Medicare, FDA urged to press ahead with new Alzheimer’s drug Leqembi

Patients, lawmakers and Alzheimer’s advocates are pushing for Medicare to fully cover a new drug for treating early stage Alzheimer’s.

The Food and Drug Administration (FDA) granted accelerated approval to Eisai’s Alzheimer’s drug Leqembi in January. The drug has been shown to moderately slow the progression of the disease in its early stages. 

However, the Centers for Medicare and Medicaid Services (CMS) will cover the medication only for patients participating in data-gathering registries. CMS has said it will provide broader coverage once the drug receives traditional FDA approval. The FDA is scheduled to make a decision on full approval July 6.

At The Hill’s “Expanding Access to Alzheimer’s Care & Treatment” event on Thursday, Alzheimer’s advocates called for CMS to fully cover Leqembi.

The $26,500 price tag on the drug “is a lot of money for any individual family to bear,” said Ian Kremer, executive director of the Leaders Engaged on Alzheimer’s Disease Coalition. “And that’s why Medicare exists, so that individual families do not face this threat.”

He pointed out that the Veterans Health Administration has decided to cover Leqembi.

“The medical evidence, the scientific evidence is identical,” he said. “But VA actually looked at the evidence and judged it to be appropriate.”

This comes after a similar drug, Aduhelm, received accelerated FDA approval in 2021 despite conflicting evidence of its effectiveness. That generated significant controversy, and several members of an FDA advisory panel resigned in protest. CMS decided to restrict coverage of all treatments of this type and maintained its decision even after Leqembi was approved.

Rep. Nanette Díaz Barragán (D-Calif.) said CMS should consider each drug individually. She’s sponsoring a bill, the Access to Innovative Treatments Act, to prohibit CMS from limiting coverage of entire classes of drugs.

The issues that Alzheimer’s patients face hit close to home for many, including Barragán, whose mother has the disease.

“My mom’s 82, she has Alzheimer’s and she’s in a later stage. So, for her, it’s been a real challenge,” Barragán said. The congresswoman said finding caregivers who speak Spanish like her mother is chief among the challenges she faces. 

She noted that earlier treatment could have made a difference for her mother, a sentiment her fellow lawmakers share.

Rep. Anna Eshoo (D-Calif.), ranking member on the health subcommittee for the House Energy and Commerce Committee, expressed frustration with the lack of progress on the registries CMS plans to establish, stressing that “time is of the essence” when it comes to Alzheimer’s patients.

Recalling her recent questioning of CMS Administrator Chiquita Brooks-Lasure’s plans for the registry, Eshoo said, “I mean, it is some long, winding, complicated road and when I questioned her, ‘What have you done to establish this registry? Do doctors in the country … have they been advised of this? What’s been set up?’ Nothing,” Eshoo said.

Patients also pushed for Medicare to cover Leqembi at The Hill’s event, which was sponsored by Eli Lilly and moderated by Editor-in-Chief Bob Cusack, national political reporter Julia Manchester and race and politics reporter Cheyanne Daniels. 

“My neurologist said that I am a perfect candidate for this drug, and the longer it takes for them to provide coverage, I could get out of that window to get the appropriate treatment that I need,” Alzheimer’s patient Jay Reinstein said. 

“So there’s a sense of desperation really for me and for others out there that desperately need these treatments.”

Reinstein said he hopes the FDA fully approves the drug in July, so Medicare will cover it.

“I just want more quality time with my family,” he said. “And that’s all I’m asking for.”