A new drug for Alzheimer’s has been in the news. Some people are very excited. But others are dubious.
You can’t sell a drug in America unless you can prove to the FDA that the drug is both safe and effective. The FDA was convinced that the new Alzheimer’s drug is safe. But they weren’t convinced that the drug was effective. But they approved it anyway. Which normally would be
illegal. A drug has to be safe AND effective in order to be approved.
But the FDA has an exception to that rule. The agency can approve a drug under a special “accelerated approval pathway” if the drug is safe and the drug “fills an unmet need for a serious disease and has effects against a biological sign of the disease” even if “there remains
uncertainty about its clinical benefit.”
I’m no doctor, but here’s my understanding of the medicine. If you look at the brains of people who have Alzheimer’s, many of them will have a sticky substance known as amyloid. Apparently, some scientist don’t agree that this sticky substance causes Alzheimer’s, but it is a
“biological sign of the disease.” The scientists think that the new drug will help reduce the sticky substance, but the scientists don’t know the reduction will actually be of any benefit to patients.
And that may be OK for some folks. If you’re desperate, you might be willing to try something that might or might not be effective. But it’s not going to be cheap. It’s been reported that the drug will cost about $50,000 a year. And even if Medicare decides to cover the drug, patients will still have to pay a 20% co-pay. That’s about $10,000 per year.
Is it worth it to you? It might be if the Medicare “doughnut hole” applied. But it doesn’t. The Medicare “doughnut hole” rule says that once your prescription drug out of pocket cost goes over $6,300 in a year, then Medicare will pay 95% of the cost for the rest of the year. But the “doughnut hole” rule does not apply to drugs that have to be administered in a doctor’s office. And the new Alzheimer’s drug must be administered in a doctor’s office.
UPDATE: Apparently, a lot of people found the price of this new Alzheimer’s drug to be too expensive. It only generated about $300,000 in revenue in the third quarter of 2021. So the drug’s manufacturer has cut the price to $28,200 per year. It is still undecided whether Medicare
will cover the drug. Expect a final decision in April 2022.