Eli Lilly: Experimental Alzheimer’s drug slows cognitive declines in large trial

LewisBraham

Stock's up 6% today, although the efficacy is far from 100%. Still, any help for this horrible disease deserves praise: https://cnn.com/2023/05/03/health/alzheimers-drug-donanemab-eli-lilly/index.html

An experimental Alzheimer’s medication slowed declines in patients’ ability to think clearly and perform daily tasks by more than a third in a large clinical trial, drugmaker Eli Lilly said Wednesday.

Based on the results, in people with early symptomatic Alzheimer’s disease, Lilly said it plans to file for approval from the US Food and Drug Administration by the end of June.

The medicine, donanemab, works by removing plaque buildups in the brain known as amyloid that are a hallmark of Alzheimer’s disease. However, there were some side effects reported; there were three deaths in the trial among people taking the drug, two of which were attributed to adverse events such as brain swelling or microhemorrhages, known as amyloid-related imaging abnormalities or ARIA. The trial was run in more than 1,700 patients for 18 months.

Alzheimer's drug lecanemab receives accelerated approval amid safety concerns

“For every medicine, for every disease, there are potential risks and potential benefits,” said Lilly’s chief scientific and medical officer, Dr. Daniel Skovronsky. But he noted that almost half of the participants taking the drug, 47%, showed no decline on a key measure of cognition over the course of a year, compared with 29% of people taking a placebo.

That’s “the kind of efficacy that’s never been seen before in Alzheimer’s disease,” Skovronsky said.

Alzheimer’s affects more than 6 million Americans, with an estimated 1.7 million to 2 million people over 65 in the early stages of the disease, according to Lilly. Drug development for Alzheimer’s has been riddled with failures, but Lilly’s drug is among a new group showing promise. The first, Eisai and Biogen’s Leqembi, received accelerated FDA approval in January.

sma3

Certainly if every Alzheimer's patient on Medicare in the US received this drug, Medicare would be bankrupt very quickly. Part B premiums increased 14% in anticipation of the costs of Anduhelm two years ago, before CMS and FDA wisely decided to limit it's use to clinical trials.

It is too early to decide if donanemab is cost effective, but at $25000 to $58,000 ( initial projected cost of Anduleum) a year, shouldn't we wait to see some data on cost reductions before wholesale approval?

The limited information Lilly released ( press releases have a bigger effect on the stock price than a peer reviewed scientific article!) indicates it "stabilizes" cognitive decline, but does not reverse it. No information on how long this lasts. Hopefully a year of treatment will provide long lasting benefit, but there is no data.

It is also not benign. 35% of patients had brain swelling and/or bleeding and at least three died. This is a common problem with these drugs. There may be ways to predict who is at most risk, but this is not a well tolerated medication.

This country needs to have a serious discussion of the goals of Alzheimer's treatment and how many Billions of Medicare money we can afford to pay for it. But, of course it is unlikely this will occur. The Alzheimer's lobby said the FDA was "ignoring" Alzheimer's patient's medical needs when it put up "barriers at every turn" to prevent patients from receiving a drug that reduced the decline in a cognitive test by few points.

The tortured course of Anduleum should be a warning of how aggressive the pharmaceutical industry, academics and patient advocates will be to force approval of drugs that show any possible benefit

https://en.wikipedia.org/wiki/Aducanumab

LewisBraham

To me, the question isn't just of efficacy, but whether the government can force these pharamaceutical companies to lower their drug costs? Somehow I don't think a year's worth of this drug costs $25,000 to $58,000 to manufacture. I wonder what the profit margins will be on it, even after factoring in the R&D costs? If it's effective even somewhat, that matters. One thing I would add is the current annual cost of a private room in a nursing home is $108,408: https://health.usnews.com/best-nursing-homes/articles/how-to-pay-for-nursing-home-costs It is sad but true that the most expensive nursing home patients are ones with Alzheimer's as they can be physically healthy otherwise, but still be mentally unfit to care for themselves, becoming both a danger to themselves and others. So, unlike most elderly patients, they can end up in nursing homes for many months or even years. As strange as this sounds, the medicine, if it works, would be cheaper.

Sven

It may take a year or longer for these companies to get to the breakeven point before the price would decline. But I agree that the government can help.

Old_Joe

We are all somewhat nervously ignoring the "elephant in the room". Given the ever escalating costs to produce new "wonder-drugs", and the ability through genetic research to focus on smaller population segments suffering from specific diseases, it seems obvious to me that the wealthier nations of the world are fast approaching a point where the existing insurance schemes, both public and private, are simply not going to be able to deal with the costs involved.

Either those able to afford many of the newer medications are going to be restricted to the wealthiest, or some radical change in the pricing mechanisms would seem to be inevitable.

I certainly don't see any easy solutions to this situation.

LewisBraham

@Old_Joe All true except Alzheimer's patients are not a small population. This is a widespread disease that affects a lot of people, and has been extremely difficult and expensive to treat. It will only get worse as our population ages. But a day of reckoning with pharma has to come with regard to pricing.

Old_Joe

Hey there Lewis- yes, for sure on the Alzheimer's. And also for a couple of other very widespread diseases. But that's really sort of a double whammy financially- we have a number of widespread diseases affecting lots of patients, which will cost a great deal of money because of the sheer numbers involved. And then also, a large number of small disease cohorts, which will be very expensive because of the unattractive research-cost/patient-base ratio. Something is definitely going to have to change in how we approach all of this.

sma3

@lewisBraham

I agree if these drugs prevented NH admissions they might be cost effective, but the limited data so far is that they only slow cognitive decline, not stop it. $100,000 is the approximate costs for private pay but most dementia patients spend down and go on Title 19, which pays far less. Good luck trying to figure out what that number is. Nursing Homes are the most intensely regulated health care institutions in the country, adding significantly to their costs.

Hopefully, if approved, Medicare will only pay for use in patients who have been proven to benefit, but as a physician and geriatrician, I can tell you the lobbying pressure on Medicare to approve cart blanche will be immense, driven by desperate families and doctors whose salaries depend on dementia, such as academics with large research laboratories and consulting contracts with big Pharma. No one is willing to stand up for the common good anymore!

If Lilly pulls the patent shenanigans that Abbvie did with Humira, they can probably keep patent protection ongoing for decades. There will be a direct spigot from the US Treasury to Lilly.