Multiple Sclerosis Treatment Options

San Diego—As the FDA approves more drugs to treat multiple sclerosis, healthcare professionals are attempting to understand the costs, benefits, and risks associated with the various treatment options.

Speakers discussed the therapies in a Satellite Symposium at the AMCP meeting titled The Evolution of Multiple Sclerosis Treatment: The Role of the Managed Care Pharmacist. The symposium was supported by an educational grant from Biogen Idec.

Jody Corey-Bloom, MD, PhD, professor in the department of neurosciences at the University of California-San Diego, said the FDA has approved the following drugs to treat multiple sclerosis: Betaseron^® (interferon beta-1b), Avonex^® (interferon beta-1a), Rebif^® (interferon beta-1a), Copaxone^® (glatiramer acetate injection), Tysabri^® (natalizumab), Gilenya^® (fingolimod), Aubagio^® (teriflunomide), and Tecfidera^TM (dimethyl fumarate).

There are also several drugs in late-stage trials, including daclizumab, alemtuzumab, ocrelizumab, and laquinimod. Alemtuzumab is currently approved to treat B-cell chronic lymphocytic leukemia, but it is associated with prolonged myelosuppression, which Dr. Corey-Bloom said would likely restrict its use to patients with malignant disease. She added that daclizumab, alemtuzumab, and ocrelizumab are all monoclonal antibodies and are associated with secondary autoimmunity, which could limit their use.

Laquinimod is an oral drug, as are fingolimod, teriflunomide, and dimethyl fumarate. Dr. Corey-Bloom said the oral medications are convenient and most patients prefer them over injection or infusion drugs, however, providers should assess the products’ risks and benefits before prescribing them.

Ronald J. DeBellis, PharmD, professor at the Keck Graduate Institute School of BioPharmacy in Claremont, California, said a consensus panel of managed care pharmacists and physicians recommended most patients with clinically definite multiple sclerosis should be treated with a disease-modifying therapy.

The recommendations, published last year in the Journal of Managed Care Pharmacy, said a health plan’s formulary should include glatiramer acetate as well as a preferred interferon, which should be selected based on efficacy, safety, and cost data. In addition, the authors recommended health plans manage access to natalizumab via prior authorization or a requirement that patients must fail on interferon or glatiramer acetate therapy before switching to natalizumab. Further, health plans should manage access to fingolimod by utilizing prior authorization, according to the recommendations.

Dr. DeBellis discussed several studies relating to the disease, including a long-term follow-up of patients taking interferon beta-1b that found 95% of patients taking 250 mcg of the drug and 92% of patients taking 50 mcg of the drug were alive after 16 years. Side effects decreased over time. Another study found that patients taking interferon beta-1a tolerated the therapy for up to 8 years and only 2% of patients discontinued therapy due to an adverse event.

According to Dr. DeBellis, the injectable therapies have the most safety and efficacy data because they have been on the market for a long time, but the newer oral agents could also be promising as standalone or combination therapies.

Kristen Helms, PharmD, associate clinical professor at Auburn University Harrison School of Pharmacy in Alabama, said healthcare professionals must provide patients with education and early intervention to improve their adherence to medications. She cited a study in which patients who discontinued therapy had higher rates of relapse and progression compared with those who remained on treatment.

Dr. Helms said patients are not adherent to multiple sclerosis medications due to adverse drug reactions, a perceived lack of efficacy, depression, an inconvenient regimen, or fear of the injections. She suggested pharmacists could alleviate patients’ concerns by being open with them, providing realistic expectations regarding drug efficacy, and including them in therapy decisions.