STAT+: Pharmalittle: FDA OKs new kind of drug to treat hot flashes; Alzheimer’s drug could cost Medicare up to $5 billion a year

The FDA approved a new kind of drug to treat hot flashes, which could offer relief to women who do not want to take hormone therapy.

May 15, 2023 - 20:00
STAT+: Pharmalittle: FDA OKs new kind of drug to treat hot flashes; Alzheimer’s drug could cost Medicare up to $5 billion a year

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online calls, dashing about, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So why not give it a nudge in a better direction with a delicious cup of stimulation? Our choice today is roasted coconut. Please feel free to join us. Meanwhile, we have assembled the latest laundry list of informative items for you to peruse. We hope you have a meaningful and productive journey today and, as always, do keep in touch. …

The U.S. Food and Drug Administration approved a new kind of drug to treat moderate to severe hot flashes caused by menopause, which could offer relief to millions of women who do not want to take hormone therapy to treat their symptoms, CBS News says. The once-a-day pill, called Veozah, blocks a chemical in the brain that affects how body temperature is regulated. As many as 80% of women face hot flashes as they age into their 40s and 50s. One study found that up to 46% of women experienced moderate or severe hot flashes for years. The list price for the pill is $550 for a 30-day supply, and it is expected to be available in pharmacies within three weeks.

Widespread coverage of the Alzheimer’s drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, Reuters writes, citing a new study. The drug, sold by Eisai and Biogen at an annual list price of $26,500, was approved this year under the FDA’s accelerated pathway. The Centers for Medicare and Medicaid Services currently covers the medication only for patients enrolled in clinical trials. CMS will broaden coverage if Leqembi and similar drugs were to receive standard FDA approval. The FDA is slated to decide by July 6 whether to grant standard approval based on evidence of Leqembi’s clinical efficacy.

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