An MRI scan of the brain of an Alzheimer’s patient.
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Medicare Part B It will cover Alzheimer’s disease treatments that receive approval from the U.S. Food and Drug Administration, according to the federal agency that administers the program for seniors.
Anyone who has Medicare Part B and meets “Eligibility Criteria“The new one will be covered Antibody treatment such as This team Once the FDA approves them, Dr Chiquita Brooks-Lasurits administrator Centers for Medicare and Medicaid ServicesThursday.
Part B is an optional part of the Medicare program for seniors that typically covers the cost of medications that patients cannot administer themselves, such as infusions.
The new policy will provide greater access to treatments like Lakembi, which slow cognitive decline.
But patients must participate in so-called registries that collect real-world data about how drugs work.
Brooks-Lasure said the expanded coverage would take effect the day the FDA approves the Alzheimer’s antibody treatment. The FDA is expected to make a decision on Lakembi on July 6.
The drug regulator’s committee of independent advisers is set to meet on June 9 to discuss data supporting Eisai’s and Biogen’s application for the FDA’s full approval of Lakembi.
The expanded coverage policy will apply to any other Alzheimer’s antibody treatment that receives full approval from the FDA. Eli Lilly plans to submit such an application for its antibody donanemeb.
The FDA granted accelerated approval to Lakembi in January, but Medicare strictly limits coverage for Alzheimer’s antibody treatments that are cleared under that fast track.
As a result, seniors currently cannot access Leqembi unless they are able to personally afford the drug’s $26,500 annual cost.
The Alzheimer’s Association, which lobbies for patients with the disease, has called for months for Medicare to lift restrictions on Lakembi and fully cover the drug.
“We believe the registry as a condition of coverage is an unnecessary barrier,” said Robert Egg, the association’s chief public policy officer.
Brooks-Lasur told Congress in April a registry “doesn’t limit people’s access to medicine in any way.” He said at the time that the goal was to have the system set up by the time the FDA makes a decision on Lakembi on July 6.
CMS will facilitate a nationwide portal where physicians can enter the necessary data, Brooks-Lasure said Thursday.
His agency plans to work with multiple agencies to set up their own registries, he said.
A leading research Medical Journal It was recently estimated that Leqembi could cost Medicare up to $5 billion a year.
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