It's the first drug proven to slow the progression of Alzheimer's disease, if only modestly, but Arkansas' largest health insurance company doesn't plan to cover Leqembi.
Neither do the health plans covering state and public school employees.
In a letter to state Rep. Julie Mayberry, R-Hensley, who is a co-chair of the state Alzheimer's Disease and Dementia Advisory Council, representatives of Arkansas Blue Cross and Blue Shield said the insurer's medical policy committee found insufficient evidence that the drug is effective, and had concerns about its risks.
The letter also alluded to the IV drug's cost -- $26,500 a year, plus tens of thousands more to have it administered in a clinic.
"We are hopeful that truly effective and safe drugs will be developed in the near future," Max Greenwood, vice president of government and media relations, and Dr. Mike Martin, corporate medical director for policy development, said in the letter.
Addressing the advisory council at its meeting on Sept. 26, Jill Johnson, a professor of pharmacy practice at the University of Arkansas for Medical Sciences and a consultant to the state and public school employee plans, also cited the drug's potential side effects and the cost, which she said outweigh the benefit.
"It has to do with how a patient feels, so although statistically Leqembi slowed the progression of Alzheimer's, it wasn't to the degree that patients could feel," Johnson said.
More than 99,000 public school employees, retirees and dependents and 55,000 state employees, retirees and dependents were covered under the plans as of Aug. 1.
Leqembi, from Biogen and Japanese drug maker Eisai, in July became the first drug aimed at slowing the progression of Alzheimer's to win full, traditional approval by the U.S. Food and Drug Administration, which in January had granted accelerated approval to the drug.
Citing the FDA's action, Medicare, which covers most Americans age 65 and older, announced July 6, the same day of the FDA's announcement, that it would broaden its coverage of the drug.
The U.S. Veterans Health Administration will also cover Leqembi, as will Arkansas' Medicaid program and Centene.
United Healthcare's standard commercial plans will add coverage of the drug for "members who meet clinical criteria" starting Wednesday, company spokeswoman Trasee Carr said in an email.
In their letter to the Alzheimer's advisory group, Arkansas Blue Cross representatives said the company's medical policy committee found Leqembi and an earlier drug, Aduhelm, also from Biogen and Eisai, "had minimal to no evidence of clinical effectiveness in slowing progression while also having substantial toxicity in people with early mild Alzheimer's dementia, the population most in need of benefit."
It also described Aduhelm, which was granted accelerated approval by the FDA in 2021, as having "a checkered history of FDA-approval resulting in a Congressional investigation of the approval process."
The insurer covers 577,283 Arkansans in fully insured individual and group plans and administers the claims for employer plans covering an additional 1,270,186 people in the state, Greenwood said.
She said in an interview that employers that pay for their employees' health care expenses, with Blue Cross administering the claims, can still choose to cover Leqembi, although she didn't know of any that were planning to do so.
David Cook, director of public policy at the Arkansas chapter of the Alzheimer's Association, said his association is urging insurers to consider covering the drug.
"When someone argues with the clinical data that we've seen, most of it has to do with the price of the drug, but when you have first-generation drugs, you're always going to have high costs," Cook said.
The FDA endorsed Leqembi, which targets a brain plaque associated with Alzheimer's, for patients with mild cognitive impairment or mild dementia.
Eisai said a trial involving about 1,800 patients showed those who took Leqembi had 27% less cognitive impairment over 18 months compared to those who were given a placebo.
Eisai also reported that 17% of patients taking Leqembi experienced swelling in the brain, and 13% had brain bleeds. The FDA's prescribing information contains a warning about those possible side effects.
Beyond a lack of insurance coverage, Cook said being diagnosed with Alzheimer's in time to start treatment may pose a challenge for patients.
"Most gerontologists that we talk to have long waiting lists, and it is possible that within these weeks or months of waiting, patients' symptoms can age out of being qualified for the drug," Cook said.
Dr. Jeanne Wei, chair of the geriatrics department at UAMS and executive director of its Reynolds Institute on Aging, said early diagnosis is likely to become more of a priority.
"[When] there was not a reason to try to identify someone early, nobody really extended much effort, but now that we know that early detection can make such a difference, I think everyone will be more motivated to catch it early," Wei said.
She said she hopes to be able to offer Leqembi to patients within the next few months.
"This has been a breakthrough after 20 years of nothing, so even though it's not the best, it's basically the first, and probably more will come because of it," she said.
An Air Force veteran, Mark Aloway, 70, of Little Rock could receive Leqembi through the Veterans Health Administration, but said he doesn't plan to. He cited the regimen that requires a patient to receive infusions every two weeks as long as symptoms are mild.
"It would be a detriment to me and my wife to have to plan our lives around my infusions," he said. "That's not a quality of life."
He was diagnosed with mild cognitive impairment and early stages of dementia three years ago. At that time, there was no treatment for the disease, and he and his wife began sorting out their wills and other affairs before he was unable to make those decisions.
"There'll be some people that say, I'm ready to get [Leqembi] right now because of the thought that it might prolong them just a little bit longer, but there are also going to be people who will be afraid of what it could do and can't even afford it," Aloway said.
Ly is a Report for America Corps member.