From Washington, DC

• An HHS fact sheet lets us know,
  • ‘Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the U.S. Department of Health and Human Services (HHS) and its subagencies continue taking action to support access to intravenous (IV) fluids, including ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders. As a result of these steps, hospitals have 50% more product available to them now compared to right after the hurricane. Baxter has moved and begun distributing more than 450 truckloads of product from their North Carolina facility over the past 10 days and is already importing additional product from their foreign plants. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and peritoneal (PD) fluids from five Baxter facilities around the world. Baxter communicated that supply availability is continually improving, and they expect to further increase customer allocations to 90%-100% of historical levels for many IV solution product codes no later than the end of the year. These supply improvements, combined with increased output from other manufacturers, will help hospitals get more of the product they need over the coming weeks.
  • ‘HHS, Food and Drug Administration (FDA), the Administration for Strategic Preparedness and Response (ASPR), and the Centers for Disease Control and Prevention (CDC) continue to use all available authorities to protect patients, support supply, and keep stakeholders informed, in partnership with manufacturers, distributors, hospitals, and other stakeholders. Additionally, HHS is announcing additional information about the airlift of Baxter products into the U.S. from international facilities, with first flights scheduled for October 19.‘

• The New York Times reports,
  • “The Veterans Affairs Department is investigating whether Acadia Healthcare, one of the country’s largest chains of psychiatric hospitals, is defrauding government health insurance programs by holding patients longer than is medically necessary, according to three people with knowledge of the inquiry.
  • “The investigation, led by the agency’s inspector general, comes three weeks after Acadia told investors that it was facing scrutiny for its admissions practices from several other federal investigators, including prosecutors in Manhattan and a grand jury in Missouri. The company, which relies on government insurance programs like Medicare and Medicaid for much of its revenue, said it was also expecting to receive inquiries from the Securities and Exchange Commission and other agencies.
  • “Acadia told investors that it was “fully cooperating with authorities and, at this time, cannot speculate on whether the outcome of these investigations will have any impact on its business or operations.” The company has denied claims that it was improperly holding patients and has said that all decisions about care are made by licensed medical professionals.”

• STAT News informs us,
  • “Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program.
  • “The data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — off all outpatient drugs to hospitals and clinics that primarily serve lower-income patients. There are more than 12,000 entities participating in the program, a number that has grown substantially.
  • “Since it began more than 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $38 billion in prescription medications were purchased under the 340B program in 2020, for instance, which was up from $16.2 billion in 2016. And this fast-paced trajectory has triggered a battle between the pharmaceutical and hospital industries.”

From the public health and medical research front

• The Center for Disease Control and Prevention announced,
  • “COVID-19 activity is declining in all areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
  • “COVID-19
    • “Nationally, COVID-19 activity has continued declining in all areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
    • “The XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
  • “Influenza
    • “Nationally, minimal seasonal influenza activity is occurring. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “RSV
    • Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
  • Vaccination
    • RSV, influenza, and COVID-19 vaccines are available to provide protection and play a key role in preventing hospitalizations. Read the 2024-2025 Respiratory Season Outlook – October Update to learn more about the role of vaccines in preventing hospitalization.

• The University of Minnesota’s CIDRAP adds,
  • “CDC wastewater tracking shows that [COVID] viral levels remain low, with levels currently highest in the northeast. The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are in the medium category nationally, with a downward trend over the last 3 weeks. It said the South and West are currently at the low level.”

• The AP tells us,
  • “Teen smoking hit an all-time low in the U.S. this year, part of a big drop in the youth use of tobacco overall, the government reported Thursday.
  • “There was a 20% drop in the estimated number of middle and high school students who recently used at least one tobacco product, including cigarettes, electronic cigarettes, nicotine pouches and hookahs. The number went from 2.8 million last year to 2.25 million this year — the lowest since the Centers for Disease Control and Prevention’s key survey began in 1999.
  • “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, in a statement. However, “our mission is far from complete.”
  • “A previously reported drop in vaping largely explains the overall decline in tobacco use from 10% to about 8% of students, health officials said.”

• The UMN CIDRAP mentions,
  • “Including preset treatment orders in the electronic medical records of children with ear infections dramatically improved compliance with antibiotic treatment guidelines, researchers reported at IDWeek 2024.
  • “In a study conducted at the University of Colorado/Children’s Hospital Colorado, researchers analyzed data on 34,324 children aged 61 days to 18 months who visited emergency and urgent care centers in the health system for acute otitis media (AOM) from January 2019 to September 2023. Their aim was to assess the effectiveness of a bundled intervention for AOM that included an electronic health record (EHR) order set (implemented in April 2021) that pre-selected a 5-day antibiotic course for children 24 months and older and a local clinical care pathway (implemented in December 2022) that encouraged observation and pain management for children with non-severe AOM. 
  • “Presenting author Joana Dimo, DO, a doctoral fellow at the University of Colorado, said the bundle was developed to address a common problem in antibiotic prescribing for AOM: while most cases (up to 75%) resolve without antibiotics, most children receive antibiotics, often for longer than needed.
  • “We noticed at our institution that children were being prescribed a lot of antibiotics for ear infections, and that the duration of antibiotics was longer than we thought necessary,” Dimo said at a press briefing.”

• Per Fierce Pharma,
  • “After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy.
  • “The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up as a first-line treatment for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
  • “With the green light, Vyloy becomes the first U.S.-approved anti-CLDN18.2 drug. The transmembrane protein, also known as Claudin-18.2, has become a red-hot target in the oncology field, ginning up interest from the likes of AstraZeneca, Leap Therapeutics, Legend, Moderna and other companies.
  • ‘Friday’s approval specifically covers Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy. Patients must have the CLDN18.2 positivity of their tumors confirmed through testing, and, to that end, the FDA has simultaneously approved a new companion diagnostic from Ventana Medical Systems and Roche.”

• Per BioPharma Dive,
  • “An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday.
  • “Called clesrovimab, the antibody met all the goals of a Phase 2b/3 study testing it in more than 3,600 healthy pre- and full-term infants. A dose of clesrovimab lowered RSV disease incidence by 60%, and RSV-associated hospitalizations by 84%, compared to placebo through five months post-treatment.
  • “While three RSV vaccines are approved in the U.S. for older adults, only one antibody drug — Sanofi and AstraZeneca’s Beyfortus — is cleared for all infants entering their first RSV season. If approved, clesrovimab would compete with Beyfortus.”
• and
  • “Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results.
  • “The FDA granted Trodelvy accelerated approval for bladder cancer in 2021, based on results that found it shrank tumors in people whose disease had progressed following treatment with chemotherapy and immunotherapies like Merck & Co.’s Keytruda. But a confirmatory study, titled TROPiCS-04, failed to show the medicine helped people live longer.
  • “Trodelvy’s withdrawal is one of several conditional approvals that have been rescinded in recent years, most notably among the “PD-1” class of drugs that includes Keytruda and Bristol Myers Squibb’s Opdivo. The Trodelvy decision, however, came months after negative trial results, a sign the FDA has become more vigilant about resolving so-called “dangling” accelerated approvals.’

From the U.S. healthcare business front,

• Healthcare Dive tells us,
  • “CVS Health replaced CEO Karen Lynch on Thursday as the healthcare and pharmacy giant’s financial challenges mount.
  • “CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held the top spot at CVS since 2021 and previously led insurer Aetna, stepped down “in agreement with the company’s Board of Directors,” according to a release. 
  • “The company also pulled earnings guidance provided last quarter due to higher medical costs in its Aetna health benefits segment. CVS’ stock fell more than 7% in early morning trade Friday following the news.”

• The Wall Street Journal adds,
  • “Roger Farah, chairman of CVS’s board of directors, will also become executive chair.” * * *
  • “Joyner and Farah said in an interview with the Journal that CVS will now move forward intact. 
  • “We believe that we have a really important part to play in terms of simplifying and delivering a better healthcare experience for this country,” Joyner said. CVS’s assembled assets will allow it “to actually deliver on the promises that we’ve made, and now it’s all about execution.” * * *
  • “CVS will also report that medical costs are still running higher than expected, an issue that has come up in other insurers’ recent reports. Aetna’s medical loss ratio, or the share of premiums spent on healthcare costs, will be around 95.2%, compared with analysts’ expected 91.1%.”
    
• Modern Healthcare reports,
  • “Cigna Group has revived efforts to combine with its smaller rival Humana Inc. after merger talks fell apart late last year, according to people familiar with the matter. 
  • “The two health insurance giants have held informal discussions recently about a potential deal, said the people who asked to not be identified because the talks aren’t public. The discussions are in early stages, they added.
  • Cigna is looking to close the sale of its Medicare Advantage business in the coming weeks before committing to any other transactions, one of the people said.

• Beckers Hospital Review lets us know,
  • “Shifting care from in-person to virtual settings could reduce total medical claims spending by 2.3% to 3.1%, according to an Oct. 17 study from Solera Health.
  • “The research analyzed longitudinal medical claims data from 50 million commercially insured U.S. adults. The study first identified patients eligible for virtual care based on an outpatient visit for a qualifying diagnosis over a six-month period. Researchers then reviewed the previous 12 months of claims to assess whether patients’ conditions were uncomplicated or complex, followed by a 12-month forward analysis to evaluate whether their conditions remained controlled or became uncontrolled after their initial in-person visit. 
  • “According to estimates from CMS on private insurer spending in 2022, this shift to virtual care could result in cost savings of over $50 billion each year.”

• Per Fierce Healthcare,
  • “Cancer continues to be employers’ biggest treatment cost, driving up healthcare spending. 
  • “Costs for cancer-related medical services and drugs are expected to reach nearly $250 billion in the U.S. by 2030—a 34% increase since 2015, according to a study by the American Association for Cancer Research.
  • “And, while oncology accounts for only 1% of claims volumes, it makes up 15% of the overall employer healthcare spend, according to a report by The Mahoney Group.
  • “Health tech company Color Health is doubling down on its play for employer-sponsored cancer care, building on its work with the American Cancer Society (ACS) to offer comprehensive cancer management.
  • The company developed a fully integrated virtual cancer clinic for employers, unions and health plans that is designed to support individuals from screening and early detection through diagnosis, treatment and survivorship.
  • “Color, a platform for large-scale care delivery, is rolling out its virtual cancer clinic to more than 45 employers, health plans and unions across the country. The offering will be made available to customers starting January 2025.”