Late Onset Alzheimer's Disease Senile Dementia. Symmetric Enlargement Of Cerebral Sulci Suggests That Cortical Gray Matter Is Affected. Axial Cut Away View. (Photo By BSIP/UIG Via Getty Images)
FDA approves an Alzheimers drug
01:45 - Source: CNN

A version of this story appeared in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here.

CNN  — 

The new Alzheimer’s drug Aduhelm costs $56,000 per person, per year – so much that it would affect the economics of Medicare.

The US Food and Drug Administration granted maker Biogen special approval despite concerns regarding evidence about how well the drug, technically called aducanumab, even works – leading to immediate backlash:

But the sheer cost of the drug is enough to raise questions.

Consider the hard math. It’s not clear exactly how many patients would be eligible for the drug under the narrower FDA approval limiting use to those with only mild impairment or dementia. But at $56,000 a person, the cost to treat 500,000 patients – a fraction of the estimated 6 million or so Americans who are estimated to have Alzheimer’s – would reach $29 billion in a single year.

For comparison, Medicare Part B, the hospital insurance plan for seniors, spent $37 billion total on all drugs in 2019.

The drug could be wrapped by Medicare into that Part B program since it is injected intravenously at a doctor’s office, rather than prescribed from a pharmacy. This one drug could drive all Medicare premiums up, according to a recent report by CNN’s Tami Luhby.

$56,000 is a lot of money. The cost per person that Biogen says it will charge is $5,000 more than one year of tuition at Harvard.

That $29 billion figure to treat 500,000 people is about a quarter of the annual cost of the Democrats’ stimulus child tax credit program that has given nearly every parent in the country a monthly check with the aim of raising US kids out of poverty.

Why does this drug cost so much? There are millions of people and their families who want a new Alzheimers treatment. Any Alzheimers treatment.

“We have established a price for Aduhelm that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation,” wrote Biogen’s CEO Michel Vounatsos in a letter announcing the approval.

The nonprofit Institute for Clinical and Economic Review, which scrutinizes drug prices, argues that because the drug has not been proven to be effective, a more reasonable and cost-effective price would be much lower – maybe as low as $3,000. That’s far from the $56,000 Biogen will charge.

The impossible problem. More than 120,000 Americans die from Alzheimer’s each year, making it among the leading causes of death in the US.

But treatment of the disease has been stuck for years, and the FDA had not approved a new drug to treat this disease since 2003.

What does the drug do? Aduhelm does not promise to cure the disease or reverse it, but rather to slow some of the debilitating symptoms, and it’s the first Alzheimer’s treatment that attacks the perceived root cause of the disease, the accumulation of “amyloid plaques” in the brain. Advocacy groups like the Alzheimers Association have applauded the FDA decision, arguing the treatment is a scientific breakthrough.

Why do people say it isn’t effective? Clinical trials, begun in 2015, were split on how effective the drug actually was in slowing the disease, and were halted in 2019, showed no clinical benefit. Biogen later worked with the FDA on post hoc review of the trials that found some marginal improvement.

Why was it approved if it’s not clinically effective? It was because high doses of the drug cut down on the plaques that the FDA approved the drug, even though studies did not definitively show it to be effective and despite the fact that more than a third of the people in clinical trials experienced brain swelling.

RELATED: New Alzheimer’s drug aducanumab: Cost, side effects, timeline and other questions answered

Do people on the drug say it works? CNN talked to a woman, Jenny Knap, 69, who was diagnosed with symptoms in 2015 who has received infusions of the aducanumab drug for about a year now as part of clinical trials in two six-month stretches. She told CNN that she underwent treatment for about six months before the study was put on hold in 2019, and then continued treatment in 2021, according to the report.

“I can’t say if I noticed it on a daily basis, but I do think overall, I’m doing much better in terms of looking for where my glasses are – things like that,” Knap said.

The Washington Post talked to 54-year-old Phil Gutis, a former reporter who has received infusions of the drug for five years and swears by it.

“There was just a fogginess I remember having a couple of years ago that I don’t really feel I have now,” Gutis told the Post.

‘Dangerous precedent.’ Doctors Reshma Ramachandran and Joseph Ross, professors at the Yale School of Medicine, wrote in detail for CNN about the red flags in the trials and argue its approval sets a dangerous precedent.

The $56,000 price tag, they point out, is only for the drug. The actual cost of infusion will be higher, and the diversion of money to this treatment could divert from other effective dementia care.

“Like our patients, we desperately want to see innovative treatments to prevent and treat Alzheimer’s disease,” they write. “Instead, the approval of aducanumab has unleashed a perilous precedent that could usher in the approval of countless, costly treatments of uncertain benefit and even harm.”

Back in November, an outside advisory committee was near unanimous in its opposition to approval of the drug and three members resigned after their recommendation was overruled.

What does FDA say? “In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research said when it was given accelerated approval. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

RELATED: FDA adviser resigns over approval of new Alzheimer’s drug

The FDA later dialed back a bit, making clear the drug is approved only for those with mild cognitive impairment or mild dementia rather than more advanced stages of the disease and dementia.

What next? The company Biogen still stands to make billions in Medicare dollars off the “accelerated approval” even as more study is done on the drug’s actual efficiency. It has nine years to conduct that study, according to Ramchandran and Ross. Nine years!

Bottom line. Certainly if there is a life-saving drug, or even a life-improving one, it should be covered. But also the cost of this one should put the cost of other programs – to fix roads and bridges, lift children out of poverty, or address climate change – in some perspective, especially as Congress debates how much it will invest in infrastructure and a sweeping package of social programs set forth by Democrats.