By ASSOCIATED PRESS
Some insurance companies including Medicare refused to cover the cost of this drug until it was fully approved.
On Thursday, the federal government gave its approval to a drug that is closely monitored by Alzheimer’s patients. This will allow Medicare and other health insurance plans the opportunity to pay for the medication.
Leqembi is a new intravenous drug that has been approved by the Food and Drug Administration for mild dementia and early Alzheimer’s symptoms. It is the only medicine to show that it can modestly slow cognitive decline in Alzheimer’s patients.
Eisai was granted conditional FDA approval for Leqembi in January after early tests suggested it cleared the sticky plaques linked to Alzheimer’s disease.
The FDA confirmed these findings after analyzing data from an even larger study of 1,800 patients, in which the drug was found to slow cognitive decline for about five months when compared to a placebo.
Teresa Buracchio is the FDA’s director of neurology drugs. She said that this study had confirmed both the safety and the effectiveness of the drug.
According to its prescribing information, Leqembi may cause bleeding and brain swelling in rare instances. Both of these conditions can be harmful. According to the labeling, other Alzheimer’s medications that target plaques can also cause similar side effects.
The FDA process to approve a new drug is not a very popular one. Alzheimer’s advocates and patients have been lobbying federal officials for several months after Medicare announced last year they wouldn’t pay for Leqembi or other drugs until FDA approval was obtained.
Leqembi costs about $26,500 per year for an IV supply that is given every other week. The cost of the new Alzheimer’s drug that targets plaques was feared to overwhelm the finances.
Leqembi, Aduhelm and other drugs are not covered by private insurers until FDA full approval is received.
The FDA will need years to determine whether Aduhelm is approved in full.
Chiquita Brooks LaSure said that Medicare would begin to pay for the drug as soon as it was approved by FDA. The government also requires that all patients register in a federal database to monitor the effectiveness and safety of the drug in real life.
Brooks LaSure stated that “Medicare would cover this medication in its entirety while collecting data to help us understand the way it works”.
Medicare beneficiaries may have to pay up to 20 percent more for Leqembi depending on the details of their coverage.
Hospitals and clinics say that patients may require time to adapt to the new drug.
Leqembi is only prescribed after doctors confirm the patient has the specific brain plaque that the drug targets. Patients must also be regularly scanned for bleeding or swelling, and nurses trained to administer it. The cost of imaging services and administrative costs are not included in the cost of the drug.
According to Eisai, approximately 100,000 Americans could be eligible for Leqembi treatment by the year 2026. Biogen’s headquarters are in Cambridge, Massachusetts.
Alexander Scott, vice-president of Eisai, said: “We want only the right patients to receive this product. “.
Eisai evaluated people who had mild to early-stage disease using a scale that measures memory, reasoning, and basic skills. After 18 months, participants who were given Leqembi showed a slower decline than those receiving dummy injections – this difference was less than half of a point.
At a June public meeting, the federal health advisors recommended the FDA approve the drug in full despite the delay. This is because the patient or family may not have noticed the slightest of changes.
