For the more than 6 million Americans currently thought to have Alzheimer’s, and their loved ones, the possible benefits of new medications can’t come soon enough. As the most common cause of dementia, Alzheimer’s Disease predominantly afflicts older women (⅔ of Alzheimer’s patients are female) and almost ¾ of those with Alzheimer’s are at least 75. As people live longer, it appears the incidence of Alzheimer’s is growing, with data showing that the reported deaths from Alzheimer’s jumped 145% between 2000-2019. In order to meet the needs of the growing number of those diagnosed, it’s important that we diagnose the disease as early as possible so that lifestyle interventions or new-to-market medications can potentially slow down or even halt the cognitive decline. Currently, that’s the best we can do, as we have no “cures.” But getting patients correctly diagnosed, and giving them access to newly developed drugs, are challenging tasks.

In January, we posted on the new drug Leqembi, which appears to slow down the cognitive decline in patients at the early stage of the disease but is still awaiting full FDA approval. Few patients are receiving Leqembi at this time: Medicare has not yet determined if it will pay for the medication (awaiting word from the FDA) and the cost to patients is currently $26,500 per year; clinical treatment centers need to staff up (too few neurologists around);  and diagnosing equipment needs to be purchased as well as devices that can monitor for side effects (including brain swelling and brain bleeding). In fact, whether it’s Leqembi, or the brand new Eli Lilly drug Donanemab, (which has just been announced in a press release and for which Eli Lilly will seek FDA approval by late June) there will be a challenge getting people accurately diagnosed and ensuring sufficient staff and monitoring equipment. This will be especially difficult for patients who don’t live near major medical centers. And, because Medicare continues to only pay for very limited diagnostic testing for Alzheimer’s, just determining if you’re eligible for these new medications may be a challenge. Experts have begun advocating for a change in this Medicare policy.

Donanemab is a potentially valuable addition to the new medications coming to market for early Alzheimer’s. In its press release, Eli Lilly reported that in a Phase III clinical trial, the drug, which targets the amyloid plaques in the brains of those with Alzheimer’s, resulted in the slowing of cognitive and functional decline in early Alzheimer’s patients by 35% in comparison to those receiving a placebo. These results were somewhat similar to those of Leqembi and, similar to Leqembi, posed risks of brain swelling and brain bleeding by taking the drug. In fact, 3 patients died as a result of the Phase III clinical trial. Eli Lilly will be submitting its data to the FDA shortly and thus we should know by the end of this year or early 2024 whether it gains FDA approval (which may lead to Medicare reimbursement). 

These side effects, as well as potential costs to the health care system, patients, and their families, have left some ambivalent about what to make of this new class of Alzheimer’s drugs. While we have clinical data of benefit, it’s not yet clear how that translates into the day-to-day reality of patients and their families, especially given the risks of serious side effects. For more on this expert hesitancy, read here. And even if patients, in consultation with their physicians, gain access to an early diagnosis and determine it’s worth the risk to take either Leqembi or Donanemab, the question is who will pay for the medication, the sophisticated diagnostic technology, and the monitoring for side effects. Plus there is the challenge of getting to a facility to receive the infusion either once a month (Donanemab) or twice a month (Leqembi). 

For the manufacturers of these drugs, the potential profits are enormous. For Medicare, the source of insurance coverage for the overwhelming majority of patients who would be prescribed these medications, the costs could be staggering. Recent estimates published in JAMA Internal Medicine put the cost to the Medicare system at potentially $5 billion if just 216,500 patients become eligible for Leqembi. This assumes Medicare would pay 80% of the reasonable cost and patients would pay 20%, depending on their insurance coverage. Of course, on the flip side are the staggering costs to patients, families, and the health care system for the current lack of treatments and the inevitable cognitive decline and need for caregiving. However, it’s important to keep in mind that even if a patient gains access to this new medication, it’s not a magic bullet. As one expert said, “There is no question that people remain impaired, there is no question that people are still progressing (with Alzheimer’s) and becoming worse, even when taking the drug.” What these drugs do is buy the patient and family some time. The question is how much is that worth, and what risks should be taken in this quest for a longer period with functional abilities? At the moment, it seems that only time will tell.