Tuesday Tidbits

David Ermer–AHRQ, FDA, Generative AI, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Supreme Court appeared likely to preserve access to the abortion pill mifepristone, following arguments Tuesday in which justices suggested that protecting doctors who oppose abortion wasn’t enough justification to roll back access to the drug.
    • “Several justices, including some who voted to overrule Roe v. Wade two years ago, focused their questioning on whether the doctors and medical associations that brought the case in fact have the right to sue. Those doctors and groups don’t prescribe mifepristone, don’t perform abortions and have no legal obligation to help women end unwanted pregnancies. 
    • “Just to confirm,” said Justice Brett Kavanaugh, “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”
    • “Yes,” answered U.S. Solicitor General Elizabeth Prelogar, who argued on behalf of the Biden administration. “We think that federal conscience protections provide broad coverage here.” 
  • American Hospital Association News tells us,
    • “This April through June under the Inflation Reduction Act, Medicare will reduce the coinsurance amount for 41 Part B prescription drugs from 20% to somewhere between 3.8% and 19.9%, depending on the drug, the Centers for Medicare & Medicaid Services announced March 26. Medicare will pay health care providers the difference between the Medicare allowed amount and the adjusted beneficiary coinsurance, after applying the Part B deductible and prior to sequestration, if applicable.
    • “The IRA requires drug companies to pay rebates to Medicare when prices for certain single-source and biosimilar prescription drugs covered under Part B increase faster than the rate of inflation. Part B drugs impacted by a coinsurance adjustment may change quarterly. For more information, see the CMS fact sheet.” 
  • HHS’s Agency for Healthcare Research and Quality released its latest medical expenditure panel survey results,
    • “Dental utilization and expenditures in the United States declined in the first year of the COVID-19 pandemic. Total dental expenditures declined by 16.1% from 2019 to 2020; the number of people using dental services declined by 12.5%, and the total number of dental visits decreased by 19.0%.
    • “In 2020, around 131 million persons utilized dental care (40.8% of the total U.S. civilian noninstitutionalized population aged 2 and over), 18 million fewer people than the year before (149 million; 46.7%).
    • “In 2020, the monthly dental visit volume dipped substantially for three consecutive months compared to the same months in 2019.
    • “Between 2019 and 2021, the average—inflation-adjusted—annual expenditures for dental care among persons with any dental care did not differ significantly.”
  • Per an FDA press release,
    • “The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law.
    • “Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking.
    • “These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

From the public health and medical research front,

  • Nature lets us know,
    • “A team led by Google scientists has developed a machine-learning tool that can help to detect and monitor health conditions by evaluating noises such as coughing and breathing. The artificial intelligence (AI) system1, trained on millions of audio clips of human sounds, might one day be used by physicians to diagnose diseases including COVID-19 and tuberculosis and to assess how well a person’s lungs are functioning.
    • “This is not the first time a research group has explored using sound as a biomarker for disease. The concept gained traction during the COVID-19 pandemic, when scientists discovered that it was possible to detect the respiratory disease through a person’s cough2.
    • “What’s new about the Google system — called Health Acoustic Representations (HeAR) — is the massive data set that it was trained on, and the fact that it can be fine-tuned to perform multiple tasks.
    • “The researchers, who reported the tool earlier this month in a preprint1 that has not yet been peer reviewed, say it’s too early to tell whether HeAR will become a commercial product. For now, the plan is to give interested researchers access to the model so that they can use it in their own investigations. “Our goal as part of Google Research is to spur innovation in this nascent field,” says Sujay Kakarmath, a product manager at Google in New York City who worked on the project.”
  • The Institute for Clinical and Economic Review announced,
    • “releasing a Draft Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life,” said ICER’s Chief Medical Officer David Rind, MD. “Current therapeutic options are insufficient for many people with PTSD. While MDMA-AP may be a promising therapy for PTSD, functional unblinding in the clinical trials and additional concerns around trial design and conduct leave many uncertainties about the balance of benefits and harms. It will be incumbent on regulators with complete access to primary data to carefully assess whether MDMA-AP has been proven safe and effective.”
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on April 22, 2024. 
  • Healio informs us,
    • “Around one in eight hospitalized adults treated for community-acquired pneumonia in a Michigan study were inappropriately diagnosed, and most of those patients received unneeded antibiotics, according to a study.
    • “For patients at high risk of poor outcomes from delayed treatment of community-acquired pneumonia (CAP), it may be pertinent to empirically prescribe antibiotics while finishing diagnostic evaluation,” Ashwin B. Gupta, MD, a clinical associate professor at University of Michigan Health, and colleagues wrote.
    • “However, according to Gupta and colleagues, “For patients at high risk of poor outcomes from delayed treatment of CAP, it may be pertinent to empirically prescribe antibiotics while finishing diagnostic evaluation. In these populations, guidelines recommend reconsideration, de-escalation, and cessation of antibiotics within 48 to 72 hours once infection has been ruled out. In the present study, we found little evidence of antibiotic cessation.”
  • American Hospital Association News notes,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine calls for developing better diagnostics, vaccines and treatments to enhance U.S. readiness for an outbreak or attack involving smallpox or related diseases, and systems and policies that would allow public health and health care systems to respond quickly and effectively.
    • “It is now possible to engineer variola virus, the virus that causes smallpox, raising the possibility of accidental or intentional release,” the press release notes. “Furthermore, illnesses related to smallpox such as mpox, Alaskapox, and cowpox are increasingly found in humans, presenting the need for medical countermeasures that can detect, treat, and prevent these diseases.”

From the U.S. healthcare business front,

  • Beckers Payer Issues calls attention to the biggest investments that payer and healthcare system executives are making this year.
  • Beckers Hospital Review lists the 21 most innovative health systems according to Fortune.
  • The Wall Street Journal reports,
    • “Merck is making a big bet that its new drug, approved Tuesday in the U.S. for a potentially fatal lung disease, will take the company a long way toward heading off a massive revenue decline later this decade.
    • “The drug, which will sell under the name Winrevair, treats a condition called pulmonary arterial hypertension that affects nearly 40,000 people in the U.S. In 2021, Merck paid $11.5 billion for the company developing the medicine. Some analysts estimate sales as high as $7.5 billion a year.
    • “Merck is counting on the blockbuster performance. More than 40% of the drug company’s revenue, some $25 billion last year, comes from cancer treatment Keytruda. The immunotherapy is the world’s top-selling drug. Merck’s main U.S. patent for it expires in 2028, opening the door for lower-cost versions to eat into sales.
    • “Winrevair will list for a price of $14,000 a vial, which for about two-thirds of patients will be the amount given every three weeks. That translates into about $242,000 for a full year, though Merck said the cost would vary by patient because dosage is weight-based.”
  • BioPharm Dive relates,
    • “A dual-acting weight loss pill from Viking Therapeutics helped people with obesity lose up to 5% of their body weight over four weeks in a small trial designed to identify a dose for more advanced studies, the company said Tuesday.
    • “The news helped Viking rebound from a stock slump that followed Novo Nordisk’s announcement a similar weight loss pill it’s developing drove double-digit weight loss over three months in a larger, more advanced trial.
    • “One Wall Street analyst noted the Viking drug’s “exceptional tolerability” may separate it from medicines being developed by Novo, Eli Lilly and Amgen. Only a small number of Viking trial participants reported gastrointestinal side effects, a principal problem people have with weight loss drugs like Novo’s Wegovy and Lilly’s Zepbound.”
  • Bloomberg adds,
    • “Patients, doctors and pharmacists across the US are struggling to get their hands on Eli Lilly & Co.’s powerful new obesity drug Zepbound, as demand for the weight-loss shot soars. * * *
    • “The [FDA] doesn’t consider Zepbound to be in shortage, a spokesperson said. However, nine pharmacists and technicians in six states at CVS, Walgreens and Walmart told Bloomberg News that some or all of the doses of Zepbound were on backorder. Two CVS pharmacies in Ohio have been unable to fill prescriptions for Zepbound’s smallest dose for at least 10 days, two pharmacy technicians said. Amazon Pharmacy, which has a partnership with Lilly, is also listing multiple doses of Zepbound as currently unavailable. None of the pharmacy chains or Amazon responded to requests for comment.” 
  • Fierce Healthcare looks at both sides of the dispute over the value of digital diabetes tools.
  • The AMA News headlined this RevCycle Intelligence article this morning because it trashes health plan claims processing. Health plans are paid to monitor spending and it shouldn’t be surprising that they deny claims.