Alzheimer’s Experts Challenge Traditional Paradigms in Race to 2025

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Third Annual Lausanne Workshop Takes Patient-Centric and Interdisciplinary Approach to Overcome Key Treatment, Regulatory and Market Access Barriers in Alzheimer’s

Last week, global stakeholders convened for the third annual Lausanne Workshop to identify, address and overcome barriers on the road to stopping Alzheimer’s by 2025. Alzheimer’s experts from government, industry, patient advocacy, regulation, public policy and academia learned lessons from those closest to Alzheimer’s disease as well as experts in other disease areas. Their goal was to challenge traditional approaches to care, drug development, regulatory and market access issues. This commitment is fueled by the urgent unmet need to provide hope and solutions to the nearly 50 million individuals affected by Alzheimer’s and other dementias worldwide – and many million more carers.

The prevalence of Alzheimer’s and other dementias is projected to double over the next twenty years. “This is currently one of the biggest challenges for our health systems—and it remains poorly understood and highly stigmatized. That’s why it is critical to put those living with Alzheimer’s and other dementias and those caring for them at home, in the hospital and in our communities at the center of our efforts,” said Tania Dussey-Cavassini, Vice-Director General of Swiss Federal Office of Public Health and Switzerland’s Ambassador for Global Health. “Advances are slowly being made that matter to those on the front lines of Alzheimer’s because we are hearing their diagnostic and care experience, and learning what they value from potential treatments in forums like the Lausanne Workshop,” said Isabella Beretta, Scientific Advisor, State Secretariat for Education, Research and Innovation SERI, Switzerland. “Now it is time to integrate these lessons systematically into clinical trial design, drug development agendas and diagnostic pathway creation in order to change the trajectory and restore hope.”

Viable treatments to restore hope may be in sight according to new research of the Phase II and Phase III drug pipelines. A 2016 analysis by ResearchersAgainstAlzheimer’s, a global network of top Alzheimer’s researchers, shows nearly 20 drugs could potentially reach the market in the next five years and over 50 more are in Phase II development. “These potentially game-changing drugs with increasing diversity in mechanisms of action will change how we treat persons with dementia,” said George Vradenburg, Convener of The Global CEO Initiative on Alzheimer’s Disease. “But to ensure that they do, we will have to question our current assumptions and approaches and potentially incorporate lessons from other disease areas. Just as combination treatment proved effective for HIV/AIDS, a similar approach to developing a ‘cocktail therapy’ for Alzheimer’s disease used by several of these compounds may provide the hope and medical progress that millions of people are demanding. And just as we learned the value of patient-centric payment to foster innovation in oncology, so must we do in Alzheimer’s.”

Critical to ensuring that these drugs make it to market and reach those most in need is the integration of new technologies and patient-reported outcomes to inform the regulatory review process. The good news is that regulators are already having open conversations with key stakeholders in Alzheimer’s, a collaborative spirit reinforced by the panel of distinguished regulators from the United States, Canada, Switzerland, European Union and Japan.

This kind of dialogue is also fundamental to the development of evidence to support the payer community charged with making reimbursement decisions. “The challenge is to advance the conversations with payers today in order to prove the value of treatments already on the market and many more still to come,” said Heiner Sandmeier, Deputy Secretary General, Interpharma. “This effort will take nuanced research and new definitions of value informed not only by traditional stakeholders but those living with Alzheimer’s and other dementias and their carers.”

Access to treatments could be especially difficult for lower income countries, where there are fewer resources and greater stigma. “Today we heard from critical voices in the global public health fight on Alzheimer’s and other dementias, including World Dementia Council Member, Advocate and Carer from Nigeria Kikelomo Laniyonu Edwards as well as Shekhar Saxena, Director at the World Health Organization,” said Dirk Pilat, Deputy Director, Directorate for Science, Technology and Innovation at the OECD. “Their voices shine a spotlight on how critical the development of sound public policy solutions and global cooperation will be to address Alzheimer’s and other dementias systematically.”

One focus of collaboration between these stakeholders needs to include creating the pathways to an early and sustainable differential diagnosis, and consequently, to a specific treatment. “If we want to tackle treatment and care barriers for people with dementia, we need to develop care pathways as an integrated and coordinated approach towards dementia in all stages,” said Marc Wortmann, Executive Director of Alzheimer’s Disease International. “This approach has worked well in other chronic disease areas when the public was aware of the importance of early detection. We need to raise awareness about the early signs of Alzheimer’s and dementia, and we need to take action today instead of waiting for new treatments.”

Taking action was top-of-mind in Lausanne, and the convening closed with several action items to accelerate advances in 2017, including:

1.    Expand the scope and reach of Lausanne to other critical themes such as digital, open science, biotech and nutrition as well as other regions of the world to create a truly global and ongoing Lausanne dialogue.
2.    Engage finance ministers, treasuries, parliamentarians and municipalities – stakeholders who drive budget decisions and public investment in Alzheimer’s research, care and insurance coverage.
3.    Focus efforts to speed the development of a validated surrogate biomarker that could transform clinical trial design duration and costs.
4.    Break down the silos between Alzheimer’s and other disease areas to draw out lessons and best practices. An immediate step is to form a group of top oncologists and Alzheimer’s researchers to explore common targets and build hypotheses for further exploration. This approach could also be pursued for top experts in other disease areas such as cardiovascular disease to investigate common disease mechanisms, trial design, prevention, disease chronicity, surrogate biomarkers and diagnostic tools.
5.    Take a disciplined and systematic look at the ways to mitigate the age-related incidence of the disease.
6.    Leverage The Big Ideas Alzheimer’s Platform, a crowdsourcing tool created by Optum Labs and The Global CEO Initiative on Alzheimer’s Disease (CEOi) launched for Lausanne III, for critical real-world evidence insights needed by payers.
7.    Initiate country-level “Lausanne Dialogue” series to increase engagement around regulatory and access solutions. The US-focused partnership will be led by the CEOi and the Duke Margolis Center for Health Policy, which is headed by Mark McClellan, Director and Robert J. Margolis, MD Professor of Business, Medicine and Health Policy, former administrator of the Center for Medicare and Medicaid Services and former commissioner of the U.S. Food and Drug Administration. Additional countries and partnerships to be announced.

The 2016 Lausanne Workshop entitled The Road to 2025: Delivering Next Generation Alzheimer’s Treatments Increasing Understanding and Collaboration Between Industry, Regulators and Payers is the third in a series of Lausanne-based annual Alzheimer’s convenings. The series began in 2014 in response to the challenge articulated at the UK G8 Dementia Summit to stop Alzheimer’s by 2025.

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Tim Tassa

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