doctor handing off medication for access to prescription medicines

 

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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Out-of-Pocket Costs

It can be challenging for some people with epilepsy to afford the anti-seizure medication(s) prescribed by their provider. While the Affordable Care Act created an overall out-of-pocket cap for most forms of insurance, deductibles and caps can be very high. Medicare has no out-of-pocket cap. 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 both people who are commercially insured and uninsured, but they are not allowed for those 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 lowering out-of-pocket costs including passing all rebates and discounts to the consumer, creating lower out-of-pocket caps, and capping out-of-pocket costs in Medicare Part D. We further call on all participants in the drug supply chain to solve the affordability crisis without putting patients in the middle.

Status

Four states 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.

Starting in 2021, plans sold on the ACA Marketplaces may have copay accumulator programs that do not count copay assistance toward deductibles and out-of-pocket maximums. The Epilepsy Foundation continues to express concern over this policy.

At the Federal level, in 2019 the Foundation supported bipartisan proposals to cap out-of-pocket costs in Medicare Part D. Those proposals did not move forward due to shifting focus to COVID-19 relief.

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 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 protocols be streamlined and exceptions created such that people in certain situations can access their medications in a timely manner.

The Epilepsy Foundation supports reasonable limitations on prior authorization, including limiting prior authorization to new starts, ending prior authorization for generic medications, and ending prior authorization for people who are stable on their medications.

Status

Federal: The Epilepsy Foundation, along with over 20 national patient and consumer organizations, supports the Safe Step Act (H.R. 2163/S.464) which does 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.

The Epilepsy Foundation has supported limits on prior authorization by engaging with the Centers for Medicare and Medicaid Services (CMS) “Patients Over Paperwork” initiative. Through both written comments and in person meetings, the Foundation urged CMS to put practical limitations on prior authorization in the health care programs they oversee. The Foundation has supported the Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107 in the last Congress) which would streamline and standardize prior authorization in Medicare Advantage.

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 so the Foundation advocates to reduce or eliminate these challenges.

Status

There have been efforts under various Administrations to weaken the Six Protected Classes policy. Most recently, on its final full day, the Trump Administration announced a demonstration that would allow Medicare Part D plans to opt out of the Six Protected Classes policy. Starting in 2022, such 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. The Foundation along with other epilepsy-related organizations and partners representing other protected classes asked the Biden Administration to rescind this dangerous demonstration. The epilepsy community came out in full force and sent almost 1,700 emails to the administration. On Tuesday, March 16, 2021, the Centers for Medicare and Medicaid Services (CMS) announced the rescission this proposal that would have restricted access to epilepsy medications in Medicare. 

Engagement and Resources

Patient Advocates Applaud Filing of the 'Safe Step Act' in U.S. House of Representatives

Epilepsy Community Calls for Rescission of Six Protected Classes Demonstration and Protection of Access to Anticonvulsants

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Authored By: 
Epilepsy Foundation Advocacy
Authored Date: 
01/2021
on: 
Monday, July 26, 2021