The FDA’s decision to grant accelerated approval for the anti-Alzheimer’s drug lecanemab, which will be sold as Leqembi, has significant potential for research into treatment of the disease. But people living with Alzheimer’s and their families will face difficult choices once the drug is made available later this month by Biogen and the Japanese firm Eisai. A trial found the [...]
After years of internal debate, the FDA has approved the sale of over-the-counter hearing aids. The move will make the devices available to consumers with mild to moderate hearing loss as soon as mid-October. The move not only could save a typical buyer several thousand dollars, it also opens the door to potential new technologies that could improve the quality [...]
In a key decision, the Centers for Medicare and Medicaid Services (CMS) said today that Medicare will not pay for the controversial Alzheimer’s drug Adulhelm until it sees positive results from a government-approved trial. In bureaucratic language: “Monoclonal antibodies directed against amyloid for the treatment of [Alzheimer’s Disease] provided outside of the CMS approved randomized controlled trials and trials supported [...]
This week, drugmaker Biogen made a stunning announcement: It is going to cut in half the price of its controversial Alzheimer’s drug Aduhelm. Instead of selling the infusion drug for $56,000 annually to a typical user it will charge $28,000-a-year. It is, to say the least, unusual, for the maker of a potential blockbuster drug to cuts its price just [...]
A funny thing happened on the way to that $56,00-a-year Alzheimer’s drug: Payers are reluctant to pay, providers are reluctant to prescribe, and the price is coming down—at least for some patients. It is a tale that could push Congress to allow Medicare to negotiate drug prices. Reuters reports that Biogen, which sells the controversial medication it calls Aduhelm, is [...]
Last month, The Food and Drug Administration (FDA) approved a controversial new drug to treat people with Alzheimer’s disease. But even though the FDA allowed the drug to be sold, Medicare is not required to pay for it. And yesterday, the Centers for Medicare & Medicaid Services (CMS) began a process to determine whether Medicare will establish a national coverage [...]
FDA’s decision last week to approve a new “Alzheimer’s disease treatment,” and the buzz that surrounds it, is a symptom of all that is wrong with the way we care for frail older adults in the US. Rather than providing the supports that people with chronic conditions desperately need, and that evidence shows works, we prefer to chase butterflies. In [...]
In a highly controversial decision, the FDA gave accelerated approval to the first drug that could slow the progression of Alzheimer’s disease. But the approval does not say the FDA thinks the drug actually will treat the disease. Rather, FDA carefully states that the drug, with the chemical name aducanumab and the brand name Aduhelm, reduces a substance on the [...]