The following letter sent to the Health and Human Services Medicaid Commission expresses the Epilepsy Foundation's concerns regarding  the Commission’s recommendation to raise co-payments for beneficiaries who must use brand name drugs versus generics.

Delivered: November 1, 2005

Medicaid Commission Members
Health and Human Services Medicaid Commission
C/O Nancy Barnes, Executive Secretary
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Dear Sirs and Mesdames:

Thank you for the opportunity to provide comments on the Commission’s recommendations.  For the reasons explained below, the Epilepsy Foundation is opposed to the Commission’s recommendation to raise co-payments for beneficiaries who must use brand name drugs versus generics.  This provision is unfair and potentially harmful to people with seizures (epilepsy) and others with related medical conditions or disabilities which may require the use of brand name products for which no generic is available.

Many individuals with epilepsy need access to newer, more expensive anti-convulsants. Fifty percent of children who have seizures have a genetic cause for their epilepsy.  The majority of these children do better on the new antiseizure medications. Recent studies also provide evidence that epilepsy is controlled with fewer side-effects, by the new, often still brand name, anti-convulsants than the older drugs.  Last year, the American Academy of Neurology published evidence-based reviews of the anticonvulsant drugs introduced since 1994 in patients with newly diagnosed epilepsy and refractory epilepsy.  The data shows that these drugs are effective and have fewer side effects than the older anticonvulsant drugs.  Most of these drugs are not available as generic medications.  It would create an undue burden to impoverished Medicaid patients to increase their co-payments for drugs that are not available as generics.   

I have been the Chair of the Health Alliance (HAP) Plan Pharmacy and Therapeutics Committee for the past decade.  HAP, a non-profit HMO, is part of the Henry Ford Health System where I work as a member of the Henry Ford Medical Group.  I am acutely aware of the costs and challenges of managing a formulary and I struggle each month to make wise decisions on drug choices, contracting, and tiering of therapy.  I promote the use of generic drugs, both in my practice and throughout the Henry Ford Health System.  You need to know that the individualized, often syndromic, response to anticonvulsant medication makes prescribing drugs for patients with epilepsy much different than prescribing drugs for hypertension or gastrointestinal reflux disorder.  Because so few of the newer anticonvulsant drugs are available as generics and because the “fail first” approach to anticonvulsant drug use is inappropriate for a potentially life-threatening condition such as epilepsy, I urge you to not change the current co-payment arrangement for Medicaid patients.

In addition, while state Medicaid programs sometimes have attempted to limit access to epilepsy medications in ways that are harmful, there are core protections in Medicaid that must be preserved. Although Medicaid permits states to operate preferred drug lists (PDLs), states must still make available all FDA-approved drugs when they are medically necessary. This is an essential protection that must be maintained.  Private commercial insurance plans which sometimes have benefit limitations and operate closed formularies may fail to effectively meet the needs of people with epilepsy, and can be more costly in the long run than simply providing the individual with the medications a physician with expertise in epilepsy prescribed.  For example, two of the older drugs likely to be featured in any plan that focuses solely on the cost of medication, phenobarbital and valproic acid, have been shown in the prospective North American Anticonvulsant Pregnancy Registry to have the highest rates of birth defects in children born to mothers taking these drugs.  Children with disabilities born to mothers on Medicaid are likely themselves to require Medicaid for their lifetimes.  Failure to treat seizures correctly can result in accidents, additional medical and hospitalization costs, loss of earnings, and even can cause an unexpected death.

I appreciate the opportunity to submit these comments on behalf of the Epilepsy Foundation.  Please feel free to contact me at 313-916-3922 or Donna Meltzer, Senior Director of Government Relations, at 301-918-3764 for additional information.

Sincerely,
 
Gregory L. Barkley, M.D.
Chair, Professional Advisory Board
Epilepsy Foundation

Clinical Vice Chair
Henry Ford Hospital
Department of Neurology

Associate Professor of Neurology
Wayne State University
Detroit, Michigan