Despite the overall safety record of approved DMTs, every MS medication has some risk, and every person has a different comfort level with risk. “I’ve had people come in and say, ‘Just tell me what to do!’ ” says Dr. Barbara Giesser, professor of clinical neurology at the David Geffen UCLA School of Medicine and clinical director of the MS program at UCLA. “Well, I can’t do that because there is no one single solution for every person with MS. What I can do is give them known data on the therapies available, order the right tests and help them process the information to make the most informed choice possible.”
The tests Dr. Giesser refers to help determine certain characteristics associated with specific drug risks. For example, in January 2012, the FDA updated Tysabri’s labeling to indicate that previous exposure to the normally harmless JC virus increases risk for developing a rare but potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML), which has occurred in people taking Tysabri. A blood test can show whether a person with MS has been exposed to the JC virus and can help people knowledgably weigh the potential consequences of taking this medication.
Similarly, people with a history of heart problems need to consider cardiac risks associated with Gilenya. “Based on someone’s past cardiac health and current medications, we can assess someone’s risk for heart complications when starting Gilenya,” says Dr. Robert Fox, staff neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic. “It doesn’t mean we don’t use the drug in people with elevated risks, but the presence of cardiac risk factors may prompt us to suggest alternative therapies.”
Dr. Kalb stresses that even after reviewing all the medications’ benefits and risks, there is no right or wrong choice. “It’s true that the first MS medications—the interferons and Copaxone—are partially effective and very safe. But safety isn’t always the final deciding factor,” she says. “If your MS is more aggressive, you may be ready to consider a therapy that comes with greater risks; otherwise, taking the ‘safest’ drug may feel like the greatest risk of all.”
Dollars and sense
Financial considerations, too, can influence treatment decisions. All MS medications are expensive, and insurance coverage varies considerably from one plan to another. Typically, the newer medications are pricier, with oral therapies the most expensive.
“As providers, we don’t always have full latitude to prescribe any of the 10 MS drugs as our first line of treatment,” Dr. Fox explains. “Often the insurance company mandates a limited number of drugs in its ‘first tier’ of coverage. You can petition for a different drug to be covered, but it’s time-consuming and isn’t always successful.”
Pharmaceutical companies that distribute DMTs offer help through their patient assistance programs (see “10 disease-modifying treatments” or call an MS Navigator at 1-800-344-4867). Needymeds.org can help direct people to these programs, as each has its own eligibility criteria and application forms. Originally established for people without insurance coverage for prescription drugs, today’s patient assistance programs are often available to help with high copays or co-insurance, depending on the applicant’s income. The patient assistance programs may change as a result of the Affordable Care Act (ACA) but exactly how is still unknown.
The ACA’s key provisions that take effect in January 2014 are expected to positively impact prescription drug coverage for the uninsured and some underinsured people. Under the ACA, all new health plans must cover prescription drugs; and for the first time, there are mandatory caps on out-of-pocket costs, which for some may mean greater coverage. However, navigating your health insurance plan will be an individual experience, says Kim Calder, director of Federal Health Affairs and Insurance Policy for the Society. She suggests visiting nationalMSsociety.org/ACAkickin to get familiar with the ACA, and then calling the Society at 1-800-344-4867 for additional help.
Additional therapies are moving along the research pipeline, including alemtuzumab, ocrelizumab, laquinimod and daclizumab—you can follow their progress at clinicaltrials.gov.
While each will bring something new to the table—pending FDA approval—each will still have side effects, risks, benefits and costs. There is still no universal “best” treatment. “The best disease-modifying medication is the one that the person with MS will take, and that is best for the person’s situation,” says Dr. Giesser. “If we had a perfect drug that definitively stopped relapses and had no side effects, I would say, ‘Why wouldn’t you take this?’”she says. “But for now, we don’t have one drug like that. So you weigh the benefits and risks and make the choice that fits your disease and your lifestyle. It’s a very individual approach.”