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By THE ASSOCIATED PRESS
Until the drug received full approval, some insurance companies, including Medicare, refused to pay for it.
The federal government approved a closely watched Alzheimer’s drug on Thursday, paving the way for Medicare and other insurance plans to cover the treatment.
A new IV drug, Leqembi, has been endorsed by the Food and Drug Administration (FDA) for patients with mild dementia and other symptoms of early Alzheimer’s disease. This is the first medicine that has been shown to modestly slow the cognitive decline associated with Alzheimer’s disease.
After early results suggested that Leqembi cleared a sticky brain plaque linked to the disease, Eisai received conditional FDA approval in January.
Those findings were confirmed by the FDA after reviewing data from a larger, 1,800-patient study in which the drug slowed cognitive decline by about five months compared with a placebo.
The FDA’s neurology drug director, Teresa Buracchio, said in a statement that the study confirmed the drug’s safety and effectiveness.
In rare cases, Leqembi can cause brain swelling and bleeding, both of which can be dangerous, according to the drug’s prescribing information. As noted on the label, similar problems occur with other plaque-targeting Alzheimer’s drugs as well.
In general, the process of converting a drug to FDA approval attracts little attention. Following Medicare officials’ announcement last year that they would not pay for routine use of drugs like Leqembi until they received FDA approval, Alzheimer’s patients and advocates have been lobbying the federal government for months.
Leqembi is priced at about $26,500 for a year’s supply of IVs, which are given every two weeks. There were concerns that the cost of new plaque-targeting Alzheimer’s drugs would overwhelm the program’s finances.
Private insurers have followed Medicare’s lead by withholding coverage for Leqembi and Aduhelm until they receive full FDA approval.
It will take years for the FDA to decide whether to approve Aduhelm in its entirety.
According to Chiquita Brooks-LaSure, Medicare will begin paying for the drug once it is approved by the FDA. Moreover, the government is requiring that patients enroll in a federal registry to track the drug’s effectiveness and safety in the real world.
“Medicare will cover this medication broadly while gathering data that will help us understand how it works”, Brooks-LaSure said.
In some cases, Medicare patients may be responsible for paying 20 percent of the cost of Leqembi, depending on their plans and other coverage details.
Patients may need time to adjust to the drug, according to hospitals and clinics.
Before prescribing Leqembi, doctors must confirm that patients have the brain plaque targeted by the drug. In addition to training nurses to administer the drug, patients must be monitored for swelling or bleeding with repeated brain scans. Hospitals incur additional costs for imaging and administration services beyond the price of the drug.
Approximately 100,000 Americans may be diagnosed and eligible to receive Leqembi by 2026, according to Eisai. Biogen is based in Cambridge, Massachusetts.
Eisai’s vice president Alexander Scott said, “We want to ensure that only appropriate patients receive this product.”.
Using a scale to measure memory, thinking, and other basic skills, Eisai assessed people with mild or early disease. Participants who received Leqembi declined more slowly than those who received a dummy infusion after 18 months – a difference of less than half a point on the scale.
In a public meeting in June, federal health advisers recommended that the FDA fully approve the drug despite that delay, which is likely too subtle to be noticed by patients or their families.
