Understanding the New Alzheimer's Treatments
For decades, families facing an Alzheimer's diagnosis had few options. Today, two new drugs have changed the conversation. These medications target the underlying cause of the disease rather than just managing symptoms. They are designed to remove amyloid plaques from the brain, which are a hallmark of Alzheimer's disease.
The first drug, called lecanemab (brand name Leqembi), received full FDA approval in 2023. The second, donanemab (brand name Kisunra), received full FDA approval in 2024. While these are not cures, clinical trials show they can slow cognitive decline in the early stages of the disease.
However, access to these treatments involves navigating a complex system of insurance, testing, and monitoring. Understanding the rules is the first step toward getting the care you need.
What Do These Drugs Actually Do?
How They Work
Both Leqembi and Kisunra are monoclonal antibodies. Think of them as specialized proteins that travel through the bloodstream to the brain. Once there, they attach to amyloid beta proteins. These proteins clump together to form plaques that damage brain cells.
By removing these plaques, the drugs aim to stop the damage from getting worse. Clinical trials showed patients taking these drugs declined slower on memory tests compared to those taking a placebo. The slowing effect is modest, but it can mean months or even years of added independence for patients.
Who Are They For?
These drugs are not for everyone. They are approved only for early-stage Alzheimer's. This includes:
- Mild Cognitive Impairment (MCI): People who have memory issues but can still live independently.
- Mild Dementia: People who have noticeable memory loss but can still manage daily tasks like eating or dressing.
If a person has moderate or severe Alzheimer's, these drugs are not currently approved for use. The goal is to intervene early before too much brain damage occurs.
Medicare Coverage Rules
In the United States, most people over age 65 rely on Medicare for health insurance. The Centers for Medicare and Medicaid Services (CMS) sets the rules for what they cover.
Current Status for Leqembi
Medicare has agreed to cover Leqembi for all beneficiaries. This means you do not need to be in a special clinical trial to get it. However, there are strict conditions you must meet.
To get coverage, your doctor must document that you have early Alzheimer's. They must also confirm you have amyloid plaques in your brain. This usually requires a PET scan or a spinal fluid test. Medicare will not pay for the drug without this proof.
Current Status for Kisunra
Donanemab (Kisunra) is newer. Medicare is rolling out coverage for this drug as of late 2024. Coverage is expanding to include all Medicare beneficiaries who meet the eligibility criteria.
Just like Leqembi, you must prove you have amyloid plaques before starting treatment. Medicare will cover the drug itself, but you may still pay for the testing and the infusion visits.
Eligibility Requirements and Testing
Getting approved for these treatments is not automatic. You must prove you fit the specific criteria set by the FDA and your insurance provider.
Step 1: Confirming the Diagnosis
Your doctor must confirm you have early Alzheimer's disease. This involves a medical history review and cognitive testing. Standard memory tests are not enough on their own. You need a clinical evaluation to rule out other causes of memory loss, like vitamin deficiencies or thyroid issues.
Step 2: Biomarker Testing
This is the most critical step. You must prove there are amyloid plaques in your brain. There are three ways to do this:
- Amyloid PET Scan: A nuclear medicine test where a radioactive tracer is injected. It shows plaques on a brain image.
- Spinal Fluid Test: A lumbar puncture is performed to collect fluid from the spine. This is very accurate but invasive.
- Blood Test: New blood tests are becoming available. They measure specific proteins in the blood that indicate plaques. Medicare is beginning to accept these for coverage.
Without one of these tests, insurance will likely deny coverage. Ask your neurologist which test is covered by your specific plan.
Step 3: MRI Safety Check
Before starting treatment, you need a baseline MRI. This checks for any existing brain bleeding or swelling. It also creates a reference point for future scans.
During treatment, you will need regular MRIs to monitor for side effects. If you have a metal implant, like a pacemaker, you must tell your doctor immediately. Some implants are not safe for MRI scans.
Costs and Out-of-Pocket Expenses
Even with insurance coverage, these treatments come with significant costs. Understanding the breakdown helps you plan your budget.
Drug Cost
The list price for Leqembi is approximately $26,500 per year. Kisunra is priced similarly, around $32,000 per year. However, most patients do not pay this full amount.
Under Medicare Part B, the drug is usually covered at 80% of the approved amount after you meet your deductible. This means you pay 20% coinsurance. If you have a supplemental Medigap plan, it may cover that 20% for you.
Infusion and Monitoring Fees
You cannot take these drugs at home. They are given through an IV in a clinic or hospital. You must visit the clinic once every four weeks.
Each visit has a facility fee. This covers the nurse, the equipment, and the monitoring time. Medicare Part B typically covers 80% of these fees. The remaining 20% can add up over a year.
Additionally, you must pay for the MRIs. These are often covered under Part B, but you may have a copay depending on your plan. Expect to spend several hundred dollars per year on monitoring scans.
Total Annual Estimate
For a patient with standard Medicare Part B and no supplemental insurance, the out-of-pocket cost could range from $5,000 to $8,000 per year. This includes the drug coinsurance and the infusion fees.
If you have a high-deductible health plan, you might pay more until you meet your deductible. Always check with your insurance provider before starting treatment.
Safety and Side Effects
These drugs are powerful, and they come with risks. The most common side effect is called ARIA.
What is ARIA?
ARIA stands for Amyloid-Related Imaging Abnormalities. It involves swelling or small bleeding in the brain. It happens in about 10% to 30% of patients.
Most cases have no symptoms. You might not know you have it until an MRI shows it. However, some people experience headaches, confusion, or vision changes. If this happens, your doctor will stop the drug temporarily.
Who Should Avoid These Drugs?
Not everyone is a candidate. You generally cannot take these drugs if you:
- Have had a brain bleed before.
- Have brain swelling from other causes.
- Are taking blood thinners like warfarin.
Your doctor will review your medical history carefully. They will also check your MRI results before every dose to ensure it is safe to continue.
Next Steps for Patients
If you or a loved one are considering these treatments, start the conversation early. Alzheimer's progresses over time, and early intervention offers the best chance for benefit.
First, schedule an appointment with a neurologist or a memory specialist. Ask specifically about amyloid testing and eligibility for new treatments. Bring a list of all medications you take to the appointment.
Second, contact your insurance provider. Ask about the specific billing codes for Leqembi or Kisunra. Confirm what testing is covered under your plan. Knowing the rules before you start saves stress later.
Finally, prepare for the commitment. Treatment requires regular visits and monitoring. It is a long-term plan that requires dedication from the patient and their care team.
Conclusion
The arrival of Leqembi and Kisunra marks a major shift in Alzheimer's care. While they are not cures, they offer a way to slow the disease in its early stages. Medicare now covers these options for eligible patients, making them more accessible than ever.
Success depends on following the rules. You need proof of amyloid plaques, regular monitoring, and careful attention to side effects. By understanding the costs and requirements upfront, you can make informed decisions about your health care.
Stay informed and work closely with your medical team. The landscape of Alzheimer's treatment is evolving, and new options may appear in the future.