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Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
THE SIGNIFICANCE OF THIS FDA DECISION MAKING. IT IS SIGNIFICANT. AND JOINING ME THIS AFTERNOON IS MEGAN WHITE, A PROGRAM MANAGER WITH THE ALZHEIMER’S ASSOCIATION. THANK YOU FOR COMING IN. THANK YOU. REALLY APPRECIATE IT. SO THE DRUG IS CALLED LACOMBE AND IT BASICALLY SLOWS THE PROGRESSION OF ALZHEIMER’S. AND SO WHY IS THIS RULING SO IMPACTFUL FOR PEOPLE LIVING WITH THE DISEASE IN THEIR FAMILIES? THE FDA APPROVAL OF THIS MEDICATION IS SO IMPORTANT BECAUSE IT DOES JUST THAT. IT SLOWS DOWN THE PROGRESSION OF THE DISEASE. THIS IS THE FIRST TREATMENT FOR ALZHEIMER’S IN OVER 20 YEARS AND PREVIOUS TREATMENTS ONLY ADDRESSED SYMPTOMS. THEY HELP MANAGE THOSE SYMPTOMS. THIS ACTUALLY SLOWS DOWN THE PROGRESSION BY 27%, WHICH MEANS INDIVIDUALS CAN HAVE MORE TIME, MORE TIME FOR RECOGNIZING THEIR SPOUSE, THEIR CHILDREN, THEIR GRANDCHILDREN, MORE TIME FOR DRIVING AND LIVING INDEPENDENTLY, MAKING FINANCIAL DECISIONS, AND MOST ESPECIALLY MAKING PLANS FOR THEIR FUTURE NEEDS AND CARE. YEAH, YOU CAN IMAGINE HOW MUCH THAT WOULD MEAN TO SOMEBODY WITH THIS DISEASE IN THEIR FAMILIES. WELL, THE CENTERS FOR MEDICARE AND MEDICAID HAS MADE REQUIREMENTS FOR COVERAGE OF LACOMBE. SO WHAT IS THE ALZHEIMER’S ASSOCIATION’S POSITION ON THAT? WE’RE NOT HAPPY. WE THE LATEST RULING FROM CMS, FROM THE CENTERS FOR MEDICARE AND MEDICAID SERVICES WAS THAT INDIVIDUALS FOR MEDICARE TO COVER THIS MEDICATION FOR INDIVIDUALS IN THE EARLY STAGES OF THE DISEASE, PHYSICIANS OR PROVIDERS MUST JOIN A REGISTRY AND PROVIDE CLINICAL DATA BASED ON TREATMENT. NOW, REGISTRIES ARE IMPORTANT. YOU KNOW, WE WANT THE REAL WORLD DATA. WE WANT TO FOLLOW AND GET LONG TERM DATA ON SAFETY AND FOLLOW THESE PATIENTS. HOWEVER, WE BELIEVE IT SHOULD NOT BE A REQUIREMENT FOR TREATMENT AND FOR COVERAGE. I SEE. DO YOU THINK THIS IS THE BEGINNING OF A NEW ERA IN ALZHEIMER’S RESEARCH AND TREATMENT? DEFINITELY. I MEAN, LACOMBE IS JUST THE LATEST AND EXCITING TREATMENT RIGHT NOW. HOWEVER, THERE’S OVER 140 DIFFERENT THERAPIES IN THE PIPELINE. SOME OF THEM ARE MEDICATIONS. WE’RE TRYING TO ATTACK THIS DISEASE FROM EVERY ANGLE AND KNOWING THAT THIS IS AN EXCITING TIME IN ALZHEIMER’S AND DEMENTIA RESEARCH THAT IS REALLY VERY EXCITING FOR THIS. MILLIONS OF PEOPLE THAT ARE AFFECTED BY THIS DISEASE. SO WE’RE VERY HOPEFUL THAT BY 5:00 TODAY THAT WILL, YES, TRADITIONAL APPROVAL. AND THEN WE ARE STILL ADVOCATING FOR THE CENTERS FOR MEDICARE AND MEDICAID TO REVERSE THEIR DECISION, NOT ONLY TO PROVIDE FULL MEDICARE COVERAGE FOR ANYONE WHO NEEDS THE DISEASE, WHO MEETS THE CRITERIA FOR THE MEDICATION, AND ALSO FOR THEIR PREVIOUS DECISION TO DENY COVERAGE FOR FOR MEDICATIONS IN THIS CLASS OF DRUG FOR ACCELERATED APPROVAL. BECAUSE WE KNOW SOME OF THOSE ARE COMING ON IN THE PIPELINE RIGHT. THEY’RE COMING RIGHT DOWN THE PIPE. ALL RIGHT. THANK YOU
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Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer's.Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said FDA's neurology drug director, Teresa Buracchio, in a statement.The drug's prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases. The label notes that those problems are seen with other plaque-targeting Alzheimer's drugs.The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer’s patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn’t pay for routine use of drugs like Leqembi until they receive FDA’s full approval.There were concerns that the cost of new plaque-targeting Alzheimer's drugs like Leqembi could overwhelm the program's finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks.The vast majority of Americans with Alzheimer’s get their health coverage through Medicare. And private insurers have followed its lead by withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive FDA's full endorsement. An FDA decision on full approval for Aduhelm is still years away.Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug's real-world safety and effectiveness.Video below: How your diet possibly contributes as a risk factor for Alzheimer'sMedicare “will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said.Some Medicare patients could be responsible for paying the standard 20% of the cost of Leqembi, though the amount will vary depending on their plans and other coverage details.Hospitals and medical clinics have also cautioned that it may take time to get people started on the drug.Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.“We want to ensure that appropriate patients only are the ones that get this product,” said Alexander Scott, a vice president with Eisai.Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer's experts say that delay is likely too subtle for patients or their families to notice.But federal health advisers said the difference could still be meaningful and recommended that FDA fully approve the drug at a public meeting in June.

U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.

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The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer's.

Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.

The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said FDA's neurology drug director, Teresa Buracchio, in a statement.

The drug's prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases. The label notes that those problems are seen with other plaque-targeting Alzheimer's drugs.

The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer’s patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn’t pay for routine use of drugs like Leqembi until they receive FDA’s full approval.

There were concerns that the cost of new plaque-targeting Alzheimer's drugs like Leqembi could overwhelm the program's finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks.

The vast majority of Americans with Alzheimer’s get their health coverage through Medicare. And private insurers have followed its lead by withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive FDA's full endorsement. An FDA decision on full approval for Aduhelm is still years away.

Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug's real-world safety and effectiveness.

Video below: How your diet possibly contributes as a risk factor for Alzheimer's

Medicare “will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said.

Some Medicare patients could be responsible for paying the standard 20% of the cost of Leqembi, though the amount will vary depending on their plans and other coverage details.

Hospitals and medical clinics have also cautioned that it may take time to get people started on the drug.

Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.

Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.

“We want to ensure that appropriate patients only are the ones that get this product,” said Alexander Scott, a vice president with Eisai.

Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer's experts say that delay is likely too subtle for patients or their families to notice.

But federal health advisers said the difference could still be meaningful and recommended that FDA fully approve the drug at a public meeting in June.