Managing Your Antiepileptic Medications for Cost Effectiveness by Randy Perkins, MPAS, PA-C, FNP Editor’s Notes by Robert S. Fisher, M.D., Ph.D., Editor-in-Chief of epilepsy.com Edited by Robin Owen, Managing Editor Most of us with epilepsy take antiepileptic medications to control our seizures. These drugs come in various sizes, shapes, colors, prices and with various side effects. Many of us have faced the dilemma of needing an expensive antiepileptic medication in order to have any reasonable quality of life, but being unable to afford the bill. Antiepileptic medications can cost from thirty to more than six hundred dollars per month for a single drug. For example, Keppra XR retails at about three dollars per 500 mg tablet. An average adult dose can be in excess of 3,000 mg per day. How do you go about weighing all the factors involved to make the best decisions regarding your medication strategy? Fortunately, there are a few methods for evaluating your situation and options to optimize your approach to medications. Analyze Total “Cost” There are different definitions of “cost.” The cost of medication can simply mean the actual dollar amount that you pay. However, this is a very narrow definition. Consider the other factors that influence your cost, such as quality of life, medication side effects, increased hospitalizations and lost job time. Several studies have evaluated quality of life in terms of dollar cost. As an example, such a study was done for sufferers of chronic hepatitis C (HCV). Quality of life research is one way that cost has been established for this disease. In this case, cost is defined as the dollar amount it takes to provide one year of quality life. There are similar models of cost effectiveness for various medications, lab tests and treatment protocols. A British meta-analysis study concluded that older antiepileptic medications would likely be more cost effective than newer agents, unless the older medications had unacceptable side effects, were not effective or were contraindicated. Some of the trials did not differentiate between generalized or partial seizures or lacked sufficient follow up and therefore limited the applicability of the studies.1 8 Epilepsy: Insights & Strategies August 2009 One of the drawbacks of cost effectiveness studies is that there tends to be a huge lag time between the end of the study and publication. Therefore, newer antiepileptic medications do not have as many long term follow-up studies to prove their effectiveness. Treatment models using evidenced-based research may not include the medicine that works best for you. It is critical that you weigh all the aspects of treatment cost, rather than only the out-of-pocket expense for your drugs. Consult with your epileptologist or neurologist, along with the most recent research to help you assess overall cost for your particular situation. I am lucky enough to have an excellent insurance plan but it only pays 50 percent of my medication’s cost. I can use a cheaper version of the medication, but it will not work as well and I would ultimately lose my job because of seizures. I could use other less expensive medications but I am fearful of side effects. At this point, I simply cut out other items in the family budget to afford an expensive but very effective epilepsy medication. Achieving a costeffective medication plan means evaluating and making trade offs. Don’t fall into the trap of creating a false economy by opting for a cheaper solution that actually costs you more in the end. Perkins Managing Your Antiepileptic Medications Evaluating Your Current Situation Policy makers may deem many antiepileptic medications to be cost effective, but that doesn’t mean that patients can afford them, especially without insurance coverage. Cost effectiveness tends to be a concern of policy makers whereas affordability tends to be more of a consumer concern. The consumer can be the patient or any agency that has to purchase medications. We can take a lesson from institutional consumers in this case—cost control is largely why hospitals and other agencies use drug formularies. A formulary is an approved medication list. Individual hospitals, insurance companies and government agencies each have their own version. Formularies were first designed as a cost control measure. Typically, formularies exclude the more expensive medications or at least eliminate medications with similar actions. An example of this is found in Holland. The insurance companies in Holland decide which medications comprise the national formulary. In the United States, we would have a choice of which statin drug we wanted if we had a cholesterol problem. In Holland, physicians have one drug, simvastatin (brand name Zocor). Holland chose this drug because all statin drugs have very similar morbitiy outcome studies (disease outcomes and quality of life). The difference is that not all statin drugs have the same side effects. Those who take antiepileptic drugs know all too well how side effects impact medication choice. Hospitals are constantly dealing with the issues of medication cost effectiveness and affordability, more so when much of the patient population is not insured. The best medications can cost hundreds or even thousands of dollars per month. The benefits of the better medications are allowing patients to live more independently, to have better social interaction, to remain employed and to require less hospitalization. Hospitals have developed several strategies to deal with cost issues that we can all apply to our own assessments, in partnership with our health-care providers and families: • First, evaluate the diagnosis. Is the diagnosis correct? Is another opinion needed to clarify the diagnosis? Is the medication appropriate for the diagnosis? An inaccurate diagnosis could mean unnecessary medication costs. • • • • What medications have been tried? How were they used? Are there less expensive medications that will achieve equal or similar results? What do you think of the medication? Were there unacceptable side effects? Focusing on a healthier life style can lower the overall medication cost. How much of your budget is spent on unhealthy habits that could be spent on treatment and avoid the additional costs of obesity, diabetes and cholesterol and triglyceride disorders? Are there obstacles that keep you from taking medications routinely? Lack of compliance adds to the cost of treatment in many respects. Are you taking your medications as prescribed? Skipping doses to manage cost often leads to more seizures. More seizures are ultimately more costly than the medication itself. • • Editor’s Note: If you are paying deductible charges for two pill sizes of the same medicine, ask your doctor if you can convert to one pill size at the same total daily dose. Then it will be only one deductible charge. For example, if you take a Lyrica (pregabalin) 100 mg pill plus a 200 mg pill, ask if you can take three of the 100 mg pills and eliminate a deductible. Medication Compliance Issues Ask yourself (and your doctor) if a different medication strategy would help you to achieve better compliance? Consider alternative drug formulations that can improve compliance and help to decrease hospitalizations to reduce total cost. Some medications have a longer acting form such as extended release versus immediate release. The longer acting formulations are usually newer versions and therefore usually cost more, but may be more effective for some individuals. It’s very important to assess your own strengths and weaknesses regarding medication compliance. Understanding your own compliance issues as well as all the possible August 2009 Epilepsy: Insights & Strategies 9 Managing Your Antiepileptic Medications Perkins medication options will help you determine which seizure medications are best suited to you. Editor’s Note: It usually is easier to remember to take a medicine once or twice a day, than three or four times a day. Weighing Generics versus Brand Name Drugs Generic medications are widely touted as cost saving. However, the Federal Drug Administration’s (FDA) requirement for generic drugs is that they have a minimum of 80 percent equivalence to the brand name, to a maximum of 125 percent equivalence. This means that the generic medication can potentially under or over perform your brand-name version and still be marketed as a government-approved alternative. This is a controversial issue in epilepsy management as some insurance carriers will only cover generics. Consider that a 15 percent difference might mean the difference between being seizure free and having job-ending seizures. My personal opinion is that generic medications require cautious use in epilepsy management. A single seizure has vastly different implications and consequences than does a single blood sugar or blood pressure elevation. However, for some, generics can be an acceptable and more affordable choice. The use of lower cost generic drugs could also become an issue in nationalized health care plans. Advocacy is critical with seizure medications as policy makers do not always understand the impact of drug formulation on conditions such as epilepsy. Editor’s Note: Some states allow generic substitution without approval by the patient or physician. It is the opinion of the editor that mandatory generic substitution without notice is not always in the patient’s best interest. If you do get handed a generic substitute by your pharmacy, make sure that you know it is to be taken instead of the brand-name drug, and not in addition. Otherwise, serious drug toxicity can result. Also be aware that the generic drugs stocked by the pharmacy may change month to month, increasing variability of the therapeutic effect. Patient education programs can help patients to better understand why medication compliance is important. Editor’s Note: See: http://www.epilepsy.com/epilepsy/medication_compliance An excellent resource in this respect is WebEase, a research study at Emory University (Atlanta) that is studying behavioral modification as it pertains to Internet self learning for patient epilepsy management. They are looking for patient volunteers. The study is designed to evaluate how people are able to develop self-management tools in areas of medication compliance, sleep and stress reduction. The plan is to market this program commercially in the next one to two years. I am part of the study population and I can verify that this is a worthwhile process, especially as it relates to medication compliance and cost control. Epilepsy.com provides information about this study at http://www.epilepsy. com/clinical_trials/showtrial/1229624336/type=all. Generic medication quality is generally reasonable. However, many inconsistencies have been documented. In September, 2008, the FDA blocked imports from a large generic drug manufacturing company, Ranbaxy, Ltd., of India because of quality control issues. One of their products was the anticonvulsant, gabapentin. The FDA cited numerous quality control concerns. Ranbaxy had worldwide sales of over 1.6 billion dollars. The same issues can arise with any manufacturer of generic antiepileptic drugs. Companies (foreign and domestic) do not always follow FDA quality control guidelines. In general, Americans are able to enjoy a higher 10 Epilepsy: Insights & Strategies August 2009 Perkins Managing Your Antiepileptic Medications standard with respect to antiepileptic medication choices, largely based on stringent quality control. But, if the least expensive medication (often an older drug) does the job well then it might be the best choice for you. Again, this is another issue to explore with your health-care providers. Newer and, therefore, more expensive medications usually have fewer side effects. However, this is not always the case. An older medication may be just as effective. Phenytoin (PHT) and phenobarbital are two examples. PHT remains a first-line medication choice for some seizures. However, the potential side effects of both drugs have been considerable. It has been said that if PHT and phenobarbital were invented today that they could not be marketed because of their extensive potential for side effects and drugdrug interactions. Yet, PHT remains a widely used antiepileptic medication because of its effectiveness and low cost. Domestic versus Foreign Prescription Drug Sources Whether you choose generics or brand-name drugs, be very careful if you order your medications from foreign countries. There can be a huge temptation to save big money but the trade off can be disastrous. The FDA cautions all consumers to be careful with out-of-country and on-line purchases. (http://www. fda.gov). Quality control can be lax in third world countries. Moreover, the manufacturing of fake drugs is a major and multinational industry. The World Health Organization has estimated that up to 30 percent of medications in parts of Africa, Asia and Latin America are fake. This will become a ten billion dollar industry by 2010. Older fake drugs were mostly lifestyle oriented (fake versions of Viagra, valium and various pain killers). The newer versions of fake drugs are treatments for cardiovascular, cancer and HIV/ AIDS medications.2 When evaluating your cost plan, remember the old saying: “If it sounds too good to be true then it probably is.” Make the Best Use of Your Prescriber and Pharmacist Ask your doctor about medication options and cost concerns. Most prescribers will be willing to involve you in the decision-making process, and will welcome the chance to review cost issues. Sometimes there are simple answers. Some patients simply continue to refill their medications without the benefit of an updated medical assessment. It’s important to reassess your situation periodically as your condition changes, in order to recognize when a more costeffective solution is appropriate. Communicate with your prescriber. If you don’t mention side effects or cost issues then he/she may assume that all is well. You need to advocate for yourself or your family member. Medication adjustment is a major part of the epilepsy story. Seizure patterns change, for better or worse, for many reasons. Don’t be satisfied with mediocre results. Consider your total medication profile. If you have other health problems that require medications then make sure that all prescribers are on the same page. In some cases, antiepileptic medications can be used for multiple purposes (e.g., seizures, pain and mood disorders). Avoid doctor shopping. Some patients will journey from doctor to doctor looking for the “magic” cure. This can result in huge amounts of medications and related costs and obtain only suboptimal results. Editor’s Note: Let the doctor know about ALL the medicines that you are taking, including natural or complementary medicines. This will help to minimize the risk of a serious drugdrug interaction. Medication cost is often related to service. Check with different pharmacies in your area to see who has the best prices. Evaluate their customer service. Talk with your pharmacist if you have special service needs (ordering dates, delivery options and drug interaction questions). Many pharmacists have a better, or at least different, overall understanding of medication August 2009 Epilepsy: Insights & Strategies 11 Managing Your Antiepileptic Medications Perkins issues including cost. Make your pharmacist part of your team of providers. New York State has a great web site, http:// rx.nyhealth.gov/pdpw. They compare 150 of the most commonly prescribed medications store to store by both brand and generic costs. Their list includes Lamictal, Lyrica, Topamax, Neurontin and Depakote. A brief site survey found that brand name Lamictal, 25 mg tab/30 tabs, ranges from $144.00 to over $200.00. The generic version ranges from $102.00 to $143.00. Topamax, 50 mg tab/30 tabs, ranges from $148.00 to $219.00. The generic version ranges from $139.00 to $189.00. One problem with this list is that it does not tell the consumer the end price. This is because third-party reimbursement has so many variations. Published medication prices have a limited use for this reason. Editor’s Note: Some insurers allow a three-month supply of medicines. If such an option is available, usually it is both cheaper and more convenient. However, only use it for established and likely stable medication regimens. • • • • • • • • • • • http://www.merck.com/merckhelps/ patientassistance/ 800-727-5400; Merck meds http://www.merck.com/merckhelps/ uninsured/home.html 800-50-MERCK; for the uninsured http://www.pfizerhelpfulanswers.com 866-776-3700; Pfizer meds http://www.pharmacyreward.com/ needymeds/index.cfm http://www.rxhelpforyou.com 800-613-4841 http://www.togetherrxaccess.com 800-444-4106; over 300 brand name meds; also generics http://www.rxassist.org 401-729-3284 http://www.pparx.com 888-477-2669 http://www.rxhope.com 732-507-7400 http://www.benifitscheckup.org (Geared to seniors.) Sponsored by National Council on the Aging http://www.accesstobenefits.org 202-479-6670 (Geared toward low-income Medicare beneficiaries and younger people with disabilities.) Patient assistance and advocate programs are available for financial assistance. Most of these programs define income based on the federal government’s poverty income guidelines. Do a Web search based on the particular pharmaceutical company, drugs and/or type of assistance required. A few examples of resources that can help are: • • • • • • • • • http://www.helpingpatients.org http://www.needymeds.com http://www.patientassistance.com http://www.patientadvocate.org http://www.fda.gov AARP Discount Program, call 877-422-7719 to enroll. Cost is $19.95 to enroll; ages 50+/AARP members. http://www.AZandME.com (AstraZeneca) 800-292-6363 http://www.gsk-access.com (GlaxcoSmithKline) 866-518-HELP; over 50 GSK meds http://www.bridgestoaccess.com (GlaxoSmithKline) 888-825-5249; over 50 GSK meds Epilepsy: Insights & Strategies August 2009 Another option, for those who cannot afford medicines (and are not on Medical Assistance, which pays for most medicines), is to send a request to the company that manufactures the medicine and ask for a compassionate free supply. They often give it. Your doctor would need to assist you in this process. The following are suggestions that could help you achieve a more cost-effective medication strategy: Consider hidden and direct costs of medicine • Side effects • Percentage of active ingredient • Interactions with other medication • Inactive ingredients (e.g., sensitivity to gluten, sugars or added dyes) • Compliance issues 12 Perkins Managing Your Antiepileptic Medications Talk with you health-care provider • • • Be sure your medical assessment is current and your diagnosis is up to date. Discuss cost issues with your health care provider. Do you have issues with medication compliance that could be addressed by a change in treatment strategy? Ask your health care provider if a generic medication is appropriate for your situation. Would an older (and less expensive) drug be appropriate for your type of epilepsy? Would the same medication in a different formulation be more affordable? In short: be informed and consider the total cost of medication; talk with your physician/health-care providers about the direct and indirect costs of medication; and be careful that you don’t do things that may cut down the short term costs but increase the long term costs. Randy Perkins has had epilepsy (both partial and generalized seizures) since high school. He is now fifty-eight years old, married (Sandy), father of four grown sons (Jon, David, Matt, Tim) and a grandfather. One of his sons, Matt, has just returned from the Iraq war and is a first-year pharmacy student. Initially, Randy was a high school English teacher. He switched careers and has practiced as both a family nurse practitioner and physician assistant (general medicine) since 1980. He is also a legal nurse consultant and owns Perkins Legal Medicine, LLC. His interests include his family time, deer hunting, making venison sausage, travel and learning foreign languages. • • • Notes and Citations 1. Wilby, J, et al. “Clinical Effectiveness, Tolerability and Cost Effectiveness of Newer drugs for Epilepsy in Adults: A Systematic Review and Economic Evaluation.” Executive Summary. Health Technology Assessment. 2005. Vol. 9: No. 15. 2. Bate, Robert. “The Deadly World of Fake Drugs.” Foreign Policy. September 2008. Caution • Avoid doctor shopping. It can increase overall costs. • Be cautious if ordering from online services, especially if ordering from out of country. Other strategies to reduce costs • Consider lifestyle changes. Can you eliminate expenses to have more income to pay for medications? Could you find a job that offers a better insurance plan? Ask your pharmacist or insurance company if you can get more than one month’s supply per refill. Often, each refill has a pharmacy fee. Coming Soon! • • A great new way to manage your seizures, medication and side effect log, and to organize information for you and your doctor. Expected by November: stay tuned. August 2009 Epilepsy: Insights & Strategies 13