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CVS is closing its clinical trial business

Its model combined precision patient recruitment from a diverse population and the delivery of hundreds of home clinical trials, the company says.

Susan Morse, Executive Editor

Photo: Mario Tama/Getty Images

CVS Health is ending the clinical trial business it started two years ago.

"We continually evaluate our portfolio of assets to ensure they are aligned with our long-term strategic priorities," said Mike DeAngelis, executive director of CVS Corporate Communications, by statement. "As a result, we're winding down our Clinical Trial Services business in a phased way, with a full exit expected by December 31, 2024. We'll work with our trial sponsors to ensure a smooth transition, as well as continuity of care and minimal disruption for patients. In parallel, we're working to support impacted colleagues, and will provide career transition support for those unable to find another role within CVS Health."
 
WHY THIS MATTERS

The closing of the clinical trial business is part of an effort by CVS to focus on its core business, according to Endpoint News.

CVS introduced CVS Health Clinical Trial Service in May 2021. The company said at the time that it would make clinical trial research more accessible and effective and encourage more equitable participation.

Studies depend on clinically appropriate volunteers, yet 80% of trials don't meet patient enrollment deadlines, and an average of 30% of those enrolled drop out for reasons including inconvenient trial location and length, CVS said.

Its model combined precision patient recruitment from a diverse population, CVS Health said, stating, "We've delivered hundreds of home clinical trials, engaged and screened hundreds of thousands of people, worked with top pharmaceutical and medical device companies and contributed to peer-reviewed research publications."

This included collaboration with the pharmaceutical industry to facilitate clinical trials for investigational COVID-19 vaccines and treatments. CVS Health used a digital model and screening to identify 300,000-plus volunteers to connect them to studies close to home. 

A year later, in June 2022, Walgreens Boots Alliance launched its own clinical trial business.

THE LARGER TREND

On May 10, CVS Health CFO and Executive Vice President Shawn Guertin talked about the headwinds and tailwinds for the business at the 2023 Bank of America Securities Health Care Conference.

Guertin did not address the closing of the clinical trial business, according to the Seeking Alpha transcript dated May 14. 

One tailwind cited by Guertin revolves around changes in the 340B, a program designed to provide discounted drugs to hospitals with vulnerable populations. CVS participated as an administrator of these claims, which have decreased, and also as a contract pharmacy, according to Guertin. 

A court ruling was interpreted by manufacturers as allowing them to dramatically reduce their definition of what was a contract pharmacy that could dispense a valid 340B claim, with litigation ongoing. This has reduced the number of 340B claims that run through the whole system, Guertin said.

There's also been a "rapid decline" in the COVID contribution, he said.

Boosting performance has been the early closings of the acquisitions of Oak Street Health earlier this month and also Signify Health, which CVS acquired in September 2022. This is updating guidance to a range of $8.50 to $8.70, Guertin said. 

"So when I think about our core business, and I'm going to exclude the two most recent acquisitions, because I want to come back to them, when I think about our core business, when you think about all the things that we've talked about for 2024 the Stars headwind, the PBM contract loss, these two things that I just mentioned, when you kind of put that through, and we run that through and project that we think the adjusted operating income for that can be kind of approximately flat, more or less for 2024," he said.

CVS reportedly took a $2 billion revenue hit from a Medicare Advantage star ratings decline and the loss of the Centene pharmacy contract to Express Scripts last year. 

In 2021, CVS announced it would close 900 stores over a three-year period to offer more health services in the remaining locations.

CVS has closed over 400 stores, Guertin said.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org