After a barrage of criticism and intense lobbying by patients, their families and advocacy groups like the Alzheimer’s Association, Medicare issued a statement Thursday saying it will cover drugs for people in the early stages of Alzheimer’s disease.

Earlier, when those drugs designed to treat Alzheimer’s disease received accelerated U.S. Food and Drug Administration approval, the Centers for Medicare and Medicaid Services declined coverage outside of clinical trials and said the drugs did not meet its “necessary and reasonable” standard. The new stance is that once the drugs receive traditional — not just accelerated — approval, the class of treatments called monoclonal antibodies will be covered for those who have Medicare’s Part B outpatient coverage as long as they meet the criteria to receive the drugs.

Alzheimer’s disease is a devastating neurodegenerative condition that impacts almost 7 million Americans, a number expected to grow dramatically along with the aging of the U.S. population. Amyloid plaques in the brain are believed to play a significant role in development of the disease. At issue are drugs that use lab-created monoclonal antibodies. Given by infusion, they target amyloid plaque in the brain of people with early-stage Alzheimer’s.

Lecanemab, marketed as Leqembi, was recently given accelerated approval by the FDA. Manufacturers Eisai and Biogen are now looking for traditional approval. Results of a confirmatory study will be considered by FDA’s Peripheral and Central Nervous System Drug Advisory Committee on June 9, with a decision expected in early July. Patients receive infusions of the drug twice monthly, at a cost of roughly $26,000 per year.

That drug is already available, since it does have accelerated approval, but outside of clinical trials patients have to be able to bear the full cost. Eli Lilly’s drug, donanemab, didn’t get accelerated approval, but is expected to apply for traditional approval in the fall or soon after.

“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does,” CMS Administrator Chiquita Brooks-LaSure said via news release Thursday in announcing the policy change. “CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease.”

The one sore spot in the revised policy, proponents of the change say, is that doctors who prescribe the drugs must join registries that provide Medicare with data on how the medications work.

How will drug registries work?

How the registries will work is still a bit of a mystery. The release said that “CMS is working with multiple organizations that are getting ready to open their own registries,” and promised more information “as they come online.”

But few details are available.

While CMS said such registries are not unique and help gather data, critics say it will complicate the process of receiving the drugs and will put an undue burden on doctors who might prescribe them — or who, because of added work, might choose not to prescribe them at all.

Thursday, the Alzheimer’s Association in a news release called the registry requirement an “unnecessary barrier.” The national patient advocacy group said that while registries can provide “much-needed real-world evidence to transform and improve patient care,” they shouldn’t be a condition of coverage when the FDA has approved a treatment.

Jeremy Cunningham, public policy director for the Utah chapter of the Alzheimer’s Association, told the Deseret News his organization is pleased about the coverage decision and looks forward to more information about the registries.

However, “The association disagrees with the need for a registry. We maintain that all FDA-approved treatments should be covered immediately, without additional conditions or burdens. We also believe it will slow the process of making these Alzheimer’s-altering drugs available to those individuals living with the disease.”

Time is of the essence when it comes to accessing the amyloid-targeting monoclonal antibodies because their use is only approved for people in the early stages of Alzheimer’s. And about 2,000 people pass out of that stage into the moderate dementia category every day, advocates told the Deseret News.

The association has also expressed frustration that CMS quibbles over traditional versus accelerated approval, noting in both cases the drugs are FDA-approved and can be prescribed to patients.

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“Our basic call to CMS is just to be fair. Usually, a group asks for an exception,” Robert Egge, Alzheimer’s Association chief policy officer, recently told the Deseret News during the protests of the decision not to cover the drugs. “We are asking the opposite. Stop making an exception for us. Make the decision based on patients and the science.”

Not a cure

The monoclonal antibodies provide a lot of hope as they are the first pharmaceutical progress against the disease in years, experts told the Deseret News. But they don’t unwind what’s been lost to the disease and they don’t cure it.

Aducanemab, marketed as Aduhelm, was the first Alzheimer’s drug in the class. It received accelerated approval in 2021 but has been controversial. Besides questions of effectiveness, an investigation said the FDA worked too closely with Eisai and Biogen, which also manufactures it, during the approval process. Those and other issues made doctors reluctant to prescribe it. And the Centers for Medicare and Medicaid took the unusual step with aducanemab of saying it would not cover that drug — or others in its class, meaning future monoclonal antibodies. CMS said they were not, in fact, “reasonable and necessary.” That is the heart of the decision the agency reversed.

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Critics have questioned how effective the drugs are. They worry about side effects — a very small number of patients in clinical trial had bleeding in the brain — and the financial impact on government-funded Medicare if a large number of patients use the drug.

Proponents say the drug is no more expensive than drugs prescribed for other conditions like multiple sclerosis, which are covered by Medicare. Cunningham recently told the Deseret News that Leqembi’s cost pales in comparison to the cost of treating Alzheimer’s disease, which is about $41,000 a year.

And other researchers are looking at different targets besides amyloid plaques to treat or even one day prevent Alzheimer’s. But the early CMS refusal to consider coverage threatened to have a cooling effect on future innovation in drug development, experts have said.

The backlash has been sustained over several months. In earlier congressional hearings, Brooks-LaSure took a lot of questions and criticism for the previous decision to ignore the FDA’s approval because it was accelerated, except for covering costs in approved studies. And as the Deseret News previously reported, besides protests, a bipartisan group of 74 House members and 20 senators sent letters to Health and Human Services Secretary Xavier Becerra and Brooks-LaSure asking that the agency reconsider denying coverage for Leqembi and other monoclonal antibodies.

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