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| Presented By Kaiser Permanente |
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| Axios Vitals |
| By Tina Reed · May 15, 2023 |
| Happy Monday, Vitals readers. Today's newsletter is 985 words or a 3½-minute read. 🍻 On tap this week: The 5th U.S. Circuit Court if Appeals on Wednesday is due to hear the Biden administration's appeal of an order suspending the FDA's approval of the widely used abortion pill mifepristone. - An FDA advisory committee will consider Pfizer's RSV vaccine for infants via maternal immunization on Thursday.
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| 1 big thing: Promising new Alzheimer's drugs face questions about real-world benefit |
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| Illustration: Aïda Amer/Axios |
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| Promising clinical trial results from another new Alzheimer's drug haven't put to bed questions about how much the treatments actually benefit patients, and whether their strong points outweigh their safety risks, Axios' Caitlin Owens and Oriana González write. Why it matters: Preliminary data for Eli Lilly's donanemab make potentially the best case so far that scientists have found a drug that slows the progression of Alzheimer's disease, a condition with no cure that affects about 50 million people worldwide. Yes, but: The drug's still modest clinical benefits may be of only marginal value to some patients, leaving them in a tough spot having to decide whether it's right for them. - Eli Lilly said it plans to apply for full FDA approval as early as this quarter.
The big picture: The trial results, which the company released earlier this month in a press release, show that donanemab was slightly more effective in slowing cognitive decline in early Alzheimer's patients than another treatment, Biogen and Eisai's Leqembi, which received accelerated approval from the FDA in January. What they're saying: While data suggests the drugs have a positive clinical effect, many experts question how much of a difference it will make to patients in the real world, and whether it's worth the considerable safety risk. By the numbers: Donanemab was found to slow cognitive decline in patients in the early stages of the disease by 36% over 18 months. In comparison, Leqembi slowed decline by 27% over the same period of time. - However, 31.4% of patients who took donanemab experienced brain bleeding, versus 17.3% of those who received Leqembi. Three trial participants who took donanemab died from donanemab's side effects. Three patient deaths have also been linked to Leqembi testing, but outside of the core clinical trial.
- "I think the top line topic is going to be, 'which of these two drugs should I take?" said Jason Karlawish, a medical professor at the University of Pennsylvania.
- "It's going to be very interesting to see how clinicians, patients, families and, frankly, health care systems, insurers line up around how to work from the choice of each of these drugs," Karlawish added.
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| 2. A new treatment for menopause effects |
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| Illustration: Tiffany Herring/Axios |
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| Women in menopause have a new drug to treat their hot flashes after the FDA approved Veozah from Japan-based Astellas Pharma on Friday. Why it matters: Nearly 80% of women experience hot flashes from menopause — and many cannot take hormone replacement therapies. Veozah is a "first in class" non-hormonal option for the treatment of moderate to severe menopausal hot flashes, officials say. - "Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA's Center for Drug Evaluation and Research.
Details: The drug targets the neural activity which causes hot flashes during menopause, per the FDA. The big picture: It comes at a time of growing attention — and investment — in addressing the impact of menopause on women's quality of life. - The menopause treatment market was estimated $16.9 billion in 2022, and is expected to grow more than 5% annually through 2030, per Grandview Research.
- Other drug companies, such as Bayer, are also eyeing non-hormonal treatments.
What we're watching: How much it will cost and whether insurers will cover it. - In January, the Institute for Clinical and Economic Review reported the results from trials looked "promising" but, they said, more data was needed to show whether there was a "net health benefit" from the drug compared to someone who has gotten no treatment.
- Their analysis suggested the drug would meet common cost-effectiveness thresholds if priced between $2,000 and $2,600 per year.
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| 3. Planned Parenthood calls for judicial reform |
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| Photo: Andrew Harrer/Bloomberg via Getty Images |
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| Planned Parenthood is calling for the major reform of the federal judiciary less than a year after the fall of Roe v. Wade, including expanding the Supreme Court, adding term limits and creating ethics and transparency requirements, Axios' Oriana González writes. Driving the news: The organization is also demanding an end to single-judge divisions, such as the Amarillo division in the Northern Texas District Court, where its sole judge, Matthew Kacsmaryk, issued a ruling suspended the FDA's approval of mifepristone. - Single-judge divisions can lead to "court-shopping," in which plaintiffs seek out a venue where the lone district court judge is known to be sympathetic to their claims.
Don't forget: Kacsmaryk's ruling has been temporarily blocked by the Supreme Court, but the 5th U.S. Circuit Court if Appeals is scheduled to hear oral arguments on Wednesday. - The three-judge panel that will hear the case is comprised of two Trump appointees and one Bush appointee, all of whom have an anti-abortion leanings.
The big picture: The overturning of Roe, as well as reports around Justice Clarence Thomas' alleged ties to a GOP megadonor, have prompted some Democrats in Congress to push for justice term limits and a code of conduct for the highest bench. Read the rest. |
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| A message from Kaiser Permanente |
| See all that health care can be |
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| Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how. |
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| 4. Quote du jour: The birth control market |
| "You can just pop into the store and it'll be more affordable than anything else you can buy today." — Susan Anderson, an analyst at Canaccord Genuity, told the Wall Street Journal about why FDA approval for over-the-counter sales of Perrigo's Opill contraceptive could be a hit for the drugmaker. A panel of FDA advisors recommended the shift from prescription-only status last week. |
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| 5. While you were weekending |
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| Illustration: Aïda Amer/Axios |
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| 💰There are more options to pay for medical care, but some may be costly. (New York Times) 👍 FDA advisers narrowly back first gene therapy for muscular dystrophy. (NPR) 🚫 North Carolina's governor vetoes abortion limits and launches an override showdown. (NBC News) 👀 Alzheimer's treatment Leqembi could cost Medicare up to $5 billion per year, study estimates (CNBC) |
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| A message from Kaiser Permanente |
| See all that health care can be |
| |
| |
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| Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how. |
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| Thanks for reading, and thanks to senior health care editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits. |
 | | Dive deeper into the future of health care | | |
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