WASHINGTON (AP) — 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, Dr. 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 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.

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 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.

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The report, titled Alzheimer’s Disease and Related Dementias Facts and Figures in California: Current Status and Future Projections, showed the number of people living with Alzheimer’s will more than double from 666,000 estimated in 2019 to nearly 1.5 million in 2040.

According to the Alzheimer’s Association, 1 in 6 Californians over the age of 65 will develop Alzheimer’s and 1 in 5 will develop dementia.

“As the most racially, ethnically, and linguistically diverse state in the nation, California can lead on equitable care, support and treatments for all affected by Alzheimer’s and dementia, including family caregivers,” said Edie Yau, director of diversity, equity & inclusion engagement for the Alzheimer’s Association.

Of California’s largest counties with a population of 700,000 or more, Contra Costa and Alameda counties are both expected to see the largest increases at 147%.

The Walk to End Alzheimer’s is the world’s largest event to raise awareness and funds for Alzheimer’s care, support, and research.

It is held every year in more than 600 communities nationwide, including right here in the Bay Area. Here are the dates and locations of the walks near you:

San Francisco, CA Nov 6, 2021

San Ramon, CA Oct 23, 2021

Suisun City, CA Oct 16, 2021

San Jose, CA Oct 16, 2021

All local events will implement safety protocols in accordance with CDC guidelines.

All walk attendees are asked to be vaccinated against COVID-19 or wear a mask when in an overcrowded area.

Alexa Mae Asperin | Contributed

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WASHINGTON (AP) — A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Wednesday.

The drug, called Aduhelm, was approved by the Food and Drug Administration only this week. It’s the first Alzheimer’s medication in nearly 20 years, though it doesn’t cure the life-sapping neurological condition. Some experts question whether Aduhelm provides any benefit to patients, but the FDA determined it can reduce harmful clumps of plaque in the brain, potentially slowing dementia.

Wednesday’s analysis by the nonpartisan Kaiser Family Foundation comes as congressional Democrats are trying to build consensus around legislation that would empower Medicare to negotiate prescription drug prices.

The chairman of the Senate Finance Committee, Democratic Sen. Ron Wyden of Oregon, said the list price for the Alzheimer’s drug was “unconscionable.” Although President Joe Biden has called for granting Medicare negotiating authority, prospects for the bill are uncertain.

The Kaiser report estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost the program nearly $29 billion a year, far more than any other medication.

“At this price, the cost of this one drug alone could top all others covered by Medicare, if it is used widely,” said Tricia Neuman, coauthor of the report.

Medicare has not made a formal determination on covering Aduhelm, but cost traditionally does not enter into such considerations. Drugmaker Biogen has said it priced Aduhelm responsibly.

Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare. “The approval of Aduhelm provides the latest high-profile example of the potential budgetary consequences of Medicare’s role as a price-taker in the pharmaceutical marketplace,” the Kaiser analysis concluded.

In addition to higher taxpayer costs, the domino effects would include higher “Part B” premiums for Medicare’s outpatient coverage and increases in monthly premiums for millions with supplemental “Medigap” plans. As an infusion drug that would be administered in a doctor’s office, Aduhelm is covered by Medicare’s outpatient care benefit. The Part B standard premium, paid by most enrollees, is currently $148.50 a month.

Beyond monthly premiums, there would also be impacts on out-of-pocket costs. Many patients taking the medication, including those signed up in Medicare Advantage plans from private insurers, could face thousands of dollars in copayments,. The maximum could reach about $11,500, researchers estimated.

That upper-bound cost out of patients’ budgets would translate to nearly 40% of the $29,650 estimated median income for Medicare beneficiaries.

“Because Aduhelm is not a cure for Alzheimer’s disease, patients could incur these annual out-of-pocket costs over multiple years,” the report noted.

Biogen, which developed the Alzheimer’s drug with Japan’s Eisai Co., said earlier this week that it expects a gradual uptake and not a sharp “hockey-stick” spike.

Biogen priced the drug after careful research, said Chirfi Guindo, Biogen’s head of global product. Biogen has committed to no price increases for four years.

Guindo said that the company looked at prices for advanced medications to treat cancer and other complex conditions. “We have priced Aduhelm at roughly a third the level of the cancer immunotherapies,” he said during a teleconference this week. “So, we consider this to be a really responsible price and we consider this to be a price that is sustainable for the system.”

Medicare has a review process known as a National Coverage Determination to evaluate new treatments that could have far-reaching implications for the program. Officials have not yet said how the program will proceed with Aduhelm. It’s possible Medicare could set conditions for covering the drug, based on clinical effectiveness.

The program covers more than 60 million people, including those 65 and older, as well as people who are disabled or have serious kidney disease. Medicare spending is approaching $1 trillion a year.

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