This Week in Managed Care: January 8, 2021

FDA advises against changes to vaccine dose schedules; first months of the pandemic see drop in mammography screenings, increase in advanced breast cancer cases; and the first anti-TIGIT therapy is granted Breakthrough Therapy Designation by the FDA.

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

FDA Advises Against Changing Vaccine Dose Schedules

Although COVID-19 vaccines began to roll out just last month, distribution challenges have already become evident, with the United States falling short of its goal of providing an initial dose to 20 million people by December 31.

As health officials caution against travel, which may cause surges in cases similar to that seen in the weeks after Thanksgiving, discussions are reportedly ongoing between White House officials of Operation Warp Speed, the FDA, and vaccine manufacturer Moderna to implement half-dose regimens that could double the number of those vaccinated against COVID-19.

However, in a statement issued this week by the FDA, the agency is warning health care workers against any changes to the authorized dosing schedules of COVID-19 vaccines.

“At this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence,” said FDA commissioner Stephen Hahn and director of the Center for Biologics Evaluation and Research, Peter Marks, in the statement.

“Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”

In other vaccine-related news this week, the United Kingdom administered the first doses of the COVID-19 vaccine manufactured by Oxford University and AstraZeneca.

In comparison with the Pfizer vaccine, which must be kept at –70 degrees Celsius, the Oxford/AstraZeneca vaccine can be stored at refrigerator temperatures between 2 and 8 degrees Celsius, which may benefit ease of distribution.

Meanwhile, cases of a highly transmissible variant of COVID-19 continue to appear throughout the United Kingdom, leading Prime Minister Boris Johnson to hint at tighter restrictions in the coming days. England is already in lockdown.

For more, visit AJMC.com.

Mammography Screenings Dropped, Advanced Breast Cancer Cases Increased in First Months of COVID-19

Based on study findings presented at the 2020 San Antonio Breast Cancer Symposium, the first few months of the COVID-19 pandemic saw mammography screenings drop drastically and patients with breast cancer present with more advanced and aggressive disease.

The retrospective double-cohort study observed patients visiting the Kaiser Permanente health care system, comparing those who visited between March 17 and May 18, 2020—during California’s shelter-in-place period—with those who visited between March and May 2019.

Compared with the 703 newly diagnosed patients identified in the 2019 period, 250 were diagnosed during the shelter-in-place period, representing a 64% drop in the number of patients who received a diagnosis.

Both groups of patients had similar baseline characteristics, although there were significantly more patients in the 2020 period that presented with symptomatic and more advanced disease.

“As screening mammography rates return to prepandemic levels, our system must prepare for a likely surge of new breast cancer diagnoses,” said said Dr Annie Tang, researcher at Kaiser Permanente Northern California’s Permanente Medical Group Breast Research Collaborative. “We will continue to monitor breast cancer screening rates, breast cancer diagnosis, and treatment trends for future research.”

Notably, the time to first treatment was shorter in 2020, with time to surgery dropping from 26 to 19 days and time to chemotherapy dropping from 28 to 24 days.

For more, visit AJMC.com.

FDA Grants Tiragolumab Breakthrough Therapy Designation for PD-L1–High NSCLC

This week, Genentech announced that tiragolumab was granted Breakthrough Therapy designation by the FDA for use in combination with atezolizumab, sold as Tecentriq, in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high levels of PD-L1 and do not have EGFR or ALK mutations.

Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy designation by the FDA, which was based on data from the phase 2 CITYSCAPE trial that was first presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program in May.

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” said Dr Levi Garraway, chief medical officer and head of Global Product Development at Genentech, in a statement.

“We look forward to advancing our tiragolumab development program, which includes chemotherapy-free combinations and trials in early stages of disease across multiple cancer types with high unmet need.”

The CITYSCAPE trial is the first randomized trial of an anti-TIGIT therapy and provides evidence that targeting both TIGIT and PD-L1 may improve antitumor activity by amplifying immune response. Biomarker analyses from the trial will be presented at the International Association for the Study of Lung Cancer 2020 World Conference, which is set for January 28-31, 2021.

For more, visit AJMC.com.

Azacitidine Shown to Improve Overall, Relapse-Free Survival in Older Adults With AML

According to study data published in The New England Journal of Medicine, older adults with acute myeloid leukemia, or AML, saw increased overall survival and relapse-free survival, as well as preserved quality of life, following oral administration of azacitidine as maintenance therapy.

Results of the phase 3 QUAZAR AML-001 study, which was conducted across 148 sites in 23 countries, showed a 40% increase of overall survival in patients administered a 300-milligram dose of azacitidine compared with placebo and a 53% difference in relapse-free survival.

As the trial utilized the CC-486 formulation of azacitidine, manufactured by Bristol Myers Squibb and sold as Onureg, it was noted that the agent is not interchangeable with the intravenous and subcutaneous forms of azacitidine.

“An overall survival benefit was observed with CC-486 regardless of whether patients had received any consolidation therapy, had been in complete remission after induction chemotherapy, or had had persistent measurable residual disease at randomization,” said the authors.

Additional findings showed an ongoing survival advantage with CC-486 vs placebo at the 1- and 2-year marks for overall survival.

For more, visit AJMC.com.

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