Strategies Used to Limit Access to Medications

The rising costs of health care and prescription drugs, cuts in state Medicaid budgets, the growing number of uninsured and the inability of Congress to pass a prescription drug benefit has led many states to develop cost containment policies that restrict access to medications and services, ultimately putting consumer care at risk. These cost containment measures operate under the theory that costs will decrease if administrative procedures, such as the ones described below, are established. In fact, costs may actually just be shifted to other parts of the health care system.

Often overlooked in this debate is the critical cost to the individual who requires medication to manage serious and life-threatening conditions like epilepsy. The Foundation has long been opposed to policies that impede appropriate and timely access to the full range of medications and treatments for epilepsy. When the cost containment measures have the effect of limiting access to medications in public programs like Medicaid, it creates a two-tiered health care system based on income level. Newer, more expensive medications would be off limits to Medicaid recipients. When evaluating medications for inclusion in public or private health plans, cost should be considered only if products of equal efficacy, safety, and clinical usefulness are available for the individual's condition. Therapeutic advantages and clinical factors are and must remain the primary reasons for deciding which products are included in a formulary. The continued availability of all products for the treatment of seizures is particularly important for people with epilepsy because of the variability of the individual's response to the medications, and this remains true no matter what one's income level. The Epilepsy Foundation cannot support policies that have the effect of denying low income people access to newer medications or to the medication the individual requires to treat his or her medical condition.

Exempting Epilepsy Medications

At the urging of advocates, some states have begun exempting medications used to treat serious and life threatening conditions from the pharmacy benefit management processes described below that restrict access to care.

The Epilepsy Foundation will continue to oppose cost containment policies that have the effect of limiting access to anti-epileptic drugs. However, if a state is intent upon passing legislation or implementing regulations requiring formulary restrictions, prior authorization, mandatory generic substitution, step therapies and other pharmacy benefit management processes, then the Foundation will support language exempting anti-epileptic or anti-seizure medications from those policies. All medications used to treat seizures will be medically necessary for some individuals with seizure disorders. The anti-epileptic drugs are not interchangeable for people with epilepsy. Access to the medication an individual requires is a matter of life and death for people with seizures. Impediments to proper treatment can have ramifications on employment, driving privileges, social interactions and self-image. The varying nature of epilepsy makes treatment of the condition highly individualized requiring all treatment options for epilepsy to be accessible and affordable.

Restrictive Formularies

Formularies are lists of drugs that are available through the health plan. Restrictive or closed formularies or "preferred list" refer to a limited list of medications.

Pharmacy benefits programs are extremely important to people with epilepsy and others who absolutely depend upon medications to control and treat a medical condition that, if untreated or unsuccessfully treated, may be life threatening. When formularies are developed, often times the medications with the lowest price in the FDA approved class are most likely to make the list, sometimes making the newest and more effective medications vulnerable to restrictions or excluded altogether.

A "preferred drug" is not always the right drug when treating seizures. Because of the varying nature of epilepsy, no one, or two, or three products currently available will be successful for all people with epilepsy. That is why it is essential that formulary plans remain "open" and should include all anti-epileptic products, both generic and brand name.

Medicaid Rebate Program

Medicaid law requires companies to provide rebates to the states in order to have their drug included in the state Medicaid formulary.

Negotiations between the state and pharmaceutical companies are an appropriate way to control costs. As overall costs are rising, some states have begun to demand steeper discounts and have threatened not to include medications on their formularies where the manufacturer does not agree to the discount. Medicaid law requires that formulary decisions take into consideration clinical usefulness of medications when considering what medications should be included. It is questionable whether the reliance upon cost factors meets the requirements of the Medicaid law. Whether or not it is acceptable under the law, the concern for epilepsy advocates is that the clinical usefulness aspect of the debate is being lost. People with epilepsy who are also Medicaid recipients are likely to be people who are significantly impacted by their seizures and have complex, difficult to treat seizure disorders. They will not have resources to purchase needed medications on their own, or to pay co-pays. Excluding or limiting medically necessary drugs creates a hardship for people with seizures and other serious and life-threatening conditions.

Prior Authorization

Administrative process used by health plans that a prescribing physician would need to follow in order to prescribe a medication not on the formulary or not a preferred drug.

The physician in the context of the patient-physician relationship, should make decisions regarding appropriate medications for the individual. Treatment of epilepsy is highly individualized and medical professionals must have the ability to determine the best treatment available with the fewest side effects. The treating physician is in the best position to make the judgment about which medication to try. Prior authorization can deter clinicians from prescribing the most appropriate medications due to the administrative burden of the process. Doctors are already pressed for time to spend with patients and may resist further bureaucratic processes.

Prior authorization is particularly burdensome to people in group home settings and institutions where often there may not be an aggressive personal advocate or health care professional making sure the individual gets the medication he or she needs. Prior authorization can also delay necessary and appropriate treatment for people with epilepsy. Continuity of care is imperative for people with epilepsy. Any delay in receiving medications can cause breakthrough seizures. The consequences of a breakthrough seizure can be far more devastating to an individual's health, productivity and to the cost of the illness to society than the recurrence of symptoms of other non-epilepsy related medical conditions.

Step Therapy ("Fail First")

In order to prescribe a certain therapy the individual must first try and fail on other medication(s).

While clinical treatment of epilepsy often requires trial and error to find the right medication or combination of medications, it should not be dictated by the health plan or the state. This is a particularly inappropriate and dangerous practice for people with a seizure condition, since the consequences of having a seizure can be so devastating. A seizure can involve severe injury to the individual and to others, and the possibility for long term brain damage as a result of seizures makes it particularly important that seizures be prevented when at all possible. Therefore, people with epilepsy must have access to all available treatment options in a timely manner. Step therapy or fail first policies impede this from occurring. Access to newer, sometimes more expensive medications are contingent upon treatment failures (often multiple tries) with other less effective medications. This restrictive policy causes unnecessary harm by not allowing the consumer access to the most appropriate line of treatment for his/her condition. Health plans should not be in the business of prescribing care. Any health program that determines effectiveness by cost rather than by sound clinical expertise and patient input is not acceptable. Medical professionals must be allowed to determine the best course of treatment for their patients.

Tiered Copayment Structures

Typically the lowest co-pay is assigned to the generic drug with higher co-pays for brand name drugs.

This cost sharing technique is used as an incentive for prescribing generic medications. This approach is acceptable for people who are able to use generic medications without safety concerns. It often poses a significant barrier, however, for those people who cannot afford to pay the higher co-pays but must use the higher priced medication because of their experienced problems with generics, their seizure type, or the need for consistent and precise control of their anti-epileptic medication levels. A significant percentage of people with epilepsy, and most epileptologists, report that there are people with epilepsy for whom generics, or switching among generics, is not medically acceptable for one of the above reasons. An even bigger problem for people with epilepsy occurs when there is no generic equivalent for the optimal medication for one's seizures, but the brand name is only covered by the health plan at the higher co-pay. The individual is forced to pay what is often very high out of pocket costs for the medically appropriate brand name product. Most of these tiered co-pay systems occur in private insurance plans, and usually there is no appeal process for challenging the placement of medically necessary drugs at the higher co-pays.

Prescribing / Dispensing Limits

Limits on the number of prescriptions per month or how much of the medication that can be prescribed in a given time period.

Sometimes a state will try to limit the number of prescriptions it will pay for an individual. This creates tremendous problems for an individual and their doctor who may be trying to manage multiple health conditions. For example a state may decide to limit the prescriptions per month to 4. This forces some people into the difficult position of trying to decide which medication they will go without in a month. The policy seems particularly egregious when applied to Medicaid recipients since this population is vulnerable, often multiply disabled, and trying to manage complex medical conditions with extremely limited resources. Again, the most medically needy are being asked to unfairly carry the burden of lowering costs for health care.