From Washington, DC

• The Wall Street Journal reports,
  • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
  • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”

• The Hill offers a potpourri of articles on this situation.

• The American Hospital Association News informs us,
  • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”

• STAT News tells us,
  • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
  • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
• It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.

• Also from STAT News,
  • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
  • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
  • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
  • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

• The NIH Directors blog points out,
  • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
  • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.¹ Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.² The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
  • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”

• Per STAT News,
  • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
  • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
  • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
• and
  • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
  • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
  • “The thing is, ADCs are actually quite an old approach.
  • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
  • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

• Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.

• Moreover, Beckers Hospital Review reports,
  • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
  • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
  • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
  • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
• and
  • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
  • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
  • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
  • “The proposed transaction still has to meet regulatory and closing conditions.”

• Per Healthcare Dive,
  • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
  • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
  • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”

• Per Fierce Healthcare,
  • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
  • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
• and
  • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
  • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
  • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
  • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”