Rising controversy over function of FDA and Medicare in selling anti-amyloid medication given restricted profit, excessive value, extreme side-effects
4 min read
The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbes):
The powerful Alzheimer’s Disease lobby is battleing a multi-billion-dollar battle on two fronts. It’s quietly attempting to limit restrictions the Meals and Drug Administration places on using new medication aimed toward gradualing the professionalgression of the mind disease. And it’s publicly pressing Medicare to pay for the hugeunfold use of the monoclonal antibodies FDA already has conditionally accepted in addition to others within the pipeline.
Whereas the FDA approves medication to be used, it doesn’t resolve who pays for them. And, for now, the Centers for Medicare and Medichelp Services (CMS) permits Medicare to pay for these medications below solely limited circumstances…
Whereas these decisions must be primarily based on science, the Alzheimer’s lobby is rolling out its political huge weapons. Members of Congress are demanding that Medicare pay. Advocates allege racial bias in Medicare’s reluctance to cover the medication. Why? As a result of they are saying trials and even registries are much less likely to incorporate Black and Hispanic sufferers in addition to these living in rural communities.
In a single unusual advocacy transfer, drugmaker Eli Lilly, which has utilized for FDA approval of its personal monoclonal antiphysique, purchased what effectively was a two-hour infomercial predespatcheded by the web information service The Hill. It featured regulationmakers, researchers, and representatives of advocacy teams all urging CMS to pay for these medication. No researchers who questioned the drug’s protectedty or efficacy have been interviewed.
European Alzheimer’s experts unconvinced by new Eisai, Biogen drug (Reuters):
…In Europe, the place cost-conscious countries rigorously weigh new medication earlier than undertakeing their use, 9 neurologists and researchers throughout six countries informed Reuters lecanemab is not likely to be hugely used if accepted. Their views belowpin analyst estimates suggesting Europe can be a small market for the drug.
Some doctors mentioned its impact on the disease might not be clinically implyingful sufficient when weighed towards the danger of mind swelling, its likely excessive worth, and limited personnel and sources to administer twice monthly infusions and monitor for mind swelling with MRI scans.
Does Medicare pay for Alzheimer’s drugs? The answer is complicated and changing (Fortune):
Typically, Medicare covers what the FDA approves.
In April 2022, CMS decided that Medicare would cover Adulhelm (value: $28,200 a yr, down from the initial $56,000 worth) and deal withments prefer it just for beneficiaries with Medicare Half B who’re enrolled in a clinical trial accepted by the company or by the National Institutes of Well being…
In early June, CMS mentioned that if the FDA grants traditional approval to medication gradualing the professionalgression of Alzheimer’s, Medicare will cover the price for qualifying beneficiaries who even have a doctor participating in a special registry.
Some critics suppose a registry could possibly be cumbersome for doctors and sufferers and would possibly exclude sufferers in rural and belowserved areas.
Ongoing petition by a lot of scientists and docs:
Lecanemab is neither protected nor effective for Alzheimer’s sufferers: Towards the FDA approval — Signal the Petition! https://t.co/ahkiJts8hj through @Change
In my opinion we’re taking place a dangerous street. We have to consult our maps and re-orient ourselves. Please consider signing.
— Karl Herrup (@KarlHerrup) June 18, 2023
