Meeting Multimodal Therapies for Brain Disorders: A Workshop When: June 14, 2016 - June 15, 2016 (1:30 PM Eastern) Where: Keck Center • 500 Fifth St. NW, Washington, DC 20001 Topics Biomedical and Health Research, Substance Use and Mental Health, Diseases, Aging, Public Health, Quality and Patient Safety Activity: Forum on Neuroscience and Nervous System Disorders Board: Board on Health Sciences Policy Multimodal therapy approaches (i.e., combinations of interventions aimed at different aspects of a disease) are emerging as a potential approach to enhance clinical outcomes for patients with nervous system disorders. This could include, for example, a drug prescribed along with a device, psychosocial intervention, lifestyle adjustment, or dietary intervention. While such an approach has face validity, there are important questions regarding how these interventions interact, how they should be used, in what subsets of patients, and in what amounts or for what period of time. Further discussion is needed about methodologies for determining efficacy in multimodal therapies compared with monotherapies and for comparing across multiple types of multimodal therapy. Multimodal therapy approaches also raise a number of important regulatory issues, both regarding combinations of regulated products (e.g., drug plus device) and approaches in which only one product is regulated (e.g., drug plus psychosocial intervention). Related questions arise for reimbursement, for example, would payers only pay for care if it includes both drugs and psychotherapy if that is what the data show is effective? This workshop, hosted by the Forum on Neuroscience and Nervous System Disorders, will bring together key stakeholders to examine scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and identify potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. Meeting objectives: • Explore recent advances in the development of multimodal therapeutic approaches for nervous system disorders and approaches to using these therapies (e.g., earlier versus later in disease progression), and discuss future research needs to further advance understanding of these approaches. • Highlight disease areas in which a multimodal approach could be particularly useful (e.g., areas in which the pathophysiology is well understood). • Discuss methodologies for establishing efficacy for multimodal therapies compared to monotherapies, including clinical and statistical considerations. • Consider regulatory issues for multimodal therapies, including for approaches in which only one component is regulated (e.g., drug plus psychosocial intervention), and discuss potential opportunities for addressing challenges. • Consider reimbursement issues for multimodal therapies for nervous system disorders, and discuss potential opportunities for addressing challenges. • Incorporate lessons learned from other therapeutic areas in which multimodal approaches are more frequently used (e.g., diabetes, HIV, cancer).