This Week in Managed Care: May 22, 2020

Health experts are alarmed by President Trump’s hydroxychloroquine use, early data on a COVID-19 vaccine trial generate both promise and controversy, and AJMC^® gets an inside look at physician burnout amid the pandemic—and how employers can help.

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

Health Experts Alarmed by Trump’s Hydroxychloroquine Use

This week, President Trump announced he was taking the malaria drug hydroxychloroquine as a preventive measure, despite testing negative for COVID-19. The news caused concern among health experts as the treatment has been linked with risks of serious heart problems and other complications.

Trump’s admission comes weeks after the FDA cautioned against the use of the drug for treatment of COVID-19, with observational studies finding it offered little to no benefit, either in infected patients or as a preventive measure.

Health experts voiced concern that Trump’s comments would generate more public frenzy for hydroxychloroquine, which has been on the FDA’s shortage list since March. Notably, vulnerable patients with conditions like lupus who depend on the drug may be at risk.

“It’s a necessary drug for them and not having access would have terrible consequences,” tweeted Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

For more, visit ajmc.com.

Moderna’s COVID-19 Vaccine Shows Early Promise

According to early data on the first COVID-19 vaccine to be tested in the United States, manufacturer Moderna Inc said its vaccine was safe and produced protective antibodies in a small group of healthy volunteers.

The announcement sparked public optimism with Moderna’s stock valuation surging to $29 billion, a typically unprecedented figure for a company that has yet to sell any products.

However, the announcement was not without controversy as several vaccine experts pointed out that based on the information released, minimal data is available to support the claims.

The small study cohort also drew attention as the company’s statement highlighted that all 45 participants in the trial received differing doses of the vaccine, but data was only revealed on 8 patients who developed antibodies to the virus.

For more, visit ajmc.com.

HHS, AstraZeneca Speed COVID-19 Vaccine Development; First Doses Due in October

In other vaccine-related news, the Trump administration announced early Thursday that HHS and AstraZeneca will collaborate on a coronavirus disease vaccine called AZD1222. A statement released from HHS said the partnership will make “at least 300 million doses” of the vaccine available, “with the first doses delivered as early as October 2020.”

“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” said HHS Secretary Alex Azar. “Getting a vaccine to the American public as soon as possible is one part of President Trump’s multi-faceted strategy for safely reopening our country and bringing life back to normal, which is essential to Americans’ physical and mental well-being in so many ways.”

In a statement, AstraZeneca said a phase 1 and 2 clinical trial of the vaccine began last month to assess its safety immunogenicity and efficacy in over 1000 healthy volunteers, with late-stage trials potentially beginning in several countries based on these results.

For more, visit ajmc.com.

Employers Design Effective Burnout Strategies for Physicians Amid Pandemic

In an interview with The American Journal of Managed Care^®, Vibhas Ratanjee, a senior practice expert at Gallup, discussed findings from a recent Gallup survey of 2175 US health care workers on physician burnout, which found that only 49% of health care workers strongly agree that their employer cares about their well-being.

This could have major implications for patient outcomes, as health care workers who strongly agree that their employer cares about their well-being were found to be 2.3 times more likely to feel “well prepared” to do their job than those who do not feel supported.

To address these issues, Ratanjee referenced his article posted on AJMC.com, co-written with Karen Drenkard, associate dean of Clinical Practice and Community Engagement at The George Washington University School of Nursing, which discussed key attributes of an effective burnout strategy for employers amid the COVID-19 pandemic and beyond.

Four key attributes—trust, stability, compassion, and hope, were highlighted, with an additional point of emphasis on consistency.

For the full interview, visit ajmc.com.

For the article, visit ajmc.com.

HHS Contracts With Pharma Companies, Further Insulating US From Global COVID-19 Response

This week, HHS signed a $354-million contract with a team of private industries to ramp up US pharmaceutical manufacturing and production in wake of the COVID-19 pandemic.

The 4-year contract involves creation of a new drug manufacturing facility in Virginia along with increased capacity to produce active pharmaceutical ingredients and chemical compounds for those ingredients.

According to HHS, advanced manufacturing processes, including continuous manufacturing, in combination with the new facility will result in lower production costs, reduced waste, and improved ingredient yields.

The contract can be extended to a total of $812 million over 10 years, which serves as one of the largest-ever grants awarded by BARDA, as reported by Forbes.

The move comes after President Trump publicly criticized the World Health Organization's response to the pandemic and accused China of withholding critical information regarding the virus.

For more, visit ajmc.com.

FDA OKs Atezolizumab for Certain Patients With NSCLC

Announced this week, the FDA approved atezolizumab, sold as Tecentriq, as an initial treatment for adults with metastatic non—small cell lung cancer, marking the fourth approval in this field and fifth in immunotherapy.

The treatment will be indicated for patients with high PD-L1 expression if it appears at least 50% of tumor cells or if tumor-infiltration covers at least 10% of the tumor area.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Dr Levi Garraway, chief medical officer and head of Global Product Development for Genentech.

A company spokesperson said Genentech also anticipates a decision on its supplemental biologics license application for atezolizumab in combination with bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

For more, 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 is from 2003 and examines off-label use of a well-known oncology drug, rituximab. Author Darren Kocs, along with AJMC^® co-editor-in-chief Mark Fendrick examined 428 rituximab administrations over a period of nearly 3 years and found that 75% of the uses were off label, based on FDA approvals in place at the time.

They caution that health plans must account for offlabel prescribing when they project drug spending.

For the full paper, visit ajmc.com.

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