This Week in Managed Care: April 16, 2021

The CDC and FDA pause distribution of J&J’s COVID-19 vaccine amid rare, severe blood clot links; the FDA clears the first artificial intelligence device to find possible cancerous hot spots during colonoscopies; and Managed Care Cast spotlights lessons from years of public health budgetary neglect which affected pandemic preparedness

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

FDA Pauses J&J Vaccine; EU Ending J&J and AZ Vaccine Contracts

This week, the FDA and the CDC paused the use of Johnson & Johnson’s single-dose COVID-19 vaccine at federal sites as they investigate cases of rare and severe blood clots caused by cerebral venous sinus thrombosis, or CVST, in combination with thrombocytopenia.

The decision, which was upheld by members of the CDC’s Advisory Committee on Immunization Practices, or ACIP, came as 6 women between the ages of 18 and 48 developed the disorder within 2 weeks of receiving the J&J dose, one of whom died and a second has been hospitalized in critical condition.

“Right now, I’d like to stress that these events seem to be extremely rare,” said Janet Woodcock, MD, acting FDA commissioner, during a media briefing. “However, COVID-19 vaccine safety is a top priority for the government.”

Urging states to follow suit in halting distribution of the vaccine, they encouraged individuals to contact their health care provider if they develop severe headache, abdominal pain, leg pain, or shortness of breath within 3 weeks of their J&J dose.

Choosing instead to focus on the vaccines from Pfizer/BioNTech and Moderna, the European Commission announced this week that it will not be renewing the current COVID-19 vaccine contracts it has with J&J and AstraZeneca, who have also been burdened by several setbacks highlighted by vaccine trial data controversy and suspended use among European countries.

European Commission President Ursula von der Leyen also announced ongoing discussions with Pfizer/BioNTech to acquire 1.8 billion vaccine doses.

UK Variant Dominant in US; UK Variant Not Linked to More Severe Disease

In other COVID-19–related news, the virus variant first identified in the United Kingdom, B.1.1.7, is now the dominant strain in the United States.

Considered by research as more contagious, a study published this week in The Lancet found that contrary to recent links to more severe disease, no difference in risks of severe disease, death, or other clinical outcomes were observed in hospitalized patients with this strain or other variants.

A separate study published in The Lancet Public Health also finds that currently approved vaccines are likely effective against B.1.1.7, with no increase in reinfection rate found compared with non-UK variants.

For more, visit AJMC.com.

FDA Clears First AI Device to Find Possible Cancerous Hot Spots During Colonoscopies

Last Friday, the FDA authorized the marketing of an artificial intelligence device based on machine learning to assist clinicians in detecting polyps or suspected tumors during a colonoscopy.

As the third leading cause of death from cancer in the United States, colorectal cancer screenings can be subject to missed lesions even among well-trained clinicians.

Through the device, called GI Genius, which is already in use in Europe, portions of the colon that have visual characteristics consistent with possible cancerous abnormalities can be detected via AI algorithm techniques, signaling when further assessment may be needed, such as a closer visual inspection, tissue sampling, testing or removal, or ablation of the lesion.

“Artificial intelligence has the potential to transform health care to better assist health care providers and improve patient care. When AI is combined with traditional screenings or surveillance methods, it could help find problems early on, when they may be easier to treat,” said Courtney H. Lias, PhD, acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in the FDA’s Center for Devices and Radiological Health.

The FDA review showed that when the device was used during a colonoscopy, lab-confirmed adenomas or carcinomas were identified in 55.1% of patients, compared with 42.0% of patients with standard colonoscopy, an observed difference of 13%.

In a statement, the FDA said its Center for Devices and Radiological Health’s Digital Health Center of Excellence is looking to the future of AI-based technology, including in its Artificial Intelligence and Machine Learning-Based Software as a Medical Device Action Plan.

For more, visit AJMC.com.

How Not to Prepare for a Pandemic: Can We Learn From Public Health Budgetary Neglect?

In an article published this month in Health Affairs, researchers from the Johns Hopkins Bloomberg School of Public Health, the University of Minnesota School of Public Health, and the College of Health Solutions at Arizona State University took a close look at state spending in 8 categories of public health from 2008 to 2018 to understand the extent to which funding has not kept up with pressing and emerging issues.

Researchers found that the stagnation in public health spending occurred during a time of rising mortality in the United States and funding, which was cut during the Great Recession, was not restored. Notably, neglecting public health in state budgets created an environment that was ill-suited to deal with the challenges of COVID-19, particularly a population beset with chronic illnesses and stark inequities in a fragmented health care system.

In this week’s episode of Managed Care Cast, we speak with Beth Resnick, DrPH, MPH, a coauthor of the study and a senior scientist in the Department of Health Policy and Management at Johns Hopkins, who discusses the state funding trends and what could be done in the future to avoid past mistakes.

For more, visit AJMC.com.

Addressing Physical, Emotional Pain in the Workplace Linked With Substantial Cost Savings

As one of the top cost drivers in health care spend for employers, musculoskeletal issues can contribute to lost wages, reduced quality of life, and adverse mental health implications for employees.

However, according to a report issued this week by the Harvard Business Review, nearly 1 in 3 employees say it’s taboo to talk about chronic pain at work, with 81% of surveyed managers also saying it is difficult to know if an employee needs support for a chronic condition.

In the report, titled, “The Future of Digital Care: Tackling the Costs of Physical and Emotional Pain in the Workplace,” findings further indicated that while 60% of respondents are aware that traditional physical therapy and other physical pain or injury treatments are available as health care benefits at their organization, out-of-pocket costs have discouraged workers from leveraging these benefits.

As COVID-19 has changed the way in which care is delivered and perceived, the expansion of digital care is thought by many to be a silver lining amid the pandemic to ameliorate the high health care costs that are often unnecessary for treatment of conditions such as musculoskeletal issues that may be better addressed through a preventive, conservative approach.

Notably, US Foods, one of America’s largest food service distributors, partnered with Hinge Health to employ its holistic digital musculoskeletal program. In addition to substantial cost savings reported by researchers from Stanford and Vanderbilt, analysis of US Foods’ 3-year medical claims showed that after partnering with Hinge Health, overall musculoskeletal claims declined by 50% and back and joint surgery claims dropped by 55% as well.

“The expansion of technology-enabled benefits during the COVID-19 pandemic can be a catalyst for supporting employees with additional digital care options that prevent and treat musculoskeletal pain,” said the study authors.

For more, visit AJMC.com.

AMCP 2021

This week, the Academy of Managed Care Pharmacy, or AMCP, presented its 2021 National Meeting in a virtual format.

Bringing together pharmacists, providers, payers, along with many more stakeholder groups in managed care pharmacy, AJMC.com provided full coverage of the virtual meeting, which took place April 12-16.

In addition to written coverage, AJMC.com has a wide array of video interviews with several key opinion leaders, including:

• Megan Olsen, MPH, principal at Avalere Health, whose presentation focused on emerging cell and gene therapies
• Brenden O’Hara, RPh, BCACP, from Blue Cross Blue Shield of North Carolina, who talked about the pharmacist’s role in improving outcomes in value-based contracts and why collaboration is needed

Additional interviews discussed biosimilars, Medicare Star ratings, and pharmacy discount cards.

For full conference coverage, visit AJMC.com.

For all of us at AJMC^®, I’m Matthew Gavidia. Thanks for joining us!