This Week in Managed Care: December 18, 2020

First COVID-19 vaccine shipments arrive nationwide, FDA panel votes to expand use of heart failure drug but doesn't agree how, and Managed Care Cast outlines efforts to address social determinants of health amid the pandemic.

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

COVID-19 Vaccine Rollout

This week, the first shipment of the Pfizer/BioNTech COVID-19 vaccine was sent to all 50 states following the FDA’s decision to grant the vaccine emergency use authorization, or EUA, for all Americans aged 16 and older.

The first dose administered in the United States came on Monday, with plans of distribution going first to health workers, followed by vulnerable populations 65 years and older or with medical conditions and essential workers. Along with each delivery of the vaccine, states will receive dry ice and special containers to keep the doses sufficiently cold for up to 10 days.

The EUA, which was granted to Pfizer late last Friday, came a day after an advisory panel recommended its use. Notably, some questioned during the panel discussion whether the vaccine should be limited to those 18 and older, given the low numbers of teenagers in the clinical trials and because most younger people tend to have less serious cases of the disease.

Another topic of discussion at the panel—whether the vaccine should be given to pregnant women—was not addressed in the FDA materials released Friday, except for advising that women discuss the vaccine with their health care provider.

Also last Friday, HHS announced it was buying 100 million additional doses of vaccine from Moderna.

The Moderna candidate, mRNA-1273, was reviewed yesterday by the same advisory panel that heard the Pfizer and BioNTech application, with panelists agreeing that the benefits outweighed the risks for individuals 18 years and older.

HHS previously agreed to buy 100 million doses from Moderna; with 100 million doses from Pfizer, the United States would have 300 million doses. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine.

Over 300,000 Americans have now died from COVID-19, while over 100,000 patients are currently hospitalized with the virus.

For more, visit AJMC.com.

FDA Panel Votes to Expand Use of Heart Failure Drug, but Doesn’t Agree How

This week, an FDA panel agreed that Novartis’ heart failure drug of sacubitril/valsartan, sold as Entresto, should be given to more patients, but just who those patients will be is up to regulators.

Entresto, which is approved for patients with heart failure with reduced ejection fraction, could become the first drug approved to treat heart failure with preserved ejection fraction, even though a trial designed to prove efficacy for this group of patients narrowly missed the mark last year. Novartis plowed ahead nonetheless, based on evidence within subgroups in the trial and data from other studies.

By a 12-1 vote, the FDA’s Cardiovascular and Renal Drugs Advisory Committee found that Entresto was worthy of some indication based on the PARAGON-HF trial, which studied patients with left ventricular ejection fraction of greater than or equal to 45%. But during a lengthy discussion of what that indication might be, or what other evidence might be needed, opinion varied.

Panelists discussed whether ejection fraction, which describes how much blood the left ventricle pumps with each contraction, is an inadequate measure of heart failure or whether the FDA should look instead to standards outlined by the American Society of Echocardiography.

The panel’s consumer representative, Cynthia Chauhan, MSW, said a new trial is needed that would have greater representation of minorities and patients with “significant comorbidities, including renal failure and pulmonary hypertension,” that are commonly seen in patients with heart failure.

"We recognize the importance of representing a diverse patient population in clinical studies, including Black patients, a population that has been shown to be at higher risk of heart failure and are often affected at an earlier age," said David Soergel, Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis, in an email to The American Journal of Managed Care®.

For more, visit AJMC.com.

Managing Social Determinants of Health During COVID-19

Addressing the social health needs of those ill with COVID-19 is a challenge for providers and health care systems.

In this week’s Managed Care Cast, we speak with Dr Bechara Choucair, MD, senior vice president and chief health officer for Kaiser Permanente, about a guide his organization released that walks clinicians through considerations to keep in mind with these patients.

Choucair discusses how the playbook can help physicians and others screen patients and connect them to local resources, in order to improve health outcomes as well as reduce community transmission.

For the full interview, visit AJMC.com.

COVID-19 and Health Disparities: An Opportunity to Refocus Resources?

As the last of a 3-part series posted on AJMC.com examining COVID-19 and health disparities, stark realities exposed by the pandemic have led some to advocate for redirecting resources to have the most impact on vulnerable populations.

A report from The Commonwealth fund entitled “Beyond the Case Count: The Wide-Ranging Disparities of COVID-19 in the United States” highlights several methods of improving these disparities. According to authors, COVID-19 relief funds ought to target Black and Latino communities, while investments in economic security and mental health support for low-income individuals are vital.

In fact, Maryland’s COVID-19 task force on vulnerable populations was able to leverage data on social determinants of health to rapidly pinpoint populations most at risk of severe COVID-19 complications, while modeling how other states can carry out similar feats. Through public-private partnerships, the state of Maryland secured immediate care for hundreds of the state’s most vulnerable residents within weeks.

“We needed a data-driven approach…to determine which targeted resources were needed,” said Dr Susan Mani, MD, the chief population health officer for LifeBridge Health, in an interview with The American Journal of Managed Care®. “We recognized we had a really significant responsibility to our vulnerable populations in the state.”

According to Mani, risk stratification within vulnerable populations played a big role in the program’s success. “We can’t just think about risk as a sort of set bubble. We really need to be able to risk stratify so that we can then disseminate this information at a neighborhood level and then down to an individual level.”

For more, visit AJMC.com.

Read part 1 in this series.

Read part 2 in this series.

Poll: The Top 5 Non–COVID-19 News Stories in 2020

As the year comes to a close, AJMC.com is spotlighting its most-read news stories in 2020 for topics related to oncology, HIV, and much more!

Interested in finding out what the top non–COVID-19 story was for this year?

Help choose it! Answer our poll on what you think is the top non–COVID-19 story, and don’t forget to look for our end of year lists for each covered topic in managed care.

For the poll, 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.

Our final paper of the week comes from January 2000, when the journal was starting its sixth year and discussion of rising prescription drug costs was taking shape.

Parts of the paper by Dr Miron Stano, “Regulating the Pharmaceutical Industry: Who Really Benefits?” read like it could be written today:

Despite the rising complaints in 2000 about drug costs, which would eventually lead to the creation of Medicare Part D, Stano notes:

“The much larger problem for the United States is that more than 90% of all health care costs are spent on nonpharmaceutical health care.”

And the paper also notes the role of pharmaceuticals in increased life expectancy, a topic explored in a recent AJMC® webinar with the National Pharmaceutical Council.

For the paper, visit ajmc.com.

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