New Alzheimer’s Treatment Would Cost $26,500 Per Year

Signage outside of the Food and Drug Administration headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

A new Alzheimer’s treatment would cost patients an estimated $26,500 per year, said the drug developer.

The Food and Drug Administration (FDA) announced on Jan. 6 that it would grant accelerated approval to Biogen and Eisai, after the drug appeared to partially slow the development of mild cases of Alzheimer’s disease in clinical trials.

The same day, Eisai submitted an application to the FDA for the drug’s full approval.

The federal agency’s accelerated approval program allows experimental drugs to be expedited to patients with serious illnesses who lack better options.

The high expense of the new treatment Leqembi and its limited coverage by Medicare will mean that few seniors with Alzheimer’s disease will have access to the drug, according to Eisai, the pharmaceutical firm which co-developed the drug with Biogen.

Eisai, which is based in Japan, said that although Leqembi would generally cost an estimated $26,500 per year, the exact price tag would vary by patient.

The Institute for Clinical and Economic Review separately found that the best cost-effective price for patients is between $8,500 to $20,600 per year, which was far lower than Eisai’s estimates, according to a preliminary report.

The FDA can give its full approval if test results confirm a clear clinical benefit, while the pharmaceutical companies continue with the clinical trials and could also remove the drug from the market if it fails to pass the test.

Alzheimer’s Patients Await Federal Approval to Make New Treatment Widely Available

Approximately 85 percent of patients who would benefit from Leqembi are insured by Medicare, Ivan Cheung, Eisai’s global Alzheimer’s disease officer, told The Wall Street Journal.

Most eligible seniors will have to pay for it out of pocket for now or wait, as Medicare coverage is restricted to patients participating in government-approved studies.

Cheung said that 100,000 patients are expected to be using the drug within three years, if federal officials happen to lift Medicare coverage restrictions.

The coverage limitations apply only to treatments using monoclonal antibodies that target a protein called amyloid, which can build up plaque in parts of the brain in Alzheimer’s patients.

The Centers for Medicare and Medicaid Services (CMS) restricted coverage for experimental Alzheimer’s drugs entering the market back in April 2022, in compliance with the FDA’s accelerated approval program.

FDA’s Fast-Tracked Alzheimer’s Drug Trials Cause Concern

CMS implemented the coverage restrictions in the aftermath of the FDA’s controversial early approval of Aduhelm in June 2021, which also happens to be developed by Biogen and Eisai, but the agency said it would consider expanding coverage based on further review.

A Congressional House investigation found the FDA approval process for Aduhelm to be inadequate and that it was approved and rushed, despite opposition from its independent review panel, reported CNBC.

The panel also found that the available study results for Aduhelm failed to demonstrate a clear clinical benefit.

Both Aduhelm and Leqembi reportedly have side effects, including brain swelling and bleeding.

CMS said in a statement that it would expand coverage for Leqembi only if it receives full FDA approval under the traditional process, but it is not known when this will happen.

The agency also said that it “is examining available information and may reconsider its current coverage based on this review.”