

anticonvulsant drug formularies that some states,

HMOs, insurance companies, and treatment centers arebeginning to establish. The Epilepsy Foundation has

been concerned about 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. What we are finding

is that too many entities that reimburse medical expen-

ditures are trying to save money by limiting the number

of treatment choices available to physicians and theirpatients—a potentially disastrous trend for patients. As

we all know, and as the guidelines demonstrate, AEDs

are not cookie cutter drugs, and like epilepsy, one size

does not fit all. Again, the new guidelines will help us

make that case.

They will also help us make the case against a two-tier

health system. Over the past 2 to 3 years, there have

been efforts in several states to limit options available toMedicaid patients to a few of the older, cheaper drugs,

which, because of their lower cost, tend to be covered

under formularies. Opposition from patients and phy-

sicians to such restrictions has been successful in de-

laying or turning back efforts in some states, for

example, Alabama, Kentucky, Michigan, and Illinois, to

limit access or require special time-consuming paper-

work to authorize newer medication. However, thetrend to cut costs by limiting access continues, and it�s aworrying 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 dis-

turbing trend.

The irony, of course, is that cost savings achieved by

restricting drug choice are often illusory when it comesto 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

Page 2: New guidelines on the treatment of epilepsy with the new antiepileptic drugs: From the Epilepsy Foundation

434 Editorial / Epilepsy & Behavior 5 (2004) 433–434

expenditures associated with hospital care. We have alsoseen that the failure to cover certain medications can

have 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 for it. At first her

parents helped her out, but could not continue to

shoulder the expense. Yet without the medication, herseizures became steadily worse. Finally, she reluctantly

applied for Medicare disability benefits and became to-

tally dependent on the government. A bad bargain all

round.

Another problem faced by people with epilepsy is

the ‘‘fail first’’ policy of some insurance 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’’ means

having a seizure and a potential cascade of life-altering

events: loss of driving privileges, possible accidents,

loss of job. So fail first policies that make having a

seizure the price of access to newer drugs are bad news

for people with epilepsy. They can also have the un-

intended effect of forever consigning a patient to a drug

that, although it prevents seizures, is associated with somany adverse effects that normal living is greatly

compromised. Such care is clearly inadequate and the

Epilepsy Foundation intends to use the new guidelinesto fight it.

Finally, we hope that the new guidelines, by com-

paring the side effect profiles of newer versus older

AEDs, will encourage more physicians to consider po-

tential side effects, or their absence, when making pre-

scribing decisions, and thus move closer to the goal of

no seizures, no side effects. We are also pleased to see

that the summary sheet on treatments for refractoryepilepsy for clinicians and a similar document for pa-

tients and families include descriptions of VNS and

surgery as therapeutic options. In both areas, the result

should be increased referrals for appropriate patients,

patients who all too often go many years before having

the opportunity to opt for newer therapies. It is often

said that the treatment of epilepsy, with all its individual

quirks and considerations, is as much art as science. TheEpilepsy Foundation looks forward to these guidelines

giving a boost to both the art and the science.

A. Scherer

Epilepsy Foundation

4351 Garden City Drive

Landover, MD 20785, USA

E-mail address: [email protected]

Available online 9 June 2004