From Washington, DC,

• The Federal Times and Federal News Network discuss OPM’s plans to tighten internal controls over family member eligibility in the FEHBP. OPM’s actions will shift the burden of monitoring family member eligibility from the FEHB plans to employing agencies, which is where the responsibility belongs.
• OPM also should be filling the greatest internal control gap in the FEHB – the fact that OPM does not allow carriers, which bear the insurance risk, to reconcile premium payments to individual enrollees. A cost effective solution is available by implementing the HIPAA 820 electronic enrollment roster transaction which systematically generates such reconciliations.

• Per BioPharma Dive,
  • “Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.
  • “The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J.
  • “The two companies are likely to enter the market after Amgen, which won approval for an interchangeable biosimilar called Wezlana in October. Amgen is also subject to a legal settlement, and the company has said its product will launch no later than Jan. 1, 2025.”

• Healthcare Dive had the time to report on the CBO report on Medicare Accountable Care Organizations which the FEHBlog noted yesterday.
  • “Accountable care organizations led by independent physicians save Medicare more money than other types of ACOs, according to a new Congressional Budget Office review of existing research.
  • “Independent physician-led ACOs have clear financial incentives to reduce hospital care to lower spending, while hospital-led ACOs — which earn more revenue when patients are admitted — do not, the CBO found. Hospitals also have less direct control over what services patients receive.
  • “ACOs with a larger proportion of primary care providers also saved Medicare more money, along with ACOs whose initial spending was higher than their peers in the same region, according to the report.”
• The FEHBlog’s primary care provider practices in such an ACO.

From the public health and medical research front,

• The New York Times reports,
  • “A pill taken once a week. A shot administered at home once a month. Even a jab given at a clinic every six months.
  • “In the next five to 10 years, these options may be available to prevent or treat H.I.V. Instead of drugs that must be taken daily, scientists are closing in on longer-acting alternatives — perhaps even a future in which H.I.V. may require attention just twice a year, inconceivable in the darkest decades of the epidemic.
  • “This period is the next wave of innovation, newer products meeting the needs of people, particularly in prevention, in ways that we didn’t ever have before,” said Mitchell Warren, executive director of the H.I.V. prevention organization AVAC.
  • “Long-acting therapies may obviate the need to remember to take a daily pill to prevent or treat H.I.V. And for some patients, the new drugs may ease the stigma of the disease, itself an obstacle to treatment.”

• STAT News lets us know,
  • “Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market.
  • “The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep.
  • “In one year-long Phase 3 study that looked at patients with obesity who were not on PAP therapy, a form of ventilation, those taking Zepbound experienced a reduction of 25.3 events per hour on the apnea-hypopnea index (AHI), a measure of the number of times breathing stops and becomes restricted while sleeping. That compares with a reduction of 5.3 events in patients on placebo, Lilly said in a press release Wednesday.
  • “In another Phase 3 study in patients who were on PAP therapy, those on Zepbound had a reduction of 29.3 events per hour on the AHI, compared with a reduction of 5.5 events in patients on placebo.
  • “Severe OSA is defined as having over 30 events per hour, and moderate OSA is defined as 15 to 30 events per hour.”

• CNBC adds,
  • “Most doses of Eli Lilly’s highly popular weight loss drug Zepbound and diabetes counterpart Mounjaro will be in short supply through the second quarter of this year due to increased demand, according to an update on the Food and Drug Administration’s drug shortage database.
  • “A previous update said some doses of both treatments would have limited availability through April.
  • “The new update suggests that the insatiable demand for a buzzy class of weight loss and diabetes drugs is still trouncing supply, even as Eli Lilly and Novo Nordisk work to increase production of those treatments.” 

• The Associated Press informs us,
  • “For decades, patients seeking medication for pain have had two choices: over-the-counter drugs like aspirin or powerful prescription opioids like oxycodone.
  • “Opioid prescriptions have plummeted over the last decade as doctors have become more attuned to the risks of addiction and misuse during the country’s ongoing drug epidemic.
  • “Vertex Pharmaceuticals recently reported positive results for a non-opioid painkiller, one of several medications the Boston-based drugmaker has been developing for various forms of pain. Patients taking the drug after surgery experienced more pain relief than those getting a placebo, although the drug didn’t meet a secondary goal of outperforming treatment with an opioid.
  • The AP interviews Vertex’s chief scientist Dr. David Altshuler about the company’s research and development plans.

• Beckers Hospital Review tells us,
  • “In recent months, parts of the U.S. have reported outbreaks of pertussis, or whooping cough. While some regional outbreaks are expected each year, health officials are underscoring the importance of boosters in adults to protect infants from severe illness, NBC News reported April 17.  * * *
  • “The TDap vaccine is recommended for children 11 and older who have not received the DTaP series. Adults should receive a Tdap booster dose every 10 years, according to the CDC. 
  • “Anyone who comes to see [a] new baby should have had a recent inoculation with Tdap vaccine to provide a cocoon of protection around that baby,” William Schaffner, MD, professor of infectious diseases at Nashville, Tenn.-based Vanderbilt University Medical Center, told NBC News.” 

From the U.S. healthcare business front,

• Healthcare Dive relates,
  • “Steward Health Care is on the clock. 
  • “The Dallas-based healthcare network has until the end of the month to prove to lenders it has the cash on hand to begin repaying its significant debts — or it could face bankruptcy proceedings. 
  • “Demonstrating solvency could be a tall order because the health system owes a lot of parties a significant amount of money, according to analysts familiar with the system. 
  • “Should Steward fail, it would be one of the largest provider bankruptcies in decades, said Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

• MedTech Dive notes, “Abbott looks to ‘highly productive’ device pipeline for future growth. CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity.”

• According to BioPharma Dive,
  • “An experimental drug designed to improve brain function in people with nerve-degrading disorders has failed a mid-stage study that tested it against Parkinson’s disease.
  • “The trial enrolled almost 90 participants, who once a day were given either a placebo or a drug from Sage Therapeutics called SAGE-718. Summary results released Wednesday showed no significant difference between the two groups in how their mental abilities changed over the course of six weeks, as measured by a scale clinicians use evaluate cognition. * * *
  • “Sage is still testing SAGE-718 across three additional trials that should have data this year. One, codenamed “Lightwave,” is focused on people with mild cognitive impairment and mild dementia due to Alzheimer’s disease. The other two, “Surveyor” and “Dimension,” are investigating whether the drug can help Huntington’s disease patients with cognitive impairment.”

• Beckers Hospital Review points out and names ten of twenty most popular drugs are in shortage.