This Week in Managed Care: July 24, 2020

States sue Trump administration for changing nondiscrimination provisions of the Affordable Care Act, experimental vaccines show promise against COVID-19 in healthy subjects, and a pair of studies from the United Kingdom suggest diagnostic delays from COVID-19 may increase cancer-related deaths.

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

States Sue Trump Administration for Changing Nondiscrimination Provisions of ACA

This week, a coalition of 23 states sued the Trump administration over an HHS rule, set to take effect next month, that would end health care discrimination protections for LGBTQ people, individuals with limited English proficiency, or LEP, and women who have had abortions.

Led by the attorneys general of New York, Massachusetts, and California, the suit was filed in the Southern District of New York and asks that the rule relating to Section 1557 of the Affordable Care Act (ACA) be set aside because it “is arbitrary, capricious, an abuse of discretion, or not in accordance with law.”

Speaking on the rule last month, HHS said it was abiding by a decision by the US District Court for the Northern District of Texas, which ruled in favor of a religious organization that had sued the federal government in 2016 over the rule.

HHS also claimed that the rule change would save nearly $3 billion a year, primarily from eliminating the LEP requirements that notices be published in the top 15 languages of each state and other requirements.

“It is more important than ever that everyone can access essential health care,” said Xavier Becerra, attorney general of California. Becerra also said the rule “authorizes discrimination" at a time when the country is reeling from the pandemic, calling the move “unbelievably immoral.”

For more, visit ajmc.com.

Experimental Vaccines Show Promise Against COVID-19 in Healthy Subjects

Published this week in The Lancet, 2 experimental vaccines, one each from CanSino Biologics and AstraZeneca, have shown promising results against COVID-19.

In the CanSino phase 2 trial, the vaccine induced significant neutralizing antibody responses, with as much as 95% of patients showing either cellular or humoral immune responses at day 28 post vaccination.

Based on interim results of AstraZeneca’s phase 1 and 2 COV001 trial of AZD1222, the vaccine was shown to be tolerated and generated robust immune responses against the virus in all participants who were evaluated.

A single dose of the vaccine elicited a spike in antibodies by day 28 with neutralizing antibody responses detected in 91% of patients. After a booster dose, all participants had neutralizing activity. The vaccine also showed increases in T-cell responses as early as day 7 and these responses were maintained for 56 days.

“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this,” said Dr Andrew J. Pollard, coauthor of the study. “We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”

Phase 3 trials of the vaccine are underway in Brazil, South Africa, and the United Kingdom.

For more, visit ajmc.com.

Diagnostic Delays From COVID-19 May Increase Cancer-Related Deaths, UK Studies Say

Based on findings from a pair of studies published in The Lancet Oncology, delays in care due to the COVID-19 pandemic for patients with breast, colorectal, esophageal, and lung cancers could lead to almost 10% more deaths in England over the next 5 years.

According to the authors, 30% to 40% of cancers in the United Kingdom are diagnosed through routine screenings and outpatient referrals, but there has been an 80% drop in urgent referrals since the lockdown began in March.

Authors of the study predict that up to 20 years of life could be lost with each death, totaling to nearly 60,000 life-years lost, and that this will “reflect a substantial proportion of deaths in younger/middle-aged people.”

“These estimates paint a sobering picture and reflect the many young people who are affected by cancer in the prime of life during their most productive years,” noted study coauthor Richard Sullivan, professor of cancer policy and global health at King’s College London.

These study findings additionally come as top cancer organizations cosigned a letter organized by the National Comprehensive Cancer Network, or NCCN, asking the Trump administration to reconsider its decision to withdraw from the World Health Organization.

The letter said that “the rapid progress of oncology research in the United States” requires that US researchers are able to access WHO information.

But it is not just the fact that the global fight against cancer requires the participation of the United States, the organizations said—they also noted that US researchers benefit from the free flow of information, which helps both domestic and international patients.

For more on the UK studies, visit ajmc.com.

For more on the NCCN letter, visit ajmc.com.

Merck Gets Priority Review in NDA for Vericiguat

This week, the FDA accepted Merck’s New Drug Application for priority review for vericiguat, an oral soluble guanylate cyclase stimulator, to cut the risk of cardiovascular death and heart failure hospitalization after an event in certain patients with chronic failure.

The announcement follows the presentation of results from the phase 3 VICTORIA trial in late March during the American College of Cardiology Scientific Sessions, one of the first major meetings to be held in a virtual format due to the coronavirus disease 2019 pandemic. Results were also published in the New England Journal of Medicine.

Results from VICTORIA showed that for heart failure patients with reduced ejection fraction who show signs of decline while taking standard medication, vericiguat may stem the tide. Results showed those taking vericiguat had fewer events, less hospitalization, and less risk of death from any cause than those taking placebo.

“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”

The company said FDA has set a date of January 20, 2021, for action under the Prescription Drug User Fee Act. Merck is developing the drug with Bayer AG.

For more, visit ajmc.com.

Paper of the Week

And, now our Paper of the Week, which looks back at some of the most important papers over the past 25 years of The American Journal of Managed Care^® and why they matter today.

Telehealth has taken off during COVID-19, but this came after years of research on remote health care delivery. The most popular study of early 2015 in The American Journal of Managed Care^® featured results from a pilot study at Aetna, which examined whether a remote behavioral health intervention involving a social worker and a health coach could make a difference with a group of cardiac patients.

After 8 weeks, the 200 patients receiving the intervention had 38% fewer hospitalizations than a comparison group, for a projected savings of $864,000 over 6 months of follow-up.

For the paper, visit ajmc.com.

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