The Equity Advocate: Volume 1, Number 1

THE DIRECTOR’S CORNER

Welcome to The Equity Advocate, a monthly overview of the critical issues and events that are trending, or influence the efforts of our members and stakeholders to identify and realign structural inequities in the American health services research, delivery, and financing system. NMQF’s Institute for Equity in Health Policy and Practice is a member-driven collaboration designed to harness the political and economic will that is amassing in response to the realization that structural and systemic inequity is the proximate cause of amenable and avoidable morbidity and premature mortality. These structural inequities include scientific research and quality metrics that ignore patient variability, in health care policies that promote disparities, and in poor health outcomes and medical errors for an increasing number of Americans. The Equity Advocate Monthly Briefing, coupled with the monthly Equity Advocate Webinar Series will serve as hubs for information exchange and increased transparency to enable empowered federal and state advocacy and engagement. Contact InstituteForHealthEquity@nmqf.org for membership information.

ABOVE THE FOLD:

•  CMS Coverage Determination for Alzheimer’s Disease Treatment Disappoints

SPOTLIGHTS:

• ICER to Assess Three Alzheimer’s Treatments at July 2022 Meeting
• NMQF and the National Urban League Co-Lead Health Equity and Accountability Act Working Group for 117th Congress
• Profiles of Institute for Equity Policy Team

CMS NCED for Alzheimer’s Disease Treatment Alarms Patient Advocates

To the dismay of the patient advocacy community, on January 11, 2022, CMS released a proposed National Coverage Determination with evidence development (NCED) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease that would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease only if they are enrolled in qualifying clinical trials. Note that although Biogen’s (aducanumab) is currently the only monoclonal antibody directed against amyloid-beta approved by the FDA for the treatment of Alzheimer’s disease, the CMS determination of coverage with evidence development applies to the entire class of drugs, not solely to Aduhelm™.

Leading organizations in the patient advocacy community have voiced their alarm through publicly released statements and during several meetings with CMS leadership. 

Alliance for Aging Research President and CEO Sue Peschin, MHS said, “We are deeply troubled by CMS’ decision today. The CMS draft national coverage decision requirements under “coverage with evidence development” for monoclonal antibody (mAB) therapies aimed at amyloid for the treatment of Alzheimer’s disease are overly restrictive, medically unethical, unlikely to meet the agency’s goal to address health equity, will directly compete with clinical trial recruitment for FDA-required post-market study and will ultimately prolong evidence collection. This decision is not about furthering clinical evidence, it is about CMS severely rationing Alzheimer’s patients’ treatment access to save Medicare costs, full stop.  Additionally, the unprecedented politicization of this coverage decision to a community that already faces a high degree of isolation and stigma has been shameful and ageist. People living with Alzheimer’s disease should not be scapegoats for this Administration’s choice to excessively increase premiums, or for its joint effort with Congress to peddle price setting for prescription drugs.” 

George Vradenberg, Chair and Co-Founder of UsAgainstAlzheimer’s, stated that CMS’s NCED determination, “…effectively denies access to an entire class of drugs for years to come and further exacerbates health disparities. This is absolutely unacceptable. If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs—not by the agency that regulates drugs but by the federal insurance bureaucracy. Why are treatments for Alzheimer’s patients being held to a different standard than those treating cancer, HIV, and other illnesses? Is it because there are so many of us? Is it because we’re old? CMS should be ashamed of the way it is discriminating against this one group of patients. The FDA is the only agency with the legal authority to approve drugs, it’s the only one with neurologists on staff, and for the first time ever, Medicare is second-guessing FDA—and not only on work that it has already done, but on work FDA will do in the future.”

National Coverage Determinations have the potential to redress structural access inequities, improve health status and incentivize innovation. They also have the potential to erect structural barriers that increase patient risk for amenable morbidity and mortality. We encourage the engagement of all concerned stakeholders by sharing your concerns with your elected representatives and your physicians.

ICER to Assess Three Alzheimer’s Treatments at July 2022 Meeting

The Institute for Clinical and Economic Review (ICER) has announced an assessment the comparative clinical effectiveness and value of donanemab (Eli Lilly & Co.) and lecanemab (Eisai Inc.) for the treatment of Alzheimer’s Disease (AD), along with aducanumab (Aduhelm™, Biogen). The assessment will be publicly discussed in July 2022 during a meeting of the California Technology Assessment Forum (CTAF). Following a public comment period, a Revised Scoping Document was posted January 27, 2022. 

The NMQF public comment noted that “African Americans are two to three times more likely than non-Hispanic Whites to develop AD; and, Latinos are 1.5 times as likely. These disparities exist throughout all phases of AD. It is estimated that by 2030, nearly 40 percent of all Americans living with AD will be Black or Latinx. In short, for communities of color in the United States – indeed worldwide – the stakes associated with ICER’s assessment of current and potential treatments for Alzheimer’s Disease cannot be higher.”

NMQF called ICER’s attention to President Biden’s Presidential Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government in which he states: “Our Nation deserves an ambitious whole-of-government equity agenda that matches the scale of the opportunities and challenges that we face. It is therefore the policy of my Administration that the Federal Government should pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. Affirmatively advancing equity, civil rights, racial justice, and equal opportunity is the responsibility of the whole of our Government. Because advancing equity requires a systematic approach to embedding fairness in decision-making processes, executive departments and agencies (agencies) must recognize and work to redress inequities in their policies and programs that serve as barriers to equal opportunity.”

In closing, NMQF noted that, “As stated in the general provisions of President Biden’s Executive Order, “Independent agencies are strongly encouraged to comply with the provisions of this order.” The National Minority Quality Forum believes that the organizations and individuals who constitute ICER’s authorizing environment have an obligation to their stakeholders, members and beneficiaries to hold ICER’s methods, values, policy statements and value assessments to a correspondingly high and responsive standard. Failure to do so can result in harms – whether intentional or unintentional – that cannot be reversed. That is a risk not worth taking.”

NMQF and the National Urban League Co-Lead Health Equity and Accountability Act Working Group for 117^th Congress

The 2022 Health Equity and Accountability Act (HEAA) will be introduced by Congresswoman Robin Kelly, the Chair of the Congressional Black Caucus (CBC) Health Braintrust. The National Minority Quality Forum (NMQF) and the National Urban League (NUL) are co-leading the HEAA Working Group that advises the Tri-Caucus (the CBC, the Congressional Hispanic Caucus, and the Congressional Asian Pacific American Caucus) on in the development of this essential legislation. Staffing the NMQF/NUL HEAA Working Group is an Institute for Equity initiative. The HEAA builds off of the health equity momentum that the Congressional Tri-Caucus started in 2003 when the first Tri-Caucus health disparity elimination bill was introduced. This comprehensive piece of legislation strives to tackle the root causes of the health disparities and inequities that leave racial and ethnic minorities and other vulnerable and marginalized individuals in poorer health and struggling with less access to affordable, quality health care because of discrimination in the health care system and/or because they are on the downside of both opportunity and advantage. The introduction of the 2022 bill is planned during April – Minority Health Month.

Introducing the Institute for Equity Policy Team

Ms. Laka Mitiku Negassa, MPH, the NMQF/Microsoft Health Policy Fellow, is Health Policy Analyst for the Institute. Ms. Negassa is an MPH graduate in Health Policy from Milken Institute School of Public Health at The George Washington University and earned her Bachelor of Science from the University of Maryland Baltimore County studying Biological Sciences with a minor in Psychology. She is a Speaker in RespectAbility’s Disability Training and Speakers Bureau. Inspired by her personal experiences in the U.S. healthcare system after a traumatic brain injury, Ms. Negassa said, “I am elated at the incredible opportunity of learning from and working with leaders in health policy, both at NMQF and outside. I know this will enable me to be part of the work in finding ways and means to allow everyone, especially people with disabilities in the country, to have access to quality healthcare.

Britt Weinstock, PhD, MA is a Special Advisor to the Institute for Equity in Health Policy and Practice. Dr. Weinstock has worked in the fields of health equity, health policy, public health planning, assessment and evaluation, and health care financing for 25 years. Dr. Weinstock currently serves as the Principal and Chief Strategist of The Health Equity Strategies Group, LLC. Dr. Weinstock has extensive expertise working with and across, and building consensus among, a diversity of organizations and other stakeholder entities that sit on both sides of the political aisle. Dr. Weinstock holds a Doctor of Philosophy in Sociology, with a co-specialization in medical sociology and social inequality, and a minor in bioethics, from Howard University; a Master of Arts degree – with a concentration in social and public policy – from Georgetown University; and a Bachelor of Arts degree from Bucknell University.  

Gretchen Clark Wartman is Vice President for Policy and Program of the National Minority Quality Forum (NMQF), and Director of the NMQF Institute for Equity in Health Policy and Practice. Ms. Wartman also directs the NMQF National Alliance for Brain Health and Awareness. Ms. Wartman has more than 40 years of experience in the public and private sectors in health policy strategy and analysis, issue advocacy, and program administration. Prior to her tenure with NMQF, Ms. Wartman held positions with the Missouri Department of Health and Senior Services, including serving as the Title V/Maternal and Child Health Director, and Director of the Division of Nutritional Health and Services. Ms. Wartman is a Peer Reviewer for the Journal of Healthcare, Science and The Humanities.