Q. I remember reading about lecanemab, an Alzheimer’s treatment, in your newsletter earlier in the year. I have heard that there are other new treatments coming out to slow Alzheimer’s progression. Do you know what else is out there, and if it will be covered by Medicare? Thanks so much for your help!
A. Good news a second drug in under a year has been shown to slow Alzheimer’s! The company Eli Lilly has reported its drug — donanemab — slows the pace of Alzheimer’s by about a third. FDA Commissioner Dr. Robert Califf praised positive trial results. “We have to look at the data when it comes in before making a judgment, but if the data look as good as the press release — this is really, really exciting,” Califf said.
Donanemab works in the same way as lecanemab, which created headlines around the world earlier this year when it was proven to slow the disease. Both are antibodies similar to those the body makes to attack viruses. But these are engineered to clear a sticky gunk , called beta amyloid, which builds up in the spaces between brain cells, forming distinctive plaques that are one of the hallmarks of Alzheimer’s.
Having two drugs slow the disease by targeting amyloid in the brain has convinced scientists they are on the right track after decades of misery and failure. “This should dispel any lingering doubts about this approach,” said Professor John Hardy, from the UK Dementia Research Institute, whose work 30 years ago led to the idea of targeting amyloid.
Results of Donanemab Trial Are the “Most Encouraging Yet”
According to Time, the results from the Donanemeb trials are the most encouraging yet for any drug that targets amyloid. The full details of Eli Lilly’s trial have yet to be published — but the drug company has revealed the following key findings:
- 1,734 people in the earliest stages of Alzheimer’s took part in the trial.
- Donanemab was given as a monthly infusion until the distinctive plaques in the brain were gone.
- The pace of the disease was slowed by about 29 percent overall — and by 35 percent in a set of patients researchers thought more likely to respond.
- In addition, those getting the drug showed 40 percent less decline in the ability to perform daily activities such as driving, managing their finances, and holding conversations.
- In comparison, lecanemab, the treatment released in January 2023, slowed cognitive decline in patients with early Alzheimer’s disease by 27 percent.
- Those given the drug also retained more of their day-to-day lives such as being able to discuss current events, drive, or pursue hobbies.
- These drugs appear to work in only the earliest stages of the disease — before the brain is too damaged.
- Similar to lecanemab, brain swelling was a common side effect in up to a third of patients.
- It was mostly mild or asymptomatic despite being detected on brain scans.
- However, 1.6 percent developed dangerous brain swelling, with two deaths directly attributed to it and a third volunteer dying after such a case.
“We are encouraged by the potential clinical benefits that donanemab may provide, although like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening,” Dr Mark Mintun, Eli Lilly group vice-president of neuroscience research and development, said in response to the brain swelling.
Will Donanemab Get FDA Approval?
Eli Lilly said it would begin the process of attempting to have its drug approved for use in hospitals in the next few months. The FDA had rejected Lilly’s earlier request for expedited approval of donanemab in January. Here’s why: The agency asked the company for more data on patients who received the treatment for at least 12 months. Lilly said it did not have the data at the time because many patients were able to stop the treatment early due to donanemab clearing their brain plaque quickly.
The FDA has been a lot more cautious after their controversial expedited approval of Biogen and Eisai’s antibody treatment Aduhelm, in June 2021. The FDA cleared Aduhelm using the FDA’s “Accelerated Approval pathway” — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy. This Accelerated Approval was granted over the objections of an independent advisory committee that warned the evidence did not demonstrate a clear clinical benefit. An investigation by Congress found the FDA approval of Aduhelm was “rife with irregularities.” Three members of the FDA advisory committee resigned over the agency’s decision on Aduhelm.
Will Alzheimer’s Treatments Ever Be Covered by Medicare?
Members of Congress and state attorneys general are pushing for Medicare to provide full and unrestricted coverage of FDA-approved Alzheimer’s antibody treatments. However, the federal Centers for Medicare and Medicaid Services, or CMS, has said they will only cover Alzheimer’s antibody treatments when such drugs receive full FDA approval, not limited approval under the Accelerated Approval program.
Currently, Medicare is restricting access to lecanemab, based on a policy that will only cover Alzheimer’s antibody treatments that receive expedited FDA approval for patients participating in clinical trials, or after full approval, as mentioned. The drug companies manufacturing lecanemab said they hope they will receive the full FDA approval July 6.
Even if approved for coverage, CMS still plans to require patients to participate in registries that collect data on the medications. The Alzheimer’s Association has said such registries will continue to restrict access to treatments and has called on Medicare to drop those requirements.
According to a recent email sent by the Alzheimer’s Association, “CMS made the wrong decision to deny Medicare coverage for FDA-approved Alzheimer’s treatments. CMS has been under intense pressure from Alzheimer’s advocates, bipartisan members of Congress, the scientific community and state attorneys general. Yet despite this pressure and despite positive action by other federal agencies, leaders at CMS have refused to undo their appalling decision, always saying they need more information.” They also stated, “just this week we learned that clinical trial results for a drug called donanemab showed the strongest benefits of any Alzheimer’s treatment research to date. These results show the drug will significantly change the course of the disease for those in the early stages. Enough is enough. CMS has all the data they need to make the right decision, they’re simply refusing to make it.” They urge the public to sign their petition demanding action today.
Veterans to Get Coverage of Alzheimer’s Drug Medicare Won’t Cover
The Veterans Health Administration said Monday that it intends to pay for a $26,500-a-year experimental Alzheimer’s drug that CMS has declined to cover.
The VA will offer coverage to veterans living with early stages of Alzheimer’s disease who meet the agency’s criteria to take the medication, as well as conditions on lecanemab’s label. Read more about this here.
We will keep our readers up-to-date as more information becomes available about donanemab and other new Alzheimer’s treatments.
Planning for a Loved One with Alzheimer’s
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 for an initial consultation to discuss life care planning and asset protection in connection with obtaining Medicaid and Veterans special pension benefits:
Northern Virginia Medicaid Planning: 703-691-1888
Fredericksburg, VA Medicaid Planning: 540-479-1435
Rockville, MD Medicaid Planning: 301-519-8041
Annapolis, MD Medicaid Planning: 410-216-0703
Washington, DC Medicaid Planning: 202-587-2797
About Evan H Farr, CELA, CAP
