Despite record ACA enrollment, report shows 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. In 2023, 8% of the population, or 26 million people, remained uninsured, while nearly a quarter of working-age adults were underinsured, facing 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% had medical debt, and 41% reported that their health worsened due to delaying care. While the ACA reforms have improved access to and protection of coverage, gaps remain, especially among those with employer-sponsored insurance, which carries increasing cost-sharing requirements. The report calls for policy changes to improve 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 sustain progress and ensure equitable access to care.
Where are the black patients now that myeloma trials are tackling first-line treatment?
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The recent FDA approval of isatuximab (Sarclisa) for newly diagnosed, transplant-ineligible multiple myeloma highlights a persistent problem in clinical research: the underrepresentation of Black patients in clinical trials. Despite black individuals making up 20% of newly diagnosed cases of multiple myeloma in the US, only 0.9% of participants in the phase 3 IMROZ trial were black. This disparity is not unique, as other studies, such as PERSEUS and CEPHEUS, also report similarly low black enrollment. These gaps hinder understanding of treatment effects within the population, contributing to disparities in care and outcomes. Although advances in the treatment of multiple myeloma have significantly improved survival rates over the past two decades, the lack of diversity in studies 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 The FDA has introduced draft guidance requiring “diversity action plans” for pivotal trials, aiming to address these disparities. However, structural barriers such as restrictive eligibility criteria and trial locations remain challenges. Advocates and researchers emphasize 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, improve certification processes and improve patient outcomes. At the recent American Heart Association (AHA) conference, Cathie Biga, MSN, president of the American College of Cardiology, emphasized the need for a dedicated certification board to ensure continued competency in this specialized field and address workforce shortages. The board could streamline skills validation, identify knowledge gaps, and personalize education for cardiologists while focusing on underserved populations and healthcare equity. An official decision from the American Board of Medical Specialties is expected in February.
Racial disparities in breast cancer care guidelines and timely treatment
A new study highlights significant racial disparities in breast cancer care among older adults, with non-Hispanic black patients more likely to not receive guideline-concordant care or timely treatment compared to non-Hispanic white patients. Analysis of data from the National Cancer Database found that non-Hispanic black women were equally likely to be diagnosed with breast cancer but had a 40% higher mortality rate, partly due to delays in starting treatment and reduced access to multimodal 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 from November 11 to 15 by the International Generics and Biosimilars Association, highlighted key challenges in biosimilar adoption, including the complexity of the patent system, payer and pharmacy benefits manager (PBM) policies ) and the indications of interchangeability. The Biologics Price Competition and Innovation Act’s “patent dance” framework has enabled the development of biosimilars, but has faced criticism for its complexity and potential to delay market introduction. Issues such as product hopping and patent exclusivity also hinder competition. Payers and PBMs influence access to biosimilars through reimbursement strategies that favor more expensive reference drugs, often resulting in higher patient costs and unexpected changes in treatment. Panelists at the event proposed policy reforms to promote biosimilar adoption, including increasing PBM transparency, revising reimbursement strategies and encouraging fair competition to reduce costs and improve patient access.