NEWDIGS Roundtable
Potential patient access to early-stage and pre-symptomatic Alzheimer’s care
November 14, 2024
Hilton Boston Logan Airport
Diagnostics and treatments for early symptomatic and pre-clinically asymptomatic Alzheimer’s disease are showing promise. Providing equitable and appropriate access in a financially and clinically feasible manner will require downstream innovation to match the upstream scientific innovation leading to the therapies.
This discussion seeks to gather insights from key stakeholders to identify real-world challenges for the US healthcare system to provide equitable access to early symptomatic and pre-symptomatic Alzheimer’s treatments for pre-Medicare as well as Medicare patients to provide initial scope for an Alzheimer’s NEWDIGS Case Study Process to develop solutions.
10:30 – 11:00 am |
Registration |
11:00 – 11:15 am |
Introductions & Overview |
11:15 am – 12:15 pm |
Discussion
|
12:15 – 1:00 pm |
Lunch |
1:00 – 2:00 pm |
Discussion
|
2:00 – 2:30 pm |
Next Steps & Close |
Roundtable participants
Chris Leibman
Senior Vice President, Value, Access, Public Policy and Government Affairs, Biogen
Chris Leibman is the Senior Vice President of Value, Access, Public Policy and Government Affairs at Biogen, where he leads the global value demonstration, patient access and pricing strategy development and execution across the Biogen portfolio, as well as, the Public Policy and Government Affairs organization. Prior to this role Chris lived in Zug, Switzerland where he led market Access and pricing at Biogen for Europe and Canada.
Mr. Leibman joined Biogen in 2014 from Janssen Pharmaceuticals (J&J), where he served as head of Market Access and Policy: Neuroscience and led the team responsible for the development and execution of market access strategies and value evidence generation across the Neuroscience franchise. Prior to this, first with Élan Pharmaceuticals and then with Janssen AI following their program acquisition, Chris led the market access launch readiness activities across the Alzheimer Immunotherapy Program in partnership with Pfizer.
J.K. Wall
Senior Director, Neuroscience Communications, Eli Lilly
J.K. Wall is senior director of neuroscience communications at Eli Lilly and Company, primarily overseeing communications of clinical trial data and commercial updates related to Alzheimer’s disease. His previous roles at Lilly include new product planning and value assessment for Lilly’s U.S. payer marketing organization, during which he was a co-author on journal articles about value assessment of Alzheimer’s disease therapies and diagnostics. He also previously served as speechwriter to Lilly’s CEO. Prior to Lilly, he was a business journalist for 15 years, focused primarily on health care finance. He holds bachelor’s and master’s degrees in history, respectively, from DePauw University and Indiana University.
Cassandra Ricci
Senior Manager, Alliance Development and Federal Government Affairs, Roche Diagnostics
Cassie Ricci brings nearly a decade of experience in the medical imaging and diagnostics industries to her position as Senior Manager, Alliance Development and Federal Government Affairs for Roche Diagnostics. Her work has focused on improving patient outcomes and increasing access to innovative technologies through legislation, policy and advocacy. In her current role, she created Roche Diagnostics' first Alliance Development program, where she builds meaningful and strategic partnerships with patient advocacy and stakeholder groups to advance the value of diagnostics in disease areas including Alzhiemer's disease and cervical cancer. Prior to joining Roche, Cassie was the Federal Sector Policy and Strategy leader at GE HealthCare, leading the veterans health policy portfolio and contributing to key legislation and policy to expand access to breast cancer screening for Women Veterans. She is also a founding member of the Brem Foundation to Defeat Breast Cancer's Young Professional Advisory Council. Cassie earned a BS in Biology from Bucknell University and currently resides in Arlington, VA.
Sharon Phares
Associate Director for Research, NEWDIGS
Sharon Phares, PhD, MPH, is the Associate Director for Research at the Center for Biomedical System Design (CBSD) at Tufts Medicine and an Assistant Professor in the Department of Medicine at Tufts University School of Medicine. She directs CBSD’s research strategy and oversees all quantitative and qualitative research activities. Previously, Dr. Phares has had a number of roles including Chief Scientific Officer of the National Pharmaceutical Council (NPC), Senior Vice President of Research and Education at the Pharmaceutical Benefit Management Institute, Director of Analytic Consulting at Pharmaceutical Strategies Group (PSG), an EPIC company, Vice President of Research & Advanced Analytics at Express Scripts, as well as senior positions in research and analytics at Laboratory Corporation of America and Walgreens.
Matt Fickie
Senior Medical Director, Medical Policy, Highmark Inc.
Dr. Matt Fickie is Senior Medical Director for Medical Policy at Highmark. As the plan’s internal expert on precision medicine, Dr. Fickie focus has been on advancing the use of genetic technologies to improve health outcomes. He oversees Highmark’s Medical Policy Department which includes Highmark’s innovative Coverage with Evidence Determination program. Prior to joining Highmark, he served as an attending physician at Mount Auburn Hospital in Cambridge, MA. Dr. Fickie is board certified in internal medicine, general pediatrics, and clinical genetics.
Amy Bassano
Managing Director, Medicare, Health Management Associates
A senior executive and nationally recognized health policy expert, Amy Bassano has more than 20 years of experience in developing organizational vision and strategic plans, designing, and implementing payment systems, and driving change in the healthcare delivery system. Ms. Bassano joined HMA in November 2021 after serving as the deputy director for the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare & Medicaid Services (CMS). As senior executive at CMMI for more than seven years, she oversaw the development and implementation of value-based purchasing models for Medicare and Medicaid, including accountable care organizations; bundled payment programs; and specialty initiatives in oncology, kidney care, prescription drugs, state-based models and dual eligibles. She collaborated with states, health plans, purchasers, and international organizations to lead the national and international movement for value in healthcare.
Prior to CMMI, Ms. Bassano spent more than 10 years at CMS leading payment and regulatory initiatives for Medicare acute fee-for-service payment systems including inpatient and outpatient hospitals, physicians, rural health clinics, federally qualified health centers, Part B prescription drugs and clinical laboratories. Ms. Bassano earned a master’s degree in policy studies from John Hopkins University and a bachelor’s degree in history from Tufts University.
Matthew Baumgart
Senior Vice President, Health Policy, Alzheimer’s Association
Matthew Baumgart is senior vice president of Health Policy for the Alzheimer’s Association, leading a range of projects at the intersection of policy and programs to achieve an aggressive agenda that serves all those affected by the disease. He oversees much of the Association’s public health work, including two grant programs funded by the Centers for Disease Control and Prevention (CDC), and the Association’s programmatic risk reduction efforts. In addition, Baumgart directs the Association's global public policy efforts, working in collaboration with Alzheimer’s Disease International, the World Dementia Council and the World Health Organization. Prior to joining the Association, Baumgart spent nearly 20 years working in the U.S. Senate, including as the legislative director for Sen. Barbara Boxer (D-Calif.) and a legislative assistant for over a decade to Sen. Joe Biden (D-Del.).
Sean Dickson
Senior Vice President, Pharmaceutical Policy and Strategy, AHIP
Sean Dickson leads Pharmaceutical Policy & Strategy at AHIP, the national association for health plans. Sean’s work focuses on policies that promote affordable access to prescription drugs. Previously, Sean led prescription drug spending research at the West Health Policy Center and the Pew Charitable Trusts, where he authored numerous peer-reviewed analyses of prescription drug policies. Prior to his research career, Sean represented both manufacturers and purchasers of prescription drugs, representing large branded manufacturers in government price reporting at Sidley Austin LLP and coordinating price negotiations for public health programs at NASTAD (National Alliance of State and Territorial AIDS Directors).
Ian Kremer
Executive Director, LEAD Coalition
Ian N. Kremer, JD, has worked on federal, state, and local dementia for over 27 years. Since 2012, Kremer has served as Executive Director of the LEAD Coalition (Leaders Engaged on Alzheimer’s Disease: http://www.leadcoalition.org), the uniting voice of over 260 member and allied organizations, along with hundreds of university-based researchers. The LEAD Coalition works collaboratively through federal public policy to improve quality of life for all people facing dementia while advancing the social and biomedical sciences to prevent, treat, and ultimately cure all forms of dementia.
Currently, Kremer serves on the CMS Medicare Evidence Development & Coverage Advisory Committee, the Public Policy & Aging Report editorial board, and on steering and advisory committees for eight NIA and CDC-supported projects, the Alzheimer’s Disease Patient and Caregiver Engagement initiative, the Digital Medicine Society's ADRD Core Digital Clinical Measures project, the Dementia Friendly America initiative, and the Davos Alzheimer’s Collaborative Champions Cabinet. Previously, Kremer served on the steering committees for the NIH’s 2017 and 2020 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, the CDC-Alzheimer’s Association Healthy Brain Initiative’s Leadership Committee developing the 2018-2023 and the 2023-2027 Public Health Roadmaps, and the FDA Stakeholders Working Groups for PDUFA VI and PDUFA VII. Kremer holds degrees from Washington University in Saint Louis and the University of Michigan School of Law.
Annie Acs
Senior Director, Value-Based Healthcare Policy, Eli Lilly
Annie Acs, MPH, is the Senior Director of Value-Based Healthcare Policy at Eli Lilly and Company. She is a recognized expert in U.S. federal and global health policy, specializing in value-based healthcare strategies, including pricing, assessment, and payment reform initiatives. In her role, Annie collaborates across the organization to design and implement innovative policy solutions tailored to critical therapeutic areas such as obesity, diabetes, and Alzheimer's disease.
Chelsea Mehalic
Director, Medical Policy, Highmark Health
Chelsea Mehalic is a master's prepared registered nurse, professional medical coder, and certified scrum master. Nursing was the perfect career because she wanted to help people. She started her career at the bedside caring for some of the most vulnerable populations. She now is the Director of Medical Policy for Highmark Health, helping individuals on a larger scale than she could have ever imagined. She leads a team that develops medical necessity criteria and monitors new technology, some of which could be life changing. Chelsea has worked for Highmark since 2018. Prior to Highmark, she worked as a nursing educator and as a legal nurse for a local Pittsburgh law firm. She aims to start every day fulfilling the mission of creating a remarkable health experience, freeing people to be their best while reinventing health. During her free time, she loves spending time with her two children, ages 14 and 10, and enjoys riding her Peloton bike.
Joel Braunstein
Co-Founder and CEO, C₂N Diagnostics
Dr. Braunstein, MD, MBA is Co-Founder and CEO of C₂N Diagnostics and has led the company's growth and commercial efforts since its inception. Dr. Braunstein has played a senior executive role in numerous emerging life sciences companies since 2004. He received his M.D. with Highest Distinction from Northwestern University Medical School in 1996. Subsequently, he trained in internal medicine at the Brigham and Women’s Hospital, Harvard Medical School, and was a Fellow in Cardiovascular Medicine and Robert Wood Johnson National Clinical Scholar at the Johns Hopkins Medical Institutions. Additionally, he completed an MBA with management and health policy focus and maintained an Assistant Professorship in Cardiology at Johns Hopkins University. In 2010, he was named a Distinguished Alumnus of Johns Hopkins University.
David Stark
Managing Director / Chief Medical Officer, Morgan Stanley
David Stark is a physician, executive, and technologist with a track record of developing and deploying data-driven products and services to improve the quality, experience, and affordability of healthcare. Currently he is a Managing Director of Morgan Stanley and serves as Chief Medical Officer and Global Head of Benefits where he leads a team responsible for the health and wellbeing of Morgan Stanley's 83,000 employees and their families in 40 countries. Additionally, David advises on population health internally and externally and co-led the Firm's global Covid-19 response. David is also a Trustee of the Morgan Stanley Foundation and serves on the advisory board of the Morgan Stanley Alliance for Children's Mental Health, which funds research on children's mental health, promotes thought leadership, and orchestrates specific programs in schools, hospitals, and physicians' offices. He also serves on the Investment Committee of Morgan Stanley Inclusive Ventures Lab, a startup accelerator that promotes early-stage tech and tech-enabled companies led by underrepresented founders.
Tom Hubbard
Senior Vice President, Policy Research, Network for Excellence in Healthcare Innovation (NEHI)
Tom Hubbard joined NEHI in 2005 from one of its founding organizations, the Massachusetts Technology Collaborative, where he served as Vice President of Technology Analysis. NEHI is a non-profit and nonpartisan organization of stakeholders from across all key sectors of U.S. health care. Its mission is to advance innovations that improve health, enhance health care quality and achieve greater value for money spent. At NEHI Tom manages projects on payer-manufacturer value-based arrangements, medication adherence, and comparative effectiveness research among other topics, and frequently serves as NEHI’s external voice among policymakers. He is the principal author of NEHI’s two recent reports on dementia and Alzheimer’s disease, Detecting Dementia: Emerging Innovations and Their Implications for American Adults and Their Health Care, and Diagnosing Hope: The New Era of Alzheimer’s Disease Treatment Hinges on Innovations in Diagnostics.
Before joining the Massachusetts Technology Collaborative Tom served on the staff of then-U.S. Senator John Kerry, as an economic development aide and Undersecretary of Economic Affairs for Massachusetts Governor Michael Dukakis, and as Director of Community Development for the City of Gardner, Massachusetts. He is a graduate of Harvard College and Harvard’s Kennedy School of Government and serves on the Embryonic Stem Cell Research Oversight Committee of the Harvard Faculty of Arts and Sciences.
Mark Trusheim
Strategic Director, NEWDIGS, Tufts Medical Center
Mark Trusheim is Strategic Director, NEWDIGS, Center for Biomedical System Design at Tufts Medical Center where he also co-leads the Financing and reimbursement of Cures in the US (FoCUS) Project.
Mark’s research focuses on the economics of biomedical innovation, especially precision financing for patient access, precision medicine, adaptive pathways, platform trials, biosimilars, and digital health advances. Mark has served as a Special Government Employee for the FDA’s Office of the Commissioner. Mark is also President of Co-Bio Consulting, LLC. His career has spanned policy as the President of the Massachusetts Biotechnology Council, diagnostics as founder of Cantata Labs, genomics as President of Cereon Genomics, eHealth as Vice President of Monsanto Health Solutions, managed care marketing at Searle Pharmaceuticals, and big data at Kenan Systems.
He holds degrees in Chemistry from Stanford University and Management from MIT.
Gigi Hirsch
Director, Center for Biomedical System Design & NEWDIGS, Tufts Medical Center
Gigi Hirsch, M.D. is the Director for the Tufts Center for Biomedical System Design and its flagship program NEWDIGS (New Drug Development Paradigms) at the Institute for Clinical Research and Health Policy Studies and Assistant Professor at Tufts University School of Medicine.
Prior to her arrival at Tufts Medical Center, Dr. Hirsch was the Executive Director of the MIT Center for Biomedical Innovation (2007-2022) where she founded and led NEWDIGS. Her prior experiences in clinical care and the biopharmaceutical industry led to her vision for NEWDIGS, a multi-stakeholder “think and do tank” that re-engineers connections between the upstream (research and development) and downstream (access to/use of drug therapies) systems to make both more patient-centered and sustainable. Under Dr. Hirsch’s leadership, NEWDIGS has advanced innovations in adaptive licensing of new drug therapies, outcomes-based payments models for durable cell and gene therapies, and real-world learning health systems designed to advance precision medicine. Her work in regulatory innovation led to her appointment on the Expert Advisory Committee of the President’s Council of Advisors on Science and Technology (PCAST) for a special report commissioned by President Obama on “Propelling Innovation in Drug Discovery, Development, and Evaluation” (2011-2012).
Dr. Hirsch trained in Internal Medicine (Brown University College of Medicine) and Psychiatry (Harvard Medical School), and practiced Emergency Medicine (Brigham and Women’s Hospital and Harvard Community Health Plan) before transitioning to her role in commercial strategy at Millennium Pharmaceuticals. In addition, leveraging insights from her non-traditional career path in medicine, she was founder and CEO of a boutique entrepreneurial venture (MD IntelliNet), funded by Boston’s Beth Israel Hospital, where she coached physicians from pre-med through retirement on career management in the rapidly changing healthcare industry.
Chatham House Rule
The Chatham House Rule is used in meetings where participants need a way to openly share information, but don't want to be identified as the source of that information in any meeting records or articles written afterward. The rule is invoked regularly in meetings dealing with sensitive topics. It reads:
“When a meeting, or part thereof, is held under the Chatham House Rule, participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed.”
Antitrust Compliance Statement
Updated November 8, 2022
Tufts Medical Center's NEWDIGS initiative spearheads initiatives focused on re-engineering drug development and delivery processes to optimize access to new medicines for patients while ensuring the sustainability of pharmaceutical innovation. Many of these initiatives involve cooperation among various constituencies, including pharmaceutical companies and other industry stakeholders, patient advocates, healthcare payers, and academic and research institutions.
Because competitors or potential competitors in the marketplace are often participating in the same initiatives, participants in NEWDIGS activities must take care to stay within antitrust boundaries.
The antitrust laws prohibit firms from entering into agreements and engaging in arrangements with competitors that are “anticompetitive” — meaning that they reduce competition more than they advance it. The antitrust laws, however, support and encourage “procompetitive” agreements and arrangements that increase efficiency, enable and improve innovation, and increase the availability of higher quality, lower cost goods and services. NEWDIGS’s initiatives are designed to facilitate “procompetitive” processes.
This Statement provides antitrust guidance to Tufts Medical Center personnel and to the representatives of companies and other institutions who participate in NEWDIGS activities with the goal of encouraging and ensuring antitrust compliance. Even for specially trained experts, it can sometimes be difficult to distinguish “anticompetitive” from “procompetitive” outcomes. This Statement articulates General Antitrust Principles that guide differentiation of various interactions and lists Specific Antitrust Guidelines to enhance the procompetitive nature of NEWDIGS activities and reduce the risk of any inadvertent violation of the antitrust laws. NEWDIGS asks all participants in NEWDIGS activities to follow the General Antitrust Principles and to adhere to the Specific Antitrust Guidelines. The Principles and the Guidelines are intended to be conservative – meaning that they will prohibit some conduct that the antitrust laws may allow – in order to provide a reasonable safety margin for everyone.
General Antitrust Principles
1. Be “antitrust aware”, including in your emails, documents, and conversations. This means remembering that no NEWDIGS activity is intended to reduce competition or create undesirable “anticompetitive” effects. These undesirable effects include increased market power, higher prices, lower quality goods or services, and the creation or strengthening of obstacles to innovation.
2. Part of being “antitrust aware” involves recognizing and memorializing, when appropriate, the desirable “procompetitive” effects that flow from cooperative exploration and innovation. These effects include faster rates of innovation, greater efficiency, increased output, lower prices, and higher quality goods and services. Documents and meeting agendas that identify those positive effects create a helpful contemporaneous record of the participants’ procompetitive vision, which can be consulted later.
3. Note that preserving a particular company’s or group of companies’ prices, profit margins, or position in an industry is not a legitimate goal, particularly in the dynamic industries involved in NEWDIGS’s activities. All companies are expected to succeed on their own merits and not because they have created obstacles to competition. The law establishes one important exception – patent holders possess a temporary, completely legal monopoly as their reward for innovation. A patent holder, acting alone, is entitled to use the legal system to exclude rivals from practicing the subject of the patent.
4. “Market power,” meaning the ability of a single company or group of companies to control the price or availability of goods and services, is rarely permissible under antitrust laws. The acquisition or use of market power is tolerated where it results from superior products, services, or business skill, but otherwise it is highly suspect. No NEWDIGS activity that makes economic sense only if it creates or intensifies market power for the participants (other than through the eventual assertion of patent rights) should be undertaken without first consulting NEWDIGS's compliance contact.
5. Other countries have their own competition regimes, and some of those regimes operate quite differently from the United States’ antitrust laws. Recognizing that much of NEWDIGS’s work may affect the global marketplace, NEWDIGS intends to comply with competition laws in all countries where its work has local effect. This Compliance Statement addresses the fundamental principles that are common to the competition regimes in the United States and the European Union. If you believe a NEWDIGS activity is likely to have a significant, negative economic effect on a company outside of the United States or European Union, please raise that issue with NEWDIGS's compliance contact.
Specific Antitrust Guidelines
1. Do not reach any of the following types of agreements with a competitor: agreements affecting the price at which goods or services are sold in competition; agreements allocating customers or markets among competitors; or agreements not to deal with any company or organization.
2. Do not discuss with a competitor information concerning any of the following: your company’s or your competitors’ prices, costs, discounts, terms of sale, or profit margins or anything else that might affect those prices; the resale prices your customers should charge for any products you sell them; markets, customers, territories, or products sold in competition; whether or not to deal with any other company or organization; or any other competitively sensitive information concerning your company or a competitor. In addition, do not share non-public data concerning these topics with a competitor.
3. Do prepare and follow an accurate agenda, even if only in summary form, for meetings attended by representatives of two or more direct competitors.
4. Do consult with NEWDIGS’s antitrust compliance contact before proceeding in any area of uncertainty. The compliance contact does not provide legal advice. When needed, the compliance contact will obtain legal advice for Tufts Medical Center participants. All non-Tufts Medical Center participants must consult their own counsel for legal advice.
5. Do recognize that the antitrust laws encourage cooperation among competitors for the legitimate, procompetitive purposes envisioned by NEWDIGS. A more detailed look at this complex area may be found in the United States’ Antitrust Guidelines for Collaborations among Competitors, found here.