OUR PURPOSE PIONEERING SCIENCE PATIENTS OUR PEOPLE ENVIRONMENT COMMUNITY REPORTING 49 ADVANCING HEALTH ACCESS AND EQUITY BIOGEN 2021 YEAR IN REVIEW In 2021, 100% of our Phase 1–4 studies in the U.S. included a plan to recruit participants from underrepresented communities to ensure the study population is representative of the intended treatment population. To help achieve these goals, we have a multi-channeled health equity strategy, including: – Incorporating diverse community perspectives and insights into our drug development through our standing Community Advisory Board. – Engaging with the community by partnering with trusted local and national organizations to educate, build awareness and establish trust within the communities to drive health equity. Events conducted in 2021 included community and faith-based disease and clinical trial education programs for lupus and Alzheimer’s disease. – Leveraging real-world and epidemiological data to inform and identify clinical trial sites in order to make our trials accessible in communities where clinical trials have historically not been offered. – Expand and address health equity and healthcare disparities globally, including programs initiated in Australia and the U.K. We have partnered with the National Minority Quality Forum (NMQF) to launch a Clinical Trial Index comprised of U.S. heat maps of Medicare/Medicaid beneficiary data by patient demographics mapped against clinical trial site locations to identify the right sites in the right locations. As our clinical trials continue recruitment, teams track and report their progress toward the study targets that represent the epidemiology of the disease. We are also identifying new sites where patients are located and investing in bringing them on as clinical trial sites. Since we have near real-time data, we can identify gaps in access and focus on different sites and locations. We also built sustained community outreach and education programs for disease awareness in Alzheimer’s disease and lupus, and general clinical trial education with the Center for Information and Study on Clinical Research Participation (CISCRP) AWARE, Proximity Health Solutions and HEAL Collaborative. Other examples include: – Alzheimer’s disease: For two years, we have sponsored the BrightFocus Foundation’s Virtual Community Outreach Series, bringing sustained Alzheimer’s disease and clinical trial education and access to communities with an underrepresented focus. We also co-developed a paper with the NMQF titled “A Roadmap for Real-World Evidence Generation in Alzheimer’s Disease.” It highlights how real-world evidence can include larger patient populations that are historically underrepresented in randomized controlled trials. In the Phase 4 confirmatory ADUHELM study, ENVISION, we will aim to recruit at least 18% of U.S. participants from Black/African American and Latino/Hispanic populations. Þ READ ABOUT OUR FINAL PROTOCOL SUBMISSION FOR THE ADUHELM PHASE 4 ENVISION TRIAL – Lupus: We collaborated with Saira Z. Sheikh, M.D., Director of University of North Carolina (UNC) Rheumatology Lupus Clinic and Director of the Clinical Trials Program at UNC’s Thurston Arthritis Research Center, to gather insights on barriers to clinical trial enrollment among underrepresented groups. Some patient barriers are concerns for safety and efficacy, and burdens of participation, such as cost. Provider barriers include low awareness of open lupus clinical trials, lack of information on enrolling patients and biases related to patient referrals. These insights are being used to inform Biogen’s clinical development programs in lupus and address equity in study participation. For our Phase 3 study of BIIB059 in systemic lupus erythematosus we set enrollment targets that reflect the prevalence of SLE in Black or African American and Hispanic and/or Latino communities to achieve appropriate representation. Through partnerships with community-based Proximity Health Solutions and faith-based HEAL Collaborative, along with expert panels of community leaders, HCPs and patient advocates, we participated in seven events across the U.S. in 2021 to educate communities about lupus and clinical trial research. – MS: We sponsored the MS PATHS (Partners Advancing Technology and Health Solutions) network to foster collaboration between leading MS centers in the U.S. and Europe to help transform patient care by generating standardized data from a diverse, real-world patient population. MS PATHS is uniquely able to collect clinical, MRI and biologic data from all patients in real time, at the point of care, to better understand the disease and ultimately improve the lives of those with MS.