Advocacy: Access Prescription Medications
For the majority of people living with epilepsy, anti-seizure medications (also known as anticonvulsants) are the most common and cost-effective treatment for controlling and/or reducing seizures. There is no “one size fits all” treatment option for epilepsy, and the response to medications can differ between seizure type and person to person. The Epilepsy Foundation therefore advocates for access to the full range of anti-seizure medications so that each person with epilepsy—with his/her healthcare provider’s guidance—can have timely, affordable and consistent access to the epilepsy medication that works for him/her.
Delaying access to the anti-seizure medication(s) that work(s) for a particular person puts the individual at increased risk for breakthrough seizures and related consequences including injury, disability or even death.
The Epilepsy Foundation engages on many policy issues to help ensure timely, affordable and consistent access to epilepsy medications as detailed in this Access to Prescription Medications position paper including out-of-pocket costs, step therapy and prior authorization and Medicare’s Protected Class Status for Anticonvulsants.
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Sign Up for our Speak Up, Speak Out! NetworkOut-Of-Pocket Costs
It can be challenging for some people with epilepsy to afford the anti-seizure medication(s) prescribed by their provider. The Affordable Care Act created an overall out-of-pocket cap for most forms of insurance and, after successful advocacy from advocates, the Foundation and organizational partners, there will be an out-of-pocket cap in Medicare Part D starting in 2025. Even with these caps, some people with both Medicare and private insurance struggle to afford their medications.
Given this problem, some prescription drug manufacturers offer copay assistance programs. There are programs for people who are commercially insured and the uninsured, but these programs are not allowed for those individuals on Medicare. Some insurance companies and pharmacy benefit managers have started discouraging the use of copay assistance. Under this practice, the coupon is accepted, but the amount of the coupon does not count toward an individual’s deductible or annual out-of-pocket maximum—making it take longer for the individual to meet his/her deductible or maximum and therefore, forcing the consumer to pay more out-of-pocket.
Position
The Epilepsy Foundation supports affordable access to anti-seizure medications including legislation to ensure that copayments paid in any form, including through a copay assistance program, count toward an individual's deductible or out-of-pocket maximum so that more financial burden is not placed on the individual. The Foundation supports other policies aimed at lowering out-of-pocket costs including passing all rebates and discounts to the consumer and creating lower out-of-pocket caps. We further call on Congress to pass pharmacy benefit manager (PBM) reform and ask all participants in the drug supply chain to solve the affordability crisis without putting patients in the middle.
Status
In August 2022, a federal law supported by the Foundation was enacted that for the first time, places an annual cap on Medicare Part D beneficiaries’ out-of-pocket expenses for their prescription drugs. This cap will start in 2025 and will be $2,000 per year. The new law will also allow a monthly cap to help beneficiaries spread costs for their prescription drugs throughout the year.
In October 2023, a federal district court struck down a 2021 rule, which more broadly permitted the use of copay accumulators. Now, copay accumulators are permissible only for branded drugs that have a generic equivalent, if allowed by state law. This was a positive step forward, but the Foundation is urging the Department of Health and Human Services (HHS) to issue updated guidance on copay accumulators to insurance companies The Foundation also supports the HELP Copays Act (S. 1375/H.R. 830) which would provide a more permanent and comprehensive solution by ensuring that copay assistance payments count towards deductibles and out-of-pocket maximums in individual, small group, and employer-sponsored health plans.
19 states and the District of Columbia have passed legislation to ensure that copay assistance counts towards deductibles and out-of-pocket maximums, and the Epilepsy Foundation continues to support these bills in more states.
Step Therapy & Prior Authorization
Step therapy, or fail first, is a process that requires individuals who have been prescribed certain medications to try and fail one or more medications preferred by the insurer before receiving the originally prescribed drug. Prior authorization is an insurance process where the insurer requires pre-approval from the insurance company before individuals can fill a prescribed medication or receive a physician-recommended treatment or test.
Both step therapy and prior authorization can delay access to physician-directed care and the most effective treatment, which can be very problematic for people with epilepsy since treatment is so individualized and the consequences of delaying treatment can be so severe.
Position
The Epilepsy Foundation opposes step therapy, prior authorization, and similar policies intended to restrict access to physician-directed care that unnecessarily prolong ineffective treatment and prevent individuals from immediately starting the treatment their practitioners think is best. The Foundation at the very least urges step therapy and prior authorization protocols to be streamlined and exceptions created such that people in certain situations—for instance, if someone has been stable on their medication—can access their medications in a timely manner.
Status
Federal: The Epilepsy Foundation, along with many national patient and consumer organizations, supports the Safe Step Act (H.R. 2630/ S.652) and has been working to get the bill included in a broader access to medications package in Congress. The Safe Step Act would not ban step therapy but would institute exemptions that would help many people with epilepsy access their medications in a timely manner—such as when the individual is currently stable on the medication.
In January 2024, the Centers for Medicare and Medicaid Services (CMS) released a regulation that requires payers, including Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) Fee for-Service, Medicaid managed care, and Affordable Care Act (ACA) plans, to send prior authorization decisions within 72 hours for urgent requests, and within 7 days for non-urgent requests. However, this regulation only applies to prior authorization for services (not medications). The Foundation continues to advocate for prior authorization reforms to ensure more timely access to medications.
State: Thirty states have passed step therapy reform protocols to help streamline the utilization management process and allow individuals to have timely access to appropriate medications. The Epilepsy Foundation, along with a coalition of health groups, continues to work at the state level to ensure that adequate step therapy override procedures are in place, preserving access to needed medications.
Medicare’s Protected Class Status For Anticonvulsants (Six Protected Classes)
The Centers for Medicare & Medicaid Services (CMS) established the Six Protected Classes policy to ensure that Medicare Part D beneficiaries living with serious and complex health care needs — such as epilepsy, HIV, mental illness, cancer, and organ transplants — have meaningful and timely access to the full range of approved medications necessary to manage their conditions and maintain their quality of life. This is critical since epilepsy medications are not interchangeable and the consequences of delaying access to provider-directed care can be devastating for people with epilepsy.
Position
The Epilepsy Foundation strongly supports Medicare Part D’s Six Protected Classes policy and has opposed efforts to weaken it. Despite the intent of the Six Protected Classes policy, Medicare Part D beneficiaries living with epilepsy may continue to confront barriers to care due to utilization management activities, including high cost-sharing, that limit access to lifesaving epilepsy medications. The Foundation advocates to reduce or eliminate these challenges.
Status
There have been efforts under various Administrations to weaken the Six Protected Classes policy. The most recent threat was proposed in early 2021 but was later rescinded by the current Administration in large part due to incredible advocacy from the Foundation, advocates, and the broader epilepsy community. This included the Foundation and more than 25 other epilepsy-related organizations sending a letter and Foundation advocates sending nearly 1,700 emails requesting rescission.
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