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The U.S. Food and Drug Administration (FDA) has approved VERQUVO to reduce the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

The FDA approval comes following the results of the phase 3 VICTORIA trial of more than 5,000 adults. The goal of the VICTORIA trial was to determine whether VERQUVO was superior to placebo in combination with other heart failure therapies, in reducing the risk of cardiovascular death, or heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event.

Participants received up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo. The therapy started at 2.5 mg once daily and was increased in two-week intervals to 5 mg once daily and then 10 mg once daily. Placebo doses were adjusted the same way.

Investigators found the drug met the primary efficacy objective (HR, .9; 95% CI, .82-.98; 

 = .019). Overall, there was a 4.2% reduction in annualized absolute risk with VERQUVO compared to placebo.

“Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. By some estimates, more than half of these patients are rehospitalized within a month of discharge due to a worsening event and approximately one in five die within two years,” Paul W. Armstrong, M.D., cardiologist and university professor of medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, said. “The approval of VERQUVO provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”

The box label indicates VERQUVO should not be used by pregnant females as it may cause fetal harm.

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The approval come following the results of a phase 3 trial.

FDA Approves VERQUVO for Patients With Chronic Heart Failure

On Friday, President-elect Joe Biden gave a speech outlining his plans for ramping up the distribution of the COVID-19 vaccines. He organized his the plan into five main points:

Work with states to open up vaccination to more priority groups. 

Biden said his administration will work with states to allow people other than healthcare workers to get vaccinated. He specifically mentioned people 65 and older and essential works such as educators, first responders and grocery workers.

Biden promised that there were 100 federally supported vaccination centers set up during the first month of his administration. He also mentioned mobile clinics, expanding the pool of healthcare workers who could administer the vaccine, and 100% reimbursement of state costs if they use their National Guard.

 Biden referred somewhat vaguely to a “new major effort” to work with independent and chain pharmacies. “This program will expand access in neighborhoods across the country so you can make an appointment and get your shot conveniently and quickly.”

Ramp up supply and don’t hold doses back for the second dose.

 The president-elect again said his administration would use the Defense Production Act to accelerate the manufacturing of supplies and equipment needed to administer the vaccine. Biden also said his administration is moving toward a policy of having the first dose of vaccine administered to people as soon as the supply is available rather than holding back doses for the second dose as the Trump administration did. But in his remarks on Friday, Biden also stressed that administration is not veering from the two-dose schedule of the two vaccines that are currently available, the Pfizer-BioNTech and the Moderna vaccines.

Biden promised to “honest and transparent about where we stand — both the good news and the bad.” State and local officials, he said, haven’t known how much vaccine they will be getting so they can’t plan. “That stops with when we are in office,” Biden promised.

The president-elect says his administration will set up 100 community vaccination sites during his first month in office.

ICYMI: The Biden Administration's Five-Point COVID-19 Vaccination Plan

The prevalence of heart failure is increasing as the demographic profile of the American population gets older. 

An estimated 6.2 million American adults, age 20 and older, had heart failure between 2013 and 2016, compared with an estimated 5.7 million between 2009 and 2012.

Of incident hospitalized heart failure events, approximately half are characterized by reduced ejection fraction and half by preserved ejection fraction. 

The prevalence of heart failure with preserved ejection fraction, compared with prevalence of heart failure with reduced ejection fraction, appears to be increasing along with aging of the population.

The prevalence of heart failure is increasing as the demographic profile of the American population gets older.

Heart Failure Cases Split Evenly Between Reduced, Preserved Ejection Fraction

The pandemic has accelerated dramatic changes in healthcare and well-being in 2020 and will continue to do so in 2021, said Ellen Kelsay, president and CEO of Business Group on Health, the premier non-profit organization representing large employers’ perspectives on health, well-being and workforce strategy issues.

“Virtual care will proliferate, companies will increasingly focus on employee mental health and emotional well-being, and the health care ecosystem will examine and address issues of health equity,” Kelsay said, identifying some of the 2021 Trends to Watch, as identified by the Business Group.

The five interrelated trends also include reimagining healthcare delivery and supporting the well-being needs of a changing workforce, according to a report by Business Group.

As the year unfolds, the Business Group will continue to offer a range of materials, including research, benchmarking calls, summits, webinars and podcasts, on the new healthcare climate.

According to the organization, some specific details on the 2021 trends to watch are:

—Virtual care, which exploded in 2020, will continue to grow in 2021. Patients will have expanded virtual options and improved availability through telehealth platforms and providers. Virtual care options will also include weight management, care management for chronic conditions such as diabetes and cardiovascular disease, prenatal care, and musculoskeletal care management/physical therapy. In addition, more attention will be given to the evaluation of the quality, outcomes, effectiveness, patient experience and cost of virtual care options and innovations, as well as the appropriateness of virtual vs. in-person care for specific services.

—The pandemic has resulted in other changes in healthcare delivery, such as moving lower acuity care out of the hospital to free up beds for patients with COVID-19 and other serious conditions. Moreover, even though employers and plans may have momentarily slowed the expansion of alternative payment and delivery models because of the pandemic, a redoubling of efforts in 2021 will drive improvements in quality and value.

A Spotlight on Mental Health and Emotional Well-being

—In large part because of the pandemic, employers stepped up their focus on employee stress and anxiety, loneliness, addiction, depression and other serious mental illness. In 2021, novel approaches such virtual counseling and the integration of Employee Assistance Programs and mental health benefits, will place mental health on par with other medical conditions.

Adapting to the Well-being Needs of a Changing Workforce

—Multiple factors, including the pandemic, the economy and the expectations of younger workers, have caused a shift in employees’ well-being needs. For instance, those living alone may struggle with social connection, while others juggling childcare, virtual school or caregiving in the home may have difficulty creating a work/life balance. In 2021, employers will continue to demonstrate flexibility and support employee needs through leave, remote work and other benefits.

—Disparities in health care as a result of race, ethnicity and geography have been magnified during the pandemic. These gaps manifest themselves in differences in health conditions and outcomes, emotional well-being and mortality. In 2021, the health care ecosystem, including providers, suppliers and payers, will boost efforts to examine and address health equity, while mitigating the harmful effects of social determinants of health.

The pandemic has accelerated dramatic changes to the health industry such as virtual care, mental health and health equity.

MHE Staff

Articles

FDA Approves VERQUVO for Patients With Chronic Heart Failure

ICYMI: The Biden Administration's Five-Point COVID-19 Vaccination Plan

Heart Failure Cases Split Evenly Between Reduced, Preserved Ejection Fraction

2021 Healthcare Trends to Watch