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



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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. This initiative will work to ensure that the patient and caregiver voice is integrated into clinical trial design, drug development, regulatory review, payer value models, coverage and payment determinations, and research on care and services.

“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 perspectives that are critical to therapy development and regulatory reviews, reimbursement decisions and care services research. The decision-making processes surrounding the disease will benefit immensely from this work.”

The work of AD PACE is driven by collaborations with its Founding Sponsors, Biogen, Lundbeck, Otsuka Pharmaceutical Development & Commercialization, Leaders Engaged on Alzheimer’s Disease (the LEAD Coalition), and Home Instead Senior Care; its Supporting Sponsor, Eli Lilly and Company;  its partners and academic advisors, the  Dementia Action Alliance, Balm in Gilead, Alzheimer’s Research United Kingdom, the Critical Path for Alzheimer’s (CPAD), MyHealios, and researchers from leading academic centers; and its federal agency advisors at NIH, FDA and CMS.

“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 effective ways to prevent, slow, or reverse the disease are not identified.  A figure that is not sustainable.”

“Biogen’s research programs target several of the identified Alzheimer’s causes, with an emphasis on early-stage disease. These programs range from preclinical experiments to Phase 3 clinical trials,” said Ivana Rubino, Global Head of Medical, Alzheimer’s Disease, Biogen. “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.”

“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 will help 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 Ann Hartry, Vice President Health Economic and Outcomes Research, Lundbeck.

AD PACE is producing several significant assets – one of which is the A-LIST, a growing online community of over 6,000+ members, including 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 surveys geared toward capturing their viewpoints on issues that touch all aspects of the lived experience with Alzheimer’s.

Another asset being developed by AD PACE is the AD PACE Data Commons. This is the first-ever repository that will house data developed through a range of preference studies contributed by nonprofit organizations, academic institutions, and industry. The AD PACE Data Commons will provide a new, rich amalgamation of de-identified insights, assuring that contributions by patients and caregivers to a particular study are not lost, but are collected to produce widely-available knowledge on outcomes that are most meaningful to them.

“AD PACE is 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 matters most.

The initiative is timely given the recently revised Food and Drug Administration (FDA) draft guidance on developing drugs for the treatment of early Alzheimer’s disease, an important contribution to the field that  UsAgainstAlzheimer’s  supports.  With the revised draft guidance, the FDA is providing to the community the Agency’s latest thinking on how to assess a drug’s impact on the trajectory of Alzheimer’s in its earliest stages. Through the What Matters Most Study, using rigorous scientific methods and building on upon the advancements of the FDA’s Patient Focused Drug Development (PFDD) initiative, AD PACE will bring new knowledge to the field of the patient’s view of these impacts and which of these are most meaningful to them. 

Further, AD PACE will use the evidence it gathers through these studies to inform emerging conversations on how to define value in the context of coverage and payment determination in Alzheimer’s.  “We know that securing FDA approval for a new therapy is just the first step.  Securing access to a new therapy is equally important to patients and caregivers.  We have designed AD PACE from the beginning in a way that will help payers understand how a new therapy affects not just the lives of those in a clinical trial, but the lives of all of those who are living with Alzheimer’s. We cannot do this work without this goal in mind,” confirmed George Vradenburg.  

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.

For more on AD PACE, look at our project overview document here, and our infographic here.