This Week in Managed Care: November 20, 2020

Moderna, Pfizer vaccines report efficacy against COVID-19; fish oil debate continues as study finds no risk reduction in cardiac events; and Dr Anthony Fauci says long-term follow-up is needed to understand effects when COVID-19 lingers.

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

SARS-CoV-2 Vaccine Updates From Pfizer and Moderna

This week, Moderna and Pfizer announced results of their messenger RNA vaccine candidates against SARS-CoV-2, the virus that causes COVID-19, with reported efficacy rates of 90% or higher for both vaccines.

Citing that the COVID-19 vaccine it developed with BioNTech is as effective as those for shingles and measles, Pfizer announced that it will seek FDA approval for the vaccine within days, with recent news suggesting it could be as early as this week. Distribution could then occur by year-end for the vaccine, which final data show is 95% effective among those who developed at least 1 symptom of COVID-19, based on results from the nearly 44,000-person trial.

For Moderna’s COVID-19 vaccine, interim results reported an efficacy of 94.5%. In August, the Trump administration announced it had reached a $1.5-billion deal with the biotech giant to develop and distribute 100 million doses of their mRNA-1273 vaccine, at an average cost of $15 per dose.

Appearing this past Monday on CNBC’s “Squawk Box,” HHS Secretary Alex Azar said the FDA will be steadfast to clear Pfizer’s and Moderna’s COVID-19 vaccines for emergency use.

“We hope those applications from both Pfizer and Moderna will get in as quickly as possible,” Azar told CNBC. “We will independently call those balls and strikes on the data and evidence, but we’re going to do so as quickly as possible, consistent with just making sure the science, the evidence and the law support authorization.”

Pending emergency use authorization by the FDA, Pfizer would receive $1.95 billion upon manufacture of the first 100 million doses of their vaccine if it is approved.

For more on Pfizer’s vaccine and Moderna’s vaccine, visit ajmc.com.

Fish Oil Debate Continues as Study Finds No Risk Reduction From Omega-3 Combo

The debate over whether medications derived from fish oil can prevent cardiac events took another turn this week, as findings from the STRENGTH trial presented at the 2020 American Heart Association Scientific Sessions indicated that a treatment combining 2 common omega-3 fatty acids did not reduce the risk of cardiac events.

These findings, along with those from the ONEMI trial testing fish oil in seniors, directly challenge results of the REDUCE-IT trial, which found that icosapent ethyl reduced initial cardiac events by 25% and all events by 30%.

Treatments used in REDUCE-IT and STRENGTH have important differences, and so do the placebo tablets used in each trial. Icosapent ethyl contains only EPA, whereas the STRENGTH trial used a therapy containing both EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid].

Investigators for REDUCE-IT have pointed out repeatedly that the 4-g daily dose used in that study is a highly purified form of EPA only, and a recent article argued that DHA may thwart the effects of EPA.

The lead author of STRENGTH, Dr A. Michael Lincoff, professor of medicine and vice chairman for research in Cardiovascular Medicine at Cleveland Clinic, said a corn oil placebo was selected precisely because it would have a neutral effect, unlike mineral oil, which would create a “negative control.”

Regarding the use of fish oil–derived medication more broadly, Lincoff said in a statement, “We believe the questions surrounding the benefit versus risk of fish oil will remain unanswered unless another trial using a neutral placebo such as corn oil is able to definitively show cardiovascular benefits for an omega-3 fatty acid medication.”

JAMA, which published the STRENGTH findings, called for a new trial. “To resolve the discrepancy between STRENGTH and REDUCE-IT, the FDA should require a postmarketing clinical trial of high-dose icosapent ethyl vs corn oil in patients at risk for cardiovascular events. This is a critical next step to shed further light on this perplexing clinical issue and research question,” said Dr Gregory Curfman, deputy editor at JAMA.

For more, visit ajmc.com.

Long-term Follow-up Needed to Understand Effects When COVID-19 Lingers, Fauci Says

In other news at this year’s American Heart Association Scientific Sessions, the nation’s top infectious disease expert, Dr Anthony Fauci discussed the cardiovascular implications of COVID-19 during his keynote presentation.

Profound fatigue, shortness of breath, muscle aches, sporadic fevers, and an inability to concentrate that patients describe as “brain fog” were all symptoms detailed by Fauci that up to a third of people will live with for weeks or months after contracting the virus.

Heart disease specialists are doing some of the most important work studying COVID-19’s effects, as they treat patients most at risk of severe disease, then track what happens to them afterward. It’s clear that although age offers the biggest risk factor for severe illness from COVID-19, certain chronic conditions are equally dangerous.

Research has shown that COVID-19 damages organ systems and causes cardiovascular complications, including thromboembolic phenomena and cardiomyopathies. About 80% of people who test positive for COVID-19 have mild to moderate symptoms, with the rest having severe symptoms—but moderate symptoms can still leave a person with lingering effects, noted Fauci.

“If you look at the manifestations of severe COVID-19, they are plentiful,” Fauci said. “I mentioned the cardiac ones, but there is also acute respiratory distress syndrome. There is kidney injury, neurological injury, a hypercoagulable state manifested by microthrombosis in small vessels and acute thrombotic phenomenon, sometimes seen in otherwise well, young individuals.”

For more, visit ajmc.com.

Driving Transparency, Payment Reform in Employer Health Care Coverage

As the health care industry continues to combat health and cost-related issues exacerbated by the COVID-19 pandemic, employers remain a key figure in the pursuit for higher-value care.

In this week’s Managed Care Cast, we spoke with Leah Binder, president and chief executive officer of the Leapfrog Group, who recently partnered with the Health Transformation Alliance, or HTA, to help delineate high-value health care services with a particular focus on transparency and payment reform.

Binder discussed details of her organization’s partnership with the HTA, the significance of their 20th anniversary this year, and how transparency and employer leverage may shape the transition toward value-based health care.

For the full interview, 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.

Pandemic or not, the holiday season starts next week—and the next 6 weeks can mean big challenges for people with diabetes. A 2008 paper from authors in Taiwan found that holiday-specific education can help people with type 2 diabetes maintain better glycemic control during periods of celebration—which in this study was the Chinese New Year.

Researchers from Taipei Veterans Hospital compared patients who received regular diabetes education to those who got special reminders during holiday periods. Blood samples showed that the extra reminder helped people maintain glycemic control.

For the paper, visit ajmc.com.

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