This Week in Managed Care: May 8, 2020

FDA grants emergency use authorization to COVID-19 treatment, dapagliflozin’s new approval breaks ground in SGLT2 competition, and AJMC^® gets an inside look at how The Michael J. Fox Foundation is assisting the Parkinson community during the pandemic

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

FDA Grants Emergency Use Authorization to COVID-19 Treatment

Last week, the FDA announced it will grant emergency use authorization to Gilead Sciences' remdesivir, an investigational antiviral drug that showed promise in treating COVID-19, based on preliminary data from an NIH trial.

Results showed that patients with advanced COVID-19 and lung involvement who received the treatment had a 31% faster recovery time compared with those who received placebo. The treatment group had a recovery time of 11 days compared with 15 days for the control group.

However, the FDA notes there is limited information on the safety and effectiveness of the treatment, which can only be given intravenously. Remdesivir is authorized for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children who are hospitalized with severe disease.

"The known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use," the FDA stated.

Currently, the US death toll from COVID-19 stands at 74,000, with President Trump predicting that it may rise to 100,000, in contrast to his forecast weeks ago that the outbreak would be kept below this mark. Overall, there have been 1.26 million cases across the US.

For more, visit ajmc.com.

FDA Approves Dapagliflozin to Treat Heart Failure, Breaking New Ground in SGLT2 Competition

In another FDA announcement this week, the agency approved AstraZeneca’s dapagliflozin, sold as Farxiga, for the treatment of heart failure with reduced ejection fraction in adults with and without type 2 diabetes.

This is the first time a drug in the SGLT2 inhibitor class, developed to treat diabetes, was approved for heart failure even if diabetes is not present.

“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the United States,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D for AstraZeneca.

Use of SGLT2 inhibitors to treat heart failure has been envisioned for nearly 5 years, ever since results of the ground-breaking cardiovascular outcomes trial involving competitor empagliflozin, sold as Jardiance, showed a reduction in cardiovascular events and death among patients with type 2 diabetes, driven primarily by the reduction in hospitalization for heart failure.

For more, visit ajmc.com.

Dr Rachel Dolhun on Innovations by MJFF to Assist the Parkinson Community Amid the COVID-19 Pandemic

Emerging issues precipitated by the COVID-19 pandemic for patients and families of patients with Parkinson disease was the topic of a new interview with Rachel Dolhun, MD, vice president of Medical Communications at The Michael J. Fox Foundation for Parkinson Research.

Dr Dolhun spoke with AJMC^® about how The Michael J. Fox Foundation is assisting the Parkinson Community, with a recent innovation providing a resource hub to educate the Parkinson disease community on emerging information related to the pandemic.

Dolhun explains that while the pandemic has caused a difficult and uncertain time for so many with and without Parkinson disease, staying connected, active, and in the present moment can prove beneficial.

For the full interview, visit ajmc.com.

Sleep Apnea Could Compound Diabetes Risk in African Americans

African Americans with severe sleep apnea were found to be more likely to have higher blood glucose levels, which may further increase the risk of developing diabetes, a disease already more prevalent in African Americans.

Findings based on information from The Jackson Heart Study and published in the Journal of the American Heart Association, suggest better sleep habits may lead to improved blood glucose control, ultimately aiding prevention and management of diabetes in African Americans.

“The study underscores the importance of developing interventions to promote regular sleep schedules, particularly in those with diabetes. It also reaffirms the need to improve the screening and diagnosis of sleep apnea, both in African Americans and other groups,” said Yuichiro Yano, MD, PhD, a lead author of the study.

Researchers note future studies are warranted to determine whether improvement of sleep apnea and sleep patterns could aid glycemic control and decrease insulin resistance.

For more, visit ajmc.com.

Seema S. Sonnad Emerging Leader in Managed Care Research Award

Last Friday, The American Journal of Managed Care^® opened nominations for the 2020 Seema S. Sonnad Emerging Leader in Managed Care Research Award.

The annual awards program recognizes rising leaders who are making exceptional early career achievement in the field of managed care.

For more information and to submit a nomination, visit ajmc.com.

Paper of the Week

Now we bring you Paper of the Week, which looks back at research and commentary of the past 25 years in The American Journal of Managed Care^® and why it matters today.

This week’s paper comes from our January 2015 issue. The authors of “Disease-Modifying Therapy and Hospitalization Risk in Heart Failure Patients” discuss the high cost of heart failure to the health system. They found that some treatments, such as ACE inhibitors or ARBs, had potential in preventing heart failure in Medicaid patients in managed care, but the projected savings were relatively modest.

The paper appeared a few months before the EMPA-REG OUTCOME trial revealed the potential of a new drug class, the SGLT2 inhibitors, in preventing hospitalization for heart failure.

For the full paper, visit ajmc.com.

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