This Week in Managed Care: February 12, 2021

President Biden’s DOJ reverses course in case seeking to overturn the Affordable Care Act, once-weekly treatment with 2.4 mg of semaglutide and lifestyle changes slashed body weight by 15% in individuals with overweight or obesity, and a COVID-19 variant exhibits differing efficacy among vaccines

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

Biden’s DOJ Reverses Course in Case Seeking to Overturn ACA

This week, under a new administration, the Department of Justice, or DOJ, dropped its previously held position that the now-defunct tax provision in the Affordable Care Act, or ACA, cannot be severed from the rest of the law, which would have made the entire health law unconstitutional.

President Joe Biden, who recently issued an executive order reopening the exchanges created by the Affordable Care Act from February 15 to May 15 to help those who lost their insurance due to the pandemic, campaigned on the idea of strengthening the ACA rather than repealing it, as the Trump administration long tried to do.

Under the previous administration, the DOJ refused to defend the constitutionality of the landmark 2010 health law, also known as Obamacare. Republican-governed states, led by Texas, sued to overturn the ACA, claiming that without the monetary penalty—which was reduced to $0—the entire ACA was invalid, as the provision could not be severed.

With the Supreme Court expected to issue a ruling by the end of June, the Biden administration formally notified the court of the change in a letter, writing, “the United States no longer adheres to the conclusions in the previously filed brief of the federal respondents.”

Furthermore, the letter indicates that if the court decides that Section 5000A(a) is unconstitutional, that provision is severable from the remainder of the ACA.

For more, visit AJMC.com.

Trial Finds Semaglutide With Lifestyle Intervention Reduces Body Weight by Nearly 15%

Once-weekly treatment with 2.4 mg of the diabetes drug semaglutide plus diet and exercise is linked to sustained, clinically relevant reductions in body weight, according to trial results published in The New England Journal of Medicine. Individuals with overweight or obesity who took semaglutide, sold as Ozempic, had a mean change in bodyweight of –14.9% after 68 weeks compared with –2.4% seen in the placebo group. In addition, 86% of participants receiving the treatment attained at least a 5% reduction in total body weight.

Those who received semaglutide also exhibited greater reductions in waist circumference, body mass index, and systolic and diastolic blood pressure compared with placebo, and had improved levels of glycated hemoglobin, fasting plasma glucose, C-reactive protein, and fasting lipid levels after 68 weeks.

Semaglutide is approved—at doses up to 1 mg once weekly—for the treatment of type 2 diabates in adults and to reduce risk of cardiovascular events in patients with type 2 diabetes and comorbid cardiovascular disease.

The authors note the study had certain limitations, such as the fact that the trial population consisted of mostly White female participants and thus results may not be generalizable to a wider population. The trial duration was also short and participants may have been more motivated to lose weight.

In addition, oral semaglutide has been associated with pancreatitis and, in rodents, with thyroid C-cell tumors, which include medullary thyroid carcinoma.

For more, visit AJMC.com.

COVID-19 Vaccine Updates

After preliminary data from a small study suggested that the AstraZeneca/Oxford COVID-19 vaccine provided minimal protection against mild to moderate disease caused by the B.1.351 coronavirus variant present in more than 90% of new cases in South Africa, the country suspended plans to vaccinate its health care workers.

Reported by The Associated Press, South Africa had received its first 1 million doses of the AstraZeneca vaccine last week, but will now transition to vaccinating its frontline workers with the 1-shot vaccine manufactured by Johnson & Johnson, or J&J.

Although the J&J vaccine candidate has yet to be authorized for general use in any country, it has been shown to be 66% effective at preventing moderate to severe COVID-19, and most notably, found to be 57% effective in a test where the more contagious variant was dominant.

Trial data on the J&J vaccine will be reviewed by the FDA advisory committee during a public meeting on February 26, following J&J’s emergency use authorization, or EUA, application submitted last week.

As another potential single-shot option, CanSino Biologics’ 1-shot experimental coronavirus vaccine was found to be 65.7% effective against symptomatic cases and 90.98% effective against severe cases of COVID-19.

While the efficacy of CanSino Biologics’ and Johnson & Johnson’s vaccine candidates are lower than that of the Pfizer and Moderna approved vaccines, the mRNA 2-dose shots require deep-freeze storage and requires recipients to return for their second dose, an issue that may prove difficult in developing countries.

In other COVID-19–related news, new trial data have led the FDA to update its original EUA application from August 2020 on the use of convalescent plasma to treat patients with COVID-19.

The revised guidance will permit only the use of high-titer convalescent plasma, restrict its use to hospitalized patients early in the disease course, and eliminates the use of low-titer convalescent plasma, which has been shown to be ineffective. This EUA also includes approvals for 9 tests to evaluate anti–SARS-CoV-2 antibody levels in potential plasma donations.

For more, visit AJMC.com.

Longer, More Intense Pollen Seasons Driven by Human-Led Climate Change, Study Says

According to an analysis published this week in the Proceedings of the National Academy of Sciences, today's pollen season is starting earlier and lasting longer than in 1990, largely because of human-caused climate change.

With smaller previous studies having found that increases in temperature and atmospheric carbon dioxide can cause more pollen production or a worsening of pollen seasons, researchers looked at the issue on a larger scale and attempted to quantify the effect of climate change.

Analyzing data from 60 pollen stations from 1990 to 2018, researchers combined that information with observational climate datasets and 22 climate simulations. They aimed to answer 3 questions:

• What are the long-term pollen trends?
• How much of a role does changing temperature, precipitation, and increasing carbon dioxide play in those metrics?
• How much of the change can be attributed to human-caused climate change?

The statistically significant findings showed that pollen season in North America, compared with 1990, is lasting 10 days longer, starting 20 days earlier, and has 21% more pollen concentration. Additionally, Texas and the Midwest were found to be affected the most, with the amount of tree pollen increasing most prominently as well.

Notably, the length of pollen season, as well as the increased concentrations of pollen, are most closely linked with global warming. Human-led climate change was a factor in about 50% of the change in pollen season and about 8% of the increase in pollen concentrations.

For more, visit AJMC.com.

Increased Rates of ED Visits for Suicide, Violence, Mental Health, and Overdoses Seen Throughout Pandemic

A new study published in JAMA Psychiatry found emergency department, or ED, visit rates for mental health conditions, suicide attempts, drug and opioid overdoses, intimate partner violence, and child abuse and neglect increased between mid-March through October 2020 compared with the same time period in 2019.

The analyses included data from 3119 EDs that reported in 2019 and 3598 in 2020. In particular, opioid overdoses “exhibited the most consistent increases in counts, with only a limited decrease observed during the period in 2020 when overall ED visits were low, never decreasing below weekly counts observed in the first 41 weeks of 2019,” according to the study.

Although ED visit counts and rates for all outcomes began to decrease toward the latter part of the study period, ED visits for all drug and opioid overdoses did not decrease like those for other outcomes, with the authors noting that the data suggest an increase in overdose burden during the pandemic.

For more, visit AJMC.com.

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