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The drug Leqembi was approved by the FDA earlier this year. Maskot/Getty Images
  • Several insurers offering individual or employer-based plans will not cover the cost of Leqembi, a treatment for Alzheimer’s disease.
  • Medicare, the Veteran’s Administration, and some larger insurers will cover the drug.
  • The majority of people who will benefit from the drug will be over age 65 and eligible for Medicare.

Some insurance companies have chosen not to cover the cost of Leqembi, a drug fully approved by the U.S. Food and Drug Administration to slow cognitive decline in people with early stages of Alzheimer’s disease.

Several insurers offering individual or employer-based plans in New York, North Carolina and Pennsylvania won’t pay for the $26,500-a-year drug because they see it as experimental, reported the Associated Press.

This is in contrast to Medicare, which announced last month that it will offer coverage of Leqembi for enrollees with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with documented evidence of beta-amyloid plaques in the brain. Patients also have to have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care.

Medicare is mainly for people ages 65 and older, but some people — such as those with a disability or end-stage kidney disease — may be able to get coverage earlier.

“The decision by a handful of local/regional insurers not to cover Leqembi — which runs contrary to the coverage decisions of Medicare and some of the nation’s largest insurers — is an inappropriate and unnecessary obstacle to [patient and family] empowerment and access to treatment,” Kristen Clifford, chief program officer at the Alzheimer’s Association, told Healthline.

Leqembi is the first drug shown to slow the cognitive decline that occurs in Alzheimer’s disease, although only with modest benefits. It works by reducing plaques in the brain formed by clumping of the beta-amyloid protein.

The Food and Drug Administration approved the IV drug after reviewing data from a large clinical trial in which the drug slowed cognitive decline by about 27%, compared to those who received an inactive placebo.

The majority of people who develop Alzheimer’s disease are age 65 or older, according to the Alzheimer’s Association.

An estimated 76% of people who take Leqembi will be covered by Medicare, according to Japanese drugmaker Eisai, which developed the drug and is co-marketing it with Massachusetts-based Biogen Inc., as reported by the AP.

Some people, though, can develop early-onset Alzheimer’s in their 40s or 50s — or even as young as their 30s, although that is rare. These people are more likely to have commercial health insurance, either through their employer or the individual market.

Dr. Greg Jicha, a neurologist and director of clinical trials at University of Kentucky’s Sanders-Brown Center on Aging in Lexington, said younger people are likely to be hardest hit by insurers deciding not to pay for Leqembi.

“I have many [Alzheimer’s] patients in their 50s and 60s that simply do not have the resources outside of their insurance to gain access to this type of medicine,” he told Healthline.

The cost of treatment with Leqembi extends beyond the price of the drug, to include screening for eligibility, genetic testing for Alzheimer’s risk, and follow-up tests to monitor for potential side effects.

With all of this included, the total cost of being treated with Leqembi could run to $80,000 or $90,000 per year, Julie Zissimopoulos, PhD, professor and co-director of the Aging and Cognition Program at the USC Schaeffer Center for Health Policy & Economics in Los Angeles, told Healthline.

The high overall cost could make it more difficult for people without insurance coverage to get treated early.

“If we can delay their disease progression, it makes sense societally,” said Jicha, “rather than allow a disease like this to progress unchecked to the point of disability.”

In addition, if younger people have to wait until they are 65 and eligible for Medicare, their symptoms could be severe enough that they are no longer eligible for the drug.

Leqembi is authorized by the FDA for people with mild cognitive impairment or Alzheimer’s disease. There is no clinical data to show that it works in those with more advanced dementia.

Jicha pointed out that in June, an FDA advisory committee voted unanimously to confirm the clinical benefits of Leqembi, showing that the benefits outweigh the risks, which include brain bleeding and swelling.

“I don’t really see how insurance companies can, ethically, make arguments that this medication is still experimental and should not be covered,” he said, “especially with full FDA approval and Medicare standing behind this drug.”

Insurers generally pay for treatments that have full FDA approval, especially when it is covered by the Centers for Medicare & Medicaid Services. But that is not a given.

“CMS decisions generally have a big impact across the insurance market, both private as well as in other systems like the Veteran’s Administration,” Zissimopoulos said.

However, sometimes insurers will choose to not follow the lead of CMS, she added, “usually for high-priced drugs, which Leqembi is.”

In March, the VA ruled to cover Leqembi for U.S. veterans with early stages of Alzheimer’s disease — a decision that, in this case, occurred before Medicare agreed in July to cover the drug.

Zissimopoulos pointed out that some larger insurers have, in fact, agreed to cover Leqembi, while many others have not yet made a decision.

The AP reports that the following insurers have declined to cover the drug: Highmark, which provides Blue Cross and Blue Shield coverage in New York, Pennsylvania, Delaware, and West Virginia; Blue Cross and Blue Shield of North Carolina; and Philadelphia-based Independence Blue Cross.

The AP reported that Independence Blue Cross declined to cover the drug after reviewing medical studies and available FDA materials.

“That re-evaluation made it clear to us that the existing evidence does not allow for conclusions to be drawn about the safety and effectiveness of Leqembi,” Dr. Heidi Syropoulos, a medical director with the insurer told the AP.

In a statement sent to Healthline officials from Blue Cross and Blue Shield of North Carolina said they will continue to review data.

“A clinical team, including practicing physicians and pharmacists independent and employed by Blue Cross NC, reviewed the data and currently considers Leqembi as investigational and not covered for commercial health plans. For Medicare Advantage plan members, Blue Cross NC follows the Centers for Medicare & Medicaid Services (CMS) rules for coverage. As new data becomes available, we will review and update coverage accordingly.”

Healthline reached out for further comment from the insurance companies but they have not immediately responded.

Insurers that will cover the drug for commercial plans, according to the AP, include Kaiser Permanente, and Elevance Health, which is the largest provider of Blue Cross-Blue Shield plans in the United States.

In a statement from Kaiser Permanente to Healthline, officials clarified they will treat Leqembi similarly to other prescription medications.

“As we do with all FDA-approved pharmaceuticals, we will cover this drug [Leqembi] when it is determined to be medically necessary by the member’s treating physician. For Medicare patients, we will follow all CMS coverage requirements,” Kaiser Permanente said in an emailed statement.

Elevance Health officials also said they will provide coverage for people who meet medical treatment criteria.

“Elevance Health covers Leqembi for our members who meet treatment criteria. Our criteria are aligned with clinical evidence to help ensure appropriate use,” Elevance Health officials said in an emailed statement.

Clifford said the Alzheimer’s Association continues to engage with and educate payors about Leqembi.

“It’s now time for all payers to ensure burden-free access to all individuals who are eligible for treatment,” she said.

As insurers are still deciding on whether to cover Leqembi, Zissimopoulos pointed out that there is still no wide-scale screening program for people under age 65, which could impact demand for the drug.

“How many people with early-stage disease at younger ages would even know that they were eligible?” she said.

In addition, she said there are also equity issues at play.

“Some populations, such as Black [people], are at higher risk of Alzheimer’s disease,” said Zissimopoulos. “Also, some studies have shown they may be more likely to develop the disease at earlier ages.”

Some groups of people may be disproportionately affected by a lack of insurance coverage of Leqembi for younger people.

Some insurers offering individual or employer-based plans will not cover the cost of Leqembi, a drug used to treat early forms of Alzheimer’s disease.

Many people with this disease are over age 65 and eligible for Medicare, which will cover the drug.

Younger people with mild cognitive impairment or early dementia may be impacted more by lack of insurance coverage.