Federal News Network is offering an Open Season interview with well known FEHB expert Walt Francis on YouTube.
From the Omicron and siblings front, STAT News reports
The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.
The findings, released Tuesday by the Centers for Disease Control and Prevention, do not, however, address the question of whether the bivalent shot offers greater protection than another shot of the original formulation would have.
The Wall Street Journal adds
The U.S. is heading into its third Covid-19 Thanksgiving in better shape than the last two, but holiday gatherings will provide a test of whether the nation can avoid another major winter surge, epidemiologists and virus experts say.
Thanksgiving once again comes at a precarious time, as new subvariants take over and the return of cold weather brings people back indoors, often in family gatherings where the virus can easily spread. The holiday last year coincided with the arrival of an early version of the Omicron variant that kicked off an explosive rise in cases and the second-deadliest Covid-19 wave. Only the prior winter, when vaccination efforts were just beginning, saw a higher peak in deaths.
This time around, some virus experts say the lack of a fresh surge triggered by newly ascendant Omicron subvariants is a hopeful sign that built-up immune protection from vaccines and prior infections is helping.
In the FEHBlog’s view, the key difference between last Thanksgiving when the original Omicron was gathering steam and this one is the availability of Pfizer’s Covid pill, Paxlovid.
In public health news
- STAT News explains why we don’t have an at-home flu test, and the answer is not a lack of technology.
- HealthDay discusses a large study concerning the impact of HDL cholesterol on developing heart disease, which makes significant conclusions. For example, “Blood levels of HDL, the famously “good” kind of cholesterol, may not make a big difference to heart health after all — particularly for Black people.”
- The Director of HHS’s Agency for Healthcare Quality and Research posted his observations on AHRQ’s “2022 National Healthcare Quality and Disparities Report: We Still Have Much Work to Do.”
From the Rx coverage front, the Food and Drug Administration announced approving
Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
“Gene therapy for hemophilia has been on the horizon for more than two decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”
Most individuals who have Hemophilia B and experience symptoms are men. The prevalence of Hemophilia B in the population is about one in 40,000; Hemophilia B represents about 15% of patients with hemophilia. Many women carriers of the disease have no symptoms. However, an estimated 10-25% of women carriers have mild symptoms; in rare cases, women may have moderate or severe symptoms.
Treatment typically involves replacing the missing or deficient clotting factor to improve the body’s ability to stop bleeding and promote healing. Patients with severe Hemophilia B typically require a routine treatment regimen of intravenous (IV) infusions of Factor IX replacement products to maintain sufficient levels of clotting factor to prevent bleeding episodes.
Hemgenix is a one-time gene therapy product given as a single dose by IV infusion. Hemgenix consists of a viral vector carrying a gene for clotting Factor IX. The gene is expressed in the liver to produce Factor IX protein, to increase blood levels of Factor IX and thereby limit bleeding episodes.
Bloomberg adds that “CSL Behring’s hemophilia B gene therapy, a one-off infusion that frees patients from regular treatments, costs $3.5 million a dose, making it the most expensive medicine in the world.”
In preventive services news, the U.S. Preventive Services Task Force proposed for public comment assigning a B grade to “screening for latent tuberculosis infection in populations at increased risk.” In 2016, the USPSTF recommended screening for LTBI in populations at increased risk (B grade recommendation). The current draft recommendation is consistent with the 2016 USPSTF recommendation. The public comment deadline is December 27, 2022.
The next FEHBlog post will be Cybersecurity Saturday, November 26. Happy Thanksgiving, all.