Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects

The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbers): 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 conditionally approved as well as others in the pipeline. While the FDA approves drugs for use, it doesn’t decide who pays for them. And, for now, the Centers for Medicare and Medicaid Services (CMS) permits Medicare to pay for these medications under only limited circumstances… While these decisions should be based on science, the Alzheimer’s lobby is rolling out its political big guns. Members of Congress are demanding that Medicare pay. Advocates allege racial bias in Medicare’s reluctance to cover the drugs. Why? Because they say trials and even registries are less likely to include Black and Hispanic patients as well as those living in rural communities. In one unusual advocacy move, drugmaker Eli Lilly, which has applied for FDA approval of its own monoclonal antibody, purchased what effectively was a two-hour infomercial presented by the online news service The Hill. It featured lawmakers, researchers, and representatives of advocacy groups all urging CMS to pay for these drugs. No researchers who questioned th...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Alzheimer's experts Alzheimer’s Disease Anti-Alzheimer’s Drugs Biogen brain swelling Eisai europe FDA lecanemab Medicare Source Type: blogs