This Week in Managed Care: April 9, 2021

A European safety committee finds very rare blood clot links with AstraZeneca’s COVID-19 vaccine, new report predicts shifts in the cancer landscape by 2040, and spotlighting the connected nature of type 1 diabetes with other autoimmune diseases.

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

AstraZeneca COVID-19 Vaccine Linked to Blood Clots in Rare Instances

This week, the European Medicines Agency’s safety committee concluded that there is a link between AstraZeneca’s COVID-19 vaccine and “very rare” clotting events, just weeks after the manufacturer had refuted the association.

Noting that unusual blood clots with low blood platelets should be listed as very rare side effects of the vaccine, regulators stressed that benefits still outweigh its risks.

“This vaccine has proven to be highly effective to prevent severe disease and hospitalization,” said Emer Cooke, executive director of the European Medicines Agency. “And it is saving lives.”

Following the reported blood clot links in adults, the University of Oxford paused the most recent arm of AstraZeneca’s COVID-19 vaccine trial among children and teenagers pending more information from the United Kingdom’s pharmaceutical watchdog, the Medicines and Healthcare Products Regulatory Agency.

Until then, UK regulators said that they would recommend that people under 30 receive other vaccines as most blood clot cases occurred in people under the age of 60.

Burdened by several setbacks highlighted by vaccine trial data controversy and suspended use among European countries, AstraZeneca is still planning to seek FDA approval for the vaccine later this month.

In other COVID-19-related news, the Biden administration appointed Gayle Smith, a former director of the US Agency for International Development, to serve as the new coordinator for its global coronavirus response.

Working to combat growing concerns of vaccine inequity, part of Smith’s responsibility will be to mobilize US resources and bolster vaccine production and distribution worldwide.

Globally, COVID-19 deaths surpassed 3 million this week, with Brazil and India currently experiencing significant spikes in cases and deaths.

For more, visit AJMC.com.

Cancer Landscape to Shift by 2040, New Report Says

According to a new study published this week in JAMA Network Open, estimates of future US cancer incidence and death indicates that the makeup of cancer will change by 2040, with increasing deaths from pancreatic and liver cancers and more melanoma cases but fewer breast cancer deaths and decreases in prostate cancer cases.

Calculating estimates by combining incidence rates from the Surveillance, Epidemiology, and End Results, or SEER, Program with existing US Census Bureau demographic projections by sex and race for 2016 to 2040 and average annual percentage changes, or AAPC, in incidence and death rates, researchers found that by 2040 the estimated makeup of cancer will be dominated by:

• breast, with 364,000 cases
• melanoma, with 219,000 cases
• lung, with 208,000 cases
• colorectal, with 147,000 cases.

Lung, colorectal, and breast cancer are also estimated to rank among the leading causes of death by cancer in 2040, along with pancreatic cancer and liver and intrahepatic bile duct cancer.

Lung cancer will maintain its distinction as the leading cause of cancer deaths from 2020 to 2040, with breast cancer moving from third to fifth.

The authors said they had previously estimated that the most common cancers overall by 2030 would be breast, prostate, lung, thyroid, and melanoma. The new estimates reflect the new AAPC data, which show an increase in melanoma and a decrease in prostate and thyroid cancers.

Currently, cancer is the leading cause of death in individuals aged 45 to 64 years; last year, there were an estimated 1.8 million diagnoses and more than 600,000 deaths.

For more, visit AJMC.com.

Understanding the Connected Nature of Type 1 Diabetes, Other Autoimmune Diseases

According to research funded in part by the JDRF, the best way to find new treatments for autoimmune diseases, including type 1 diabetes, is to study the immune system and targeted tissues together.

The research, appearing earlier this year in Science Advances, indicates that while immune targets of type 1 diabetes, lupus, multiple sclerosis, and rheumatoid arthritis are distinct, they share several similar elements, including common variants that pattern disease risk, local inflammation with contribution by innate immunity, and downstream mechanisms mediating target tissue damage.

In their work, the researchers mined RNA sequencing datasets from relevant organ and tissue cells in the different diseases, and identified “similar and dissimilar gene signatures.” In doing so, they identified both candidate genes for the 4 major diseases as well as major common gene expression changes in tissues among them.

"Discovering the common pathways of tissue destruction across multiple autoimmune diseases will dramatically accelerate our path to a cure for T1D,” said Frank Martin, PhD, JDRF director of research, in a statement. “Drugs that are effective in one autoimmune disease could be equally beneficial for another and quickly repurposed to make a big impact for people living with that disease.”

JDRF has undertaken a large-scale screening project, called T1Detect, that offers participants a blood test to find antibodies, which tell whether a person is at an early stage of type 1 diabetes and likely to become insulin dependent.

The project comes not only as rates of type 1 diabetes are rising overall, but as they are rising faster among Black and Hispanic youth.

For more, visit AJMC.com.

Idiopathic Hypersomnia Campaign Seeks to Spread Awareness, Empower Patients

Through a recently launched disease awareness campaign by Jazz Pharmaceuticals and the Hypersomnia Foundation on idiopathic hypersomnia, called I Have IH, both organizations are seeking to foster a better understanding of patient challenges as well as empower patient communication with care teams.

Characterized by chronic excessive daytime sleepiness, symptoms of IH can often overlap with other more common sleep disorders such as narcolepsy. However, unlike narcolepsy, IH has no FDA-approved therapies, with patients often struggling to manage their social, school, and occupational tasks.

Researchers polled 305 health care providers from February 5 to 12, 2021 and found that more than half said they had personally misdiagnosed IH, with 39% saying that it can take between 2 to 5 years to receive an accurate diagnosis.

This experience was shared by Meghan M, a 26-year-old patient with IH who said in an email exchange with The American Journal of Managed Care^® that she had to wait 5 years before receiving her IH diagnosis after first experiencing symptoms in high school when she couldn’t stay awake in class.

Forced to drop out of college, but currently working in a part-time job that accommodates her sleeping schedule, Meghan says that she continues to struggle with daily tasks and maintaining a social life.

With more than 90% of respondents saying that physicians need more education on IH, increasing comprehension and spreading awareness of the debilitating condition could be invaluable in providing patients with timely care and support from both physicians and the general public.

“Although my IH changed life as I knew it and continues to be an everyday struggle, I refuse to let it define me,” said Meghan.

For more, visit AJMC.com.

2021 Community Oncology Virtual Conference

This week, the Community Oncology Alliance, or COA, presented its 2021 Community Oncology Conference in a virtual format.

Covering issues in oncology ranging from lessons and actions taken amid COVID-19 to the latest cancer politics and policy updates from Capitol Hill, AJMC.com provided full coverage of the virtual meeting, which took place April 8-9.

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

• Ted Okon, MBA, executive director for COA
• Kathy Oubre, MS, chief operating officer of the Pontchartrain Cancer Center
• Lalan Wilfong, MD, executive vice president of Value Based Care & Quality Programs at Texas Oncology, and Payment Reform Co-Chair at COA
• And many more!

For full conference coverage, visit AJMC.com.

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