Access to Anticonvulsants

February 4, 2021

On its final full day, the previous administration announced a demonstration program that would enable Medicare Part D plans to opt out of the Six Protected Classes policy starting in 2022 (with a delay for one of the classes, antiretrovirals, which would start in 2023). Medicare’s Six Protected Classes has broad bipartisan support and was established to ensure that people with particularly vulnerable health conditions, such as the epilepsies, have access to the full range of treatments approved by the U.S. Food and Drug Administration (FDA). Under the demonstration, Part D plans would no longer have to cover all or substantially all anticonvulsants and instead, could cover only one drug per therapeutic class—which is even less than Part D’s standard for non-Protected Class medications of two drugs per class.

Epilepsy is a spectrum condition with a wide range of seizure types and seizure control varying from person to person. With advances in genetics, imaging, and mechanistic understanding, a growing number of people are known to have a rare form of epilepsy.

“Given its complex nature, epilepsy medications are not interchangeable,” said Dr. Jacqueline French, Chief Medical and Innovation Officer, Epilepsy Foundation; and Professor, Comprehensive Epilepsy Center, NYU Langone Health. “If people with the epilepsies do not have access to the most effective anticonvulsant(s), their risk of breakthrough seizures and related complications — including injury, disability and even death — vastly increases.”

Weakening the Six Protected Classes policy will also result in higher costs to Medicare, as epilepsy-related medical costs associated with uncontrolled epilepsy are two to 10 times higher than costs associated with controlled epilepsy.

“These classes of medications were protected for a reason,” said Amy Brin, MSN, MA, PCNS-BC, Chief Executive Officer and Executive Director, Child Neurology Foundation; and Chair, Epilepsy Leadership Council. “Allowing Part D plans to so drastically restrict coverage of anticonvulsants is dangerous and potentially life-threatening for people with the epilepsies.”

American Epilepsy Society (AES)
BPAN Warriors
The Brain Recovery Project
CACNA1A Foundation
CFC International
Child Neurology Foundation
CURE Epilepsy
Dravet Syndrome Foundation
Dup15q Alliance
Epilepsy Foundation
Epilepsy Leadership Council (ELC)
Glut1 Deficiency Foundation
Gould Syndrome Foundation
Hope for Hypothalamic Hamartomas
International Foundation for CDKL5 Research
LGS Foundation
National Association of Epilepsy Centers (NAEC)
NORSE Institute
PCDH19 Alliance
Rare Epilepsy Network (REN)
Ring14 USA
SLC6A1 Connect
STXBP1 Foundation
SynGAP Research Fund (SRF)
Tuberous Sclerosis Alliance
Wishes for Elliott/DEE-P Connections

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