New Alzheimer’s Drug Sparks Controversy

New Alzheimer’s Drug Sparks Controversy

One of the biggest items in the news last week that is of interest to so many seniors is about a new drug, which will be marketed as Aduhelm, related to the treatment of Alzheimer’s disease.  We are not doctors or scientists so we thought we would relay to you some of the information we have seen about this new drug.

To say the least, it is controversial and there is reason to doubt it works.  We know for sure that it is incredibly expensive.  Having said that, here is some of the information we have seen.

This is from STAT News, a company that “delivers trusted and authoritative journalism about health, medicine, and the life sciences.

“That [FDA] approval is broad, making no distinction between the mild, moderate, and advanced stages of the memory-robbing disease and setting no requirements for its diagnosis.”

“The FDA’s action came despite a 10-0 vote in November against approval by its panel of expert advisers, who were dubious that data from two clinical trials showed the drug was effective in early Alzheimer’s patients with mild cognitive impairment; three members resigned in protest from the panel last week. The surprising decision leaves doctors turning back to data from those trials, which had conflicting results: One barely met its primary endpoint, and the other did not. As if that is not confusing enough, the mental decline that is considered an early sign of Alzheimer’s disease is also present in other age-related disorders, which makes it hard to discern which patients have the disease.”

“The side effects of the drug, to be sold as Aduhelm by maker Biogen, are troubling and the cost is staggering, at $56,000 per year ‘forever,’ doctors told STAT. More than one-third of trial participants developed brain swelling and 17% to 19% had small bleeds in their brains.”

“’The risks are known. The benefits are still in question,’” said Zaldy Tan, a neurologist and medical director of the Center for Alzheimer’s and Memory Disorders at Cedars-Sinai in Los Angeles. “

“’It’s modest in terms of efficacy. It’s [statistically] significant, but it may not be observable by the family or caregiver or even the physician,’” he said. “’I would tell them this is not a cure — something to set the expectation that this is likely not going to be a dramatic improvement, but this could be something more subtle.’”

And there is this report from Vox News:

“Medicare, the federal health insurance program that covers Americans over 65, is facing an impossible dilemma: Should it cover a new and expensive medication for Alzheimer’s disease, which afflicts 6 million Americans and for which there is no existing treatment, even though the drug might not actually work?”

“But the evidence on whether Biogen’s treatment, called aducanumab, is effective is, at best, mixed; the FDA approved it this week over the objections of its own advisory committee. And with a preliminary announced price of nearly $60,000 annually per patient, covering the treatment could cost upward of $100 billion a year, mostly to Medicare, which would almost double the program’s drug spending. Patients themselves could be on the hook for thousands of dollars in out-of-pocket costs.”

“Independent analysts think the drug is worth more like $8,000, but Medicare has no authority to charge a lower price. Instead, the federal program is likely in effect obligated to cover the new drug now that it has FDA approval. The tools it has to make a determination about whether or not to cover aducanumab and for whom are fraught with legal and ethical risk.”

“The government now finds itself trying to figure out how to satisfy patients who desperately need help, even though scientists think this particular treatment lacks strong evidence for its effectiveness and policy experts warn it is setting up a budgetary nightmare for Medicare in the future.”

TSCL will be keeping a close eye on this subject because we know that so many seniors and their families are desperately hoping there will be some new breakthrough that will effectively treatment Alzheimer’s and other forms of dementia.  But the cost of this drug is so expensive, and it could have a major impact on the Medicare budget that already is in critical financial condition.