UsAgainstAlzheimer’s Launches Revolutionary Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) Initiative

Leading pharmaceutical companies, advocacy organizations, academic institutions, and care services companies join forces to create a new model for bringing patient and caregiver voices into therapy development, the drug review process, policymaking, and care. May 21, 2018 – Today, UsAgainstAlzheimer’s is launching the first of its kind Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) Initiative. AD PACE is an innovative, pre-competitive collaboration spanning the public and private sectors, aimed at identifying and prioritizing the needs and preferences of those living with and affected by Alzheimer’s disease. It will ensure that the patient and caregiver voice is integrated into the drug development and approval process. “The level and quality of the partnerships involved in this effort are a testament to the size of the Alzheimer’s public health emergency and the urgency with which meaningful solutions are needed,” said George Vradenburg, Chairman of UsAgainstAlzheimer’s. “Developing treatments that can truly help improve patients’ lives should be rooted in a firm understanding of the daily challenges patients face, their needs, and the trade-offs they are willing to make for improved outcomes. To create valuable treatments, patient needs and preferences must be integrated in all aspects of the healthcare system, including research priorities, product development, trial design, regulatory approval, access, reimbursement, and treatment decisions,” added Vradenburg. “AD PACE is poised to become the leading voice for Alzheimer’s patients and caregivers, providing the perspectives that are so critical to therapy development and regulatory reviews, and continues on to reimbursements and care services. So much of this is missing from the decision-making processes surrounding the disease.” The work of AD PACE would not be possible without the contributions, commitment and leadership from: Leaders Engaged on Alzheimer’s Disease (the LEAD Coalition), Biogen, Lundbeck, Otsuka Pharmaceutical Development & Commercialization, HomeInstead Senior Care, and Alzheimer’s patients and caregivers, Eli Lilly and Company, and Partnership Support from the Dementia Action Alliance, Balm in Gilead, Alzheimer’s Research United Kingdom, and researchers from leading academic centers, including Columbia University, Cleveland Clinic, University of California, Irvine, and the University of North Carolina. “These leaders recognize that the economic impact of this disease extends well beyond those bearing the research and development burdens,” added Vradenburg. “This year, Alzheimer’s disease is expected to cost the world economy $1 trillion, a figure that will continue to rise if suitable ways to prevent, slow, or reverse the disease are not identified.  A figure that is not sustainable.” Biogen is currently testing one potentially promising treatment for Alzheimer’s disease, aducanumab, which is in Phase III clinical trials.  “We are acutely aware of the need to ensure that the drug achieves outcomes that matter to our patient population and those who care for them” said Ivana Rubino, Senior Medical Director and Head of Alzheimer and Neurodegeneration. “Collaborating with AD PACE will facilitate a deeper understanding of how Alzheimer’s disease impacts patients and caregivers over time,” said Holly Krasa, Senior Director, Health Outcomes, Otsuka Pharmaceutical Development & Commercialization.  “In addition, it helps us collectively address the changes that are most troubling to those who are directly affected by the disease.” “AD PACE will influence the Alzheimer’s landscape by enabling all of us who are working to improve the lives of those affected by Alzheimer’s disease to better define the goals of our interventions so that we can provide targeted solutions to groups of patients and caregivers based on their preferences,” said Gregg Pratt, Vice President, US Regulatory Affairs, Lundbeck. AD PACE is producing several significant assets – one of which is its access to patient and caregiver insights. Known as its A-LIST, AD PACE has a growing online community of over 6,000 members that consists of those living with Alzheimer’s disease, other dementias, and mild cognitive impairment, as well as their current and former care partners and those at risk for developing any of these conditions. These members actively engage in AD PACE analyses geared toward capturing their viewpoints on issues that span the entire scope of Alzheimer’s disease. “AD PACE is so clearly grounded in the obvious yet often undervalued premise that every stage of Alzheimer’s drug development should be centrally informed by the preferences and priorities of people living with the disease. Ethically and practically, people living with Alzheimer’s disease deserve an equal seat at the table. Their voices deserve to be heard and heeded. AD PACE represents a sea change in how the scientific community and people living with the disease collaborate to achieve the national priority, the economic and budgetary necessity, the health and moral imperative of overcoming Alzheimer’s,” said Ian Kremer, Executive Director of the LEAD Coalition. Brett Hauber, Vice President of Health Preference Assessments at RTI Health Solutions will lead the AD PACE What Matters Most two-part study focused on identifying and quantifying treatment-related needs, preferences, and priorities, from people prior to any cognitive impact but pathological evidence of AD, to care partners of patients with advanced disease. In the first phase of this study, AD PACE will work to understand which treatment-related outcomes matter to individuals with Alzheimer’s, and in the second phase, how much each of those outcomes matter to determine which potential outcome matter most. The initiative is timely and aligned with the revised Food and Drug Administration (FDA) guidance on developing drugs for the treatment of early Alzheimer’s disease, a major regulatory change for which UsAgainstAlzheimer’s has been pushing.  With the revised guidance, it will be possible to intervene at all stages of the disease, even before symptoms are present, which opens up enormous opportunities to help those impacted by the disease and to incorporate their perspectives into new solutions.  AD PACE will use the data gathered through the What Matters Most studies to build upon the advancements of the FDA’s Patient Focused Drug Development (PFDD) initiative and to encourage the FDA to consider the way in which proposed treatments affect symptoms and functions that patients and caregivers feel are most important. Similarly, AD PACE will use the evidence it gathers through these studies to frame discussions on coverage and reimbursement around how interventions improve quality of life and productivity for patients and caregivers. Following this initial set of studies, AD PACE aims to develop a survey instrument that can detect differences in needs and preferences among various Alzheimer’s populations. Given that the experiences and preferences of certain patients and caregivers may diverge, this approach will allow AD PACE to provide targeted recommendations that enable tailored solutions.  Additional assets that will be developed as a result of the AD PACE initiative include a knowledge landscape, technical assessment of relevant tools and outcome measures that are currently in use in Alzheimer’s trials, and a gap analysis of those tools and if they are measuring what matters most to patients. Through its innovative research and compiled assets, AD PACE will develop the most comprehensive, quantitative Alzheimer’s experience data and will be the first of its kind in the fight against Alzheimer’s disease. This initiative’s forward-looking approach and its commitment to patients and caregivers is a response to the urgent and unmet need in Alzheimer’s and positioned to be a much needed and ground-breaking development for those who are impacted by this devastating disease.

Connect with UsAgainstAlzheimer’s.

Learn about UsA2’s work around the globe through their social channels: twitter logo for use in the Otsuka US news section external website link logo facebook logo for use in the Otsuka US news and media
May 201800US18EUC0013