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