The Food and Drug Administration (FDA) has granted final approval to the anti-Alzheimer’s drug lecanamab, marked as Leqembi by drugmakers Eisai and Biogen. Here is what you need to know: What does it do? In a formal phase 3 trial, Leqembi was shown to slow the progression of memory loss and cognitive impairment in patients with early-stage Alzheimer’s disease by [...]
The drug industry and its supporters are blasting the Centers for Medicare and Medicaid Services (CMS) for proposing to limit Medicare payments for the new anti-Alzheimer’s drug lecanemab to patients who participate in a trial or a special registry aimed at tracking their experience with the drug. CMS says the record-keeping will help provide important, real-world information about the benefits [...]
The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly trying to limit restrictions the Food and Drug Administration puts on the use of new drugs aimed at slowing the progression of the brain disease. And it is publicly pressing Medicare to pay for the widespread use of the monoclonal antibodies FDA already has [...]
Medical experts are raising new questions about the safety of the anti-Alzheimer’s drug lecanemab, which is marketed as Leqembi by drugmakers Biogen and Eisai. One study, which looked in detail at the death of a participant in a Leqembi research trial, suggests that people with a condition that affects as many as half of those with Alzheimer’s Disease may be [...]
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 [...]