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The Food and Drug Administration is poised to grant full approval to the first drug that slows down Alzheimer's disease. NPR's Jon Hamilton reports on who that might affect.
JON HAMILTON, BYLINE: The drug is lecanemab, marketed under the name Leqembi. It removes a substance called amyloid beta from the brain. Lecanemab received conditional approval from the FDA in January, but until it gets full approval, it won't be covered for most Medicare patients, who represent the vast majority of people with Alzheimer's. Robert Egge of the Alzheimer's Association says that makes the FDA's impending decision a big deal, even though patients know the drug isn't a cure.
ROBERT EGGE: Just the idea that they can gain more time is profoundly important and exciting. That's why patients, their families have been speaking up so loudly for the need for Medicare coverage.
HAMILTON: Even with full approval, expected by July 6, lecanemab's rollout could be slow. Medicare will require doctors to join a registry that tracks the drug's safety and effectiveness. Egge says the extra paperwork may keep some doctors from prescribing the drug.
EGGE: We're most likely to see that happen in areas that are already traditionally underserved, where doctors are already stretched thin. So our biggest concern is that there'll be whole communities that are left out entirely in terms of ability to access this treatment.
HAMILTON: Another concern is that payers may not cover all the brain scans and related services that go with lecanemab treatment. Dr. Zaldy Tan of Cedars-Sinai Medical Center in Los Angeles says insurers could also require doctors and medical facilities to meet certain criteria before offering treatment.
ZALDY TAN: If that requirement becomes very restrictive, then only specialized centers will really be able to do this. And because of the limited capacity, I anticipate there will be a wait to get this medication.
HAMILTON: Tan says many patients who could get the drug may choose not to. He says it takes 18 months of treatment to slow the loss of memory and thinking by about six months.
TAN: So what does that six months mean to them, is my question, and whether that is worth showing up for an infusion every two weeks and risking brain bleeding and swelling.
HAMILTON: Even so, Tan says he supports the FDA's expected approval of lecanemab.
TAN: It is a positive thing because if we are going to get, eventually, to an effective and safe therapy, we need to start somewhere.
HAMILTON: That view is shared by Dr. Mia Yang, a geriatrician in Winston-Salem. But Yang says the U.S. doesn't have enough memory specialists or infusion clinics to handle all the potential lecanemab patients.
MIA YANG: I think we're all flying the plane while we're building it in terms of the health care infrastructure.
HAMILTON: Yang says it will take a huge effort just to identify the right patients. People with advanced Alzheimer's, for example, are not eligible, and people taking blood thinners may face a higher risk of bleeding in the brain.
YANG: Of the millions of Americans who have Alzheimer's disease, I definitely don't think this is a drug that's applicable for the majority of them.
HAMILTON: Lecanemab's price may pose another barrier, even with insurance. The drug's maker, Eisai, expects the drug alone to cost $26,500 a year. Diagnostic and follow-up tests will add to that, and a patient's share could run into the thousands. The nonprofit Institute for Clinical and Economic Review analyzed lecanemab's value to patients. Dr. David Rind says it found the current price too high.
DAVID RIND: A fair price for this would range from about $8,900 up to $21,500 per year, which is a very wide price range.
HAMILTON: Rind favors something toward the low end of that range. At its current price, he says, lecanemab could be very profitable for Eisai and its U.S. partner, Biogen.
RIND: I would guess that there are going to be a lot of people with early Alzheimer's who are asking for this drug. And if so, it could be a multibillion-dollar drug.
HAMILTON: Thanks mostly to coverage by Medicare. Jon Hamilton, NPR News.
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