Friday Factoids

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC. Roll Call informs us,

“Top negotiators for President Joe Biden and Speaker Kevin McCarthy resumed talks Friday evening to lift the nation’s borrowing cap, ending a “pause” put in place hours earlier when Republicans expressed frustration with the White House position.

“After a nearly daylong setback, White House Counselor Steve Ricchetti, White House budget director Shalanda Young, Rep. Garret Graves, R-La., and House Financial Services Chairman Patrick T. McHenry, R-N.C., resumed talks at the Capitol shortly after 6 p.m.”

From the public health front —

  • Reuters reports
    • “The U.S. Centers for Disease Control and Prevention is urging people at high risk of mpox to get two doses of Bavarian Nordic’s (BAVA.CO) Jynneos vaccine, based on new evidence from a U.S. study showing that the regimen is more effective at preventing infection than one shot.
    • “The study, published on Thursday, offered some of the first evidence on the efficacy of the Jynneos vaccine, which was deployed last year during a global outbreak of mpox that affected more than 30,000 people in the United States.”
  • and
    • “A World Health Organization (WHO) advisory group on Thursday recommended that this year’s COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
    • “New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
    • “The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce “undetectable or very low levels of neutralizing antibodies” against currently circulating variants.
    • “COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), , Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.
    • “The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.”
  • CNBC reports
    • “NIH is enrolling patients in an early-stage clinical trial to test a universal flu vaccine based on mRNA technology.
    • “The technology is behind Moderna’s and Pfizer’s widely used Covid vaccines.
    • “Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year.” 
  • Health Payer Intelligence reminds us that the Affordable Care Act requires health plans to cover four categories of preventive services without cost-sharing when delivered in-network, not just U.S. Preventive Services Task Force Grades A and B recommendations. In addition,
    • “(1) Payers have to cover routine immunizations per the recommendations of the Advisory Committee on Immunization Practices (ACIP), a federal immunization committee. ACIP recommendations are finalized when adopted by the director of the Centers for Disease Control and Prevention (CDC). * * *
    • “(2) The ACA rules around covering preventive care services for women are based on USPSTF and ACIP recommendations. But they also consider Health Resources and Services Administration (HRSA) guidelines, which draw from the Women’s Preventive Services Initiative (WPSI) standards. To comply with the requirements of preventive care services for women, payers must fully cover well-woman visits, breastfeeding support, and screening and counseling related to intimate partner violence and other conditions and circumstances. Contraceptives approved, granted, or cleared by the Food and Drug Administration (FDA) are also covered. * * *
    • “(3) ACA preventive care coverage also encompasses services for children. These requirements are based on HRSA’s Bright Futures Project. They include well-child visits, immunizations, screenings, behavioral and developmental assessments, and more. As of May 2023, the immunization list covered conditions including but not limited to HPV, hepatitis A and B, rubella, influenza, and tetanus.” * * *
  • The Department of Health and Human Services “and the non-profit organization Baby2Baby announced a new pilot program to distribute a one-time only Newborn Supply Kit made up of essential goods and critical maternal health items to new mothers and their infants. * * * HS and Baby2Baby will first distribute 3,000 of the Newborn Supply Kits across Arkansas, Louisiana, and New Mexico – three states experiencing deep levels of family poverty – via hospitals and community-based partner organizations. Any mother giving birth during pilot implementation at one of the partner sites will be eligible to receive a kit. * * * HHS also launched a new website, www.hhs.gov/newbaby, that includes information across all Federal agencies for families on health, feeding, sleeping, child development and programmatic information.”

From the FDA front —

  • Biopharma Dive tells us
    • “A panel of Food and Drug Administration advisers on Thursday backed maternal use of Pfizer’s RSV vaccine for protecting young infants, but recommended its early use be closely monitored to confirm study safety data.
    • “The panel of outside advisers voted 14-0 that Pfizer’s vaccine, called Abrysvo, was effective in protecting infants from infections caused by respiratory syncytial virus, or RSV, when given to their mothers during pregnancy.
    • “Despite some concerns around the shot’s potential risk, they agreed in a 10-4 vote that Pfizer’s data showed it to be generally safe. The FDA, which usually follows the advice of its advisers, is expected to decide whether to approve maternal use of the shot by August. Separately, its use in older adults is due for a decision this month.”
  • MedCity News relates
    • “The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition.
    • “Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder.”
  • “Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.”

From the Rx coverage front

  • Healio tells us,
    • “Of adolescents with obesity receiving semaglutide in the STEP TEENS trial, 44.9% improved to overweight or normal weight.
    • “The odds of improving body mass index category with semaglutide were 23 times higher than placebo.”
  • STAT News adds.
    • Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug.
    • “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy. We are also assessing our promotional efforts to healthcare professionals and adjusting accordingly.” The news was earlier reported by Endpoints.
  • Medscape informs us,
    • “Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.
    • “The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” said Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”
    • “As of earlier this month, there were 15 oncology drugs on the official US Food and Drug Administration (FDA) drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.” * * *
    • “Drug shortages in the United States have been a chronic problem for more than two decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.”

From the U.S. healthcare business front —

  • MedCity News points out,
    • “If you enter a drugstore in any major American city, there’s a good chance you might see a retail health clinic. In the past decade or so, healthcare stakeholders have gone back and forth as to whether these clinics will have a significant impact on healthcare delivery in the U.S. But a new report reveals that retail clinics are solidifying their position as a major force in the U.S. healthcare system.
    • “Retail clinic claims volumes have shot up by 200% in the past five years, according to the report, which was released Thursday by analytics company Definitive Healthcare. 
    • Claims growth for these clinics, which are usually located in stores like Walmart, CVS and Walgreens, have greatly outpaced growth in claims for urgent care centers, emergency departments and physician practices. Urgent care center claims grew by 70% in the past five years. Meanwhile, emergency room usage dropped by 1%, and primary care office claims declined by 13%.
    • As of this year, there are more than 1,800 active retail clinics across 44 states. Most of these are in major metropolitan areas, with just 2% of clinics located in rural areas. The report argued that this paucity stems from the same factors that have produced care deserts in rural America — mainly low population density and difficulty attracting workers.
    • The report also revealed that about half of all retail clinics are concentrated in the following seven highly populated states: California, Georgia, Illinois, Florida, Ohio, Tennessee and Texas.