Health Equity & Access Weekly Roundup: November 23, 2024

Despite Record ACA Enrollment, Report Reveals Underinsured Americans Are in Crisis

Despite significant progress under the Affordable Care Act (ACA), millions of Americans still face critical gaps in health insurance coverage and affordability. As of 2023, 8% of the population, or 26 million people, remained uninsured, while nearly a quarter of working-age adults were underinsured, struggling with high deductibles and out-of-pocket costs that prevent timely care. A report from The Commonwealth Fund highlights alarming trends: 57% of underinsured adults avoided necessary care due to cost, nearly 30% carried medical debt, and 41% reported worsened health from delaying care. While ACA reforms improved coverage access and protections, gaps persist, particularly among those with employer-sponsored insurance, which increasingly includes higher cost-sharing requirements. The report calls for policy changes to enhance affordability and coverage, such as permanent tax credits, closing the Medicaid gap, reducing out-of-pocket costs, and addressing the root causes of high health care prices. These steps are essential to sustaining progress and ensuring equitable access to care.

As Myeloma Trials Tackle Frontline Treatment, Where Are the Black Patients?

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The recent FDA approval of isatuximab (Sarclisa) for newly diagnosed, transplant-ineligible multiple myeloma highlights a persistent issue in clinical research: the underrepresentation of Black patients in clinical trials. Despite Black individuals constituting 20% of newly diagnosed multiple myeloma cases in the US, only 0.9% of participants in the phase 3 IMROZ trial were Black. This disparity is not unique, as other trials, such as PERSEUS and CEPHEUS, also report similarly low Black enrollment. These gaps hinder understanding of treatment effects across populations, contributing to inequities in care and outcomes. While advances in multiple myeloma therapy have significantly improved survival rates over 2 decades, the lack of diversity in trials raises questions about the safety and efficacy of treatments for Black patients, who experience the disease at disproportionately higher rates. The FDA has introduced draft guidelines requiring "diversity action plans" for pivotal trials, aiming to address these disparities. However, structural barriers like restrictive eligibility criteria and trial site locations remain challenges. Advocates and researchers stress the need for inclusive clinical research to ensure equitable access to life-saving therapies.

Proposed New Cardiology Board Could "Reshape" the System: AHA 2024

The proposed creation of an American Board of Cardiovascular Medicine aims to address evolving complexities in cardiovascular care, enhance certification processes, and improve patient outcomes. At the recent American Heart Association (AHA) conference, Cathie Biga, MSN, president of the American College of Cardiology, highlighted the need for a dedicated certifying board to ensure ongoing competence in this specialized field and address workforce shortages. The board could streamline skill validation, identify knowledge gaps, and personalize education for cardiologists while focusing on underserved populations and health equity. An official decision from the American Board of Medical Specialties is expected in February.

Racial Inequities in Guideline-Adherent Breast Cancer Care and Timely Treatment

A new study highlights significant racial disparities in breast cancer care among older adults, with non-Hispanic Black patients facing increased odds of not receiving guideline-concordant care or timely treatment compared with non-Hispanic White patients. Analysis of National Cancer Database data revealed that non-Hispanic Black women were as likely to be diagnosed with breast cancer but had a 40% higher mortality rate, partly due to delays in treatment initiation and reduced access to multimodality therapy. Even after adjusting for clinical and demographic variables, non-Hispanic Black patients showed a higher risk of all-cause mortality, underscoring the need for equitable and timely care.

Addressing Patent Hurdles, Payer Barriers, and Interchangeability

Global Biosimilars Week, held November 11–15 by the International Generics and Biosimilars Association, highlighted key challenges in biosimilar adoption, including patent system complexities, payer and pharmacy benefit manager (PBM) policies, and interchangeability designations. The Biologics Price Competition and Innovation Act's "patent dance" framework has facilitated biosimilar development but faces criticism for its complexity and potential to delay market entry. Issues such as product hopping and patent exclusivity also hinder competition. Payers and PBMs influence biosimilar access through reimbursement strategies favoring higher-priced reference drugs, often resulting in higher patient costs and unexpected treatment changes. Panelists at the event proposed policy reforms to enhance biosimilar adoption, including increasing PBM transparency, revising reimbursement strategies, and encouraging fair competition to reduce costs and improve access for patients.