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 the drug’s safety or efficacy were interviewed.
…In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.
Some doctors said its effect on the disease may not be clinically meaningful enough when weighed against the risk of brain swelling, its likely high price, and limited personnel and resources to administer twice monthly infusions and monitor for brain swelling with MRI scans.
Typically, Medicare covers what the FDA approves.
In April 2022, CMS decided that Medicare would cover Adulhelm (cost: $28,200 a year, down from the initial $56,000 price) and treatments like it only for beneficiaries with Medicare Part B who are enrolled in a clinical trial approved by the agency or by the National Institutes of Health…
In early June, CMS said that if the FDA grants traditional approval to drugs slowing the progression of Alzheimer’s, Medicare will cover the cost for qualifying beneficiaries who also have a doctor participating in a special registry.
Some critics think a registry could be cumbersome for doctors and patients and might exclude patients in rural and underserved areas.
Ongoing petition by a number of scientists and doctors:
In my opinion we are going down a dangerous road. We need to consult our maps and re-orient ourselves. Please consider signing.
— Karl Herrup (@KarlHerrup) June 18, 2023