Often when new medications are authorized in the U.S., they arrive at pharmacies within days or weeks of Food and Drug Administration (FDA) approval and are just a doctor’s prescription away from patients getting and using them.

That’s not the case with Leqembi, the first drug in 20 years to treat Alzheimer’s Diseaseto receive full FDA approvalafter getting provisional approval earlier this year.

Not everyone on the drug will perceive the benefits, according toMary Sano, PhD,director of Alzheimer’s Disease Research Center at the Icahn School of Medicine at Mount Sinai.

Here’s why it won’t be accessible—or appropriate—for everyone with mild Alzheimer’s.

What To Know About Leqembi, the New Alzheimer’s Disease Treatment

Cost of the Drug

Leqembi is administered every two weeks as an infusion, which means that patients will have to go to a clinic, doctor’s office, or hospital to get the drug. (There are currently trials testing whether patients might be able to take the drug as an injection at home.) That means that in addition to the$26,500 per year costof Leqembi, patients may need to front the costs of travel expenses and infusion administration costs.

The day Leqembi received full approval,Medicare announcedit would cover the drug under its Part B coverage for outpatient drugs. Patients with only traditional Medicare plans face a 20% copay, which would amount to over $5,200 per year for Lequmbi.

People who take the drug and have additional insurance to cover Medicare copays, such as a Medicare Advantage or Medigap plan or have Medicaid in addition to Medicare, could see some to all of their copay covered. And Eisai has launcheda patient assistance planthat may help people who don’t have insurance or can’t afford copays afford the drug.

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Private insurers are also expected to cover Leqembi for eligible patients. A copay will still be necessary in many cases.

Costly Pre-approval Tests

Nicole Purcell, DO, a neurologist and Senior Director of Clinical Practice at the Alzheimer’s Association, says since the specific blood tests are not yet FDA-approved, Medicare does not cover them, though people can pay for the test out of pocket. According to theBright Focus Foundation, which funds Alzheimer’s research, the cost for the test can range from $500 to $1,200.

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Medicare only covers one PET scan per patient lifetime, which could make getting a beta amyloid PET scan difficult. But on July 17, the agency issued a proposal to expand its coverage, leaving the reimbursement decision up to the providers it contracts with. The public has 30 days from the date of the proposal to comment, and then Medicare will make a final decision.

Side Effects

The most significant side effects reported during the Leqembi trial were brain bleeding and brain swelling. Both did get better in many patients, and some were able to safely go back on the drug, but two trial participants died of brain bleeding.

The FDA recommends that patients have a genetic test—a blood test—to see if they are at increased risk for brain bleeding. Purcell says doctors will be likely to recommend that patients also have an MRI as part of their evaluation about whether Leqembi is right for them, in addition to MRIs once on the drug in order to check for brain bleeding.

According to the Medicare spokesperson, the genetic test and MRIs are “coverable,” but patients without supplemental insurance can expect to have copays of at least hundreds of dollars.

Potential Contraindications

Taking blood thinners such as Warfarin or Xarelto puts patients at higher risk of brain bleeding. The FDA hasn’t disqualified people on those drugs from taking Leqembi, but it does note the concern.

People with a pacemaker may not be good candidates for the Leqembi, since they may not be able to have an MRI to check for brain bleeding.

What This Means for You

Even if you were ready to start Leqembi tomorrow, it could take some time to even begin the prep work needed to assess you for the drug.

Sano said that hospitals that were part of the Leqembi clinical trial may start giving patients the drug sooner because they have experience with the eligibility tests, infusion, and tools to monitor brain bleeding. Other clinics may take time to ramp up.

While neurologists are the physicians who most frequently treat Alzheimer’s disease, there is an average wait time of 12 months for a first appointment with a neurologist, said Jim Taylor, founder and director of advocacy groupVoices for Alzheimer’s.

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Purcell said that if you are trying to see a neurologist about Leqembi and are given an appointment date months away, ask to be put on an appointment waiting list. Then, you should call every few days to see if there has been a canceled appointment you can take.

If you’re not eligible for Leqembi, Taylor recommends checking to see if an academic medical center near you runs Alzheimer’s clinical trials. Taylor’s wife joined a Leqembi clinical trial over seven years ago, and the couple believes it has slowed the disease’s progression.

1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Eisai.FDA grants traditional approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease.

1 Source

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Eisai.FDA grants traditional approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Eisai.FDA grants traditional approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease.

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