Epilepsy Foundation Provides Comments to U.S. Pharmacopeia

EpilepsyUSA staff
Posted: November 4, 2004

The Epilepsy Foundation is actively involved to ensure people with epilepsy have access to a full range of current medications and treatments. When Congress passed the Medicare Modernization Act last year, a prescription drug benefit, which will become effective in January 2006, was established and will be administered by private plans.

As part of the establishment of the Act, Congress mandated that U.S. Pharmacopeia develop a model set of guidelines to assist prescription drug plan sponsors and Medicare Advantage organizations when drug formularies are instituted. U.S. Pharmacopeia is a nonprofit, nongovernmental scientific standards-setting organization whose charge is to ensure the quality and consistency of medicines and to promote the safe and proper use of medications throughout the country.

After reviewing these guidelines, the Epilepsy Foundation is concerned they will adversely impact Medicare patients' access to needed medications. Senior citizens are the fastest-growing segment of the population to be affected by epilepsy. This population is particularly vulnerable and often has multiple medical needs.

The U.S. Pharmacopeia guidelines, as they are currently written, offer insufficient therapeutic classes of drugs to ensure the safest and most effective treatment options. They also promote outdated seizure-management medications that have unacceptable side-effect profiles.

If these guidelines are followed, newer medications with fewer or less adverse side effects would be more difficult to access and could possibly not be available at all.

U.S. Pharmacopeia has recommended in its guidelines that a health plan would only have to include two antiepileptic drugs of any type on its formulary. In theory, this limits the number of antiepileptic medications a patient could access to only two. The Epilepsy Foundation believes that for formularies to be required to cover fewer than 10 percent of all available seizure medications is dangerous and inappropriate.

The Epilepsy Foundation recommends U.S. Pharmacopeia revise its proposed guidelines. Recommendations from the Foundation include:

• Medicare drug plans must have an open, unrestricted formulary for patients with complex medical conditions;
• Patients must have access to brand-name medications without undue financial burden if they are prescribed by the physician as necessary;
• Health plans should be prohibited from limiting access to clinically-appropriate off-label uses of drugs;
• Procedures for updating and modifying formularies must be developed with input from the public.