'It's devastating:' New Alzheimer's drug inaccessible for patients due to cost, lack of coverage

A drug that Alzheimer’s patients thought was going to be their next big hope has gotten much harder for them to access.

The out-of-pocket cost for treatment is about $28,000 per year. It’s very rare that federal insurance coverage is denied for an FDA-approved drug.

"It was devastating news for me," says Jay Reinstein, a patient who was diagnosed with early-onset Alzheimer's three years ago at the young age of 57. He left his job as an assistant city manager in Fayetteville.

He hoped Aduhelm {agu-helm} would be the answer to slowing down the progression of the disease.

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"I had high hopes. I've been very excited about it," he says.

In a preliminary decision, the Centers for Medicare and Medicaid, known as CMS, says it plans to deny coverage for the drug – saying research shows it has unclear benefits and safety risks. It would only be covered for use in clinical trials, which is something most patients don’t have access to.

"Their decision is not only detrimental, it's devastating to our lives," says Reinstein.

Katherine Lambert, Executive Director of the Alzheimer’s Association in North Carolina, says they are lobbying CMS to reverse its decision.

She says CMS' decision effectively denies coverage to many.

"That is really why the Alzheimer's Association is being so vocal," she says. "It's about ensuring that those that are living with this disease or those that may find themselves with a diagnosis in the future have access to what's been FDA-approved."

Aduhelm is not the only drug that falls under the decision. Several others in the same category are being studied, and they too could be denied coverage.

"The decision as currently drafted effectively impacts not just one drug, but everything in this class of drugs. And that's what we find really concerning," says Lambert.

Reinstein said his hope has turned into severe disappointment.

CMS is expected to make its final decision on coverage for this drug by mid-April.

Biogen, which manufactures Aduhelm, said in a statement that there is no evidence it adversely effects patients and that limiting coverage to clinical trials basically excludes anyone who might benefit from it.