The FDA recently granted accelerated approval for a new drug called Leqembi to help slow cognitive decline in the early stage of Alzheimer’s disease.
The treatment isn’t covered by Medicare or Medicaid right now, and it comes with a huge price tag that puts it out of reach for most patients.
Alzheimer’s is a debilitating brain disease that causes memory loss and dementia. The disease affects more than 6 million people in the United States and most, but not all, are over the age of 65. Right now, there’s no cure. So when a new treatment that might slow disease progression becomes available, it raises hope for patients and their families.
Lindsey Leonard is the executive director of the Central Coast Chapter of the Alzheimer’s Association. She said the FDA approved drug lecanamab, marketed as Leqembi, is a step forward in the treatment of Alzheimer’s disease.
“It works to remove the proteins in the brain that are thought to cause this disease. In clinical trials lecanamab was proven to slow the rate of cognitive decline by 27%,” she said.
Leonard said there seems to be a window of time when the treatment works, so early detection of the disease as well as early access to the medication is key. But the cost for treatment is prohibitive for most patients, especially because Medicare and Medicaid won’t cover it.
“Currently, the out-of-pocket expense is $26,500 per year,” Leonard said.
A similar drug, Aduhelm, is also FDA approved, expensive, and not covered. The Alzheimer’s Association has filed a formal request with the Centers for Medicare and Medicaid Services urging them to change their position.
Pharmacy director Maurina Bartlett is with Central Coast Community Health Centers. CHC sees patients of all ages in Santa Barbara and San Luis Obispo counties, many of whom are covered by Medicare and Medicaid.
She said FDA accelerated approval is given to drugs that are likely to make a significant difference for patients.
“They are so promising to the general public that they don’t want to hinder it and wait for it to go through all of the clinical testings because it takes so much time,” Bartlett said.
However, she said FDA approval does not automatically lead to Medicare coverage.
“Just because a drug is approved by the FDA doesn’t mean that any of the insurance companies are going to pay for it,” she said.
The number one risk factor for Alzheimer’s disease is being over the age of 65, yet in some cases, patients are much younger.
Tony Gonzales from Santa Maria is only 48 years old. He said no one, not even the doctors, expected someone so young to have early stage dementia, and it took two years for a diagnosis.
“Unfortunately, everyone sees Alzheimer’s dementia in only over-65. They immediately picture in their mind an elderly person,” Gonzales said.
Over the years, Gonzales worked in broadcasting and real estate – jobs that require quick thinking and the ability to multitask. He said he began to notice subtle changes, like forgetting a story or struggling to do basic math, then he got lost driving home.
“It used to be that I went to work. I mowed the lawn. I don't do those things anymore, my son comes and helps me, my daughter comes and helps me,” he said.
Gonzales recently became a national spokesperson for the Alzheimer’s Association. He said he wants to share his story and focus attention on the need for more research and resources.
His wife Kori drives him where he needs to go. She said the dementia diagnosis came as a shock to both of them.
“I had seen gaps as far as his memory, I just really thought it was exhaustion or stress,” she said.
Kori said she went through periods of disbelief and sadness, then she studied up on the disease.
“What I really delved into was, ‘okay what can I control?’ Diet, exercise, brain exercises. I just kind of took a hold of that, and I changed a lot of things for him,” she said.
In addition to lifestyle changes and daily brain exercises, Tony participates in a support group through the Alzheimer’s Association. He described feeling anxious and shaky, especially in the late afternoons and said, at those times, he relies on Kori’s reassurances and a long nap.
Gonzales said the clinical trials for Leqembi are encouraging and he might even be a candidate for the drug. But whether or not he benefits directly, he said getting treatment shouldn’t depend on your ability to pay out of pocket.
More information is available at the Alzheimer’s Association's website.
