Drug Formularies and the Availability of Antiepileptic Medications

Background

The nation's health care system has undergone fundamental change recently as a greater number of Americans are enrolled in managed care plans. As of 1996, 127 million out of 225 million Americans with health insurance were covered under some type of managed care plan. In an effort to keep rapidly rising prescription costs down, it is becoming more common for health maintenance organizations, as well as state Medicaid programs, to develop drug formularies.

People with epilepsy are concerned about the availability of all antiepileptic drug options when enrolling in managed care plans. This is due to the unique nature of epilepsy and differing response to anti-epileptic medications. Managed care plans that use restrictive drug formularies to contain costs often make appropriate treatment inaccessible.

Drug formularies are intended to control or reduce expenditures for prescription drugs. The Foundation is committed to avoiding unnecessary medical expenditures. It is, however, particularly important for individuals with epilepsy and seizure disorders to have access to all the available anti-epileptic medications through prescription drug formularies, including new as well as established formulations of both brand and generic products.

The Unique Nature of Epilepsy

Seizures and epilepsy develop in approximately 181,000 Americans of all ages each year. Overall, more than 2 million Americans have been diagnosed with epilepsy.

Not all people with epilepsy are the same. The unique nature of epilepsy, more precisely termed "the epilepsies", refers to the various reasons that a seizure may occur and affect different parts of the brain in very different ways. Anti-epileptic drug therapy is usually started when a patient has had more than one unprovoked seizure. Although one anti-epileptic drug product may prove to be highly effective with an individual, accurate prediction of an individual's response to medication is not possible.

As a result of new anti-epileptic drugs and other forms of treatment which have been developed in recent decades, the control of seizures has become an attainable goal for many people with epilepsy. However, a recent study has shown that over 1 million individuals continue to have persistent seizures even with treatment.

It is important to note that no one or two or three products currently available to treat seizures will be successful for all people with epilepsy. In 25% of individuals with epilepsy, seizures resist control and become intractable. Drug dosages may be increased in an attempt to control seizures. As a result, an individual may experience unpleasant side effects caused by the medications themselves.

Drug formularies, with their inherent restrictions, may have the untoward result of preventing individuals with epilepsy from following an optimal or prescribed drug therapy. A restrictive formulary does not take into account that medications for seizures are not interchangeable. The proper medication with the fewest side effects for one person is not the same as it is for another. Determining the right medication for a particular person may require trial-and-error or the off-label use of a drug, along with close observation of blood levels and side effects. In addition, switching of medications, e.g., from brand name to generic, from generic to generic, without a physician's oversight and monitoring, can result in breakthrough seizures. The consequences of a breakthrough seizure can be far more devastating to an individual's health, his productivity and to the cost of the illness to society than the recurrence of symptoms of other non-epilepsy related medical conditions.

Disclosure of Drug Formulary Information

The health and well-being of most individuals with epilepsy are dependent to a great extent on their anti-epileptic medications. The Foundation believes that drug formularies should include all anti-epileptic drugs, whether brand name or generic. In addition, the following drug formulary information should be disclosed to participants in all health plans:

• Plan policies regarding prescription drugs including information on drugs specifically included or excluded from coverage;
• In the absence of complete coverage, the health plan should provide for rapid approval of requests for any non-formulary anti-epileptic medication; this rapid approval procedure should be explicit and communicated to all plan neurologists;
• Information on how off-label uses of drugs listed in the formulary are covered by the plan;
• Information on how to get a drug added to the formulary and how to request an exception to allow coverage of a drug not listed in the formulary;
• Information on how to adequately address coverage policy problems; and,
• Policies regarding therapeutic substitutions and experimental medications.