Evaluating risks, costs, and benefits of new and emerging therapies to optimize outcomes in multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a complex, chronic, and often disablingneurological disease. Despite the recent incorporation of new treatmentapproaches early in the disease course, care providers still face difficultdecisions as to which therapy will lead to optimal outcomes and whento initiate or escalate therapies. Such decisions require proper assessmentof relative risks, costs, and benefits of new and emerging therapies, as wellas addressing challenges with adherence to achieve optimal managementand outcomes.At the 24th Annual Meeting Expo of the Academy of Managed CarePharmacy (AMCP), held in San Francisco on April 18, 2012, a 4-hour activitytitled "Analyzing and Applying the Evidence to Improve Cost-Benefit andRisk-Benefit Outcomes in Multiple Sclerosis" was conducted in associationwith AMCP's Continuing Professional Education Partner Program (CPEPP).The practicum, led by the primary authors of this supplement, featureddidactic presentations, a roundtable session, and an expert panel discussiondetailing research evidence, ideas, and discussion topics central to MSand its applications to managed care. OBJECTIVES: To review (a) recent advances in MS management, (b) strategiesto optimize the use of disease-modifying therapies for MS, (c) costs ofcurrent MS therapies, (d) strategies to promote adherence and complianceto disease-modifying therapies, and (e) potential strategies for managedcare organizations to improve care of their MS patient populations and optimizeclinical and economic outcomes. SUMMARY: Advances in magnetic resonance imaging and newer therapieshave allowed earlier diagnosis and reduction of relapses, reduction in progressionof disability, and reduction in total cost of care in the long term.Yet, even with the incorporation of new disease-modifying therapies intothe treatment armamentarium of MS, challenges remain for patients, providers,caregivers, and managed care organizations as they have to makeinformed decisions based on the properties, risks, costs, and benefits ofeach individual drug as part of an individualized shared decision-makingprocess. Case management and collaborative practice models, which incorporateself-management, medication therapy, formulary management, andcontinuous education, while promoting symptom management, medicationadherence, and a health-promoting lifestyle, are important in the overallmanagement of MS and can provide outcomes-based interventions aimedat controlling costs while maximizing treatment efficacy.

Implications of Risk Evaluation and Mitigation Strategy (REMS) programs for managed care pharmacy.

In the last 2 decades, health care management has been challenged by more aggressive therapy, the increased number of specialty medications, and more stringent guidelines to monitor adverse events or health risk. To promote patient safety, various communication requirements are mandated to increase the risk awareness of patients and physicians. These include black-box warnings, "Dear Health Care Provider" letters, U.S. Food and Drug Administration (FDA) Talk Papers, MedGuides, and Risk Minimization Action Plans (RiskMAPs).