Pat Bishara, 79, was diagnosed with mild cognitive impairment in late 2017. Beginning in 2021, she participated in both the phase 3 trial and the extension trial for donanemab. Along with the monthly infusion, she was also regularly evaluated by a psychologist. She had her final infusion last month.
When asked about her progress, Bishara said she had no noticeable side effects during the trial. Although she still sometimes has trouble remembering names and faces, most people don’t even realize she has the disease. She attributes that to the treatment.
FDA and CMS Approve Kisunla for People with Early Symptomatic Alzheimer’s Disease
The U.S. Food and Drug Administration (FDA) recently approved Eli Lilly’s Kisunla (donanemab), a once-monthly injection intended for those with mild cognitive impairment (MCI) and those who have mild dementia with confirmed amyloid pathology. I previously wrote about donanemab about a year ago, while it was still being studied.
Now approved, Kisunla works in the same way as Biogen and Eisai’s Leqembi (lecanemab), which created headlines around the world last year when it was shown to slow the pace of Alzheimer’s by 27 percent. Both drugs use antibodies similar to those the body makes to attack viruses. They are also both engineered to clear the sticky gunk, called beta amyloid, that builds up in the spaces between brain cells, forming distinctive plaques that are one of the hallmarks of Alzheimer’s disease.
Results from Kisunla Trials Are the Most Encouraging Yet
According to Time magazine, the results from Kisunia trials were the most encouraging yet for any drug that targets amyloid. In fact, in phase 3 trials published in May 2023, Kisunla was shown to “significantly slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease,” according to a press release on Eli Lilly’s website. Here are ten additional things you should know about Kisunla.
- Both Kisunla (donanemab) and Leqembi (lecanemab) are part of a new Alzheimer’s drug category of monoclonal antibody drugs (“mab” drugs for short). These therapies are among the first disease-modifying drugs for Alzheimer’s disease because they don’t just help to lessen symptoms; they actually help temporarily reverse the disease by preventing the buildup of amyloid plaques in the brain. The first drug in this category was the controversial Aduhelm (aducanumab), also from Biogen and Eisai, which I first wrote about back in 2021. Biogen and Eisai actually ended two major studies of aducanumab back in 2019 after preliminary results suggested it did not work, but it was later approved by the FDA, only to be taken off the market by its manufacturers earlier this year.
- Kisunla may be more effective than Lequembi: Kisunla is similar to Lequembi, the current main drug on the market that blocks amyloid formation. However, Kisunla has been found in studies to be somewhat more effective as it slows the progression of Alzheimer’s by nearly half versus around a third for Lequembi. Click here for the article I wrote last year about the controversial approval of Lequembi.
- Kisunla works best on those with the mildest symptoms: Kisunla is intended to be prescribed to individuals with mild symptoms of Alzheimer’s disease, either those who are still functioning independently or only need slight assistance. The group that responded the best to it in the trials were those with the mildest symptoms. It is not indicated for people with more advanced stages of Alzheimer’s disease.
- Side effects are similar to other Alzheimer’s drugs: Side effects of Kisunla may include flu-like symptoms, nausea, vomiting, headache, and changes in blood pressure. The most serious potential side effect of Kisunla is rare brain swelling or bleeding which can be life threatening. Some patients may also experience serious allergic reactions during or shortly after the drug’s infusion.
- Kisunla is given less frequently and for a shorter duration than Lequembi: Both drugs are given by outpatient infusion, but the Kisunla infusion is only once a month, whereas the Lequembi infusion is given twice a month. In addition, the recommended treatment course of Lequembi is 18 months, but the newly-approved Kisunla is given only up to the point when the amyloid plaque is removed and then is stopped, even if this occurs at six or 12 months. Given that it is only given once a month and is stopped once plaque is removed, both the financial cost and burden of infusions are likely to be less with Kisunla than Lequembi.
- Kisunla might help slow the progression of Alzheimer’s disease, but it’s not a cure. The Phase 3 trial found the drug did not stop cognitive decline, but appeared to slow the progress of the disease in the early stages, and lowered the risk of progressing to the next stage of Alzheimer’s. Over the course of a year, one in six patients who received the drug progressed to the next stage of the disease compared to one in four in the placebo group.
- ApoE4 carriers should be aware of higher risks of side effects when taking “mab” drugs, such as lecanemab and donanemab. The Alzheimer’s risk gene variant ApoE4 did not affect how well the drug worked. But it did seem to influence a person’s vulnerability to side effects.
- Medicare and Medicaid will cover Kisunla: CMS has already announced that both Medicare and Medicaid will cover the cost of Kisunla, as they already do with Lequembi. However, depending on your insurance plan, both of these medications can be very pricey. Assuming you have Medicare, after meeting your Part B deductible, you’ll be responsible for 20% of the cost, but if you have a Medicare supplement policy, it should pick up some or all of this cost. For a 12-month supply, Eli Lilly’s list price for Kisunla is $32,000; Biogen’s list price for Lequembi is $26,500. According to CMS, in order for you to receive Medicare coverage for either of these drugs, you “will need to: 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain, and 3) have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians participating in the registry will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.”
- Kisunla requires one additional MRI prior to the second infusion: While Lequembi requires four brain MRI scans before infusions, Kisunla demands five. The requirement for the extra MRI scan was expected after Lilly showed that an MRI prior to the second infusion led to a 25% reduction in serious side effects.
- Deaths have occurred with all three Alzheimer’s drugs: Four patients died while taking Aduhelm (aducanumab) which, as mentioned, was the first “mab” drug approved by the FDA, but then later taken off the market by its manufacturer) due to problems that may have been treatment related. Three people died during the lecanemab (Lequembi) trials and three people died during the donenamab (Kisunla) trial, all potentially as a result of treatment-related effects.
Some Scientists are Skeptical About these Alzheimer’s Treatments, Yet Others See Them as Hopeful
Some scientists and clinicians are skeptical about these drugs in terms of their ability to make much of an impact in the disease progression of Alzheimer’s. They are cautious because they see only modest benefits amidst the potential for serious side effects which include death.
On the flip side, these drugs are the only currently available treatments for Alzheimer’s, meaning they offer some hope and benefit for many. According to Joanne Pike, DrPH, Alzheimer’s Association President and CEO, “(h)aving multiple treatment options is the kind of advancement we’ve all been waiting for – all of us who have been touched, even blindsided, by this difficult and devastating disease.” In their press release, the Alzheimer’s Association adds that “(b)ecause multiple FDA-approved Alzheimer’s treatments are now available, early detection and diagnosis are even more critical to ensure individuals receive the most benefit.”
Planning for a Loved One with Alzheimer’s
An estimated 6.7 million people in the U.S. age 65 and older were living with Alzheimer’s last year, according to the Alzheimer’s Association. The number is projected to increase to 13.8 million by 2060.
If you have a loved one who suffers from Alzheimer’s or another form of dementia, it’s important to plan in advance. Those with Alzheimer’s and their families face special legal and financial challenges. At the Farr Law Firm, we are dedicated to easing the financial and emotional burden on families who have a loved one suffering from dementia or other degenerative diseases.
If you or a family member are facing a diagnosis of Alzheimer’s or another form of dementia, please call us to make an appointment to discuss life care planning and asset protection in connection with obtaining Medicaid:
Alzheimer’s Planning Northern Virginia: 703-691-1888
Medicaid Planning Fredericksburg, VA: 540-479-1435
Elder Law Rockville, MD: 301-519-8041
Elder Care Washington, DC: 202-587-2797
About Evan H Farr, CELA, CAP
