Nearly half a million American veterans have Alzheimer's. The VA has announced that they'll subsidize the cost of the newly FDA-approved anti-amyloid drug Leqembi for those who meet certain prerequisites.
Early this year, the Food and Drug Administration (FDA) granted accelerated approval to a new anti-amyloid treatment developed by Eisai and Biogen, Leqembi. In clinical trials, the drug lowered beta-amyloid plaques leading to small cognitive improvements. Because it’s unclear from the data whether these changes are meaningful for patients, the Centers for Medicare & Medicaid Services (CMS) limited coverage of the pricey drug to clinical trial participants only, while independent insurers outside of Medicare and Medicaid have differing coverage policies. For those with private insurance, they will need to check with their insurance company case by case. It isn’t clear whether other private insurers will cover the costs.
The potential lack of insurance coverage makes Leqembi difficult to get, and as one of only two drugs on the market that is designed to fundamentally address the root causes of Alzheimer’s disease, ideally slowing or stopping its progress, there is unmet demand. Veterans of the United States Military, Navy or Air Force may have a new option: On March 13, Eisai announced the Department of Veterans Affairs will cover the drug. Veterans over the age of 65 with mild cognitive impairment or early Alzheimer’s who meet certain requirements will be eligible for this coverage.
Around 16.5 million Americans are veterans — about 6.4 percent of the U.S.’s adult population — according to 2021 Census data. Well over half of that number are over the age of 65, putting them at an increased risk of developing Alzheimer’s disease.
According to the Alzheimer’s Association, an estimated 451,000 veterans were living with Alzheimer’s and over 130,000 new cases were diagnosed in 2022. According to the VA, close to 170,000 of these veterans were enrolled for healthcare through the VA in 2022.
“For a patient to receive the medication, it must be specifically requested by a clinician, receive approval through the local non-formulary process, and the patient’s case must meet strict criteria,” Terrence Hayes, press secretary at the department told Being Patient over email. “Each dose of the medication administered for each patient will be tracked and monitored for safety and appropriateness of use, in real time, by VA’s Center for Medication Safety.”
Patient advocacy organizations like Voices of Alzheimer’s and the Alzheimer’s Association lauded the VA’s recent decision to provide coverage.
“We are pleased to see the VA taking a leadership role in providing coverage for this important treatment,” said Jim Taylor, president and CEO of Voices of Alzheimer’s. “This decision will make a tremendous difference in the lives of people living with Alzheimer’s and their families.”
Vets may have a higher risk of Alzheimer’s
Age aside, veterans have other risk factors: Veterans are more likely to develop injuries and mental health conditions associated with a higher risk of Alzheimer’s. This includes:
Black, Hispanic, and Indigenous veterans are more likely to get Alzheimer’s than white veterans. Together, this suggests that veterans are more likely to develop Alzheimer’s than the general population. Being Patient did not find recent research studies which compared the rates of Alzheimer’s between veterans and non-veterans.
“For a patient to receive the medication,
it must be specifically requested by a clinician,
receive approval through the local non-formulary
process, and the patient’s case
must meet strict criteria.”
To help connect vets with the care they need, the first necessity is an accurate diagnosis. Unlike Medicare and Medicaid, the VA also provides coverage for PET amyloid scans — an important diagnostic test that can tell the difference between Alzheimer’s and similar dementias — and which can cost up to $7,000 out of pocket without help from insurance. This type of scan can be a crucial step toward getting an accurate diagnosis. However, they are not available at all VA clinics, due to the specialized equipment required.
Who is eligible for subsidized Lequmbi through the VA?
There are many restrictions for use of Leqembi through the VA.
First, veterans must be 65 or older. They must not have early-onset Alzheimer’s — a rarer form of the disease that occurs in younger individuals. They may need to undergo a urine drug screen to confirm they are not using any illegal drugs.
Further, the VA will not cover the drug for an individual who has any one of the following risk factors, some of which are associated with a higher risk of the drug’s adverse side effects, like brain bleeds.
The full list of disqualifiers includes:
- Medical, neurological, or mental health conditions that may be a contributing or primary cause of cognitive impairment. These conditions could include alcohol-related disorders, depression, or vascular dementia.
- Transient ischemic attack, stroke, or seizures within the past year
- Evidence of other clinically significant lesions on brain MRI that indicate another cause of dementia
- Two copies of the APOE4 gene
- Any immunological disease which is not controlled, or which requires treatment with biologic drugs
- Untreated bleeding disorders
- Low vitamin B12 levels
- A history of hospitalization or treatment for suicidal behavior in the past five years
- Current substance use disorder or positive urine drug screen
What it cost?
The VA provided Being Patient with a chart of the organization’s co-pay rates to help veterans understand the out-of-pocket cost they will incur. Meanwhile, some veterans may be exempt from co-pays altogether, according to the exemptions listed along with the co-pay rates.
For veterans with multiple conditions or medications, once a threshold between $996 and $1,337 (depending on dependents) is reached for the year, they are exempted from the copay, according to the VA.
According to the VA, veterans seeking more information about Leqembi and possible VA coverage can use this tool to get in touch with their local VA office, or call the VA’s health benefits hotline at 877-222-8387 any weekday between 8:00 AM and 8:00 PM ET.
UPDATE, 20 November 2023: As of a landmark policy change in October 2023, Medicare now also covers beta-amyloid PET scans for diagnosing Alzheimer’s disease.