by the ASSOCIATED PRESS
Until the full approval of this medication, certain insurance companies such as Medicare have refused to pay.
A closely-watched Alzheimer’s drug was approved by the federal government on Thursday. Medicare and insurance companies can now cover this treatment.
Leqembi has received FDA approval for the treatment of mild dementia and symptoms associated with early Alzheimer’s. The FDA has approved Leqembi, a new IV drug that is indicated for patients with mild dementia and other symptoms of early Alzheimer’s.
Eisai’s conditional FDA authorization in January was based on early test results that suggested Leqembi had cleared a brain plaque associated with the disease.
After reviewing the data of a large study involving 1,800 participants, the FDA concluded that the drug had a cognitive improvement by five months in comparison to the placebo.
Teresa Buracchio said, in a press release, that the FDA neurology drug director’s study proved the drug was safe and effective.
Leqembi’s prescribing instructions warn that in some cases it can cause dangerous brain swelling or bleeding. The label also notes that similar issues can occur with Alzheimer’s plaque-targeting drugs.
In general, FDA approval is not given much attention. Alzheimer’s sufferers and their advocates have been lobbying for the federal government since last year, when Medicare officials announced that they wouldn’t cover routine usage of Leqembi unless it received FDA approval.
Leqembi, a drug that delivers intravenous injections every two weeks for one year, costs around $26,500. It was thought that new Alzheimer’s plaque-targeting drugs could overwhelm program finances.
Leqembi and Aduhelm are still not covered until the FDA has approved them.
FDA approval of Aduhelm will not be granted in its entirety for many years.
Chiquita brooks-LaSure says that Medicare will start paying for this drug after it has been approved by FDA. Further, patients are required to register with a federal registry in order to keep track of the actual effectiveness and safety.
Brooks LaSure, Brooks’s deputy secretary of health and human services said: “Medicare is going to cover the medication as a whole while we collect data on its effectiveness”.
Medicare may require patients to cover up to 20% of Leqembi’s cost, depending on how their plan is structured and any other details.
According to hospital and clinic staff, patients might need some time to get used to the medication.
Leqembi can only be prescribed by doctors who confirm that their patients possess the plaque in the brain targeted by this drug. Brain scans must be repeated to monitor for swelling and bleeding. In addition to the costs of the drugs, hospitals must pay for additional imaging and administration fees.
Eisai estimates that approximately 100,000 Americans will be diagnosed by 2026 and may qualify for Leqembi. Biogen has its headquarters in Cambridge Massachusetts.
Alexander Scott, Vice President of Eisai said “We are committed to ensuring that this product is only given to patients who need it.” “.
Eisai measured the basic abilities of people with early or mild disease, using a scale for measuring memory and thinking. Leqembi-treated participants declined less slowly after 18 months than those that received the dummy. This difference is only a half point.
Federal health advisers in a meeting held on June recommended to the FDA that it approve the drug fully despite this delay. The FDA’s recommendation was likely not noticed by the patients and their families.