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