From Washington, DC,

• Healthcare Dive lets us know,
  • The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.
  • The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers.
  • As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.

• The FTC has decided to try the case in the FTC’s administrative court, instead of a federal district court. Any appeal would be taken to a federal circuit court of appeals, typically the D.C. Circuit.

• Modern Healthcare adds,
  • “CVS Caremark in a statement said it had worked to drive down insulin prices by creating new formulary options and negotiating discounts on behalf of clients. It pointed to a program available to patients at its network pharmacies offering lower-cost insulin.
  • “Any action that limits the use of these PBM negotiating tools would reward the pharmaceutical industry and return the market to a broken state, leaving American businesses and patients at the mercy of the prices drugmakers set,” a spokesperson said in the statement.
  • “Cigna Chief Legal Officer Andrea Nelson refuted the FTC’s allegations and reiterated the role PBMs such as Express Scripts play in the healthcare system. She said the case could lead to higher drug prices.
  • “Express Scripts intends to vigorously defend itself to protect our ability to lower drug costs for the thousands of clients and the millions of Americans we serve,” Nelson said in a statement.
  • “An OptumRx spokesperson said in a statement its negotiations with drugmakers and other actions have led to lower insulin costs for members.
  • “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” the spokesperson said.”

• CMS posted the presentation from the agency’s September 10 webinar about group health plan Section 111 reporting.

• Fierce Healthcare tells us,
  • “The Medicaid unwinding is coming to a close, and a new analysis from KFF finds that while many people have lost coverage during this period, enrollment remains above pre-pandemic levels.
  • “The report estimates that more than 25 million people were disenrolled as part of the Medicaid redeterminations, while more than 56 million renewed coverage successfully. However, while millions have lost coverage, there are about 10 million more people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) compared to the start of the COVID-19 pandemic.
  • “KFF found that most states completed the redeterminations with higher enrollment than they reported in February 2020. In seven states, enrollment was 30% above pre-pandemic levels.
  • “Also playing a role is the fact that five states—Missouri, Nebraska, North Carolina, Oklahoma, and South Dakota—expanded their Medicaid programs since the pandemic began, COVID-19 said.
  • “There have always been people eligible for Medicaid but not enrolled, as well as people who get dropped from Medicaid for failing to complete regular renewal processes,” the researchers wrote. “During the unwinding period, many states took steps to improve their renewal systems, leading to fewer people getting dropped even though they remain eligible.”
    
    

From the public health and medical research front,

• The Centers for Disease Control and Prevention announced,
  • “Seasonal influenza and RSV activity are low nationally and COVID-19 activity is decreasing in most areas.
  • “COVID-19
    • “There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
  • “Influenza
    • Nationally, seasonal influenza activity remains low. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “RSV
    • “Nationally, RSV activity remains low.
  • “Vaccination
    • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 2.8% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 6.8% reporting receipt of an influenza vaccine. Among adults 75 years and older, 33.1% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.

• In Covid news, The University of Minnesota’s CIDRAP adds,
  • “Test positivity for COVID was 13.5% last week, down from 14.9% the week before.
  • “Hospitalizations continue to decline but remain highest in seniors, followed by adults ages 50 to 64 and children younger than age 4 years. 
  • “Emergency department visits dropped about 19% compared to the previous week and are now at low levels across much of the country. 
  • “Deaths held steady, and provisional data show that the CDC received reports of 563 COVID deaths for the week ending September 14.
  • “Detections of SARS-CoV-2 in wastewater are still high nationally, according to CDC tacking. The highest levels remain in the West, followed by the Midwest and the South. However, all regions show downward trends.
  • ‘The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are still high nationally and, in the Midwest, with no significant up or down trend over the past 3 weeks.”

• NBC News informs us,
  • “The U.S. is experiencing more than four times as many whooping cough cases compared with last year — a spike that some experts attribute to post-pandemic vaccine fatigue. 
  • “With the increase in vaccine hesitancy that has been going on since the Covid-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” said Dr. Tina Tan, president-elect of the Infectious Diseases Society of America.
  • “Babies are given the DTaP vaccine, which helps protect against three diseases: pertussis, diphtheria and tetanus. The vaccine works well against diphtheria and tetanus, but is less effective over time for pertussis. 
  • “Advisors to the Food and Drug Administration met Friday to discuss the need for more robust and longer-lasting versions of the whooping cough vaccine. 
  • “Until next generation vaccines are developed, boosters are recommended about every 10 years, starting in the tween years, as kids start middle school. 
  • “It’s the tweens and teens whose immunity against whooping cough has waned that are driving outbreaks in many states, experts say.”
  • “On Thursday, the CDC reported that 14,569 cases of whooping cough had been confirmed so far in 2024. That’s a significant increase over last year’s total of 3,475 cases.”

• The New York Times reports,
  • “The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.
  • “The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.
  • “AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45 but may be less depending on insurance coverage.
  • “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.”

• The American Hospital Association News points out,
  • Drug overdose deaths have dropped by 10% this year compared to last, according to data from the Centers for Disease Control and Prevention. This year also marked an annual decline in overdose deaths for the first time in five years. On Aug. 31, federal agencies awarded an additional $416 million to respond to the overdose crisis and support substance use treatment and recovery services. The AHA remains focused on supporting hospitals and health systems in reducing drug overdose deaths, including by providing resources to enhance opioid stewardship. Learn more from AHA’s Opioid Stewardship Hub.” 

• Per an FDA press release,
  • “Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older.
  • “Miplyffa is the first drug approved by the FDA to treat NPC. NPC is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction. It is caused by changes in either the NPC1 or NPC2 gene, affecting the necessary transport of cholesterol and other lipids within a cell. As a result, these cells do not function as they should, ultimately causing organ damage. On average, individuals affected by this devastating disease only live for about 13 years.
  • “NPC is a serious disease that leads to enormous adverse impacts on patients and families. Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), in the FDA’s Center for Drug Evaluation and Research. “The first-ever approval of a safe and effective drug option for NPC will undoubtedly support the essential medical needs of those suffering.”

• STAT News lets us know,
  • “A next-generation obesity drug candidate from Novo Nordisk produced modest weight loss, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances — results that pose a challenge to the pharma giant’s efforts to find novel obesity drugs that could extend its success from its blockbuster Wegovy.
  • “A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year. Those on the lowest dose of 10 mg lost on average 6.4% of their weight at 16 weeks, compared with 0.6% in the placebo group, Novo said Friday. The study also tested higher doses of 20 mg and 50 mg, but Novo said “limited additional weight loss” was seen at these higher doses and did not disclose specific data.”

From the U.S. healthcare business front,

• Beckers Hospital Review Becker’s has compiled “a list of 189 hospitals with a CMS five-star rating for care transitions” and identified the “top ranked hospitals for coronary bypass in the U.S., according to the WebMD Choice Awards.
  
• The Wall Street Journal reports,
  • “A price battle has broken out in the hot market for weight-loss drugs.
  • “Eli Lilly and Novo Nordisk, the pharmaceutical heavyweights selling the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines.
  • For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month.
  • Price concessions are a new, major development in the burgeoning market for weight-loss drugs, after high prices and limited supplies led many health plans to refuse coverage and prompted some patients to turn to lower-priced but unapproved custom-made version.

• MedTech Dive notes,
  • “GE Healthcare has received 510(k) clearance for a tool designed to help clinicians assess people who may have Alzheimer’s disease, the company said Tuesday.
  • “The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to enable clinicians to determine the density of amyloid plaque in a patient’s brain from PET scans. Amyloid is a protein that, in Alzheimer’s, can clump up into toxic plaques in the brain. Scientists have linked the formation of those plaques to symptoms such as memory loss.
  • “Researchers developed the Centiloid scale, which Eisai and Eli Lilly used during the development of their recently approved Alzheimer’s drugs, to standardize amyloid imaging measures.
• and
  • “Abbott ramps up Libre 3 production amid shortages. Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.” * * *
  • “Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
  • “Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre 3 sensors. The company is ramping up production, adding capacity to an existing manufacturing facility this month, and opening a new manufacturing facility later this year, she wrote in an email.” * * *
  • “If people are unable to get Libre 3 sensors through their pharmacy or mail order company, Delco recommended checking back in a few days to see if they have new supply.
  • “If there are prolonged delays, another option is to talk to a healthcare provider about switching to a prescription for Freestyle Libre 3 Plus, Delco said. The Food and Drug Administration cleared the newer version of the sensor last year. It has a 15-day wear time, instead of 14 days for the Libre 3. The Libre 3 Plus has supply at both pharmacies and mail-order companies, according to Abbott.”